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Code · REGISTER · 2008-05-22 · PROPOSED RULES · Agriculture Agriculture Department See Forest Service NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, E8-11477 29734-29735 E8-11481 Centers Centers for Disease · Unknown

Unknown. Final rule

29,601 words·~135 min read·/register/2008/05/22/08-1285·

A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

--- schema: federal-register doc_type: fedreg source_file: FR-2008-05-22.xml --- 73 100 Thursday, May 22, 2008 Contents Agriculture Agriculture Department See Forest Service NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, E8-11477 29734-29735 E8-11481 Centers Centers for Disease Control and Prevention NOTICES Meetings: Board of Scientific Counselors, National Center for Health Marketing, 29759 E8-11448 Centers Centers for Medicare & Medicaid Services RULES Medicare Program:
Changes for Long-Term Care Hospitals Required by Certain Provisions of the Medicare, Medicaid, SCHIP Extension Act of 2007: 3-Year Moratorium on the Establishment of New Long-Term Care Hospitals and Long-Term Care Hospital Satellite Facilities etc., 29699-29711 08-1285 Children Children and Families Administration See Refugee Resettlement Office Coast Guard Coast Guard RULES Drawbridge Operation Regulations: Illinois Waterway, Lockport, IL; Repair and Maintenance, 29688 E8-11441 Mill Neck Creek, Oyster Bay, NY, 29688-29690 E8-11443 Drawbridge Operation Regulations;
Thames River, New London, CT, 29690-29691 E8-11437 PROPOSED RULES Drawbridge Operation Regulations: Atlantic Intracoastal Waterway (AIWW), Albemarle and Chesapeake Canal, Chesapeake, VA, 29722-29723 E8-11405 Duwamish Waterway, Seattle, WA, 29723-29725 E8-11439 Safety Zones: Annual Events Requiring Safety Zones in the Captain of the Port Detroit Zone, 29725-29731 E8-11408 Commerce Commerce Department See International Trade Administration See National Oceanic and Atmospheric Administration Commission of Fine Commission of Fine Arts RULES Procedures and Policies, 29711-29712 E8-11238 Commodity Commodity Futures Trading Commission NOTICES Meetings;
Sunshine Act, 29742 08-1290 08-1292 08-1293 Defense Defense Department PROPOSED RULES National Security Personnel System, 29882-29927 E8-11364 Drug Drug Enforcement Administration RULES Changes to Patient Limitation for Dispensing or Prescribing Approved Narcotic Controlled Substances for Maintenance or Detoxification Treatment by, etc., 29685-29688 E8-11471 Education Education Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 29742-29743 E8-11460 Election Election Assistance Commission NOTICES Meetings;
Sunshine Act, 29743 E8-11302 E8-11483 Employment Employment and Training Administration PROPOSED RULES Labor Certification Process and Enforcement: Temporary Employment in Occupations Other Than Agriculture or Registered Nursing in the United States, etc., 29942-29975 E8-11214 NOTICES Amended Certification Regarding Eligibility to Apply for Worker Adjustment Assistance, etc.: Magnesium Aluminum Corp. et al., 29781 E8-11370 Determinations Regarding Eligibility to Apply for Worker Adjustment Assistance, etc., 29781-29783 E8-11367 Negative Determination Regarding Application for Reconsideration:
Russound, a/k/a Folded Metal Products, Inc., Newmarket, NH, 29783-29784 E8-11372 Revised Determination on Reconsideration: Fraser Timber Ltd. Including On-Site Leased Workers of Tempo Employment Services, Ashland, ME, 29784 E8-11369 Termination of Investigation: Automated Equipment, Inc., Paris, TN, 29784 E8-11377 Employment Giant, LLC, Warren, MI, 29784 E8-11371 Honeywell International, Inc., Phoenix, AZ, 29784-29785 E8-11374 Sun Chemical Corp., North American Inks Division, Hopkinsville, KY, 29785 E8-11375 Energy Energy Department See Federal Energy Regulatory Commission EPA Environmental Protection Agency RULES Approval and Promulgation of Implementation Plans;
Mississippi; CFR Correction, 29691 E8-11526 Requirements for Preparation, Adoption, and Submittal of Implementation Plans; CFR Correction, 29691 E8-11525 Update of Continuous Instrumental Test Methods; Technical Amendments, 29691-29698 E8-11398 PROPOSED RULES Approval and Promulgation of Implementation Plans: South Carolina; Interstate Transport of Pollution, 29731-29733 E8-11484 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 29750-29752 E8-11489 Massachusetts Marine Sanitation Device Standard - Notice of Determination, 29752-29753 E8-11485 Receipt of a Request from the State of Texas for a Waiver of a Portion of the Renewable Fuel Standard, 29753-29755 E8-11486 Executive Executive Office of the President See Management and Budget Office FAA Federal Aviation Administration PROPOSED RULES Airworthiness Directives:
Boeing Model 747-100, 747-100B, 747-100B SUD, et al. Series Airplanes, 29716-29720 E8-11474 Dornier Model 328-100 Airplanes, 29720-29722 E8-11469 NOTICES Meetings: RTCA Special Committee 216; Aeronautical System Security, 29836 E8-11270 RTCA Special Committee 218; Future ADS-B/TCAS Relationships, 29836 E8-11272 Special Committee 214; Standards for Air Traffic Data Communication Services Joint with EUROCAE Working Group 78, 29836-29837 E8-11268 Transport Airplane Wheels and Wheel and Brake Assemblies, 29837 E8-11267 FCC Federal Communications Commission RULES Universal Service Fund Contribution, 29712-29715 E8-11258 NOTICES Agency Information Collection Activities;
Proposals, Submissions, and Approvals, 29755-29758 E8-11494 Federal Energy Federal Energy Regulatory Commission NOTICES Applicant Prepared Environmental Assessment Using the Alternative Licensing Procedures: Alaska Power & Telephone Co., 29743-29744 E8-11506 Application for Temporary Amendment of License, etc.: Pacific Gas and Electric Co., 29744-29745 E8-11507 Combined Notice of Filings, 29745-29746 E8-11410 Filings: Department of Energy, Portsmouth/Paducah Project Office, 29746 E8-11505 Intent to Prepare an Environmental Assessment:
Eric Jacobson, 29746-29747 E8-11508 South System Expansion III Project and Joint Pipeline Expansion Phase II Project, 29747-29750 E8-11509 Issuance of Order: Polytop Corp., 29750 E8-11510 Federal Highway Federal Highway Administration NOTICES Environmental Impact Statements; Notice of Intent: Virginia; Rescind Five Notices, 29837-29838 E8-11452 Federal Railroad Federal Railroad Administration NOTICES Petition for Waiver of Compliance, 29838 E8-11457 Railroad Safety Advisory Committee;
Working Group Activity Update, 29838-29841 E8-11532 Federal Reserve Federal Reserve System NOTICES Formations of, Acquisitions by, and Mergers of Bank Holding Companies, 29758-29759 E8-11463 Proposals to Engage in Permissible Nonbanking Activities or to Acquire Companies that are Engaged in Permissible Nonbanking Activities, 29759 E8-11462 Federal Transit Federal Transit Administration NOTICES Buy America Waiver for the National Fuel Cell Bus Technology Development Program, 29841-29843 E8-11403 Fiscal Year 2008 Clean Fuels Grant Program Funds:
Solicitation of Project Proposals, 29843-29846 E8-11224 Fine Arts Fine Arts Commission See Commission of Fine Arts Food Food and Drug Administration RULES Implantation or Injectable Dosage Form New Animal Drugs: Cefovecin, 29685 E8-11515 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 29759-29760 E8-11514 Draft Guidance for Industry: Considerations for Allogeneic Pancreatic Islet Cells; Availability, 29760-29761 E8-11516 Meetings: Cardiovascular and Renal Drugs Advisory Committee, 29761-29762 E8-11450 Endocrinologic and Metabolic Drugs Advisory Committee, 29762-29763 E8-11449 Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee, 29763 E8-11455 Ophthalmic Devices Panel of the Medical Devices Advisory Committee, 29763-29764 E8-11451 Memorandum of Understanding With the U.S.
Army Corps of Engineers, Mobile District, 29764-29769 E8-11521 Foreign Foreign Assets Control Office NOTICES Additional Designations of Entities Pursuant to Executive Order (13405), 29849 E8-11472 Forest Forest Service NOTICES Plumas National Forest, CA; Moonlight and Wheeler Fires Recovery and Restoration Project, 29735-29736 E8-11222 Health Health and Human Services Department See Centers for Disease Control and Prevention See Centers for Medicare & Medicaid Services See Food and Drug Administration See National Institutes of Health See Refugee Resettlement Office Homeland Homeland Security Department See Coast Guard See U.S.
Citizenship and Immigration Services NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 29773-29774 E8-11454 Housing Housing and Urban Development Department NOTICES Certification and Funding of State and Local Fair Housing Enforcement Agencies, 29775-29776 E8-11541 Interior Interior Department See Land Management Bureau International International Boundary and Water Commission, United States and Mexico NOTICES Final Supplemental Environmental Impact Statement:
South Bay International Wastewater Treatment Plant, San Diego County, CA, 29779 E8-11503 International International Trade Administration NOTICES Antidumping Duties; New-Shipper Review and Rescission: Solid Urea from the Russian Federation, 29736-29738 E8-11520 Extension of Time Limit for Final Results of Second Administrative Reviews: Certain Frozen Warmwater Shrimp from Thailand and the Socialist Republic of Vietnam, 29738 E8-11511 Extension of Time Limit for Preliminary Results of Antidumping Duty Administrative Review:
Polyethylene Retail Carrier Bags; Thailand, 29738-29739 E8-11519 Scope Rulings, 29739-29741 E8-11518 International International Trade Commission NOTICES Investigation: Certain Steel Nails from China and The United Arab Emirates, 29779-29780 E8-11459 Justice Justice Department See Drug Enforcement Administration NOTICES Record of Decision: Contract to House Federal Detainees within a Contractor-Owned/Contractor-Operated Detention Facility in the Las Vegas, NV Area, 29780-29781 E8-11291 Labor Labor Department See Employment and Training Administration Land Land Management Bureau NOTICES Motor Vehicle Travel Closure and Restrictions on Public Lands in Beaver County, UT, 29776 E8-11431 Proposed Reinstatement of Terminated Oil and Gas Lease:
Wyoming, 29777 E8-11456 Realty Action: Direct Sale of Public Lands in Nye County, NV, 29777-29779 E8-11504 Management Management and Budget Office NOTICES Standard Occupational Classification Policy Committee's Recommendations for the 2010 SOC, 29930-29939 E8-11447 Mexico Mexico and United States, International Boundary and Water Commission See International Boundary and Water Commission, United States and Mexico National Credit National Credit Union Administration NOTICES Meetings;
Sunshine Act, 29785 E8-11278 NIH National Institutes of Health NOTICES Meetings: Center for Scientific Review, 29769 E8-11304 National Cancer Institute, 29769-29770 E8-11442 E8-11444 National Institute of Child Health and Human Development, E8-11305 29770-29772 E8-11306 E8-11312 E8-11313 National Institute of Nursing Research, 29772 E8-11311 National Institute on Drug Abuse, E8-11307 29771-29772 E8-11310 NOAA National Oceanic and Atmospheric Administration NOTICES Endangered Species;
(File No. 1576), 29741-29742 E8-11388 Nuclear Nuclear Regulatory Commission NOTICES Combined License Application: Progress Energy Carolinas, Inc.; Shearon Harris Nuclear Power Plant (Units 2 And 3), 29785-29787 E8-11500 Consideration of Issuance of Amendment to Facility Operating License etc.: FirstEnergy Nuclear Operating Co., 29787-29791 E8-11470 Draft Regulatory Guide; Issuance, Availability, 29791-29792 E8-11473 Office Office of Management and Budget See Management and Budget Office Personnel Personnel Management Office PROPOSED RULES National Security Personnel System, 29882-29927 E8-11364 Pipeline Pipeline and Hazardous Materials Safety Administration NOTICES Agency Information Collection Activities;
Proposals, Submissions, and Approvals, 29846-29847 E8-11540 Application for Special Permits, 29847-29848 E8-11229 Applications for Modification of Special Permit, 29848-29849 E8-11226 Postal Postal Regulatory Commission NOTICES Universal Postal Service Obligation, 29792-29793 E8-11453 Refugee Refugee Resettlement Office NOTICES Supplement Funding to the 2008 Voluntary Agency Matching Grant Program, 29773 E8-11440 SEC Securities and Exchange Commission NOTICES Agency Information Collection Activities;
Proposals, Submissions, and Approvals, 29793 E8-11430 Self-Regulatory Organizations; Proposed Rule Changes: American Stock Exchange LLC, 29793-29796 E8-11424 Chicago Board Options Exchange, Inc., 29796-29797 E8-11419 Fixed Income Clearing Corp., 29797-29798 E8-11425 Municipal Securities Rulemaking Board, 29799-29800 E8-11434 NASDAQ Stock Market LLC, 29800-29804 E8-11426 E8-11429 New York Stock Exchange LLC, 29804-29805 E8-11427 Philadelphia Stock Exchange, Inc., 29805-29808 E8-11428 Subcommittee Reports of the SEC Advisory Committee on Improvements to Financial Reporting, 29808-29832 E8-11276 SBA Small Business Administration NOTICES Disaster Declaration:
Missouri, 29832-29833 E8-11475 E8-11482 Oklahoma, 29832 E8-11466 Social Social Security Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 29833-29834 E8-11542 State State Department NOTICES Culturally Significant Objects Imported for Exhibition Determinations: Women Impressionists: Berthe Morisot, Mary Cassatt, Eva Gonzales, Marie Bracquemond, 29834 E8-11533 Thrift Thrift Supervision Office NOTICES Agency Information Collection Activities;
Proposals, Submissions, and Approvals, 29849-29850 E8-11446 Transportation Transportation Department See Federal Aviation Administration See Federal Highway Administration See Federal Railroad Administration See Federal Transit Administration See Pipeline and Hazardous Materials Safety Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 29834-29836 E8-11438 Treasury Treasury Department See Foreign Assets Control Office See Thrift Supervision Office MISSING FOR:
U.S. Citizenship and Immigration Services U.S. Citizenship and Immigration Services NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, E8-11534 29774-29775 E8-11535 Veterans Veterans Affairs Department RULES Accreditation of Agents and Attorneys; Agent and Attorney Fees, 29852-29880 E8-10779 Separate Parts In This Issue Part II Veterans Affairs Department, 29852-29880 E8-10779 Part III Defense Department; Personnel Management Office, 29882-29927 E8-11364 Part IV Executive Office of the President, Management and Budget Office, 29930-29939 E8-11447 Part V Labor Department, Employment and Training Administration, 29942-29975 E8-11214 Reader Aids Consult the Reader Aids section at the end of this issue for phone numbers, online resources, finding aids, reminders, and notice of recently enacted public laws.
To subscribe to the Federal Register Table of Contents LISTSERV electronic mailing list, go to http://listserv.access.gpo.gov and select Online mailing list archives, FEDREGTOC-L, Join or leave the list (or change settings); then follow the instructions. 73 100 Thursday, May 22, 2008 Rules and Regulations DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 522 Implantation or Injectable Dosage Form New Animal Drugs; Cefovecin AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule. SUMMARY: The Food and Drug Administration
(FDA)is amending the animal drug regulations to reflect approval of a new animal drug application
(NADA)filed by Pfizer, Inc. The NADA provides for the veterinary prescription use of a solution of cefovecin sodium in cats and dogs by subcutaneous injection for the treatment of skin infections. DATES: This rule is effective May 22, 2008. FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for Veterinary Medicine (HFV-110), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-276-8337, e-mail: *melanie.berson@fda.hhs.gov* . SUPPLEMENTARY INFORMATION: Pfizer, Inc., 235 East 42d St., New York, NY 10017, filed NADA 141-285 that provides for the veterinary prescription use of CONVENIA (cefovecin sodium) Injectable in cats and dogs by subcutaneous injection for the treatment of skin infections. The application is approved as of April 25, 2008, and the regulations are amended in 21 CFR part 522 to reflect approval. In accordance with the freedom of information provisions of 21 CFR part 20 and 21 CFR 514.11(e)(2)(ii), a summary of safety and effectiveness data and information submitted to support approval of this application may be seen in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday. Under section 512(c)(2)(F)(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(i)), this approval qualifies for 5 years of marketing exclusivity beginning on the date of approval. The agency has determined under 21 CFR 25.33(d)(1) that these actions are of a type that do not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required. This rule does not meet the definition of “rule” in 5 U.S.C. 804(3)(A) because it is a rule of “particular applicability.” Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801-808. List of Subjects in 21 CFR Part 522 Animal drugs. Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, 21 CFR part 522 is amended as follows: PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS 1. The authority citation for 21 CFR part 522 continues to read as follows: Authority: 21 U.S.C. 360b. § 522.311 [Redesignated as § 522.300] 2. Redesignate § 522.311 as § 522.300. § 522.312 [Redesignated as § 522.304] 3. Redesignate § 522.312 as § 522.304. 4. Add new § 522.311 to read as follows: § 522.311 Cefovecin.
(a)*Specifications* . Each milliliter of constituted solution contains 80 milligrams
(mg)cefovecin as the sodium salt.
(b)*Sponsor* . See No. 000069 in § 510.600(c) of this chapter.
(c)*Special considerations* . Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(d)*Conditions of use* —(1) *Dogs* —(i) *Amount* . Administer 3.6 mg/pound
(lb)(8 mg/kilograms (kg)) body weight as a single subcutaneous injection. A second subcutaneous injection of 3.6 mg/lb (8 mg/kg) may be administered if response to therapy is not complete.
(ii)*Indications for use* . For the treatment of skin infections (secondary superficial pyoderma, abscesses, and wounds) in dogs caused by susceptible strains of *Staphylococcus intermedius* and *Streptococcus canis* (Group G).
(2)*Cats* —(i) *Amount* . Administer 3.6 mg/lb (8 mg/kg) body weight as a single, one-time subcutaneous injection.
(ii)*Indications for use* . For the treatment of skin infections (wounds and abscesses) in cats caused by susceptible strains of *Pasteurella multocida* . Dated: May 13, 2008. Bernadette Dunham, Director, Center for Veterinary Medicine. [FR Doc. E8-11515 Filed 5-21-08; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF JUSTICE Drug Enforcement Administration 21 CFR Part 1301 [Docket No. DEA-275F] RIN 1117-AA99 Changes to Patient Limitation for Dispensing or Prescribing Approved Narcotic Controlled Substances for Maintenance or Detoxification Treatment by Qualified Individual Practitioners AGENCY: Drug Enforcement Administration (DEA), Justice. ACTION: Final rule. SUMMARY: On September 20, 2007, the Drug Enforcement Administration
(DEA)published a Notice of Proposed Rulemaking
(NPRM)in the **Federal Register** (72 FR 53734) proposing to conform its regulations to recent statutory amendments to the Controlled Substances Act that changed certain patient limitations for practitioners who dispense or prescribe certain narcotic drugs for maintenance or detoxification treatment. DEA received one comment in support of this rulemaking. DEA is finalizing the rule as proposed. DATES: *Effective Date:* This rule is effective June 23, 2008. FOR FURTHER INFORMATION CONTACT: Mark W. Caverly, Chief, Liaison and Policy Section, Office of Diversion Control, Drug Enforcement Administration, Washington, DC 20537, Telephone
(202)307-7297. SUPPLEMENTARY INFORMATION: Overview On August 2, 2005, the President signed amendments to the Controlled Substances Act to increase the patient limitation on prescribing drug addiction treatments by qualified medical practitioners in group practices from 30 patients for each group to 30 patients for each qualified practitioner in a group (Pub. L. 109-56; 119 Stat. 591) (21 U.S.C. 823(g)(2)). On December 29, 2006, the President signed amendments to the Controlled Substances Act to permit certain qualifying physicians to dispense and prescribe Schedule III, IV, and V narcotic controlled substances approved by the Food and Drug Administration
(FDA)specifically for use in maintenance or detoxification treatment to up to 100 patients at any one time, after the practitioner submits to the Secretary of Health and Human Services
(HHS)a notification of the practitioner's need and intent to treat the increased number of patients. The amendment was made as part of the Office of National Drug Control Policy Reauthorization Act of 2006 (ONDCPRA) (Section 1102 of Pub. L. 109-469, 120 Stat. 3502). Notice of Proposed Rulemaking On September 20, 2007 (72 FR 53734), DEA published a Notice of Proposed Rulemaking
(NPRM)proposing to conform DEA regulations to Public Law 109-56 by removing the requirement in 21 CFR 1301.28(b)(iv) that limits to 30 the number of patients that could receive maintenance or detoxification treatment through a group practice. This change means that each qualifying practitioner whether working individually or in a group practice may offer maintenance and detoxification treatment to 30 patients at any one time. That NPRM also proposed to conform DEA regulations to Section 1102 of Public Law 109-469 by permitting certain qualifying physicians to treat up to 100 patients. As discussed in 21 U.S.C. 823(g)(2)(B) and
(D)(and not modified by this rule), to be a “qualifying physician” the practitioner must submit to the Secretary of HHS notification of the practitioner's intent to begin dispensing the drugs approved by FDA specifically for maintenance or detoxification treatment. The notification must contain the following certifications: • The practitioner is registered with DEA as an individual practitioner. • The practitioner is a “qualifying physician.” A practitioner is a “qualifying physician” if he is licensed under State law and has specific medical certification, training, or experience in maintenance or detoxification treatment as specified in the CSA. • With respect to patients to whom the practitioner will provide such drugs or combinations of drugs, the practitioner has the capacity to refer the patients for appropriate counseling and other appropriate ancillary services. • The total number of such patients of the practitioner at any one time will not exceed the applicable number. The applicable number is 30, unless, not sooner than one year after the date on which the practitioner submitted the initial notification, the practitioner submits a second notification to the Secretary of HHS of the need and intent of the practitioner to treat up to 100 patients. • The notification to the Secretary of HHS must be in writing and must state the name and DEA registration number of the practitioner. • If the practitioner is a member of a group practice, the notification states the names of the other practitioners in the practice and identifies the registrations issued for the other practitioners. As noted, certain qualifying physicians may treat up to 100 patients, instead of the thirty permitted for all qualifying physicians. To qualify to treat the additional patients, not sooner than one year after the practitioner submitted the initial notification, the practitioner must submit a second notification to the Secretary of HHS of the need and intent of the practitioner to treat up to 100 patients. Further, the practitioner must be a “qualifying physician” under 21 U.S.C. 823(g)(2)(G) as discussed above (21 CFR 1301.28(b)(1)(i) and (ii)). These amendments do not change the requirement that each practitioner must first qualify to prescribe and dispense these medications for maintenance and detoxification treatment, or must be prescribing these approved substances using the “good faith” exception, found within current regulations at 21 CFR 1301.28(e). The “good faith” exception was established by the Drug Addiction Treatment Act of 2000, and is not affected by this Final Rule. The Controlled Substances Act
(CSA)(21 U.S.C. 823(g)(2)(D)) states that not later than 45 days after the Secretary of HHS receives a notification discussed above, the Secretary shall make a determination of whether the practitioner meets all requirements for a waiver of the requirement of separate registration. Upon the expiration of the 45-day time period, a practitioner who in good faith submits a notification discussed above and reasonably believes that the conditions specified in 21 U.S.C. 823(g)(2)(B) through
(D)have been met shall, in dispensing narcotic drugs in schedule III, IV, or V or combinations of such drugs for maintenance treatment or detoxification treatment, be considered to have a waiver until notified otherwise by the Secretary of HHS. The practitioner may commence to prescribe or dispense such narcotic drugs for maintenance or detoxification treatment prior to the expiration of the 45-day period if it facilitates the treatment of an individual patient and both the Secretary and the Attorney General are notified by the practitioner of the intent to commence prescribing or dispensing such narcotic drugs. Background On October 17, 2000, Congress passed the Drug Addiction Treatment Act of 2000 (DATA), amending the Controlled Substances Act
(CSA)(21 U.S.C. 801 *et seq.* ) to establish “waiver authority for physicians who dispense or prescribe certain narcotic drugs for maintenance treatment or detoxification treatment” (Pub. L. 106-310, title XXXV; 114 Stat. 1222, codified at 21 U.S.C. 823(g)(2)). Prior to DATA, the Controlled Substances Act and DEA regulations required practitioners who wanted to conduct maintenance or detoxification treatment using narcotic controlled drugs to be registered as a Narcotic Treatment Program
(NTP)in addition to the practitioner's individual registration. The separate NTP registration authorized the practitioner to dispense or administer, but not prescribe, narcotic drugs. With passage of DATA, DEA published a NPRM (68 FR 37429; June 24, 2003) proposing to amend the regulations affecting maintenance and detoxification treatment for narcotic treatment by establishing an exemption from the separate registration requirement. After consideration of the comments received on the NPRM, DEA published a Final Rule on June 23, 2005 (70 FR 36338). The June 23, 2005, Final Rule permitted the following:
(1)Qualifying physicians to dispense and prescribe Schedule III, IV, and V narcotic controlled drugs approved by the Food and Drug Administration specifically for use in maintenance or detoxification treatment.
(2)Narcotic-dependent patients to have one-on-one consultations with a practitioner in a private practice setting.
(3)Pharmacies to fill prescriptions for Schedule III, IV, and V narcotic controlled drugs approved by the Food and Drug Administration specifically for use in maintenance or detoxification treatment.
(4)Practitioners to offer maintenance and detoxification treatment with Schedule III, IV, and V narcotic controlled drugs approved by the Food and Drug Administration specifically for use in maintenance or detoxification treatment to no more than 30 patients in their private practices without having a second registration as a NTP. The exemption and other amendments established by the Final Rule apply to individual practitioners working in traditional NTPs as well as any other practice setting. The rule does not affect the existing prohibition against prescribing any Schedule II narcotic controlled drugs for maintenance or detoxification treatment. Under the provisions of DATA implementing regulations as codified in 21 CFR 1301.28(b)(1)(iii) and (iv), the 30-patient limitation applied equally to individual practices and to group practices (i.e., 30 patients per group), severely limiting the number of patients that could be treated by physicians in group practices. Pursuant to Public Law 109-56 effective on August 2, 2005, and Section 1102 of Public Law 109-469 effective on December 29, 2006, this Final Rule makes conforming changes to DEA's regulations at 21 CFR 1301.28(b)(1)(iii) and (iv). Specifically, paragraph (b)(1)(iii) is amended to permit the treatment of up to 100 patients by a qualifying practitioner if the necessary criteria are met (i.e., the practitioner previously was granted authority to dispense or prescribe Schedule III, IV, or V narcotic controlled drugs or combinations of narcotic controlled drugs approved by the Food and Drug Administration specifically for use in maintenance or detoxification treatment without being separately registered as a narcotic treatment program, and, not sooner than one year after the submission of the initial notification, the practitioner submits a second notification to the Secretary of HHS of the need and intent of the practitioner to treat up to 100 patients) and notification is submitted to the Secretary of Health and Human Services. Further, paragraph (b)(1)(iii) is amended by removing the phrase “Where the individual practitioner is not a member of a group practice,” since there is no longer a distinction between practitioners in group practices and those practicing independently. Finally, paragraph (b)(1)(iv) is deleted to remove language regarding members of group practices. Relevant to the change regarding the treatment of up to 100 patients, the Director of the Center for Substance Abuse Treatment in the Department of Health and Human Services issued a letter announcing the statutory change as follows: Under ONDCPRA (effective December 29, 2006), physicians who meet the following criteria may notify the Secretary of Health and Human Services
(HHS)of their need and intent to treat up to 100 patients at any time:
(1)The physician must currently be qualified under DATA 2000;
(2)at least one year must have elapsed since the physician submitted the initial notification for authorization;
(3)the physician must certify their capacity to refer patients for appropriate counseling and other appropriate ancillary services; and
(4)the physician must certify that the total number of patients at any one time will not exceed the applicable number. DEA emphasizes that practitioners must meet these HHS criteria before prescribing a Schedule III, IV, or V controlled substance for narcotic maintenance or detoxification treatment to more than 30 patients at any one time. Comments Received DEA received one comment to its NPRM published September 20, 2007 at 72 FR 53734 from an association representing physicians. The commenter supported the rulemaking as proposed. The commenter strongly supported the proposed change to conform DEA regulations to the statutory changes made by Public Law 109-56, believing that the previous requirement limiting the number of patients who could receive treatment through a group practice to 30 was a barrier to treatment access. Further, the commenter supported the proposed change to conform DEA regulations to Section 1102 of Public Law 109-469, believing that the requirement for physicians to submit a supplemental notification to the Secretary of HHS of their need and intent to treat up to 100 patients, not sooner than one year after the practitioner submitted the initial notification, is “a reasonable compromise at this time.” Therefore, DEA is finalizing this rulemaking as proposed. Regulatory Certifications Regulatory Flexibility Act The Deputy Assistant Administrator, Office of Diversion Control, has reviewed this regulation and hereby certifies that it has been drafted in accordance with the Regulatory Flexibility Act (5 U.S.C. 601-612) and that it will not have a significant economic impact on a substantial number of small entities. This rule relieves a restriction on practitioners desiring to treat narcotic dependent patients by removing the 30-patient limit for group practices and by permitting certain qualifying physicians to treat up to 100 patients after certain criteria are met. Thus, the changes provide greater access to care for patients due to increased patient limits. Executive Order 12866 The Deputy Assistant Administrator further certifies that this rule has been drafted in accordance with the principles in Executive Order 12866 Section 1(b). It has been determined that this is a significant regulatory action and, therefore, this action has been reviewed by the Office of Management and Budget. This rule will not impose additional costs on practitioners as it simply increases the number of patients that a practitioner may treat for narcotic dependence. As previously noted, this change provides greater access to care for patients due to the increased patient limits. Executive Order 12988 This rule meets the applicable standards set forth in Sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform. Executive Order 13132 This rule does not preempt or modify any provision of State law; nor does it impose enforcement responsibilities on any State; nor does it diminish the power of any State to enforce its own laws. Accordingly, this rulemaking does not have Federalism implications warranting the application of Executive Order 13132. Unfunded Mandates Reform Act of 1995 This rule will not result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $120,000,000 or more (adjusted for inflation) in any one year, and will not significantly or uniquely affect small governments. Therefore, no actions were deemed necessary under the provisions of the Unfunded Mandates Reform Act of 1995. Congressional Review Act This rule is not a major rule as defined by Section 804 of the Small Business Regulatory Enforcement Fairness Act of 1996 (Congressional Review Act). This rule will not result in an annual effect on the economy of $100,000,000 or more; a major increase in costs or prices; or significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of United States-based companies to compete with foreign-based companies in domestic and export markets. List of Subjects in 21 CFR Part 1301 Administrative practice and procedure, Drug traffic control, Security measures. For the reasons set out above, 21 CFR part 1301 is amended as follows: PART 1301—REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, AND DISPENSERS OF CONTROLLED SUBSTANCES 1. The authority citation for part 1301 continues to read as follows: Authority: 21 U.S.C. 821, 822, 823, 824, 871(b), 875, 877, 886a, 951, 952, 953, 956, 957. 2. Section 1301.28 is amended by revising paragraph (b)(1)(iii) and removing paragraph (b)(1)(iv) to read as follows: § 1301.28 Exemption from separate registration for practitioners dispensing or prescribing Schedule III, IV, or V narcotic controlled drugs approved by the Food and Drug Administration specifically for use in maintenance or detoxification treatment. (b)(1) * * *
(iii)The total number of patients to whom the individual practitioner will provide narcotic drugs or combinations of narcotic drugs under this section will not exceed 30 at any one time unless, not sooner than 1 year after the date on which the practitioner submitted the initial notification to the Secretary of Health and Human Services, the practitioner submits a second notification to the Secretary of the need and intent of the practitioner to treat up to 100 patients. A second notification under this subparagraph shall contain the certifications required by subparagraphs
(i)and
(ii)of this paragraph. The Secretary of Health and Human Services may promulgate regulations to change the total number of patients. Dated: May 13, 2008. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control. [FR Doc. E8-11471 Filed 5-21-08; 8:45 am] BILLING CODE 4410-09-P DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 117 [USCG-2008-0339] Drawbridge Operation Regulation; Illinois Waterway, Lockport, IL; Repair and Maintenance AGENCY: Coast Guard, DHS. ACTION: Notice of temporary deviation from regulations. SUMMARY: The Commander, Eighth Coast Guard District has issued a temporary deviation from the regulation governing the operation of the Elgin, Joliet, and Eastern Railroad Drawbridge, across the Illinois Waterway, Mile 290.1, at Lockport, Illinois. The deviation is necessary for the bridge to remain closed-to-navigation unless 1 hour advance notice is given. This deviation allows the bridge owner time to perform necessary repairs to the bridge. DATES: This deviation is effective from 7 a.m. to 5 p.m., May 20, 2008, through June 2, 2008. ADDRESSES: Documents indicated in this preamble as being available in the docket are part of docket USCG-2008-0339 and are available online at *http://www.regulations.gov* . They are also available for inspection or copying at two locations: The Docket Management Facility (M-30), U.S. Department of Transportation, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays, and the Robert A. Young Federal Building, Room 2.107F, 1222 Spruce Street, St. Louis, MO 63103-2832, between 8 a.m. and 4 p.m., Monday through Friday, except Federal holidays. FOR FURTHER INFORMATION CONTACT: Roger K. Wiebusch, Bridge Administrator,
(314)269-2378. SUPPLEMENTARY INFORMATION: The Elgin, Joliet, and Eastern Railway requested a temporary deviation for the Elgin, Joliet, and Eastern Railroad Drawbridge, mile 290.1, at Lockport, Illinois across the Illinois Waterway to perform needed maintenance and repairs. The Elgin, Joliet, and Eastern Railroad Drawbridge currently operates in accordance with 33 CFR 117.393(d), which states the bridge is remotely operated and normally maintained in the open-to-navigation position, closing only to pass rail traffic and then reopening promptly for navigation. In order to facilitate the needed maintenance and repairs, the drawbridge must be kept in the closed-to-navigation position. This deviation allows for the bridge to remain closed-to-navigation unless 1 hour advance notice is given, from 7 a.m. to 5 p.m., May 20, 2008, through June 2, 2008. There are no alternate routes for vessels transiting this section of the Illinois Waterway. The Elgin, Joliet, and Eastern Railroad Drawbridge, in the closed-to-navigation position, provides a vertical clearance of 24.6 feet above pool stage. Navigation on the waterway consists primarily of commercial tows and recreational watercraft. This temporary deviation has been coordinated with waterway users. No objections were received. In accordance with 33 CFR 117.35(e), the drawbridge must return to its regular operating schedule immediately at the end of the designated time period. This deviation from the operating regulations is authorized under 33 CFR 117.35. Dated: May 5, 2008. Roger K. Wiebusch, Bridge Administrator. [FR Doc. E8-11441 Filed 5-21-08; 8:45 am] BILLING CODE 4910-15-P DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 117 [Docket No. USCG-2008-0010] RIN 1625-AA09 Drawbridge Operation Regulations; Mill Neck Creek, Oyster Bay, NY AGENCY: Coast Guard, DHS. ACTION: Final rule. SUMMARY: The Coast Guard has changed the drawbridge operation regulations that govern the operation of the Bayville Bridge, mile 0.1, across Mill Neck Creek at Oyster Bay, New York. This final rule will allow the bridge to open on signal between 7 a.m. and 11 p.m. from May 1 through October 31 and between 7 a.m. and 5 p.m., Monday through Friday, from November 1 through April 30. At all other times the bridge will open after a two-hour advance notice is given by calling the number posted at the bridge. The purpose of this rule is to help relieve the bridge owner from the burden of crewing the bridge during time periods that the bridge receives few requests to open. DATES: This rule is effective June 23, 2008. ADDRESSES: Comments and material received from the public, as well as documents indicated in this preamble as being available in the docket, are part of docket (USCG-2008-0010) and are available online at *http://www.regulations.gov.* This material is also available for inspection or copying at two locations: the Docket Management Facility (M-30), U.S. Department of Transportation, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590-0001, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays, and the First Coast Guard District, Bridge Branch, One South Street, New York, NY 10004, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. FOR FURTHER INFORMATION CONTACT: Ms. Judy Leung-Yee, Project Officer, First Coast Guard District,
(212)668-7195. SUPPLEMENTARY INFORMATION: Regulatory Information On March 7, 2008, we published a notice of proposed rulemaking
(NPRM)entitled “Drawbridge Operation Regulations; Mill Neck Creek, Oyster Bay, NY,” in the **Federal Register** (73 FR 12315). We received two letters commenting on the proposed rule. No public meeting was requested, and none was held. Background and Purpose The Bayville Bridge has a vertical clearance of 9 feet at mean high water, and 16 feet at mean low water in the closed position. The existing drawbridge operating regulations listed at 33 CFR 117.5, require the bridge to open on signal at all times. On March 8, 2007, the bridge owner, the County of Nassau, Department of Public Works, requested a change to the drawbridge operation regulations to help provide relief from the burden of providing a draw tender at the bridge during time periods when bridge seldom receives a request to open. On April 13, 2007, the Coast Guard authorized a temporary deviation with a request for public comment in order to test the proposed rule change. The temporary test deviation was in effect from May 25, 2007, through November 20, 2007, with a comment period open until November 30, 2007. The Coast Guard received no comments or complaints from mariners in response to the temporary test deviation. As a result of the above information, the Coast Guard published a notice of proposed rulemaking proposing to permanently change the drawbridge operation regulations for the Bayville Bridge. Under the notice of proposed rulemaking the bridge would be required to open on signal between 7 a.m. and 11 p.m., from May 1 through October 31, and between 7 a.m. and 5 p.m., Monday through Friday, from November 1 through April 30. At all other times the draw shall open on signal after at least a two-hour advance notice is provided by calling the number posted at the bridge. Discussion of Comments and Changes The Coast Guard received two comment letters from the New York State Office of Parks and Tennessee Gas Pipeline Company in response to the notice of proposed rulemaking. Both comment letters stated no objection to the proposed rule change and as a result, no changes have been made to this final rule. Regulatory Analysis We developed this rule after considering numerous statutes and executive orders related to rulemaking. Below we summarize our analysis based on 13 of these statutes or executive orders. Regulatory Planning and Review This rule is not a “significant regulatory action” under section 3(f) of Executive Order 12866, Regulatory Planning and Review, and does not require an assessment of potential costs and benefits under section 6(a)(3), of that Order. The Office of Management and Budget has not reviewed it under that Order. This conclusion is based on the fact that vessel traffic will still be able to transit through the Bayville Bridge at any time provided they give a two-hour advance notice during the time periods the bridge is not crewed. Small Entities Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we considered whether this rule would have a significant economic impact on a substantial number of small entities. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b), that this rule will not have a significant economic impact on a substantial number of small entities. This conclusion is based on the fact that vessel traffic will still be able to transit through the Bayville Bridge at any time provided they give a two-hour advance notice during time periods the bridge is not crewed. Assistance for Small Entities Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we offered to assist small entities in understanding the rule so that they could better evaluate its effects on them and participate in the rulemaking process. No small entities requested Coast Guard assistance and none was given. Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard. Collection of Information This rule calls for no new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). Federalism A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on State or local governments and would either preempt State law or impose a substantial direct cost of compliance on them. We have analyzed this rule under that Order and have determined that it does not have implications for federalism. Unfunded Mandates Reform Act The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble. Taking of Private Property This rule will not effect a taking of private property or otherwise have taking implications under Executive Order 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights. Civil Justice Reform This rule meets applicable standards in sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden. Protection of Children We have analyzed this rule under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. This rule is not an economically significant rule and does not concern an environmental risk to health or risk to safety that may disproportionately affect children. Indian Tribal Governments This final rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. Energy Effects We have analyzed this rule under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use. We have determined that it is not a “significant energy action” under that order because it is not a “significant regulatory action” under Executive Order 12866 and is not likely to have a significant adverse effect on the supply, distribution, or use of energy. The Administrator of the Office of Information and Regulatory Affairs has not designated it as a significant energy action. Therefore, it does not require a Statement of Energy Effects under Executive Order 13211. Technical Standards The National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note) directs agencies to use voluntary consensus standards in their regulatory activities unless the agency provides Congress, through the Office of Management and Budget, with an explanation of why using these standards would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (e.g., specifications of materials, performance, design, or operation; test methods; sampling procedures; and related management systems practices) that are developed or adopted by voluntary consensus standards bodies. This rule does not use technical standards. Therefore, we did not consider the use of voluntary consensus standards. Environment We have analyzed this rule under Commandant Instruction M16475.1D, and Department of Homeland Security Management Directive 5100.1, which guides the Coast Guard in complying with the National Environmental Policy Act of 1969
(NEPA)(42 U.S.C. 4321-4370f), and have concluded that there are no factors in this case that would limit the use of a categorical exclusion under section 2.B.2 of the Instruction. Therefore, this rule is categorically excluded, under figure 2-1, paragraph (32)(e), of the Instruction, from further environmental documentation considering that it relates to the promulgation of operating regulations or procedures for drawbridges. Under figure 2-1, paragraph (32)(e), of the instruction, an environmental analysis checklist and a categorical exclusion determination are not required for this rule. List of Subjects in 33 CFR Part 117 Bridges. Regulations For the reasons discussed in the preamble, the Coast amends 33 CFR part 117 as follows: PART 117—DRAWBRIDGE OPERATION REGULATIONS 1. The authority citation for part 117 continues to read as follows: Authority: 33 U.S.C. 499; 33 CFR 1.05-1(g); Department of Homeland Security Delegation No. 0170.1. 2. Add § 117.800 to read as follows: § 117.800 Mill Neck Creek. The draw of the Bayville Bridge, mile 0.1, at Oyster Bay, New York, shall open on signal between 7 a.m. and 11 p.m., from May 1 through October 31, and between 7 a.m. and 5 p.m., Monday through Friday, from November 1 through April 30. At all other times the draw shall open on signal provided at least a two-hour advance notice is given by calling the number posted at the bridge. Dated: May 13, 2008. Timothy S. Sullivan, Rear Admiral, U.S. Coast Guard, Commander, First Coast Guard District. [FR Doc. E8-11443 Filed 5-21-08; 8:45 am] BILLING CODE 4910-15-P DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 117 [USCG-2008-0356] Drawbridge Operation Regulations; Thames River, New London, CT AGENCY: Coast Guard, DHS. ACTION: Notice of temporary deviation from regulations. SUMMARY: The Commander, First Coast Guard District, has issued a temporary deviation from the regulations governing the operation of the Amtrak Bridge, mile 3.0, across the Thames River at New London, Connecticut. While this temporary deviation is in effect, the bridge may remain in the closed position for sixteen days and operate on a temporary operating schedule for ten days. DATES: This deviation is effective from June 1, 2008, through June 30, 2008. ADDRESSES: Documents indicated in this preamble as being available in the docket are part of docket USCG-2008-0356 and are available online at *http://www.regulations.gov.* They are also available for inspection or copying at two locations: the Docket Management Facility (M-30), U.S. Department of Transportation, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays, and the First Coast Guard District, Bridge Branch Office, 408 Atlantic Avenue, Boston, Massachusetts 02110, between 7 a.m. and 3 p.m., Monday through Friday, except Federal holidays. FOR FURTHER INFORMATION CONTACT: Judy Leung-Yee, Project Officer, First Coast Guard District, at
(212)668-7165. SUPPLEMENTARY INFORMATION: The Amtrak Bridge, across the Thames River at mile 3.0, at New London, Connecticut, has a vertical clearance in the closed position of 30 feet at mean high water and 33 feet at mean low water. The existing drawbridge operation regulations are listed at 33 CFR 117.224. The waterway has seasonal recreational vessels, fishing vessels, and U.S. Navy vessels of various sizes. The U.S. Navy and other marine facilities were notified regarding this deviation and no objections were received. The owner of the bridge, National Railroad Passenger Corporation (Amtrak), requested a temporary deviation to facilitate rehabilitation construction at the bridge. Under this temporary deviation the Amtrak Bridge, mile 3.0, across the Thames River at New London may remain in the closed position from June 1, 2008, through June 13, 2008, and from June 18, 2008, through June 20, 2008. From June 21, 2008, through June 30, 2008, the draw may remain in the closed position; except that, the draw shall open for the passage of vessel traffic during the following time periods: Monday through Friday from: 5 a.m. to 5:40 a.m.; 11:20 a.m. to 11:55 a.m.; 3:35 p.m. to 4:15 p.m.; and 8:30 p.m. to 8:55 p.m. Saturday from: 8:30 a.m. to 9:10 a.m.; 12:35 p.m. to 1:05 p.m.; 3:40 p.m. to 4:10 p.m.; 5:35 p.m. to 6:05 p.m.; and 7:35 p.m. to 8:40 p.m. Sunday from: 8:30 a.m. to 9:20 a.m.; 11:35 a.m. to 12:15 p.m.; 1:30 p.m. to 1:55 p.m.; 6:30 p.m. to 7:10 p.m.; and 8:30 p.m. to 9:15 p.m. The draw shall open on signal at any time for U.S. Navy submarines and their associated escort vessels. Vessels that can pass under the bridge without a bridge opening may do so at all times. In accordance with 33 CFR 117.35(e), the bridge must return to its regular operating schedule immediately at the end of the designated time period. This deviation from the operating regulations is authorized under 33 CFR 117.35. Dated: May 9, 2008. Gary Kassof, Bridge Program Manager, First Coast Guard District. [FR Doc. E8-11437 Filed 5-21-08; 8:45 am] BILLING CODE 4910-15-P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 51 Requirements for Preparation, Adoption, and Submittal of Implementation Plans CFR Correction In title 40 of the Code of Federal Regulations, parts 50 to 51, revised as of July 1, 2007, on page 296, in § 51.357, remove paragraphs (b)(1)(i) and (b)(1)(ii). [FR Doc. E8-11525 Filed 5-21-08; 8:45 am] BILLING CODE 1505-01-D ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 Approval and Promulgation of Implementation Plans; Mississippi CFR Correction In title 40 of the Code of Regulations, part 52.1019 to End, revised as of July 1, 2007, on page 222, in section 52.1270, in the table in paragraph (c), under APC-S-2, the entry for Section VI, is corrected in the column titled “EPA approval date”, is corrected to read “7/10/2006, 71 FR 38775”. [FR Doc. E8-11526 Filed 5-21-08; 8:45 am] BILLING CODE 1505-01-D ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 60 [EPA-HQ-OAR-2002-0071; FRL-8568-7] RIN 2060-AP13 Update of Continuous Instrumental Test Methods: Technical Amendments AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. SUMMARY: EPA is taking final action to correct errors in a final rule published May 15, 2006, that updated five continuous instrumental test methods. As published, the rule contained inadvertent errors and provisions that needed to be clarified. We published a direct final rule with a parallel proposed rule on September 7, 2007 to correct the errors and to add clarifying language. However, we received an adverse comment on the direct final rule, and it was subsequently withdrawn on November 5, 2007. This action finalizes the parallel proposal. In this final rule, EPA corrects errors, clarifies certain provisions, and responds to the adverse comment received on the direct final rule published on September 7, 2007. DATES: This final rule is effective on May 22, 2008. ADDRESSES: EPA has established a docket for this action under Docket ID No. EPA-HQ-OAR-2002-0071. All documents in the docket are listed on the *www.regulations.gov* Web site. Although listed in the index, some information is not publicly available, *e.g.* , CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available either electronically through *www.regulations.gov* or in hard copy at the Update of Continuous Instrumental Test Methods Docket, Docket ID No. EPA-OAR-2002-0071, EPA Docket Center, EPA/DC, EPA West, Room 3334, 1301 Constitution Ave., NW., Washington, DC. This Docket Facility is open from 8:30 a.m. to 4:30 p.m. Monday through Friday excluding legal holidays. The Docket telephone number is
(202)566-1742. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is
(202)566-1744. FOR FURTHER INFORMATION CONTACT: Mr. Foston Curtis, Air Quality Assessment Division, Office of Air Quality Planning and Standards (E143-02), Environmental Protection Agency, Research Triangle Park, North Carolina 27711; telephone number
(919)541-1063; fax number
(919)541-0516; e-mail address: *curtis.foston@epa.gov.* SUPPLEMENTARY INFORMATION: Table of Contents I. Does This Action Apply to Me? II. Where Can I Obtain a Copy of This Action? III. Background IV. This Action A. Method 3A—40 CFR Part 60, Appendix A-1 B. Method 6C—40 CFR Part 60, Appendix A-4 C. Method 7E—40 CFR Part 60, Appendix A-4 D. Method 20—40 CFR Part 60, Appendix A-7 V. Public Comments on the Proposed Rule VI. Judicial Review VII. Statutory and Executive Order Reviews A. Executive Order 12866: Regulatory Planning and Review B. Paperwork Reduction Act C. Regulatory Flexibility Act D. Unfunded Mandates Reform Act E. Executive Order 13132: Federalism F. Executive Order 13175: Consultation and Coordination With Indian Tribal Governments G. Executive Order 13045: Protection of Children From Environmental Health Risks and Safety Risks H. Executive Order 13211: Actions That Significantly Affect Energy Supply, Distribution, or Use I. National Technology Transfer and Advancement Act J. Executive Order 12898: Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Populations K. Congressional Review Act I. Does This Action Apply to Me? This rule applies to certain sources that are subject to New Source Performance Standards (40 CFR part 60), are required to conduct continuous emission monitoring pursuant to 40 CFR Part 75, or are subject to other regulations that require the use of Method 3A, of Appendix A-1, Methods 6C, 7E of Appendix A-4, and Method 20 of Appendix A-7 to 40 CFR Part 60. Regulated Entities. Categories and entities potentially affected include the following: Category NAICS a Examples of regulated entities Industry 332410 Fossil Fuel Steam Generators. Industry 332410 Industrial, Commercial, Institutional Steam Generating Units. Industry 332410 Electric Generating Units. Industry 333611 Stationary Gas Turbines. Industry 324110 Petroleum Refineries. Industry 562213 Municipal Waste Combustors. Industry 322110 Kraft Pulp Mills. Industry 325188 Sulfuric Acid Plants. a North American Industry Classification System. This table is not intended to be exhaustive, but rather to provide a guide for readers regarding entities likely to be affected by this action. This table lists examples of the types of entities EPA is now aware could potentially be affected by the final rule. Other types of entities not listed could also be affected. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed in the preceding FOR FURTHER INFORMATION CONTACT section. II. Where Can I Obtain a Copy of This Action? In addition to being available in the docket, an electronic copy of this rule will also be available on the Worldwide Web
(www)through the Technology Transfer Network (TTN). Following the Administrator's signature, a copy of the final rule will be placed on the TTN's policy and guidance page for newly proposed or promulgated rules at *http://www.epa.gov/ttn/oarpg* . The TTN provides information and technology exchange in various areas of air pollution control. III. Background Methods 3A, 6C, 7E, 10, and 20 measure oxygen, carbon dioxide, sulfur dioxide, nitrogen oxides, and carbon monoxide emissions from stationary sources. They are prescribed for use in determining compliance with a number of Federal, State, and local regulations. The EPA published updates to simplify, harmonize, and update these test methods on May 15, 2006 (71 FR 28081). The rule promulgating these updates became effective August 14, 2006. As published, the rule contained inadvertent errors and provisions that needed clarification. On September 7, 2007, EPA simultaneously published a proposed rule (72 FR 51392) and a direct final rule (72 FR 51365) to correct errors and clarify certain provisions in the May 15, 2006 rule. Because EPA received one adverse comment during the public comment period, EPA withdrew the direct final rule on November 5, 2007 (72 FR 62414). EPA is taking final action on the corrections and clarifications proposed for approval on September 7, 2007, and is responding to the adverse comment received in response to that proposal. IV. This Action In this final rule, EPA corrects errors and clarifies portions of the May 15, 2006 rule to reflect the intent of the rule and to make it more understandable. Specifically, EPA is taking the following actions: A. Method 3A—40 CFR Part 60, Appendix A-1 1. We are clearly stating that pre-cleaned or scrubbed air may be used for the high-level calibration gas provided no interfering gases are present. 2. An incorrect reference in Section 8.1 to Section 8.2 of Method 3 for sampling to determine gas molecular weight is corrected to reference Section 8.2.1 of Method 3. B. Method 6C—40 CFR Part 60, Appendix A-4 In Section 6.2, a reference to Section 6.2.8.1 for dual-range analyzers is expanded to include Section 6.2.8.2 which also applies. C. Method 7E—40 CFR Part 60, Appendix A-4 1. Under the descriptions for calibration gases in Section 3.3, the quality of zero gas allowed for instrument calibration is clarified. The current requirement is that all calibration gases be of EPA traceability protocol quality. However, the traceability protocol does not have a specification for zero gas. Therefore, we are adopting the specification for “zero air material” in 40 CFR 72.2 for zero gas in place of the traceability protocol. 2. In Section 3.4, we recommend the instrument calibration span be chosen such that emission concentrations are between 20 to 100 percent of the calibration span, “to the extent practicable.” We are adding a note, as an example, that meeting this 20 to 100 percent criterion may not be practicable when emissions are low relative to the emission limit and the purpose of the test is to show compliance with the emission limit. 3. Section 3.9 is clarified to note that drift is the difference between the pre- and post-run system bias checks instead of the difference between the measurement system readings for the pre- and post-run bias checks. 4. Section 3.12 is corrected to remove erroneous citations to 40 CFR 53.55 and 53.56 which have nothing to do with the manufacturer's stability test (MST). 5. In Section 6.2.2, we are specifically stating that the particulate media must be included in the system bias test only when using out-of-stack filters. 6. In Section 6.2.6, the description of the calibration gas manifold is clarified to note that blocking the sample flow is not necessary when in direct calibration mode, as suggested in the current method, but the calibration gas may simply supply an excess of calibration gas through the system. 7. The method implies that all analyzers with calibration spans of 20 ppmv or less are required to perform the MST. In Section 6.2.8.2, we are clarifying the MST requirement to note that it is only required for those analyzers that are routinely calibrated with a calibration span of 20 ppmv or less. 8. The new converter efficiency check that was added in Section 16.2.2 requires the nitrogen dioxide (NO <sup>2</sup> ) test gas be of EPA traceability protocol quality. Subsequent discussions with the National Institute of Standards and Technology
(NIST)concerning the quality of the NIST NO <sup>2</sup> standard revealed that this standard contains small but consistent amounts of nitric acid (HNO <sup>3</sup> ). Some converters may not be able to completely convert this HNO <sup>3</sup> to nitric oxide
(NO)for analysis. There are also concerns about the cost and stability of certified NO <sup>2</sup> gas over time. We are, therefore, dropping the new requirement that the converter efficiency gas be of EPA traceability protocol quality and reverting to the previous requirement that the gas be of a manufacturer-certified concentration. In addition, for this converter check procedure, the gas is required to be in the 40 to 60 ppmv range while the two alternative procedures require gas in the mid- to high-calibration range. We are dropping the 40 to 60 ppmv requirement in favor of recommending the concentration be in the mid- to high-calibration range in order to keep the three procedures consistent. Subsequent references to the 40 to 60 ppmv requirement have been deleted from the method. 9. In Section 7.2, we are clearly stating that the appropriate test gases listed in Table 7E-3, or others not listed that can potentially interfere, as noted elsewhere, must be used for the test. We are also making it clear that the gases used should be manufacturer-certified but are not required to be prepared by the EPA traceability protocol. 10. In Section 8.1.2, we are explicitly stating that the required stratification test is to be performed at each test site except for small stacks that are less than 4 inches in diameter. 11. In Section 8.2.1, we are making it clear that testers must obtain a certificate from the gas manufacturer documenting the quality of the calibration gas. 12. In Section 8.2.4, we are clearly stating that the converter efficiency test may be performed either before or after a test or after a series of tests. 13. In Section 8.2.7, paragraph
(1)is reworded to add clarity to the interference test, and paragraph
(2)is corrected to note that the interference test is valid for the life of the instrument unless major components are replaced with different model parts. 14. In the sample traversing procedure in Section 8.4, we delete redundant language in paragraphs
(1)and (2). 15. In paragraph
(1)of Section 8.5, we clarify the handling of failed post-run bias checks by removing unnecessary wording. 16. In Section 10.0, we clearly state that analyzers which measure NO and NO <sup>2</sup> without using a converter must be calibrated with both NO and NO <sup>2</sup> . The current wording is not clear to some users. 17. In Section 12.1, we are revising certain definitions to reflect the corrections being made to the calculations. 18. In Section 12.4, we correct the system calibration error equation by adding a term for the dilution factor. 19. In Section 12.6, we add a missing equation for calculating sample concentration when a non-zero gas is used as the low-level calibration gas. 20. In Section 12.9 we replace the erroneous equation added in the updates rule with the one traditionally used by the method. 21. In Section 12.11, we correct the equation for calculating the spike recovery. 22. In Section 13.5, we are adding the 2 percent limit for the alternative converter efficiency test. 23. In Section 16.2.2, we are deleting the procedures in paragraphs
(2)and
(3)because they are not needed for the test and are confusing. 24. In Section 16.3, the erroneous references to 40 CFR 53.55 and 53.56 are removed; only 53.53 is followed for the MST. A note is added to clarify that alternative procedures or documentation of instrument stability are acceptable. 25. In Table 7E-3, the title is edited to note that the table contains example interference gases and concentrations. We are removing a table footnote instructing dilution extractive systems to use the hot wet concentrations because it may not be applicable in all cases. In its place, a footnote is added to remind the tester to use the highest gas concentration expected at test sites for the interference test. 26. In Table 7E-5, we correct the typographical error listing the NO <sup>X</sup> concentration at “.80% of calibration span” to read “80% of calibration span.” We have removed the note to evaluate each model by the MST at least quarterly or once per 50 production units because it is not necessary. D. Method 20—40 CFR Part 60, Appendix A-7 1. In Section 8.4, we are adding a minimum sample run time of 21 minutes. V. Public Comments on the Proposed Rule Two public comment letters were received on the direct final rule that was published on September 7, 2007. Because the comments was considered adverse, the direct final rule was withdrawn on November 5, 2007 (72 FR 62414). One commenter identified an error in the definition of “system bias.” We inadvertently proposed to change the definition to note that system bias is calculated from the difference between the system calibration response and the manufacturer certified gas concentration and not from the difference between the system calibration response and the direct calibration responses. Therefore, we are not revising the definition of system bias as indicated in the September 7, 2007, notice. Another commenter asked that we amend the suggested gas concentrations that were proposed for the Method 7E converter check to make it clear that gases in the 40 to 60 ppm range were not the only ones allowed but that other concentrations were acceptable if they were more appropriate for the source conditions. We agree and have made this change in the final rule. Another error in the published equation for calculating system calibration error was pointed out. The dilution factor was not in the correct place in Equation 7E-3. This has been corrected. VI. Judicial Review Under section 307(b)(1) of the Clean Air Act (CAA), judicial review of this final rule is available by filing a petition for review in the U.S. Court of Appeals for the District of Columbia Circuit by July 21, 2008. Under section 307(d)(7)(B) of the CAA, only an objection to this final rule that was raised with reasonable specificity during the period for public comment can be raised during judicial review. Moreover, under section 307(b)(2) of the CAA, the requirements established by this action may not be challenged separately in any civil or criminal proceedings brought by EPA to enforce these requirements. VII. Statutory and Executive Order Reviews A. Executive Order 12866: Regulatory Planning and Review This action is not a “significant regulatory action” under the terms of Executive Order 12866 (58 FR 51735, October 4, 1993) and is, therefore, not subject to review under the Executive Order. B. Paperwork Reduction Act This action does not impose an information collection burden under the provisions of the *Paperwork Reduction Act,* 44 U.S.C. 3501 *et seq.* Burden is defined at 5 CFR 1320.3(b). These amendments do not add information collection requirements beyond those currently required under the applicable regulation. The amendments being made correct technical inaccuracies in the existing testing methodology. C. Regulatory Flexibility Act The Regulatory Flexibility Act
(RFA)generally requires an agency to prepare a regulatory flexibility analysis of any rule subject to notice and comment rulemaking requirements under the Administrative Procedure Act or any other statute unless the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. Small entities include small businesses, small organizations, and small governmental jurisdictions. For purposes of assessing the impacts of this rule on small entities, small entity is defined as:
(1)A small business whose parent company has fewer than 100 or 1,000 employees, or fewer than 4 billion kilowatt-hr per year of electricity usage, depending on the size definition for the affected North American Industry Classification System code;
(2)a small governmental jurisdiction that is a government of a city, county, town, school district or special district with a population of less than 50,000; and
(3)a small organization that is any not-for-profit enterprise which is independently owned and operated and is not dominant in its field. After considering the economic impacts of this final rule on small entities, I certify that this action will not have a significant economic impact on a substantial number of small entities. This final rule will not impose any requirements on small entities because it does not impose any additional regulatory requirements. D. Unfunded Mandates Reform Act Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public Law 104-4, establishes requirements for Federal agencies to assess the effects of their regulatory actions on State, local, and tribal governments and the private sector. Under section 202 of the UMRA, EPA generally must prepare a written statement, including a cost-benefit analysis, for proposed and final rules with “Federal mandates” that may result in expenditures to State, local, and tribal governments, in the aggregate, or to the private sector, of $100 million or more in any 1 year. Before promulgating an EPA rule for which a written statement is needed, section 205 of the UMRA generally requires EPA to identify and consider a reasonable number of regulatory alternatives and adopt the least costly, most cost-effective or least burdensome alternative that achieves the objectives of the rule. The provisions of section 205 do not apply when they are inconsistent with applicable law. Moreover, section 205 allows EPA to adopt an alternative other than the least costly, most cost-effective, or least burdensome alternative if the Administrator publishes with the final rule an explanation why that alternative was not adopted. Before EPA establishes any regulatory requirements that may significantly or uniquely affect small governments, including tribal governments, it must have developed, under section 203 of the UMRA a small government agency plan. The plan must provide for notifying potentially affected small governments, enabling officials of affected small governments to have meaningful and timely input in the development of EPA regulatory proposals with significant Federal intergovernmental mandates, and informing, educating, and advising small governments on compliance with the regulatory requirements. EPA has determined that this final rule does not contain a Federal mandate that may result in expenditures of $100 million or more for State, local, and tribal governments, in the aggregate, or the private sector in any one year, nor does this rule significantly or uniquely impact small governments, because it contains no requirements that apply to such governments or impose obligations upon them. Thus, this rule is not subject to the requirements of sections 202 and 205 of the UMRA. EPA has determined that this rule contains no regulatory requirements that might significantly or uniquely affect small governments because it contains no requirements that apply to such governments or impose obligations upon them. Thus, this rule is not subject to the requirements of sections 202 and 205 of the UMRA. E. Executive Order 13132: Federalism Executive Order 13132 entitled “Federalism” (64 FR 43255, August 10, 1999) requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive Order to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” This final rule does not have federalism implications. It will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132. The amendments in this rule will benefit State and local governments by clarifying and correcting provisions they currently implement. No added responsibilities or increase in implementation efforts or costs for State and local governments are being added in this action. Thus, Executive Order 13132 does not apply to this rule. F. Executive Order 13175: Consultation and Coordination With Indian Tribal Governments Executive Order 13175 entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000) requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” This final rule does not have tribal implications as specified in Executive Order 13175. It will not have substantial direct effects on tribal governments, on the relationship between the Federal government and Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule. G. Executive Order 13045: Protection of Children From Environmental Health Risks and Safety Risks EPA interprets EO 13045 (62 FR 19885, April 23, 1997) as applying only to those regulatory actions that concern health or safety risks, such that the analysis required under section 5-501 of the EO has the potential to influence the regulation. This action is not subject to EO 13045 because it does not establish an environmental standard intended to mitigate health or safety risks. H. Executive Order 13211: Actions That Significantly Affect Energy Supply, Distribution, or Use This rule is not subject to Executive Order 13211, “Actions Concerning Regulations that Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001) because it is not a significant regulatory action under Executive Order 12866. I. National Technology Transfer and Advancement Act Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (“NTTAA”), Public Law No. 104-113, 12(d) (15 U.S.C. 272 note) directs EPA to use voluntary consensus standards in its regulatory activities unless to do so would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards ( *e.g.* , materials specifications, test methods, sampling procedures, and business practices) that are developed or adopted by voluntary consensus standards bodies. NTTAA directs EPA to provide Congress, through OMB, explanations when the Agency decides not to use available and applicable voluntary consensus standards. This action does not involve technical standards. Therefore, EPA did not consider the use of any voluntary consensus standards. J. Executive Order 12898: Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Populations Executive Order 12898 (59 FR 7629 (Feb. 16, 1994)) establishes Federal executive policy on environmental justice. Its main provision directs federal agencies, to the greatest extent practicable and permitted by law, to make environmental justice part of their mission by identifying and addressing, as appropriate, disproportionately high and adverse human health or environmental effects of their programs, policies, and activities on minority populations and low-income populations in the United States. EPA has determined that this final rule will not have disproportionately high and adverse human health or environmental effects on minority or low-income populations because it does not affect the level of protection provided to human health or the environment. This final rule does not relax the control measures on sources regulated by the rule and, therefore, will not cause emissions increases from these sources. K. Congressional Review Act The Congressional Review Act, 5 U.S.C. 801 *et seq.* , as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the **Federal Register** . A major rule cannot take effect until 60 days after it is published in the **Federal Register** . This action is not a “major rule” as defined by 5 U.S.C. 804(2). This rule will be effective May 22, 2008. List of Subjects in 40 CFR Part 60 Environmental protection, Administrative practice and procedures, Air pollution control, Intergovernmental relations, Reporting and recordkeeping requirements. Dated: May 15, 2008. Stephen L. Johnson, Administrator. For the reasons set out in the preamble, title 40, chapter I of the Code of Federal Regulations is amended as follows: PART 60—STANDARDS OF PERFORMANCE FOR NEW STATIONARY SOURCES 1. The authority citation for part 60 continues to read as follows: Authority: 23 U.S.C. 101; 42 U.S.C. 7401-7671q. Appendix A-2—[Amended] / 2. Amend Method 3A as follows: a. Add a sentence after the second sentence of Section 7.1. b. Revise the second sentence in Section 8.1. Method 3A—Determination of Oxygen and Carbon Dioxide Concentrations in Emissions From Stationary Sources (Instrumental Analyzer Procedure) *7.1 Calibration Gas.* * * * Pre-cleaned or scrubbed air may be used for the O 2 high-calibration gas provided it does not contain other gases that interfere with the O 2 measurement. *8.1. Sampling Site and Sampling Points.* * * * In that case, you may use single-point integrated sampling as described in Section 8.2.1 of Method 3. Appendix A-4—[Amended] 3. Amend Method 6C by revising the last sentence in Section 6.2 to read as follows: Method 6C—Determination of Sulfur Dioxide Emissions From Stationary Sources (Instrumental Analyzer Procedure) *6.2* * * * The low-range and dual-range analyzer provisions in Sections 6.2.8.1 and 6.2.8.2 of Method 7E apply. 4. Amend Method 7E as follows: a. Revise Sections 3.3, 3.4, and 3.9. b. Revise Section 3.12 by removing the third sentence and adding two new sentences. c. Revise Section 6.2.2. d. Revise the second sentence in Section 6.2.6. e. Revise Section 6.2.8.2. f. Add a sentence after the second sentence in Section 7.1. g. Revise Section 7.1.4. h. Revise Section 7.2. i. Add three sentences to the beginning of Section 8.1.2. j. Revise the second sentence in Section 8.2.1. k. Revise the first sentence in Section 8.2.4. l. Revise Section 8.2.4.1. m. Revise the first and second sentences in paragraph
(1)and the second sentence in paragraph
(2)of Section 8.2.7. n. Revise paragraphs
(1)and
(2)in Section 8.4. o. Revise the introductory paragraph and paragraph
(1)of Section 8.5. p. In Section 9.0, revise the table entitled “Summary Table of QA/QC” by amending the entry for “M” “System Performance” “NO 2 -NO conversion efficiency” “≥ 90% of certified test gas concentration” “before each test.” q. Revise the last sentence in paragraph
(1)of Section 10.0. r. Add definitions for “C native, ” “C OA ,” and “DF” in alphabetical order to Section 12.1. s. Remove the definition for “NO final ” in Section 12.1. t. Revise the definitions of “C 0 ” and “SB f ” in Section 12.1. u. Revise Section 12.4. v. Revise Sections 12.6 and 12.9. w. Revise Equation 7E-12 in Section 12.11. x. Revise Section 13.5. y. Revise the third sentence in paragraph
(1)of Section 16.2.2. z. Remove and reserve paragraph
(2)and remove paragraph
(3)of Section 16.2.2. aa. Revise Section 16.3. bb. Revise Table 7E-3. cc. Revise Table 7E-5. Method 7E—Determination of Nitrogen Oxides Emissions From Stationary Sources (Instrumental Analyzer Procedure) *3.3 Calibration Gas* means the gas mixture containing NO <sup>X</sup> at a known concentration and produced and certified in accordance with “EPA Traceability Protocol for Assay and Certification of Gaseous Calibration Standards,” September 1997, as amended August 25, 1999, EPA-600/R-97/121 or more recent updates. The tests for analyzer calibration error, drift, and system bias require the use of calibration gas prepared according to this protocol. If a zero gas is used for the low-level gas, it must meet the requirements under the definition for “zero air material” in 40 CFR 72.2 in place of being prepared by the traceability protocol. *3.4* *Calibration Span* means the upper limit of the analyzer's calibration that is set by the choice of high-level calibration gas. No valid run average concentration may exceed the calibration span. To the extent practicable, the measured emissions should be between 20 to 100 percent of the selected calibration span. This may not be practicable in some cases of low-concentration measurements or testing for compliance with an emission limit when emissions are substantially less than the limit. In such cases, calibration spans that are practicable to achieving the data quality objectives without being excessively high should be chosen. *3.9 Drift* means the difference between the pre- and post-run system bias (or system calibration error) checks at a specific calibration gas concentration level ( *i.e.* low-, mid- or high-). *3.12* * * * An MST subjects the analyzer to a range of line voltages and temperatures that reflect potential field conditions to demonstrate its stability following procedures similar to those provided in 40 CFR 53.23. Ambient-level analyzers are exempt from the MST requirements of Section 16.3. * * * *6.2.2 Particulate Filter.* An in-stack or out-of-stack filter. The filter must be made of material that is non-reactive to the gas being sampled. The filter media for out-of-stack filters must be included in the system bias test. The particulate filter requirement may be waived in applications where no significant particulate matter is expected ( *e.g.* , for emission testing of a combustion turbine firing natural gas). *6.2.6 Calibration Gas Manifold.* * * * In system calibration mode, the system should be able to flood the sampling probe and vent excess gas. * * * *6.2.8.2 Low Concentration Analyzer.* When an analyzer is routinely calibrated with a calibration span of 20 ppmv or less, the manufacturer's stability test
(MST)is required. See Table 7E-5 for test parameters. *7.1 Calibration Gas.* * * * If a zero gas is used for the low-level gas, it must meet the requirements under the definition for “zero air material” in 40 CFR 72.2. * * * *7.1.4 Converter Efficiency Gas. What reagents do I need for the converter efficiency test?* The converter efficiency gas is a manufacturer-certified gas with a concentration sufficient to show NO 2 conversion at the concentrations encountered in the source. A test gas concentration in the 40 to 60 ppm range is suggested, but other concentrations may be more appropriate to specific sources. For the test described in Section 8.2.4.1, NO 2 is required. For the alternative converter efficiency tests in Section 16.2, NO is required. *7.2 Interference Check. What reagents do I need for the interference check?* Use the appropriate test gases listed in Table 7E-3 or others not listed that can potentially interfere (as indicated by the test facility type, instrument manufacturer, etc.) to conduct the interference check. These gases should be manufacturer certified but do not have to be prepared by the EPA traceability protocol. *8.1.2 Determination of Stratification.* Perform a stratification test at each test site to determine the appropriate number of sample traverse points. If testing for multiple pollutants or diluents at the same site, a stratification test using only one pollutant or diluent satisfies this requirement. A stratification test is not required for small stacks that are less than 4 inches in diameter * * * *8.2.1 Calibration Gas Verification.* * * * Obtain a certificate from the gas manufacturer documenting the quality of the gas. * * * *8.2.4* NO 2 to NO Conversion Efficiency. Before or after each field test, you must conduct an NO 2 to NO conversion efficiency test if your system converts NO 2 to NO before analyzing for NO <sup>X</sup> . You may risk testing multiple facilities before performing this test provided you pass this test at the conclusion of the final facility test. A failed final conversion efficiency test in this case will invalidate all tests performed subsequent to the test in which the converter efficiency test was passed. * * * *8.2.4.1.* Introduce NO <sup>2</sup> converter efficiency gas to the analyzer in direct calibration mode and record the NO <sup>X</sup> concentration displayed by the analyzer. Calculate the converter efficiency using Equation 7E-7 in Section 12.7. The specification for converter efficiency in Section 13.5 must be met. The user is cautioned that state-of-the-art NO 2 calibration gases may have limited shelf lives, and this could affect the ability to pass the 90-percent conversion efficiency requirement. *8.2.7 Interference Check.* * * *
(1)You may introduce the appropriate interference test gases (that are potentially encountered during a test, see examples in Table 7E-3) into the analyzer separately or as mixtures. Test the analyzer with the interference gas alone at the highest concentration expected at a test source and again with the interference gas and NO <sup>X</sup> at a representative NO <sup>X</sup> test concentration. * * *
(2)* * * This interference test is valid for the life of the instrument unless major analytical components ( *e.g.* , the detector) are replaced with different model parts. If major components are replaced with different model parts, the interference gas check must be repeated before returning the analyzer to service. *8.4 Sample Collection.*
(1)Position the probe at the first sampling point. Purge the system for at least two times the response time before recording any data. Then, traverse all required sampling points, sampling at each point for an equal length of time and maintaining the appropriate sample flow rate or dilution ratio (as applicable). You must record at least one valid data point per minute during the test run.
(2)Each time the probe is removed from the stack and replaced, you must recondition the sampling system for at least two times the system response time prior to your next recording. If the average of any run exceeds the calibration span value, that run is invalid. *8.5 Post-Run System Bias Check and Drift Assessment.* How do I confirm that each sample I collect is valid? After each run, repeat the system bias check or 2-point system calibration error check (for dilution systems) to validate the run. Do not make adjustments to the measurement system (other than to maintain the target sampling rate or dilution ratio) between the end of the run and the completion of the post-run system bias or system calibration error check. Note that for all post-run system bias or 2-point system calibration error checks, you may inject the low-level gas first and the upscale gas last, or vice-versa. You may risk sampling for multiple runs before performing the post-run bias or system calibration error check provided you pass this test at the conclusion of the group of runs. A failed final test in this case will invalidate all runs subsequent to the last passed test.
(1)If you do not pass the post-run system bias (or system calibration error) check, then the run is invalid. You must diagnose and fix the problem and pass another calibration error test (Section 8.2.3) and system bias (or 2-point system calibration error) check (Section 8.2.5) before repeating the run. Record the system bias (or system calibration error) results on a form similar to Table 7E-2. *9.0 Quality Control* Summary Table of QA/QC Status Process or element QA/QC specification Acceptance criteria Checking frequency * * * * * * * M System Performance NO <sup>2</sup> -NO conversion efficiency ≥ 90% of certified test gas concentration Before or after each test. * * * * * * * * * * *10.0 Calibration and Standardization* * * *
(1)* * * Analyzers that measure NO and NO 2 separately without using a converter must be calibrated with both NO and NO 2 . *12.1 Nomenclature.* * * * C native = NO <sup>X</sup> concentration in the stack gas as calculated in Section 12.6, ppmv. * * * C O = Average of the initial and final system calibration bias (or 2-point system calibration error) check responses from the low-level (or zero) calibration gas, ppmv. C OA = Actual concentration of the low-level calibration gas, ppmv. * * * DF = Dilution system dilution factor or spike gas dilution factor, dimensionless. * * * SB final = Post-run system bias, percent of calibration span. *12.4 System Calibration Error.* Use Equation 7E-3 to calculate the system calibration error for dilution systems. Equation 7E-3 applies to both the initial 3-point system calibration error test and the subsequent 2-point calibration error checks between test runs. In this equation, the term “C s ” refers to the diluted calibration gas concentration measured by the analyzer. ER22MY08.000 *12.6 Effluent Gas Concentration.* For each test run, calculate C avg , the arithmetic average of all valid NO <sup>X</sup> concentration values ( *e.g.* , 1-minute averages). Then adjust the value of C avg for bias using Equation 7E-5a if you use a non-zero gas as your low-level calibration gas, or Equation 7E-5b if you use a zero gas as your low-level calibration gas. ER22MY08.001 ER22MY08.002 *12.9* *Alternative NO* 2 *Converter Efficiency.* If the alternative procedure of Section 16.2.2 is used, determine the NO <sup>X</sup> concentration decrease from NO XPeak after the minimum 30-minute test interval using Equation 7E-9. This decrease from NO XPeak must meet the requirement in Section 13.5 for the converter to be acceptable. ER22MY08.003 *12.11 Calculated Spike Gas Concentration and Spike Recovery for the Example Alternative Dynamic Spiking Procedure in Section 16.1.3.* * * * ER22MY08.004 *13.5* *NO* 2 to *NO Conversion Efficiency Test (as applicable).* The NO 2 to NO conversion efficiency, calculated according to Equation 7E-7, must be greater than or equal to 90 percent. The alternative conversion efficiency check, described in Section 16.2.2 and calculated according to Equation 7E-9, must not result in a decrease from NO XPeak by more than 2.0 percent. 1 *6.2.2 Tedlar Bag Procedure.* * * * Fill the remainder of the bag with mid- to high-level NO in nitrogen (or other appropriate concentration) calibration gas. *16.3 Manufacturer's Stability Test.* A manufacturer's stability test is required for all analyzers that routinely measure emissions below 20 ppmv and is optional but recommended for other analyzers. This test evaluates each analyzer model by subjecting it to the tests listed in Table 7E-5 following procedures similar to those in 40 CFR 53.23 for thermal stability and insensitivity to supply voltage variations. If the analyzer will be used under temperature conditions that are outside the test conditions in Table B-4 of Part 53.23, alternative test temperatures that better reflect the analyzer field environment should be used. Alternative procedures or documentation that establish the analyzer's stability over the appropriate line voltages and temperatures are acceptable. Table 7E-3.—Example Interference Check Gas Concentrations Potential interferent gas 1 Concentrations 2 sample conditioning type Hot wet Dried CO <sup>2</sup> 5 and 15% 5 and 15% H <sup>2</sup> O 25% 1% NO 15 ppmv 15 ppmv NO <sup>2</sup> 15 ppmv 15 ppmv N <sup>2</sup> O 10 ppmv 10 ppmv CO 50 ppmv 50 ppmv NH <sup>3</sup> 10 ppmv 10 ppmv CH <sup>4</sup> 50 ppmv 50 ppmv SO <sup>2</sup> 20 ppmv 20 ppmv H <sup>2</sup> 50 ppmv 50 ppmv HCl 10 ppmv 10 ppmv
(1)Any applicable gas may be eliminated or tested at a reduced level if the manufacturer has provided reliable means for limiting or scrubbing that gas to a specified level.
(2)As practicable, gas concentrations should be the highest expected at test sites. Table 7E-5.—Manufacturer Stability Test Test description Acceptance criteria (note 1) Thermal Stability Temperature range when drift does not exceed 3.0% of analyzer range over a 12-hour run when measured with NO <sup>X</sup> present @ 80% of calibration span. Fault Conditions Identify conditions which, when they occur, result in performance which is not in compliance with the Manufacturer's Stability Test criteria. These are to be indicated visually or electrically to alert the operator of the problem. Insensitivity to Supply Voltage Variations ± 10.0% (or manufacturers alternative) variation from nominal voltage must produce a drift of ≤ 2.0% of calibration span for either zero or concentration ≥ 80% NO <sup>X</sup> present. Analyzer Calibration Error For a low-, medium-, and high-calibration gas, the difference between the manufacturer certified value and the analyzer response in direct calibration mode, no more than 2.0% of calibration span. Note 1: If the instrument is to be used as a Low Range analyzer, all tests must be performed at a calibration span of 20 ppm or less. Appendix A-7—[Amended] 5. Amend Method 20 by adding a sentence to the end of Section 8.4 to read as follows: Method 20—Determination of Oxygen and Carbon Dioxide Concentrations in Emissions From Stationary Sources (Instrumental Analyzer Procedure) *8.4 Sample Collection.* * * * A test run must have a duration of at least 21 minutes. [FR Doc. E8-11398 Filed 5-21-08; 8:45 am] BILLING CODE 6560-50-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services 42 CFR Part 412 [CMS-1493-IFC2] RIN 0938-AP33 Medicare Program; Changes for Long-Term Care Hospitals Required by Certain Provisions of the Medicare, Medicaid, SCHIP Extension Act of 2007: 3-Year Moratorium on the Establishment of New Long-Term Care Hospitals and Long-Term Care Hospital Satellite Facilities and Increases in Beds in Existing Long-Term Care Hospitals and Long-Term Care Hospital Satellite Facilities; and 3-Year Delay in the Application of Certain Payment Adjustments AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Interim final rule with comment period. SUMMARY: This interim final rule with comment period implements certain provisions of section 114 of the Medicare, Medicaid, and SCHIP Extension Act of 2007 relating to long-term care hospitals (LTCHs) and LTCH satellite facilities. It implements a 3-year moratorium on the establishment of new LTCHs and LTCH satellite facilities; and on increases in beds in existing LTCHs and LTCH satellite facilities. This interim final rule with comment period also implements a 3-year delay in the application of certain payment policies which apply payment adjustments for discharges from LTCHs and LTCH satellites that were admitted from certain referring hospitals in excess of various percentage thresholds. DATES: *Effective date:* The provisions of this interim final rule with comment period are effective on December 29, 2007. In accordance with section 1871(e)(1)(A)(i) and
(ii)of the Social Security Act (the Act), the Secretary has determined that retroactive application of the provisions of this interim final rule with comment period is necessary to comply with the statute and that failure to apply the changes retroactively would be contrary to public interest. *Comment date:* To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on July 21, 2008. ADDRESSES: In commenting, please refer to file code CMS-1493-IFC2. Because of staff and resource limitations, we cannot accept comments by facsimile
(FAX)transmission. You may submit comments in one of four ways (please choose only one of the ways listed): 1. *Electronically.* You may submit electronic comments on this regulation to *http://www.regulations.gov.* Follow the instructions for “Comment or Submission” and enter the filecode to find the document accepting comments. 2. *By regular mail.* You may mail written comments (one original and two copies) to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-1493-IFC2, P.O. Box 8013, Baltimore, MD 21244-8013. Please allow sufficient time for mailed comments to be received before the close of the comment period. 3. *By express or overnight mail* . You may send written comments (one original and two copies) to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-1493-IFC2, Mail Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850. 4. *By hand or courier.* If you prefer, you may deliver (by hand or courier) your written comments (one original and two copies) before the close of the comment period to either of the following addresses: a. Room 445-G, Hubert H. Humphrey Building, 200 Independence Avenue, SW., Washington, DC 20201. (Because access to the interior of the HHH Building is not readily available to persons without Federal Government identification, commenters are encouraged to leave their comments in the CMS drop slots located in the main lobby of the building. A stamp-in clock is available for persons wishing to retain a proof of filing by stamping in and retaining an extra copy of the comments being filed.) b. 7500 Security Boulevard, Baltimore, MD 21244-1850. If you intend to deliver your comments to the Baltimore address, please call telephone number
(410)786-7195 in advance to schedule your arrival with one of our staff members. Comments mailed to the addresses indicated as appropriate for hand or courier delivery may be delayed and received after the comment period. *Submission of comments on paperwork requirements.* You may submit comments on this document's paperwork requirements by following instructions at the end of the “Collection of Information Requirements” section in this document. For information on viewing public comments, see the beginning of the SUPPLEMENTARY INFORMATION section. FOR FURTHER INFORMATION CONTACT: Tzvi Hefter,
(410)786-4487, General information Judy Richter,
(410)786-2590, Moratorium and 25 percent patient threshold adjustment. SUPPLEMENTARY INFORMATION: *Inspection of Public Comments:* All comments received before the close of the comment period are available for viewing by the public, including any personally identifiable or confidential business information that is included in a comment. We post all comments received before the close of the comment period on the following Web site as soon as possible after they have been received: *http://www.regulations.gov.* Follow the search instructions on the Web site to view public comments. Comments received timely will be also available for public inspection as they are received, generally beginning approximately 3 weeks after publication of a document, at the headquarters of the Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, Maryland 21244, Monday through Friday of each week from 8:30 a.m. to 4 p.m. To schedule an appointment to view public comments, phone 1-800-743-3951. I. Background A. Legislative and Regulatory Authority Section 123 of the Medicare, Medicaid, and SCHIP [State Children's Health Insurance Program] Balanced Budget Refinement Act of 1999
(BBRA)(Pub. L. 106-113), as amended by section 307(b) of the Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000
(BIPA)(Pub. L. 106-554), provides for payment for both the operating and capital-related costs of hospital inpatient stays in long-term care hospitals (LTCHs) under Medicare Part A based on prospectively set rates. The Medicare prospective payment system
(PPS)for LTCHs applies to hospitals described in section 1886(d)(1)(B)(iv) of the Social Security Act (the Act), effective for cost reporting periods beginning on or after October 1, 2002. Section 1886(d)(1)(B)(iv)(I) of the Act defines a LTCH as “a hospital which has an average inpatient length of stay (as determined by the Secretary) of greater than 25 days.” Section 1886(d)(1)(B)(iv)(II) of the Act also provides an alternative definition of LTCHs: Specifically, a hospital that first received payment under section 1886(d) of the Act in 1986 and has an average inpatient length of stay
(LOS)(as determined by the Secretary of Health and Human Services (the Secretary)) of greater than 20 days and has 80 percent or more of its annual Medicare inpatient discharges with a principal diagnosis that reflects a finding of neoplastic disease in the 12-month cost reporting period ending in fiscal year
(FY)1997. Section 307(b)(1) of the BIPA, among other things, mandates that the Secretary shall examine, and may provide for, adjustments to payments under the LTCH PPS, including adjustments to diagnosis related group
(DRG)weights, area wage adjustments, geographic reclassification, outliers, updates, and a disproportionate share adjustment. In the August 30, 2002 **Federal Register** , we issued a final rule that implemented the LTCH PPS authorized under BBRA and BIPA (67 FR 55954). This system uses information from LTCH patient records to classify patients into distinct long-term care diagnosis-related groups (LTC-DRGs) based on clinical characteristics and expected resource needs. Payments are calculated for each LTC-DRG and provisions are made for appropriate payment adjustments. Payment rates under the LTCH PPS are updated annually and published in the **Federal Register** . In the August 30, 2002 final rule, we also presented an in-depth discussion of the LTCH PPS, including the patient classification system, relative weights, payment rates, additional payments (short-stay outliers), and the budget neutrality requirements mandated by section 123 of the BBRA. The same final rule that established regulations for the LTCH PPS under 42 CFR part 412, subpart O, also contained LTCH provisions related to covered inpatient services, limitation on charges to beneficiaries, medical review requirements, furnishing of inpatient hospital services directly or under arrangement, and reporting and recordkeeping requirements. We refer readers to the August 30, 2002 final rule for a comprehensive discussion of the research and data that supported the establishment of the LTCH PPS (67 FR 55954). The most recent annual update to the LTCH PPS was presented in the RY 2009 LTCH PPS final rule (73 FR 26788). In that final rule, among other things, we established a 2.7 percent update to the Federal rate for RY 2009, and presented other payment rate and policy changes, including revising the rate year to a year beginning October 1 and ending on September 30. (The 2009 rate year will begin on July 1, 2008 and end on September 30, 2009). On December 29, 2007 the Medicare, Medicaid, and SCHIP Extension Act (MMSEA) (Pub. L. 110-173) was enacted. Specifically, section 114 of MMSEA, entitled “Long-term care hospitals,” made a number of changes affecting payments to LTCHs for inpatient services. Two of the provisions of section 114 of MMSEA are discussed in this interim final rule with comment period. B. Criteria for Classification as a LTCH Under the existing regulations at § 412.23(e)(1) and (e)(2)(i), which implement section 1886(d)(1)(B)(iv)(I) of the Act, to qualify to be paid as a LTCH, a hospital must have a provider agreement with Medicare and must have an average Medicare inpatient LOS of greater than 25 days. Alternatively, to be classified as a LTCH, a hospital must have a provider agreement with Medicare and meet the average LOS requirement in § 412.23(e)(2)(ii). Section 412.23(e)(2)(ii) states that for cost reporting periods beginning on or after August 5, 1997, a hospital that was first excluded from the PPS in 1986 meets the LOS criteria if it has an average inpatient LOS for all patients, including both Medicare and non-Medicare inpatients, of greater than 20 days, and can also demonstrate that at least 80 percent of its annual Medicare inpatient discharges in the 12-month cost reporting period ending in FY 1997 have a principal diagnosis that reflects a finding of neoplastic disease. Section 412.23(e)(3) currently provides that, subject to the provisions of paragraphs (e)(3)(ii) through (e)(3)(iv) of this section, the average Medicare inpatient LOS, specified under § 412.23(e)(2)(i) is calculated by dividing the total number of covered and noncovered days of stay for Medicare inpatients (less leave or pass days; that is, days where the inpatient is not occupying a bed but has not been discharged) by the number of total Medicare discharges for the hospital's most recent complete cost reporting period. The fiscal intermediaries
(FIs)or Medicare Administrative Contractors
(MACs)verify that LTCHs meet the average LOS requirements. (For a more detailed explanation, see the June 6, 2003 final rule (68 FR 34123).) II. Provisions of this Interim Final Rule with Comment Period Section 114 of MMSEA made a number of changes affecting payments to long-term care hospitals (LTCHs) for inpatient services. This interim final rule with comment period implements the following provisions affecting LTCH PPS payments: • Modification of payment adjustments to LTCHs and LTCH satellite discharges that were admitted from specific referring hospitals and that exceed various percentage thresholds. Sections 114(c)(1) and
(2)of MMSEA mandates specific changes for 3 years, beginning with cost reporting periods beginning on or after December 29, 2007, with respect to existing § 412.534, which governs the “25 percent threshold” payment adjustment to LTCH hospitals-within-hospitals
(HwHs)and LTCH satellite facilities for discharges that were admitted from their co-located hosts (established in the FY 2005 IPPS final rule and amended in the RY 2008 LTCH PPS final rule), and existing § 412.536, which applies a payment adjustment policy (that was in transition to 25 percent prior to the enactment of this law) to LTCH and LTCH satellite facility discharges that were admitted from any individual hospital not co-located with the LTCH or LTCH satellite facility (established in the RY 2008 LTCH PPS final rule), as discussed in section II.B. of this interim final rule with comment period. • *Moratorium on new LTCHs, LTCH satellite facilities, and increase in beds in existing LTCHs and LTCH satellite facilities.* Section 114(d) of MMSEA established a 3-year moratorium beginning on December 29, 2007 on the establishment and classification of new LTCHs, LTCH satellite facilities, and on any increase in beds in existing LTCHs and LTCH satellite facilities, with certain exceptions. Section 114 of MMSEA made other changes affecting LTCH PPS payments. The following is a listing of the other rulemaking documents published and respective provisions of section 114 of MMSEA that were implemented: • In the May 1, 2008 interim final rule with comment period (73 FR 24871)— ++ *Modification of payment adjustments to certain SSO cases.* Section 114(c)(3) of MMSEA specifies that the refinement of the SSO policy implemented in RY 2008 (see § 412.529(c)(3)(i)) shall not apply for a 3-year period beginning with discharges occurring on or after December 29, 2007. Specifically, the fourth SSO payment option in § 412.529(c)(3)(i) as revised in the RY 2008 LTCH PPS final rule shall not apply for a 3-year period. ++ *Revision to the RY 2008 rate provision.* Section 114(e)(1) of MMSEA provides that the base rate for RY 2008 “shall be the same as the base rate for discharges for the hospital occurring during the rate year ending in 2007.” Furthermore, in accordance with section 114(e)(2) of MMSEA, the revised rate will not be applicable to discharges occurring on or after July 1, 2007 and before April 1, 2008. • In the January 29, 2008 proposed rule and May 9, 2008 final rule Section 114(c)(4) of MMSEA specifies that for a 3-year period beginning on December 29, 2007, the Secretary shall not make the one-time prospective adjustment to the LTCH PPS payment rates provided for in existing § 412.523(d)(3). We also note that section 114 of MMSEA included additional provisions focusing on LTCHs but are not directly related to payment policy. The following is a list of those policies which are not included in this interim final rule with comment period: • Section 1861 of the Act is amended by adding a new paragraph
(ccc)defining LTCHs. • The Secretary is directed to conduct a study and submit a report to the Congress within 18 months after the date of enactment of MMSEA. The Secretary will conduct a study on the establishment of national LTCH facility and patient criteria. • The Secretary is directed to provide an expanded review of medical necessity for LTCH admission and continued stay. A. Payment Adjustment to LTCHs and LTCH Satellite Facilities The enactment of section 114(c) of MMSEA requires several modifications to payment provisions applicable to various types of LTCHs under the regulations at § 412.534 and § 412.536. (Throughout this section, “LTCH” or “LTCH satellite facility” refers exclusively to “subclause (I)” LTCHs and LTCH satellite facilities, that is, LTCHs defined by section 1886(d)(1)(B)(iv)(I) of the Act. This is the case because the policies established at § 412.534 and § 412.536 do not apply to a “subclause (II)” LTCH defined under section 1886(d)(1)(B)(iv)(II) (69 FR 49205 and 72 FR 26924). Currently, § 412.534 provides for a payment adjustment for a co-located LTCH (HwH or satellite), based upon the percentage of the HwH's or satellite's Medicare discharges that had been admitted from a hospital with which it is co-located (typically, an acute care hospital). As specified in the RY 2008 LTCH PPS final rule (72 FR 26870), § 412.534 also applies to a “grandfathered” LTCH HwH or LTCH satellite facility, that is not required to meet the “separateness and control” policies at § 412.22(e) or (h)(2)(iii), respectively, regarding its relationship to the hospital with which it is co-located (see 72 FR 26926 through 26928). In the RY 2008 LTCH PPS final rule, we also established, at § 412.536, an adjustment based on the percentage of Medicare discharges that had been admitted to a LTCH or LTCH satellite facility, from an individual referring hospital with which the LTCH or LTCH satellite facility is not co-located. When we extended the policy in § 412.534 to grandfathered LTCH HwHs and LTCH satellite facilities in the RY 2008 LTCH PPS final rule, we provided for a parallel 3-year transition to the full percentage threshold for cost reporting periods beginning on or after July 1, 2007 at § 412.534(h) for “grandfathered” LTCHs and LTCH satellite facilities discharging patients admitted from their host hospitals and at § 412.536(f) for discharges that were admitted to a LTCH or LTCH satellite facility from any referring hospital with which they were not co-located (72 FR 26944). In this interim final rule with comment period, we are revising our regulations at § 412.534 and § 412.536 to implement the requirements of sections 114(c)(1) and 114(c)(2) of MMSEA. Specifically, for cost reporting periods beginning on or after December 29, 2007 and before December 29, 2010, section 114(c)(1) of MMSEA generally exempts “freestanding” LTCHs (that is, as newly defined in § 412.23(e)(5), a LTCH that meets the requirements at § 412.23(e)(1) and (2), and does not occupy space in a building also used by another hospital or does not occupy space in one or more separate or entire buildings located on the same campus as buildings used by another hospital, and is not part of a hospital that provides inpatient services in a building also used by another hospital and “grandfathered” LTCH HwHs (that is, “a long-term care hospital identified by the amendment made by section 4417(a) of the Balanced Budget Act of 1997 (Pub. L. 105-33)”) from the applicable percentage threshold policy established at § 412.536. The statutory provision also exempts grandfathered HwHs from the applicable percentage threshold at § 412.534(h). Accordingly, for cost reporting periods beginning on or after December 29, 2007, for a 3-year period, the adjustments at § 412.536 will not apply to “freestanding” LTCHs and the adjustments at § 412.534 and § 412.536 will not apply to “grandfathered” LTCH HwHs. Furthermore, the legislation prohibits the application of “any similar provisions” to either “freestanding” LTCHs or to “grandfathered” LTCH HwHs for that same 3-year period. Section 114(c)(2) of MMSEA also revises the current percentage thresholds at § 412.534 for applicable LTCHs HwHs and LTCH satellite facilities. We are providing two tables to illustrate the statutory and regulatory changes for LTCHs and LTCHs satellite facilities associated with the implementation of section 114(c)(1) and
(2)of MMSEA. Table 1 indicates the applicability of the specific provisions of section 114(c)(1) and
(2)of MMSEA by type of LTCH or LTCH satellite facility. Table 2, indicates the applicability of § 412.534 and § 412.536 by type of LTCH or LTCH satellite facility. Table 1.—Applicability of Section 114(c)(1) and
(2)of MMSEA by LTCH Type LTCH type Applicability of Section 114(c)(1)(A) of MMSEA Section 114(c)(1)(B) of MMSEA Section 114(c)(2)(A) of MMSEA Section 114(c)(2)(B) of MMSEA Freestanding LTCHs Yes N/A N/A N/A. Grandfathered HwHs (under section 4417(a) of the BBA § 412.22(f)) 1 N/A Yes N/A N/A. Nongrandfathered HwHs Subject to Transition at § 412.534(g) 2 N/A N/A Yes Yes. Nongrandfathered HwHs *not* Subject to Transition at § 412.534(g) 3 N/A N/A N/A N/A. Grandfathered LTCH Satellites (§ 412.22(h)(3)(i)) 4 N/A N/A N/A N/A. Nongrandfathered LTCH Satellites Subject to Transition at § 412.534(g) 5 N/A N/A Yes Yes. Nongrandfathered LTCH Satellites *not* Subject to Transition at § 412.534(g) 6 N/A N/A N/A N/A. 1 These are LTCH HwHs that were not required to meet the “separateness and control” policies at § 412.22(e) and were so classified by the Secretary on or before September 30, 1995. 2 These are LTCH HwHs subject to the separateness and control policies at § 412.22(e) that were paid under the LTCH PPS as of October 1, 2004 or an LTCH HwH paid under the LTCH PPS as of October 1, 2005 whose qualifying period began on or before October 1, 2004. 3 These are LTCH HwHs subject to the separateness and control policies at § 412.22(e) *not* paid under the LTCH PPS as of October 1, 2004, or October 1, 2005 with a qualifying period that began on or before October 1, 2004. 4 These are LTCH satellites not subject to the separateness and control policies at§ 412.22(h)(2)(iii) and that were structured as satellite facilities on September 30, 1999 and excluded from the IPPS on that date. 5 These are LTCH satellites subject to the separateness and control policies at § 412.22(h)(2)(iii) that were paid under the LTCH PPS as of October 1, 2004. 6 These are LTCH satellites subject to the separateness and control policies at § 412.22(h)(2)(iii) that were *not* paid under the LTCH PPS as of October 1, 2004. Table 2.—Revisions to § 412.534 and § 412.536 of the Regulations in Accordance With Section 114(c)(1) and
(2)of MMSEA by LTCH Type LTCH type* Applicability of § 412.534 § 412.536 Freestanding (as described § 412.23(e)(5) of the regulations) N/A 3-year delay for cost reporting periods beginning on or after 12/29/2007 and before 12/29/2010. (Section 114(c)(1)(A) of MMSEA). Nongrandfathered HwH (as described § 412.23(e)(2)(i) that meet the criteria in § 412.22(e))
(1)If subject to the transition at § 412.534(g) (including those located in rural areas or co-located with an MSA-dominant hospital or urban-single hospital), applicable but with *revised* thresholds No change. Applicable subject to existing transition at § 412.536(f).
(2)If not subject to the transition at § 412.534(g) (including those located in rural areas or co-located with an MSA-dominant hospital or urban-single hospital), § 412.534 is applicable with *no change* in thresholds Grandfathered HwH (as described in section 4417(a) of the BBA and described in § 412.23(e)(2)(i) and meets the criteria of § 412.22(f) of the regulations) 3-year delay for cost reporting periods beginning on or after 12/29/2007 and before 12/29/2010 (as specified in section 114(c)(1)(B) of MMSEA 3-year delay for cost reporting periods beginning on or after 12/29/2007 and before 12/29/2010 (as specified in section 114(c)(1)(B) of MMSEA). Nongrandfathered LTCH Satellite Facility (as described in § 412.23(e)(2)(i) and meets the criteria of § 412.22(h) of the regulations)
(1)If subject to the transition in § 412.534(g) (including those located in rural areas or co-located with an MSA-dominant hospital or urban-single hospital), is applicable but with *revised* thresholds No change—Applicable Subject to existing transition at § 412.536(f).
(2)If not subject to the transition in § 412.534(g) (including those located in rural areas or co-located with an MSA-dominant hospital or urban-single hospital), is applicable with *no change* in thresholds Grandfathered LTCH Satellite Facility (as described in § 412.23(e)(2)(i) that meets the criteria § 412.22(h)(3)(i)) Applicable—subject to transition at § 412.534(h) No change. Applicable subject to existing transition at § 412.536(f). * Neither § 412.534 or § 412.536 apply to a section 1886(d)(1)(B)(iv)(II) of the Act “subclause (II)” LTCH or LTCH satellite facility. For purposes of the requirements of section 114(c) of MMSEA, the distinction between a freestanding LTCH and a LTCH that is co-located as either an HwH or a LTCH satellite facility is significant. A “freestanding” LTCH is a LTCH which is not co-located with another hospital-level provider as either a HwH, defined at § 412.22(e), or as a satellite of a hospital as defined at § 412.22(h)(1). A HwH is defined at § 412.22(e) as “* * * a hospital that occupies space in a building also used by another hospital, or in one or more separate buildings located on the same campus as buildings used by another hospital * * *” At § 412.22(f) we describe “grandfathered” HwHs which meet the definition at § 412.22(e) but are exempt from the “separateness and control” policies at § 412.22(e)(1). The term “satellite facilities” defined at § 412.22(h) which addresses satellites of hospitals; is “* * * a part of a hospital that provides inpatient services in a building also used by another hospital, or in one or more entire buildings located on the same campus as buildings used by another hospital * * *” For purposes of the HwH regulations at § 412.22(e) and the satellite regulations at § 412.22(h), we utilize the definition of “campus” in the provider-based regulations at § 413.65(a)(2). Section 413.65 defines a campus as “the physical area immediately adjacent to the provider's main buildings, other areas and structures that are not strictly contiguous to the main buildings but are located within 250 yards of the main buildings, and any other areas determined on an individual basis, by the CMS regional office, to be part of the provider's campus.” Section 114(c) of MMSEA employs the term “freestanding” in identifying one group of LTCHs which the provision exempted from the 25 percent patient threshold adjustment for 3 years. The statute did not define the term freestanding LTCHs in section 114(c)(1)(A) of MMSEA which pertains to the adjustment policy in § 412.536 or any similar provision. In order to minimize confusion and ensure the MMSEA is implemented consistently, we are adding a definition for freestanding LTCH to our regulations at § 412.23(e)(5). The definition is consistent with our application of the concept under § 412.534 and § 412.536. For purposes of section 114(c) of MMSEA, therefore, we are establishing a regulatory definition of a “freestanding LTCH” at § 412.23(e)(5), as a hospital that meets the requirements of § 412.23(e)(1) and
(2)that does not occupy space in a building also used by another hospital, or in one or more separate or entire buildings located on the same campus as buildings used by another hospital or is not part of a hospital that provides inpatient services in a building also used by another hospital. As noted above, section 114(c)(1)(B) of MMSEA specifies a 3-year delay, effective with cost reporting periods beginning on or after the date of enactment of MMSEA (that is, December 29, 2007), in the application of “such section, or § 412.534 of title 42, Code of Federal Regulations, or any similar provisions to a long-term care hospital identified by the amendment made by section 4417(a) of the Balance Budget Act
(BBA)of 1997 (Pub. L. 105-33).” We believe that the phrase “such section” refers to § 412.536 because this provision is the main topic of the preceding subparagraph (A). We further believe that the inclusion of the phrase “or any similar provisions” after specifying § 412.534, in section 114(c)(1)(B) of MMSEA exempts “grandfathered” LTCHs from any regulatory scheme which would apply a percentage patient payment adjustment similar to that in § 412.534 or § 412.536 for a 3-year period. As noted above, the type of LTCH identified by section 4417(a) of the BBA is limited to a “grandfathered” LTCH HwH. Section 4417(a) of the BBA (which amended section 1886(d)(1)(B) of the Act) specifies that “[a] hospital that was classified by the Secretary on or before September 30, 1995, as a hospital described in clause
(iv)shall continue to be so classified notwithstanding that it is located in the same building as, or on the same campus as, another hospital.” (Section 1886(d)(1)(B)(iv) of the Act sets forth the definition of LTCHs.) Section 4417(a) of BBA effectively exempted this particular group of LTCH HwHs from the “separateness and control” policies at § 412.22(e)(2) which govern the relationship between a HwH and the hospital with which it is co-located. These “grandfathered” LTCHs are allowed to maintain their IPPS-exclusions so long as they continue to comply with applicable Medicare requirements. As noted above, section 114(c)(1)(B) of MMSEA provides that the Secretary shall not apply the percentage thresholds established at § 412.536 and § 412.534 (or any similar provisions) for a 3-year period, for cost reporting periods beginning on or after the date of enactment, December 29, 2007, to “grandfathered” LTCH HwHs. Section 114(c)(1)(A) of MMSEA also specifies that the Secretary shall not apply the provisions at § 412.536 (or any similar provision) to “freestanding” LTCHs for the 3-year period for cost-reporting periods beginning on or after December 29, 2007. However, it is important to note that both “grandfathered” LTCH HwHs and “freestanding” LTCHs for cost reporting periods beginning *before* December 29, 2007, *remain* subject to the applicable payment adjustments specified in § 412.534(h) and § 412.536, for that particular cost reporting period. Section 412.534(h), with respect to “grandfathered” LTCHs, and § 412.536 with respect to all LTCHs were implemented for cost-reporting period beginning on or after July 1, 2007. The policy modifications mandated by section 114(c) of MMSEA are effective” * * * for cost reporting periods beginning on or after the date of enactment of this Act for a 3-year period.” Therefore, a “grandfathered” or a “freestanding” LTCH with a cost reporting period that begins on or after July 1, 2007 but before December 29, 2007, would be subject to the provisions of § 412.534 and § 412.536, as appropriate, until the start of its next cost reporting period. For example, for a LTCH with a cost reporting period beginning on July 1, 2007, the changes required by section 114(c) of MMSEA would only apply beginning on or after July 1, 2008. The 3 years of relief available to such a facility would continue until the end of its cost reporting period that began before December 29, 2010 (that is, the LTCH's last cost reporting period affected by this provision would begin July 1, 2010 and end June 30, 2011). In another example, for a LTCH that had a September 1 through August 31 cost reporting period, the first cost reporting period for which it would be granted the relief specified in section 114(c) of MMSEA, would be its cost reporting period beginning on September 1, 2008 and the last cost reporting period would be the period beginning on September 1, 2010 and ending on August 31, 2011. Although section 114(c)(1) of MMSEA exempts “grandfathered” LTCH HwHs from the “25 percent patient threshold payment adjustment” at § 412.534 and § 412.536, a “grandfathered” satellite of a LTCH, under § 412.22(h)(3) continues to be subject to the applicable percentage thresholds outlined in § 412.536 for patients admitted from any individual hospital with which it is not co-located because there are no exceptions under the MMSEA for such entities for purposes of § 412.536. Also, grandfathered LTCH satellites continue to be subject to the applicable existing percentage thresholds in § 412.534(h) for patients admitted from their co-located hospital because there are no exceptions for these entities under the MMSEA for purposes of § 412.534. The existing transitions to the full payment adjustments for “grandfathered” LTCH satellites at § 412.534(h)(2) also continue to apply. The revision to the percentages made by section 114(c)(2) of MMSEA were limited to a hospital a LTCH satellite subject to the transition rules at § 412.534(g). Grandfathered LTCH satellites are subject to the transition at § 412.534(h), not to those at § 412.534(g). Specifically, in the case of a satellite of a LTCH that is described under paragraph (h)(1), the thresholds applied at (c), (d), and
(e)will not be less than the percentage specific below: • For cost reporting periods beginning on or after July 1, 2007 and before July 1, 2008 a threshold of the lesser of 75 percent of the total number of Medicare discharges that were admitted to the LTCH satellite facility from its co-located hospital during the cost reporting period or the percentage of Medicare discharges that had been admitted to the LTCH satellite facility from that co-located hospital during the satellite's RY 2005 cost reporting period. • For cost reporting periods beginning on or after July 1, 2008 and before July 1, 2009, we use the formula in the paragraph above except that we substitute 50 percent for 75 percent; and • For cost reporting periods beginning on or after July 1, 2009, the 25 percent adjustment is applied. Similarly, the transition to the full 25 percent threshold or applicable threshold provided at § 412.536(f) continues to be applicable for discharges that were admitted to a nongrandfathered HwH or a nongrandfathered LTCH satellite facility or grandfathered satellite facility from any hospital with which the HwH or LTCH satellite facility is not co-located, because section 114(c)(1) of MMSEA provides no exceptions for such entities. This transition at § 412.536 parallels the transition at § 412.534(h)(2). With respect to LTCH HwHs and LTCH satellite facilities that are not grandfathered, the applicable percentage thresholds established at § 412.536, continue to apply because the MMSEA provides no exceptions for such entities. In addition, nongrandfathered HwHs and both grandfathered and nongrandfatered LTCH satellite facilities continue to be subject to § 412.534. However, to the extent a nongrandfathered LTCH HwH or LTCH satellite facility meets the definition of an “applicable long-term care hospital or satellite facility,” the *revised* percentage thresholds in section 114(c)(2)(A) and (B)(i) of MMSEA apply for cost reporting periods beginning on or after December 29, 2007 and before December 29, 2010. Specifically, section 114(c)(2)(B)(i) of MMSEA of 2007 modifies the percentage thresholds specified in existing § 412.534(c) from 25 percent to 50 percent for “an applicable” LTCH HwH or LTCH satellite facility described below, for 3 years, for cost reporting periods beginning on or after December 29, 2007. Therefore, payment to an applicable LTCH or LTCH satellite facility which is co-located with another hospital shall not be subject to any payment adjustment under § 412.534 if no more than 50 percent of the hospital's Medicare discharges during the hospital's fiscal year (other than discharges described in § 412.534(c)(3)) are admitted from the co-located hospital. (We note that § 412.534(c)(3) expressly excludes patients who had achieved high cost outlier status at the discharging co-located hospital.) Section 114(c)(2)(B)(ii) of MMSEA defines “an applicable long-term care hospital or satellite facility” as “* * * a hospital or satellite facility that is subject to the transition rules under § 412.534(g) * * *” The transition rules in § 412.534(g) apply to LTCH HwH and satellites that had been paid under the LTCH PPS as of October 1, 2004 or a LTCH HwH that is paid under the LTCH PPS on October 1, 2005 whose qualifying period under § 412.23(e) began on or before October 1, 2004 (see 69 FR 49206). Accordingly, an applicable LTCH HwH and LTCH satellite facility for purposes of section 114(c)(2)(ii) of the MMSEA is “* * * a long-term care hospital or a satellite facility that is paid under the provisions of subpart O on October 1, 2004 or of a hospital that is paid under the provisions of subpart O and whose qualifying period under § 412.23(e) began on or before October 1, 2004 * * *” (§ 412.534(g)). (For a more detailed explanation, see the FY 2005 IPPS final rule.) Therefore, if a nongrandfathered LTCH or LTCH satellite facility does not meet the definition of an “applicable long-term care hospital or satellite facility”, the thresholds established under existing § 412.534 are not modified by section 114(c)(2) of MMSEA. The revised thresholds under section 114(c)(2)(A) of MMSEA for “applicable” LTCH HwHs and LTCH satellite facilities are as follows: The provision raises the existing 50 percent ceiling on percentage thresholds for “applicable” LTCH HwHs or LTCH satellite facilities that are located either in rural areas or that are co-located with an urban single or metropolitan statistical area (MSA-dominant) hospital (under § 412.534 (d)(1), (e)(1), and (e)(4) of the regulations) to 75 percent. (We note that § 412.534(d)(2) and (e)(3), which expressly excludes patients who had achieved high cost outlier status at the discharging co-located hospital prior to admission to the LTCH or LTCH satellite from being counted towards the threshold has not been modified.) In other words, payment to an applicable LTCH or satellite facility which is located in a rural area or which is co-located with an urban single or MSA dominant hospital under § 412.534(d)(1), (e)(1), and (e)(4) is not subject to any payment adjustment under such section if no more than 75 percent of the hospital's Medicare discharges (other than discharges described in § 412.534(d)(2) or (e)(3)) are admitted from a co-located hospital. Section 114(c)(2) of MMSEA also raises the existing 25 percent patient threshold payment adjustment to “applicable” LTCH HwHs and LTCH satellites, defined previously, from 25 percent to 50 percent. Furthermore, we would also emphasize that since this modification only applies to “applicable” LTCHs and LTCH satellites, as defined in paragraph section 114(c)(2)(B)(ii) of MMSEA, those LTCH HwHs and LTCH satellites that were not subject to the transition policy set forth at § 412.534(g), will continue to have the existing patient percentage threshold applied. In accordance with the transition policy specified at § 412.534(g), for cost reporting periods beginning on or after October 1, 2007, the percentage threshold even for “applicable” LTCH HwHs and LTCH satellite facilities decreased from 50 percent to 25 percent for LTCH HwHs and LTCH satellite facilities and the thresholds for rural, MSA-dominant, and urban single LTCHs and LTCH satellite facilities were held at 50 percent (see § 412.534(d) and (e)). Since the percentage threshold modifications established under section 114(c)(2) of MMSEA are implemented for cost reporting periods beginning on or after December 29, 2007, if an “applicable” LTCH HwH and LTCH satellite had a cost reporting period beginning before that date (specifically, a cost reporting period beginning on or after October 1, 2007 and before December 29, 2007), the facility would be subject to the 25 percent threshold that was in effect at the start of that cost reporting period or a 50 percent threshold if the facility was located in a rural area or is co-located with an MSA-dominant or urban single hospital. However, for 3 years, beginning with the “applicable” HwH's or LTCH satellite's first cost reporting period beginning on or after December 29, 2007 the percentage thresholds increase to 50 percent and for an “applicable” LTCH HwHs and satellites located in a rural area, or co-located with an MSA-dominant, or urban single hospital for that 3-year period, the 50 percent threshold increases to 75 percent. In compliance with section 114(c) of MMSEA, we have revised § 412.534 and § 412.536 to implement the 3-year delay in the application of the percentage patient threshold payment adjustment to “freestanding and grandfathered LTCHs” and the 3-year revision in the percentage payment thresholds adjustments for “applicable” LTCHs and satellite facilities. We have also made technical corrections to § 412.534(b) in order to clarify the effective dates of the percentage patient threshold policy for discharges from a LTCH HwH or from a LTCH satellite that were admitted from the hospital with which it is co-located. B. Moratorium on the Establishment of Long-Term Care Hospitals, Long-Term Care Hospital Satellite Facilities, and on the Increase in Number of Beds in Existing Long-Term Care Hospitals or Long-Term Care Hospital Satellite Facilities 1. Overview Section 114(d) of MMSEA provides a 3-year moratorium with two distinct aspects, one for the establishment of new LTCHs and LTCH satellite facilities, and the other for the increase of hospital beds in existing LTCHs and LTCH satellite facilities. Specifically, section 114(d)(1)(A) of MMSEA provides that the Secretary shall impose a moratorium “subject to paragraph (2), on the establishment and classification of a long-term care hospital or satellite facility, other than an existing long-term care hospital or facility.” Section 114 (d)(1)(B) of MMSEA provides that, the Secretary shall impose a moratorium “subject to paragraph (3), on an increase of long-term care hospital beds in existing long-term care hospitals or satellite facilities.” Sections 114(d)(2) and (d)(3) of MMSEA provide for exceptions to the moratorium imposed by section 114(d)(1) of MMSEA. It is important to note that the two categories of exceptions are mutually exclusive. The three exceptions specified in section 114(d)(2) of MMSEA, discussed below, are only applicable to the moratorium provision at section 114(d)(1)(A) of MMSEA, which applies exclusively to the establishment and classification of a LTCH or LTCH satellite facility. The three exceptions in section 114(d)(2) do not apply to the moratorium on an increase in beds at section 114(d)(1)(B) of MMSEA. Similarly, the exception at section 114(d)(3)(A) of MMSEA only applies to the moratorium on increases in beds at existing LTCHs or LTCH satellites facilities, and not to the moratorium on the establishment of LTCHs and LTCH satellite facilities. 2. Analysis of Exceptions to the Moratorium on the Establishment of New LTCHs and LTCH Satellite Facilities In section 114(d)(1)(A) of MMSEA, the statute specifically provides for a 3-year moratorium effective on the date of enactment of the MMSEA on the establishment and classification of a long-term care hospital or satellite facility, other than an existing LTCH or facility. (The term “existing,” with respect to a hospital or satellite facility, is defined in the legislation at section 114(d)(4) of MMSEA as “a hospital or satellite facility that received payment under the provisions of subpart O of part 412 of title 42, Code of Federal Regulations, as of the date of the enactment of this Act.”) The MMSEA was enacted on December 29, 2007. Therefore, the moratorium will be effective from December 29, 2007 through December 28, 2010. Section 114(d)(2) of MMSEA specifies that the moratorium on the establishment and classification of a LTCH or LTCH satellite facility does not apply to a LTCH that, as of December 29, 2007, met one of the following three exceptions: • The LTCH began “its qualifying period for payment as a long-term care hospital under section 412.23(e) of title 42, Code of Federal regulations, on or before the date of enactment of this Act” (section 114(d)(2)(A)). • The LTCH has a binding written agreement with an outside, unrelated party for the actual construction, renovation, lease, or demolition for a LTCH and has expended before December 29, 2007 at least 10 percent of the estimated cost of the project or, if less, $2,500,000 (section 114(d)(2)(B)). • The LTCH has obtained an approved certificate of need in a State where one is required on or before December 29, 2007 (section 114(d)(2)(C)). In implementing the provisions of section 114(d) of MMSEA, we found that, in light of the unique nature of LTCHs as a category of Medicare provider, some of the terminology in the provision is internally inconsistent. Therefore, we were required to interpret the provisions in the way we believe reasonably reconciles seemingly inconsistent provisions and that results in an application of the provisions that is logical and workable. We discuss our interpretations below. Specifically, section 114(d)(1)(A) of MMSEA indicates that the moratorium on the establishment and classification of a LTCH or satellite facility, other than an existing LTCH or satellite facility, is “subject to paragraph (2).” In contrast paragraph
(2)is titled, “Exception for Certain Long-Term Care Hospitals” and it begins with “[t]he moratorium under paragraph (1)(A) shall not apply to a long-term care hospital that as of the date of the enactment of this Act.” We note that the term “satellite” is omitted in paragraph
(2)even though satellites are entities subject to the moratorium provision. Because section 114(d)(1)(A) of MMSEA appears to contemplate an exception to the moratorium for both qualifying LTCHs and qualifying satellite facilities, we believe that it is appropriate to apply paragraph
(2)to new LTCH satellite facilities just as it applies to LTCHs. Our interpretation of the statute is premised on this presumption. An additional problem with paragraph
(2)of section 114(d) of MMSEA is that a strictly literal reading of the statutory language in that paragraph presents practical challenges for implementation in light of the established LTCH classification criteria in section 412.23(e). Below, we examine the exceptions to the moratorium on the establishment and classification of a long-term care hospital or satellite facility in light of the classification criteria for LTCHs at § 412.23(e) and the presumption that the provision allows, where practicable in limited situations, a new LTCH satellite facility to qualify for an exception under section 114(d)(2) of MMSEA. The first exception in section 114(d)(2)(A) of MMSEA applies to “a long-term care hospital that as of the date of the enactment of this Act* * * began its qualifying period for payment as a long-term care hospital under section 412.23(e) of title 42, Code of Federal Regulations, on or before the date of the enactment of this Act.” We believe this exception regarding the qualifying period refers to the period established in our regulations at § 412.23(e)(3) during which the predecessor hospital is collecting LOS data to be used to demonstrate that the hospital meets the LOS requirements (explained in more detail below) to be classified as a LTCH. Specifically in order for a hospital to be designated as a LTCH, the LTCH classification criteria regulations at § 412.23(e) stipulate the following:
(e)*Long-term care hospitals.* A long-term care hospital must meet the requirements of paragraph (e)(1) and (e)(2) of this section and, when applicable, the additional requirement of § 412.22(e), to be excluded from the prospective payment system specified in § 412.1(a)(1) and to be paid under the prospective payment system specified in § 412.1(a)(4) and in Subpart O of this part.
(1)*Provider agreements.* The hospital must have a provider agreement under Part 489 of this chapter to participate as a hospital; and
(2)*Average length of stay.*
(i)The hospital must have an average Medicare inpatient length of stay of greater than 25 days; * * * As provided by § 412.23(e)(1), the qualifying period for a “new” or “planned” LTCH may not begin before the facility has obtained a provider agreement, under 42 CFR part 489, to participate in the Medicare program as a hospital. Typically, when a new hospital is established, after operating as a hospital, such a facility could present patient LOS data from a short (6 months) cost report using data from at least 5 months of the 6-month period immediately preceding the start of the cost reporting period for which the hospital is seeking LTCH designation. In light of how we view the qualifying period under section 412.23(e), we note that it is not possible for a LTCH, as of the date of enactment of MMSEA, to begin its qualifying period as a LTCH. Technically, under the LTCH classification criteria regulations at 412.23(e), it is an existing hospital, not a LTCH, that has a qualifying period for LTCH status. Therefore, we believe that the exception specified at section 114(c)(2)(A) of MMSEA applies to an existing hospital that began its qualifying period on or before December 29, 2007 for LTCH status. To qualify for the exception to the moratorium, the LOS data used to demonstrate that the hospital has an average LOS greater than 25 days must be from its cost reporting period that began on or before December 29, 2007. In addition, we note that the exception at section 114(d)(2)(A) of MMSEA would not be applicable to satellite facilities since there is no “qualifying period” for the establishment of a satellite facility for payment as a LTCH under § 412.23(e). Next, under section 114(d)(2)(B) of MMSEA, an exception to the moratorium is made for a long-term care hospital that, as of the date of the enactment of the MMSEA (December 29, 2007), satisfies the two prongs of the exception:
(1)it has a binding written agreement with an outside, unrelated party for the actual construction, renovation, lease, or demolition for a long-term care hospital; and
(2)It has expended, before the date of enactment of this Act, at least 10 percent of the estimated cost of the project (or, if less, $2,500,000). As drafted, this provision is problematic in light of § 412.23(e). For example, where a hospital has not even been built, but there is a binding written agreement for the actual construction of a hospital that intends to be classified as a LTCH, technically it is not a LTCH that is party to the binding written agreement. In such a situation, no LTCH would yet exist. Prior to the existence of a LTCH, a hospital must first be established, certified, and complete the procedures specified in § 412.23(e) in order to qualify as a LTCH, at which point the hospital would be classified as a LTCH. In light of the LTCH classification criteria in § 412.23(e), and our presumption that new LTCH satellite facilities are included in the exceptions in section 114(d)(2) of MMSEA, the exception in section 114(d)(2)(B) of MMSEA applies in the following three circumstances:
(1)As of the date of enactment of the MMSEA, an existing hospital (that is, one that was certified as a hospital as of December 29, 2007) that will become an LTCH has a binding written agreement with an outside unrelated party for the actual construction, renovation, lease, or demolition for converting the hospital to a LTCH and has expended, before December 29, 2007, at least 10 percent of the estimated cost of the project (or, if less, $2,500,000);
(2)as of the date of enactment of the MMSEA, an entity that will develop a hospital that will ultimately become a LTCH has a binding written agreement with an outside unrelated party for the actual construction, renovation, lease, or demolition for a hospital and that entity has expended, before December 29, 2007, at least 10 percent of the estimated cost of the project (or, if less, $2,500,000); and
(3)an existing LTCH, as of December 29, 2007, has a binding written agreement with an outside unrelated party for the actual construction, renovation, lease or demolition for a new LTCH satellite facility and the LTCH has expended before December 29, 2007 at least 10 percent of the estimated cost of the project (or, if less, $2,500,000). With regard to the first prong, we believe that the use of the term “actual” in the context of the “actual construction, renovation, lease, or demolition,” indicates that the the provision focuses only on the specific accomplishments cited in the statute and does not include those that are contemplated or have not yet been executed. Although we are aware that a hospital or entity may enter into binding written agreements regarding services and items (for example, feasibility studies or land purchase) and incur costs for those services and items prior to actual construction, renovation, lease or demolition, we believe those services or items are not included in the statute as a basis for the exception. With respect to the second prong, the statute specifies that the hospital or entity must have expended before December 29, 2007, at least 10 percent of the estimated cost of the project (or, if less, $2.5 million). By “cost of the project,” we believe the statute refers to the activities enumerated in the first prong: “The actual construction, renovation, lease, or demolition for a long-term care hospital.” The statute requires that the hospital or entity has spent the amount specified in the statute on the actual construction, renovation, lease, or demolition for the contemplated LTCH. Furthermore, because the statute uses the phrase “has expended” we believe that the statute requires that hospital or entity would have actually transferred funds as payment for the project as opposed to merely obligating capital and posting the cost of the project on its books as of December 29, 2007. We believe that the provision addressed the concept of “obligate” in the first prong of the test where the statute specifies “a binding written agreement * * * for the actual construction, renovation, lease, or demolition of the long-term care hospital. . .” and there is no reason to believe that the second prong of the test, which requires the “expenditure” of 10 percent of the project or if less, $2,500,000, was intended as a redundancy. The ability to post the expense on the hospital's or entity's books could be satisfied by merely having a binding written agreement under the first prong of section 114(d)(2)(B) of MMSEA. The fact that a second requirement is included that involves an expenditure indicates that an additional threshold must be met. Finally, section 114(d)(2)(C) of MMSEA provides an exception for a long-term care hospital that, as of the date of the enactment of the Act, “has obtained an approved certificate of need in a State where one is required on or before the date of the enactment of this Act.” We do not believe that the provision limits the exception to only an existing long-term care hospital that has obtained an approved certificate of need to create a new satellite of the LTCH. We note that in many instances, prior to being classified as a LTCH, a hospital is to be built by an entity with the express intention of making it into a LTCH as soon as possible. In those instances, it is not uncommon for the entity to obtain a certificate of need from the State prior to the development of the hospital. We believe that the certificate of need exception applies to a hospital or entity that was actively engaged in developing a LTCH, as evidenced by the fact that either an entity that wanted to create a LTCH but did not exist as a hospital as of December 29, 2007, had obtained a certificate of need for a hospital by the date of enactment, or an existing hospital had obtained a certificate of need to convert the hospital into a new LTCH by that date. However, this exception would not apply to a hospital that was already in existence prior to the date of enactment and that had previously obtained an approved certificate of need for a hospital (other than a LTCH) on or before December 29, 2007. The fact that a hospital may have had a certificate of need issued to it years before December 29, 2007, to operate a hospital (other than a LTCH) would not be a reason to grant it an exception, unless that certificate of need was specifically for a LTCH. Since the certificate of need process is controlled at the State level, in determining whether the hospital or entity has obtained an approved certificate of need on or before December 29, 2007, we will look to the State for that determination. 2. Analysis of Exception to the Moratorium on the Increase in Number of Long-Term Care Hospital Beds in Existing Long-Term Care Hospitals and Satellite Facilities In section 114(d)(1)(B) of MMSEA, a moratorium is also imposed on existing LTCHs or LTCH satellite facilities for the 3-year period beginning December 29, 2007 through December 28, 2010. The moratorium is on an increase of LTCH beds in existing LTCHs or LTCH satellite facilities. Therefore, during the 3-year moratorium, an existing LTCH or LTCH satellite facility may not increase the number of beds in excess of the number of Medicare-certified beds at the hospital on December 29, 2007. We are using the number of beds certified by Medicare, because this number can be verified by CMS and its contractors and this is currently referenced in our regulations at § 412.22(h)(2)(i), and similarly referenced in § 412.22(f)(1). The moratorium on an increase of beds is subject to the exception at section 114(d)(3) of MMSEA. Specifically, section 114(d)(3) of the MMSEA states that the moratorium on an increase in beds shall not apply if an existing LTCH or LTCH satellite facility is “located in a State where there is only one other long-term care hospital; and requests an increase in beds following the closure or the decrease in the number of beds of another long-term care hospital in the State.” Section 114 (d)(3)(B) of the MMSEA also provides that the exception to the moratorium on the increase in bed numbers for existing LTCHs or LTCH satellite facilities does not apply to the limit on the number of beds in “grandfathered” LTCH HwHs as specified at § 412.22(f) and LTCH satellite facilities as specified at § 412.22(h)(3). Under § 412.22(f) and § 412.22(h)(3), respectively, “grandfathered” LTCH HwHs and LTCH satellite facilities (that is, HwHs that were in existence on or before September 30, 1995 and LTCH satellite facilities that were in existence on or before September 30, 1999 and that meet certain specified conditions) are exempted from compliance with “separateness and control” policies as long as they do not increase their bed numbers. (See the FY 2007 IPPS final rule (71 FR 48106 through 48115).) Therefore, even if a “grandfathered” LTCH HwH or LTCH satellite facility is located in a State where there is only one other LTCH and it requests an increase in beds following the closure or the decrease in the number of beds of another long-term care hospital in the State, it would not be able to maintain its grandfathered status if it would increase the number of beds at the LTCH under this exception. Decisions regarding whether a specific situation will be considered to meet the exceptions to the establishment and classification of new LTCHs or new LTCH satellite facilities or the exceptions on increasing the number of beds in existing LTCHs or LTCH satellite facilities will be determined on a case-by-case basis by the applicant's FI/MAC and the CMS Regional Office (RO). In compliance with section 114(d) of MMSEA, we are revising our regulations at § 412.23 to include a description of the moratorium on the establishment of new LTCHs and LTCH satellites and the moratorium on increasing the number of beds in existing LTCHs and existing LTCH satellites. Additionally, in § 412.23(e)(5) we have established a definition of a freestanding LTCH. III. Response to Comments Because of the large number of public comments we normally receive on **Federal Register** documents, we are not able to acknowledge or respond to them individually. We will consider all comments we receive by the date and time specified in the DATES section of this preamble, and, when we proceed with a subsequent document, we will respond to the comments in the preamble to that document. IV. Waiver of Proposed Rulemaking We ordinarily publish a notice of proposed rulemaking and invite public comment on a proposed rule in accordance with 5 U.S.C. 553(b) of the Administrative Procedure Act (APA). In addition, section 1871(b)(1) of the Act provides that the Secretary shall provide for notice of the proposed regulation in the **Federal Register** and a period of not less than 60 days for public comment thereon. Section 1871(b)(2) of the Act provides for an exception to the requirement that the Secretary provide for notice of a proposed rulemaking and a period of not less than 60 days for public comment. Specifically, section 1871(b)(2)(B) of the Act provides an exception to these requirements when a law establishes a specific deadline for the implementation of a provision and the deadline is less than 150 days after the date of the enactment of the statute in which the deadline is contained. Several provisions of the MMSEA changed existing LTCH PPS policies (it affected the adjustment policies in § 412.534 and § 412.536; and placed a moratorium on new LTCHs and LTCH satellite facilities, as well as a moratorium on bed increases in existing LTCHs and LTCH satellite facilities). These changes were required to be implemented:
(1)Beginning December 29, 2007 (section 114(d) of MMSEA); or
(2)beginning with cost reporting periods beginning on or after December 29, 2007 (section 114(c)(1) and
(2)of MMSEA). Thus, the statute's deadline for implementation of the MMSEA-related policies contained in this interim final regulation was less than 150 days after the date of the enactment of the statute in which the deadline was contained. We also note that we established a definition of “freestanding LTCH” at § 412.23(e)(5) consistent with our application of § 412.534 and § 412.536 in order to ensure consistent implementation of section 114(c)(1) of the MMSEA. Therefore, under the authority of section 1871(b)(2)(B) of the Act, we are waiving notice and comment procedures for the MMSEA policy changes pertaining to § 412.534 and § 412.536 (including the addition of the definition of freestanding LTCH at § 412.23(e)(5)) as well as the moratorium on new LTCHs and LTCH satellite facilities, and the moratorium on increasing beds at an existing LTCH and an existing satellite facility of a LTCH. Moreover, we also find good cause to waive the requirement for publication of a notice of proposed rulemaking and comment on the grounds that it is unnecessary, impracticable and contrary to the public interest under the authority of 5 U.S.C. 553(b)(B). In general, this interim final rule with comment period sets forth nondiscretionary provisions of the MMSEA with respect to a moratorium on the establishment of new long-term care hospitals and long-term care satellite facilities and on the increase of long-term care hospital beds in existing LTCHs or LTCH satellite facilities, and payment policies pertaining to § 412.534 and § 412.536. Therefore, we believe pursuing notice and comment is unnecessary. Moreover, because that process would prevent timely implementation of congressionally mandated policy changes that are to be effective, as described previously in this section, we believe notice and comment procedures are impracticable and contrary to the public interest. In addition, notice and comment would delay significantly the issuance of essential guidance to the public which is necessary to assist them in making complex, time-sensitive business decisions of significant financial consequence with respect to their efforts to comply with section 114 of the MMSEA. Failure to provide this guidance would impede such business decisions. Section 1871(e)(1)(A) of the Act provides that a substantive change in regulations, manual instructions, interpretative rules, statements of policy, or guidelines of general applicability under this title shall not be applied (by extrapolation or otherwise) retroactively to items and services furnished before the effective date of the change unless the Secretary determines that
(i)such retroactive application is necessary to comply with statutory requirements; or
(ii)failure to apply the change retroactively would be contrary to the public interest. As explained in the paragraph above, the MMSEA requires the Secretary to implement various policy changes either contemporaneously with the enactment of the MMSEA on December 29, 2007 or beginning with cost reporting periods beginning on or after December 29, 2007 as applicable. Therefore, under the authority of section 1871(e)(1)(A)(i) of the Act, we are making the provisions of this interim final rule with comment period that implement sections 114(d) of MMSEA retroactive to December 29, 2007. The statute also requires that section 114(c)(1) and
(2)be implemented beginning with cost reporting periods beginning on or after December 29, 2007. Therefore, under the authority of section 1871(e)(1)(A)(i) of the Act, we are making the provisions of this interim final rule with comment period that implement section 114(c)(1) and
(2)effective for cost reporting periods beginning on or after December 29, 2007. Additionally, as explained previously, the Secretary also finds that it would be contrary to the public interest if these provisions were not made effective on December 29, 2007 or for cost reporting periods beginning on or after December 29, 2007, as indicated above. Therefore, under the authority of section 1871(e)(1)(A)(ii) of the Act, we are making these changes effective under the timeframe noted above. For the same reasons noted above, we find good cause under section 553(d)(3) of the APA to waive the 30-day delay in effective date. V. Collection of Information Requirements This document does not impose information collection and recordkeeping requirements. Consequently, it need not be reviewed by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995. VI. Regulatory Impact Analysis We have examined the impacts of this rule as required by Executive Order 12866 (September 1993, Regulatory Planning and Review), the Regulatory Flexibility Act
(RFA)(September 19, 1980, Pub. L. 96-354), section 1102(b) of the Social Security Act, the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4), Executive Order 13132 on Federalism, and the Congressional Review Act (5 U.S.C. 804 (2)). Executive Order 12866 (as amended by Executive Order 13258) directs agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). A regulatory impact analysis
(RIA)must be prepared for major rules with economically significant effects ($100 million or more in any 1 year). The enactment of section 114(c) of MMSEA requires several modifications to the regulations at § 412.534 and § 412.536, which, as discussed in section II.A of this interim final rule with comment period, address the percentage thresholds between referring hospitals (typically acute care hospitals) and LTCHs and satellites of LTCHs. We estimate that the implementation of MMSEA provisions pertaining to § 412.534 and § 412.536 will result in a projected increase of approximately $30 million in estimated aggregate LTCH PPS payments for RY 2008. We note that at this time, we are unable to quantify the impact of the provision at section 114(d) of MMSEA which provides for a moratorium on the establishment of LTCHs, LTCH satellite facilities, and on the increase of LTCH beds in existing LTCHs or satellite facilities for a period of 3 years. We are unable to provide an estimate of the impact of the moratorium provisions in section II.B. of this interim final rule with comment period because we have no way of determining how many LTCHs would have opened in the absence of the moratorium, nor do we have sufficient information at this time to determine how many new LTCHs will meet the exceptions criteria provided for in the statute. Because the distributional effects and estimated changes to the Medicare program payments would not be greater than $100 million, this interim final rule with comment period would not be considered a major economic rule, as defined in this section. The RFA requires agencies to analyze options for regulatory relief of small businesses. For purposes of the RFA, small entities include small businesses, nonprofit organizations, and small governmental jurisdictions. Most hospitals and most other providers and suppliers are small entities, either by nonprofit status or by having revenues of $6.5 million to $31.5 million in any 1 year. (For further information, see the Small Business Administration's regulation at 70 FR 72577, December 6, 2005.) Individuals and States are not included in the definition of a small entity. Because we lack data on individual hospital receipts, we cannot determine the number of small proprietary LTCHs. Therefore, we assume that all LTCHs are considered small entities for the purpose of this impact discussion. Medicare FIs and MACs are not considered to be small entities. As we discuss in detail throughout the preamble of this interim final rule with comment period, we believe that the provisions specified by the MMSEA presented in this rule would result in an increase in estimated aggregate LTCH PPS payments. Accordingly, the Secretary certifies that this interim final rule with comment period would not have a significant economic impact on a substantial number of small entities. In addition, section 1102(b) of the Act requires us to prepare a regulatory impact analysis if a rule may have a significant impact on the operations of a substantial number of small rural hospitals. This analysis must conform to the provisions of section 604 of the RFA. For purposes of section 1102(b) of the Act, we define a small rural hospital as a hospital that is located outside of a Metropolitan Statistical Area for Medicare payment regulations and has fewer than 100 beds. As stated above, implementing the provisions specified by the MMSEA that are discussed in this interim final rule with comment period will result in an increase in estimated aggregate LTCH PPS payments. Therefore, we believe this rule will not have a significant impact on small rural hospitals. Accordingly, the Secretary certifies that this interim final rule with comment period would not have a significant economic impact on the operations of a substantial number of small rural hospitals. Section 202 of the Unfunded Mandates Reform Act of 1995 also requires that agencies assess anticipated costs and benefits before issuing any rule whose mandates require spending in any 1 year of $100 million in 1995 dollars, updated annually for inflation. In 2008, that threshold level is currently approximately $130 million. This interim final rule with comment period would not mandate any requirements for State, local, or tribal governments, nor would it result in expenditures by the private sector of $130 million or more in any 1 year. Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a proposed rule (and subsequent final rule) that imposes substantial direct requirement costs on State and local governments, preempts State law, or otherwise has Federalism implications. Since this regulation does not impose any costs on State or local governments, the requirements of Executive Order 13132 are not applicable. In accordance with the provisions of Executive Order 12866, this regulation was reviewed by the Office of Management and Budget. List of Subjects in 42 CFR Part 412 Administrative practice and procedure, Health facilities, Medicare, Puerto Rico, Reporting and recordkeeping requirements. For the reasons stated in the preamble of this interim final rule with comment period, the Centers for Medicare & Medicaid Services is amending 42 CFR Chapter IV as follows: PART 412—PROSPECTIVE PAYMENT SYSTEMS FOR INPATIENT HOSPITAL SERVICES 1. The authority citation for part 412 is revised to read as follows: Authority: Secs. 1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and 1395hh). 2. Section 412.23 is amended by adding new paragraphs (e)(5) through (e)(7) to read as follows: § 412.23 Excluded hospitals: Classifications.
(e)* * *
(5)*Freestanding long-term care hospital.* For purposes of this paragraph, a freestanding long-term care hospital means a hospital that meets the requirements of paragraph (e)(1) and
(2)of this section and all of the following:
(i)Does not occupy space in a building also used by another hospital.
(ii)Does not occupy space in one or more separate or entire buildings located on the same campus as buildings used by another hospital.
(iii)Is not part of a hospital that provides inpatient services in a building also used by another hospital.
(6)*Moratorium on the establishment of new long-term care hospitals and long-term care hospital satellite facilities.*
(i)*General rule.* Except as specified in paragraph (e)(6)(ii) of this paragraph, for the period beginning December 29, 2007 and ending December 28, 2010, a moratorium applies to the establishment and classification of a long-term care hospital or long-term care hospital satellite facility as described in § 412.23(e).
(ii)*Exception.* The moratorium specified in paragraph (e)(6)(i) of this section is not applicable to the establishment and classification of a long-term care hospital that meets the requirements in paragraph
(e)of this section or a long-term care hospital satellite facility that meets the requirements in § 412.22(h), if the long-term care hospital met one of the following criteria on or before December 29, 2007:
(A)Began its qualifying period for payment in accordance with paragraph
(e)of this section. (B)( *1* ) Has a binding written agreement with an outside, unrelated party for the actual construction, renovation, lease or demolition for a long-term care hospital; and ( *2* ) Has expended, before December 29, 2007, at least 10 percent (or, if less, $2.5 million) of the estimated cost of the project specified in paragraph (ii)(B)(1) of this paragraph.
(C)Had obtained an approved certificate of need from the State, when required by State law.
(7)*Moratorium on increasing the number of beds in existing long-term care hospitals and existing long-term care hospital satellite facilities.*
(i)For purposes of this paragraph, an existing long-term care hospital or long-term care hospital satellite facility means a long-term care hospital that meets the requirements of paragraph
(e)of this section or long-term care hospital satellite facility that meets the requirements of § 412.22(h) of this part and received payment under the provisions of subpart O of this part on or before December 29, 2007.
(ii)Effective for the period beginning December 29, 2007 and ending December 28, 2010—
(A)Except as specified in paragraph (e)(7)(ii)(B) of this section, the number of Medicare-certified beds in an existing long-term care hospital or an existing long-term care hospital satellite facility as defined in paragraph (e)(7)(i) of this section must not be increased beyond the number of Medicare-certified beds on December 29, 2007.
(B)Except as specified in paragraph (e)(7)(ii)(C) of this section, the moratorium specified in paragraph (e)(7)(ii)(A) of this section is not applicable to an existing long-term care hospital or existing long-term care hospital satellite facility as defined in paragraph (e)(7)(i) of this section that meets both of the following requirements: ( *1* ) Is located in a State where there is only one other long-term care hospital that meets the criteria specified in § 412.23(e) of this subpart. ( *2* ) Requests an increase in the number of Medicare-certified beds after the closure or decrease in the number of Medicare-certified beds of another long-term care hospital in the State.
(C)The exception specified in paragraph (e)(7)(ii)(B) of this section does not effect the limitation on increasing beds under § 412.22(f) and § 412.22(h)(3) of subpart. 4. Section 412.534 is amended by revising paragraphs
(b)through (e), and
(h)to read as follows. § 412.534 Special payment provisions for long-term care hospitals within hospitals and satellites of long-term care hospitals.
(b)*Patients admitted from hospitals not located in the same building or on the same campus as the long-term care hospital or long-term care hospital satellite.*
(1)*For cost reporting periods beginning on or after October 1, 2004 and before July 1, 2007.* Payments to the long-term care hospital as described in § 412.23(e)(2)(i) meeting the criteria in § 412.22(e)(2) for patients admitted to the long-term care hospital or to a long-term care hospital satellite facility as described in § 412.23(e)(2)(i) that meets the criteria of § 412.22(h) from another hospital that is not the co-located hospital are made under the rules in this subpart with no adjustment under this section.
(2)*For cost reporting periods beginning on or after July 1, 2007.* For cost reporting periods beginning on or after July 1, 2007, payments to one of the following long-term care hospitals or long-term care hospital satellites are subject to the provisions of § 412.536 of this subpart:
(i)A long-term care hospital as described in § 412.23(e)(2)(i) of this part that meets the criteria of § 412.22(e) of this part.
(ii)Except as provided in paragraph
(h)of this section, a long-term care hospital as described in § 412.23(e)(2)(i) of this part that meets the criteria of § 412.22(f) of this part.
(iii)A long-term care hospital satellite facility as described in § 412.23(e)(2)(i) of this part that meets the criteria in § 412.22(h) or § 412.22(h)(3)(i) of this part.
(c)*Patients admitted from the hospital located in the same building or on the same campus as the long-term care hospital or satellite facility.* Except for a long-term care hospital or a long-term care hospital satellite facility that meets the requirements of paragraphs
(d)or
(e)of this section, payments to the long-term care hospital for patients admitted to it or to its long-term care hospital satellite facility from the co-located hospital are made under either of the following:
(1)*For cost reporting periods beginning on or after October 1, 2004 and before December 29, 2007 and for cost reporting periods beginning on or after December 29, 2010.*
(i)Except as provided in paragraphs
(g)and
(h)of this section, for any cost reporting period beginning on or after October 1, 2004 and before December 29, 2007 and for cost reporting periods beginning on or after December 29, 2010 in which the long-term care hospital or its satellite facility has a discharged Medicare inpatient population of whom no more than 25 percent were admitted to the hospital or its satellite facility from the co-located hospital, payments are made under the rules at §§ 412.500 through 412.541 in this subpart with no adjustment under this section.
(ii)Except as provided in paragraph
(g)or
(h)of this section, for any cost reporting period beginning on or after October 1, 2004 and before December 29, 2007 and for cost reporting periods beginning on or after December 29, 2010 in which the long-term care hospital or satellite facility has a discharged Medicare inpatient population of whom more than 25 percent were admitted to the hospital or satellite facility from the co-located hospital, payments for the patients who are admitted from the co-located hospital and who cause the long-term care hospital or satellite facility to exceed the 25 percent threshold for discharged patients who have been admitted from the co-located hospital are the lesser of the amount otherwise payable under this subpart or the amount payable under this subpart that is equivalent, as set forth in paragraph
(f)of this section, to the amount that would be determined under the rules at § 412.1(a). Payments for the remainder of the long-term care hospital's or satellite facility's patients are made under the rules in this subpart at §§ 412.500 through 412.541 with no adjustment under this section.
(iii)In determining the percentage of patients admitted to the long-term care hospital or its satellite from the co-located hospital under paragraphs (c)(1)(i) and (c)(1)(ii) of this section, patients on whose behalf an outlier payment was made to the co-located hospital are not counted towards the 25 percent threshold.
(2)*For cost reporting periods beginning on or after December 29, 2007 and before December 29, 2010.*
(i)Except for a long-term care hospital and long-term care hospital satellite facility subject to paragraphs
(g)or
(h)of this section, payments are determined using the methodology specified in paragraph (c)(1) of this section.
(ii)Payments for a long-term care hospital and long-term care hospital satellite facility subject to paragraph
(g)of this section are determined using the methodology specified in paragraph (c)(1) of this section except that 25 percent is substituted with 50 percent. *(d) Special treatment of rural hospitals.*
(1)*For cost reporting periods beginning on or after October 1, 2004 and before December 29, 2007 and for cost reporting periods beginning on or after December 29, 2010.*
(i)Subject to paragraphs
(g)and
(h)of this section, in the case of a long-term care hospital or satellite facility that is located in a rural area as defined in § 412.503 and is co-located with another hospital for any cost reporting period beginning on or after October 1, 2004 and before December 29, 2007 and for any cost reporting period beginning on or after December 29, 2010 in which the long-term care hospital or long-term care satellite facility has a discharged Medicare inpatient population of whom more than 50 percent were admitted to the long-term care hospital or satellite facility from the co-located hospital, payments for the patients who are admitted from the co-located hospital and who cause the long-term care hospital or satellite facility to exceed the 50 percent threshold for discharged patients who were admitted from the co-located hospital are the lesser of the amount otherwise payable under this subpart or the amount payable under this subpart that is equivalent, as set forth in paragraph
(f)of this section, to the amount that were otherwise payable under § 412.1(a). Payments for the remainder of the long-term care hospital's or long-term care hospital satellite facility's patients are made under the rules in this subpart at §§ 412.500 through 412.541 with no adjustment under this section.
(ii)In determining the percentage of patients admitted from the co-located hospital under paragraph (d)(1)(i) of this section, patients on whose behalf outlier payment was made at the co-located hospital are not counted toward the 50 percent threshold. *(2) For cost reporting periods beginning on or after December 29, 2007 and before December 29, 2010.*
(i)Except for long-term care hospitals and long-term care hospital satellite facilities subject to paragraphs
(g)or
(h)of this section, payments are determined using the methodology specified in paragraph (d)(1) of this paragraph.
(ii)Payments for long-term care hospitals and long-term care hospital satellite facilities subject to paragraph
(g)of this section are determined using the methodology specified in paragraph (d)(1) of this section except that 50 percent is substituted with 75 percent. *(e) Special treatment of urban single or MSA-dominant hospitals.*
(1)*For cost reporting periods beginning on or after October 1, 2004 and before December 29, 2007 and for cost reporting periods beginning on or after December 29, 2010.*
(i)Subject to paragraphs
(g)and
(h)of this section, in the case of a long-term care hospital or a long-term care hospital satellite facility that is co-located with the only other hospital in the MSA or with a MSA-dominant hospital as defined in paragraph (e)(1)(iv) of this paragraph, for any cost reporting period beginning on or after October 1, 2004 and before December 29, 2007 and for any cost reporting periods beginning on or after December 29, 2010 in which the long-term care hospital or long-term care hospital satellite facility has a discharged Medicare inpatient population of whom more than the percentage calculated under paragraph (e)(1)(ii) of this paragraph were admitted to the hospital from the co-located hospital, payments for the patients who are admitted from the co-located hospital and who cause the long-term care hospital to exceed the applicable threshold for discharged patients who have been admitted from the co-located hospital are the lesser of the amount otherwise payable under this subpart or the amount under this subpart that is equivalent, as set forth in paragraph
(f)of this section, to the amount that otherwise would be determined under § 412.1(a). Payments for the remainder of the long-term care hospital's or satellite facility's patients are made under the rules in this subpart with no adjustment under this section.
(ii)For purposes of paragraph (e)(1)(i) of this paragraph, the percentage used is the percentage of total Medicare discharges in the Metropolitan Statistical Area in which the hospital is located that are from the co-located hospital for the cost reporting period for which the adjustment was made, but in no case is less than 25 percent or more than 50 percent.
(iii)In determining the percentage of patients admitted from the co-located hospital under paragraph (e)(1)(i) of this section, patients on whose behalf outlier payment was made at the co-located hospital are not counted toward the applicable threshold.
(iv)For purposes of this paragraph, an “MSA-dominant hospital” is a hospital that has discharged more than 25 percent of the total hospital Medicare discharges in the MSA in which the hospital is located. *(2) For cost reporting periods beginning on or after December 29, 2007 and before December 29, 2010.*
(i)Except for long-term care hospitals and long-term care hospital satellite facilities subject to paragraphs
(g)or
(h)of this section, payments are determined using the methodology specified in paragraph (e)(1) of this section.
(ii)Payments for long-term care hospitals and long-term care hospital satellite facilities subject to paragraph
(g)of this section are determined using the methodology specified in paragraph (e)(1) of this section except that 75 percent is substituted for 50 percent.
(h)*Effective date of policies in this section for certain co-located LTCH hospitals and satellites of LTCHs.* The policies set forth in this section apply to Medicare patient discharges that were admitted from a hospital located in the same building or on the same campus as a long-term care hospital described in § 412.23(e)(2)(i) that meets the criteria in § 412.22(f) and a satellite facility of a long-term care hospital as described at § 412.22(h)(3)(i) for discharges occurring in cost reporting periods beginning on or after July 1, 2007.
(1)Except as specified in paragraph (h)(4) of this section, in the case of a long-term care hospital or long-term care hospital satellite facility that is described under paragraph
(h)of this section, the thresholds applied at paragraphs (c), (d), and
(e)of this section are not less than the following percentages:
(i)For cost reporting periods beginning on or after July 1, 2007 and before July 1, 2008, the lesser of 75 percent of the total number of Medicare discharges that were admitted to the long-term care hospital or long-term care hospital satellite facility from its co-located hospital during the cost reporting period or the percentage of Medicare discharges that had been admitted to the long-term care hospital or satellite from that co-located hospital during the long-term care hospital's or satellite's RY 2005 cost reporting period.
(ii)For cost reporting periods beginning on or after July 1, 2008 and before July 1, 2009, the lesser of 50 percent of the total number of Medicare discharges that were admitted to the long-term care hospital or the long-term care hospital satellite facility from its co-located hospital or the percentage of Medicare discharges that had been admitted from that co-located hospital during the long-term care hospital's or satellite's RY 2005 cost reporting period.
(iii)For cost reporting periods beginning on or after July 1, 2009, 25 percent of the total number of Medicare discharges that were admitted to the long-term care hospital or satellite from its co-located hospital during the cost reporting period.
(2)In determining the percentage of Medicare discharges admitted from the co-located hospital under this paragraph, patients on whose behalf a Medicare high cost outlier payment was made at the co-located referring hospital are not counted toward this threshold.
(3)Except as specified in paragraph (h)(4) of this section, for cost reporting periods beginning on or after July 1, 2007, payments to long term care hospitals described in § 412.23(e)(2)(i) that meet the criteria in § 412.22(f) and satellite facilities of long-term care hospitals described at § 412.22(h)(3)(i) are subject to the provisions of § 412.536 for discharges of Medicare patients who are admitted from a hospital not located in the same building or on the same campus as the LTCH or LTCH satellite facility.
(4)For a long-term care hospital described in § 412.23(e)(2)(i) that meets the criteria in § 412.22(f), the policies set forth in this paragraph and in § 412.536 of this part do not apply for discharges occurring in cost reporting periods beginning on or after December 29, 2007 and before December 29, 2010. 5. Section 412.536 is amended by revising paragraph
(a)to read as follows: § 412.536 Special payment provisions for long-term care hospitals and satellites of long-term care hospitals that discharged Medicare patients admitted from a hospital not located in the same building or on the same campus as the long-term care hospital or satellite of the long-term care hospital.
(a)*Scope.*
(1)Except as specified in paragraph (a)(2) of this section, for cost reporting periods beginning on or after July 1, 2007, the policies set forth in this section apply to discharges from the following:
(i)Long-term care hospitals as described in § 412.23(e)(2)(i) that meet the criteria in § 412.22(e).
(ii)Long-term care hospitals as described in § 412.23(e)(2)(i) and that meet the criteria in § 412.22(f).
(iii)Long-term care hospital satellite facilities as described in § 412.23(e)(2)(i) and that meet the criteria in § 412.22(h).
(iv)Long-term care hospitals as described in § 412.23(e)(5).
(2)For cost reporting periods beginning on or after December 29, 2007 and before December 29, 2010, the policies set forth in this section are not applicable to discharges from a long-term care hospital described in § 412.23(e)(5) of this part or described in § 412.23(e)(2)(i) of this part and that meet the criteria specified in § 412.22(f) of this part. (Catalog of Federal Domestic Assistance Program No. 93.773, Medicare—Hospital Insurance; and Program No. 93.774, Medicare—Supplementary Medical Insurance Program) Dated: May 8, 2008. Kerry Weems, Acting Administrator, Centers for Medicare & Medicaid Services. Approved: May 15, 2008. Michael O. Leavitt, Secretary. [FR Doc. 08-1285 Filed 5-16-08; 4:00 pm]
Connectionstraces to 31
Traces to 31 documents
31 references not yet in our index
  • 21 CFR 522
  • 21 CFR 20
  • 5 USC 801-808
  • 21 CFR 1301
  • Pub. L. 109-56
  • 119 Stat. 591
  • Pub. L. 109-469
  • Pub. L. 106-310
  • 114 Stat. 1222
  • 5 USC 601-612
  • 33 CFR 117
  • Pub. L. 104-121
  • 44 USC 3501-3520
  • 2 USC 1531-1538
  • 42 USC 4321-4370f
  • 40 CFR 51
  • 40 CFR 52
  • 40 CFR 60
  • 40 CFR 75
  • 40 CFR 72.2
  • 5 CFR 1320.3(b)
  • Pub. L. 104-4
  • Pub. L. 104-113
  • 42 USC 7401-7671q
  • 42 CFR 412
  • Pub. L. 106-113
  • Pub. L. 106-554
  • Pub. L. 110-173
  • Pub. L. 105-33
  • 42 CFR 489
  • Pub. L. 96-354
Citation graph
cites case law
Unknown
Final rule
C.F.R.§ 514.11
U.S.C.§ 360b
C.F.R.§ 25.33
U.S.C.§ 804
U.S.C.§ 823
Stat.Public Law 111–356
C.F.R.§ 1301.28
U.S.C.§ 801
Fed. Reg.Notices
Cite21 CFR 522
Cite21 CFR 20
Cite5 USC 801-808
Cites 62 · showing 12Cited by 0 across 0 sources
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