Substance Abuse and Mental Health Services Administration; requirements applicable to protection and advocacy of individuals with mental illness; final rule--Center for Mental Health Services, SAMHSA. Final rule

On December 14, 1994, the Department of Health and Human Services (Department or HHS) published a Notice of Proposed Rulemaking to comply with the requirements of section 116 of the Protection and Advocacy for Mentally III Individuals Act of 1986 (Act) (42 U.S.C. 10801 et seq.) which required that the Secretary promulgate regulations for the implementation of authorized activities of Protection and Advocacy (P&A) Systems to protect and advocate the rights of individuals with mental illness. The Department is issuing this final rule to implement Titles I and III of the Act. These regulations will govern activities carried out by the P&A systems under the Act. The rule includes: definitions: basic requirements regarding determination of, eligibility for and use of allotments, grant administration, eligibility for protection and advocacy services, annual and financial status reports, and remedial actions; and requirements regarding program administration, priorities, the conduct of P&A activities, access of the P&As to residents, facilities and records and confidentiality. DATES: Effective Date: This regulation is effective November 14, 1997 except for the information collection requirements in sections 51.8, 51.10, 51.23 and 51.25. These sections will become effective upon approval under the Paperwork Reduction Act. A notice of approval will appear in the Federal Register.     

Medicare program: request for public comments on implementation of risk adjusted payment for the Medicare+Choice program and announcement of public meeting--HCFA. Solicitation of comments; announcement of meeting

This notice solicits further public comments on issues related to the implementation of risk adjusted payment of Medicare+Choice organizations. Section 1853(a)(3) of the Social Security Act (the Act) requires the Secretary to implement a risk adjustment methodology that accounts for variation in per capita costs based on health status and demographic factors for payments no later than January 1, 2000. The methodology is to apply uniformly to all Medicare+Choice plans. This notice outlines our proposed approach to implementing risk adjusted payment. In order to carry out risk adjustment, section 1853(a)(3) of the Act also requires Medicare+Choice organizations, as well as other organizations with risk sharing contracts, to submit encounter data. Inpatient hospital data are required for discharges on or after July 1, 1997. Other data, as the Secretary deems necessary, may be required beginning July 1998. The Medicare+Choice interim final rule published on June 26, 1998 (63 FR 34968) describes the general process for the collection of encounter data. We also included a schedule for the collection of additional encounter data. Physician, outpatient hospital, skilled nursing facility, and home health data will be collected no earlier than October 1, 1999, and all other data we deem necessary no earlier than October 1, 2000. Given any start date, comprehensive risk adjustment will be made about three years after the year of initial collection of outpatient hospital and physician encounter data. Comments on the process for encounter data collection are requested in that interim final rule. We intend to consider comments received in response to this solicitation as we develop the final methodology for implementation of risk adjustment. This notice also informs the public of a meeting on September 17, 1998, to discuss risk adjustment and the collection of encounter data. The meeting will be held at the Health Care Financing Administration headquarters, located at 7500 Security Boulevard, Baltimore, MD, beginning at 8:30 a.m. Additional materials on the risk adjustment model will be available on or after October 15, 1998, and may be requested in writing from Chapin Wilson, Health Care Financing Administration, Department of Health and Human Services, 200 Independence Avenue, S. W., Room 435-H, Washington, DC 20201.     

Medicare program; additions to and deletions from the current list of covered surgical procedures for ambulatory surgical centers--HCFA. Final notice with comment period

This final notice with comment period implements section 1833(i)(1) of the Social Security Act, which requires, in part, that the list of covered ambulatory surgical center (ASC) procedures be reviewed and updated at least every 2 years. This notice announces the specific additions to and deletions from the list of surgical procedures for which facility services are covered when the procedures are performed in a Medicare-participating ASC, as well as the assigned payment groups for each addition. The notice also announces a change in our criteria for deleting procedures from the ASC list. This notice also responds to public comments received in response to our proposed notice published December 14, 1993 (58 FR 65357). In that notice, we requested comments on the proposed additions to and deletions from the list of covered surgical procedures for ASCs; the proposed quantitative change in our deletion criteria; the development of alternatives to the proposed quantitative deletion criteria; and the assignment of payment groups for each addition. Finally, this notice solicits public comment on certain additions to and deletions from the ASC list that had not been suggested in our December 1993 proposed notice. It also solicits public comment on the assignment of payment groups for certain new procedure codes.     

New vaccine information materials for hepatitis B, Haemophilus influenzae type b (Hib), and varicella (chickenpox) vaccines, and revised vaccine information materials for measles, mumps, rubella (MMR) vaccines. Centers for Disease Control and Prevention (CDC), Department of Health and Human Services. Notice

Under the National Childhood Vaccine Injury Act (42 U.S.C. 300aa-26), the CDC must develop vaccine information materials that all health care providers, whether public or private, are required to distribute to patients/parents prior to administration of each dose of specific vaccines. On September 3, 1998, CDC published a notice in the Federal Register (63 FR 47026) seeking public comment on proposed vaccine information materials for the newly covered vaccines hepatitis B, Haemophilus influenzae type b, and varicella vaccines, and also seeking comment on proposed revised vaccine information materials for measles, mumps, rubella (MMR) vaccines. The 60 day comment period ended on November 2, 1998. Following review of the comments submitted and consultation as required under the law, CDC has finalized these vaccine information materials. The final materials are contained in this notice.     

Final notice regarding section 602 of the Veterans Health Care Act of 1992 duplicate discounts and rebates on drug purchases--HRSA. Final notice

Section 602 of Public Law 102-585, the "Veterans Health Care Act of 1992," enacted section 340B of the Public Health Service Act, "Limitation on Prices of Drugs Purchased by Covered Entities." Section 340B provides discounts on covered outpatient drugs to eligible entities. Section 340B(a)(5)(A) provides that a drug purchase shall not be subject to both a discount under section 340B and a Medicaid rebate under section 1927 of the Social Security Act. The Department is directed to establish a mechanism to assure that covered entities comply with this prohibition. The purpose of this notice is to announce the final mechanism to prevent duplicate discounts and rebates. The proposed mechanism was announced in the Federal Register at 58 FR 27293 on May 7, 1993. A comment period of 30 days was established to allow public comment on the proposed mechanism. Two comments were received. Both comments concerned issues involving implementation of the mechanism and did not raise substantive issues concerning the mechanism itself; therefore, we will address both comments in the Effective Date section. The mechanism, in its final form, is adopted as proposed.     

Medicare program: data, standards, and methodology used to establish fiscal year 1994 budgets for fiscal intermediaries and carriers--HCFA. Final notice

This notice is published in accordance with sections 1816(c)(1) and 1842(c)(1) of the Social Security Act which require us to publish the final data, standards, and methodology used to establish budgets for Medicare intermediaries and carriers. In this notice, we respond to the comments received in response to our notice of October 5, 1993 and we announce the adoption of the proposed data, standards, and methodology that we used to establish the Medicare fiscal intermediary and carrier budgets for fiscal year (FY) 1994, beginning October 1, 1993, as final and without revision.     

Disclosure of children's free and reduced price meals and free milk eligibility information in the child nutrition programs. Final rule

This final rule establishes requirements for the disclosure of children's free and reduced price meals or free milk eligibility information under the Child Nutrition Programs. The Child Nutrition Programs include the National School Lunch Program, School Breakfast Program, Special Milk Program, Summer Food Service Program, and Child and Adult Care Food Program. Within certain limitations, children's free and reduced price meal or free milk eligibility information may be disclosed, without parental/guardian consent, to persons directly connected to certain education programs, health programs, means-tested nutrition programs, the Comptroller General of the United States, and some law enforcement officials. Additionally, officials also may disclose children's free and reduced price meal or free milk eligibility information to persons directly connected with State Medicaid (Medicaid) and the State Children's Health Insurance Program (SCHIP) when parents/guardians do not decline to have their information disclosed. These regulations affect State agencies and local program operators that administer the Child Nutrition Programs and households which apply for and/or are approved for free and reduced price meals or free milk. The final rule reflects the disclosure provisions of the Healthy Meals for Healthy Americans Act of 1994 and comments received on the proposed rule published in anticipation of implementing those provisions. Additionally, this final rule includes the regulatory disclosure provisions implementing the Agricultural Risk Protection Act of 2000 and comments received on the interim rule issued to implement those provisions. This final rule also implements nondiscretionary provisions of the Child Nutrition and WIC Reauthorization Act of 2004, allowing certain third party contractors access to children's eligibility status and will allow school officials to communicate with Medicaid and SCHIP officials to verify that children are eligible for free and reduced price school meals or free milk. The disclosure provisions are intended to reduce paperwork for administrators of certain programs that target low-income households and for low-income households which may benefit from those programs by allowing some sharing of household's free and reduced price meal eligibility information. This rule also includes several technical amendments.     

Criteria for designation of mental health professional shortage areas--PHS. Final rule

This final rule amends the existing regulations governing the criteria for designation of health manpower shortage areas, or HMSAs (now health professional shortage areas, or HPSAs; name changed by Public Law 101-597, the National Health Service Corps Revitalization Amendments of 1990) under section 332 of the Public Health Service Act. Specifically, this amendment revises the existing criteria for designation of HMSAs having shortages of psychiatric manpower, transforming them into criteria for designation of HPSAs having shortages of mental health professionals, to take into account not only psychiatrists but also mental health service providers other than psychiatrists. The intended effect of this amendment is to more accurately assess the supply of mental health service providers when making shortage area determinations. This notice also summarizes the comments received by the Department on the Notice of Proposed Rulemaking published on August 8, 1989, which set forth the proposed methodology for making this and other changes to the HMSA criteria. It also formally changes "HMSA" to "HPSA" throughout the regulation, to conform with Public Law 101-597.     

Regulations implementing the Federal Coal Mine Health and Safety Act of 1969, as amended. Employment Standards Administration, Labor. Final rule

On January 22, 1997, the Department issued a proposed rule to amend the regulations implementing the Black Lung Benefits Act. 62 FR 3338-3435 (Jan. 22, 1997). When the comment period closed on August 21, 1997, the Department had received written submissions from almost 200 interested persons, including coal miners, coal mine operators, insurers, physicians, and attorneys. The Department also held hearings in Charleston, West Virginia, and Washington, D.C. at which over 50 people testified. The Department carefully reviewed the testimony and the comments and, on October 8, 1999, issued a second notice of proposed rulemaking. 64 FR 54966-55072 (Oct. 8, 1999). In its second notice, the Department proposed changing several of the most important provisions in its initial proposal. The Department also explained its decision not to alter the original proposal with respect to other key regulations based on the comments received to date. Finally, the Department prepared an initial regulatory flexibility analysis. In order to ensure that small businesses that could be affected by the Department's proposal received appropriate notice of the Department's proposed changes, the Department mailed a copy of the second notice of proposed rulemaking to all coal mine operators contained in the databases maintained by the Mine Safety and Health Administration. The Department initially allowed interested parties until December 7, 1999 to file comments to its second proposal, but extended that period until January 6, 2000. The Department received 37 written submissions before the close of the comment period, from groups representing both coal miners and coal mine operators. The Department also received comments from individual miners, various coal mining and insurance companies, as well as from claims processing organizations, attorneys, and various professional organizations. The Department has carefully reviewed all of the comments, and is issuing its final rule. The rule contains a final regulatory flexibility analysis as required by the Regulatory Flexibility Act.     

Medicare program; Medicare+Choice program. Health Care Financing Administration (HCFA), HHS. Final rule with comment period

This final rule with comment period responds to comments on the June 26, 1998 interim final rule that implemented the Medicare+Choice (M+C) program and makes revisions to those regulations where warranted. We also are making revisions to the regulations that are necessary to reflect the changes to the M+C program resulting from the Balanced Budget Refinement Act of 1999 (BBRA). Revisions to the regulations reflecting changes in the law made by the BBRA are subject to public comment. Issues discussed in this rule include eligibility, election, and enrollment policies; marketing requirements; access requirements; service area and benefit policy; quality improvement standards; payment rates, risk adjustment methodology, and encounter data submission; provider participation rules; beneficiary appeals and grievances; contractual requirements; and preemption of State law by Federal law. This final rule also addresses comments on the interim final rule published on December 2, 1997, which implemented user fees for section 1876 risk contractors for 1998, and formed the basis for the M+C user fee provisions in the June 26, 1998 interim final rule, and the provider-sponsored organization (PSO) interim final rule published April 14, 1998.     

Revised medical criteria for evaluating endocrine disorders. Final rules

We are revising the criteria in the Listing of Impairments (the listings) that we use to evaluate claims under titles II and XVI of the Social Security Act (Act) involving endocrine disorders in adults and children. The revisions reflect our adjudicative experience, advances in medical knowledge, information from medical experts, and comments we received from the public in response to an advance notice of proposed rulemaking (ANPRM), a notice of proposed rulemaking (NPRM), and at an outreach policy conference.     

Medicare program; update of ratesetting methodology, payment rates, payment policies, and the list of covered procedures for ambulatory surgical centers effective October 1, 1998; extension of comment period--HCFA. Notice of extension of comment period for proposed rule

This notice extends the comment period for a proposed rule published in the Federal Register on June 12, 1998 (63 FR 32290). In that rule we proposed to: Update the criteria for determining which surgical procedures can be appropriately and safely performed in an ambulatory surgical center (ASC): Make additions to and deletions from the current list of Medicare covered ASC procedures based on the revised criteria; Rebase the ASC payment rates using cost, charge, and utilization data collected by a 1994 survey of ASCs; Refine the ratesetting methodology that was implemented by a final notice published on February 8, 1990 in the Federal Register; Require that ASC payment, coverage, and wage index updates be implemented annually on January 1 rather than having these updates occur randomly throughout the year; Reduce requlatory burden; and Make several technical policy changes. This proposed rule implements requirements of section 1833(i) (1) and (2) of the Social Security Act. The comment period is extended for 30 days.     

Medicaid program; state allotments for payment of Medicare Part B premiums for qualifying individuals: federal fiscal year 1998--HCFA. Notice with comment period

Section 4732 of the Balanced Budget Act of 1997 (Public Law 105-33) amended the Social Security Act to provide for two additional eligibility groups of low-income Medicare beneficiaries for whom Medicaid payment can be made for Medicare Part B premiums during the period beginning January 1998 and ending December 2002. This notice announces the Federal fiscal year 1998 State allotments that are available to pay Medicare Part B premiums for these two new eligibility groups and describes the methodology used to determine each State's allotment.     

Grants to states for operation of qualified high risk pools. Final rule

This final rule implements a provision of the Trade Adjustment Assistance Reform Act of 2002 by providing $40 million in Federal fiscal year 2003 and $40 million in Federal fiscal year 2004 to States that have incurred losses in connection with the operation of qualified high risk pools that meet certain criteria. This final rule also addresses comments received in response to the interim final rule that was published on May 2, 2003. This grant program implements section 2745 of the Public Health Service Act, as added by the Trade Adjustment Assistance Reform Act of 2002.     

Medicare program; physician fee schedule conversion factor for calendar year 1998 and sustainable growth rate for fiscal year 1998--HCFA. Final notice

This final notice announces the calendar year 1998 Medicare physician fee schedule conversion factor and the fiscal year 1998 sustainable growth rate for expenditures for physicians' services under the Medicare Supplementary Medical Insurance (Part B) program as required by sections 1846(d) and (f), respectively, of the Social Security Act. The 1998 Medicare physician fee schedule conversion factor is $36,6873. The sustainable growth rate for fiscal year 1998 is 1.5 percent.     

Medicaid program; eligibility changes under the Affordable Care Act of 2010. Final rule, Interim final rule

This final rule implements several provisions of the Patient Protection and Affordable Care Act of 2010 and the Health Care and Education Reconciliation Act of 2010 (collectively referred to as the Affordable Care Act). The Affordable Care Act expands access to health insurance coverage through improvements to the Medicaid and Children's Health Insurance (CHIP) programs, the establishment of Affordable Insurance Exchanges ("Exchanges"), and the assurance of coordination between Medicaid, CHIP, and Exchanges. This final rule codifies policy and procedural changes to the Medicaid and CHIP programs related to eligibility, enrollment, renewals, public availability of program information and coordination across insurance affordability programs.     

Medicare program: data, standards and methodology used to establish fiscal year 1993 budgets for fiscal intermediaries and carriers--HCFA. Final notice

This notice is published in accordance with sections 1816(c)(1) and 1842(c)(1) of the Social Security Act which requires us to publish the final data, standards and methodology used to establish budgets for Medicare intermediaries and carriers. It announces that we are adopting as final, and responds to comments about, the data, standards, and methodology we proposed to use to establish Medicare fiscal intermediary and carrier budgets for the fiscal year (FY) 1993, beginning October 1, 1992.     

Revision of health service area boundaries; interim regulation--PHS

This notice sets forth interim rules establishing criteria, procedures and requirements for the revision of existing health service area boundaries under section 1511(b)(4) of the Public Health Service Act, as amended by the Health Planning and Resources Development Amendments of 1979, Pub. L. 96-79. Interested persons are invited to submit written comments and suggestions concerning these interim rules.     

Federal old-age, survivors and disability insurance (1950- ); determining disability and blindness; extension of expiration date for cardiovascular system listing--Social Security Administration. Final rule

We are extending the expiration date of the cardiovascular system listing found in appendix 1 of part 404, subpart P, from June 6, 1991, to June 6, 1992. We have made no revisions in the medical criteria in the cardiovascular listings; they remain the same as they now appear in the Code of Federal Regulations. We are presently considering revisions to update the medical criteria contained in part A and part B of the listing, and any revised criteria will be published as a proposed rule when we have completed our review. Insofar as Medicare eligibility is based on entitlement to disability insurance benefits under title II of the Act, this proposed regulation affects the Medicare program. To the extent that Medicaid eligibility is based on title XVI eligibility, this proposed regulation affects the Medicaid program.