Medicare program; prospective payment system for hospital outpatient services. Health Care Financing Administration (HCFA), HHS. Interim final rule with comment period

This interim final rule with comment period provides for the annual update to the Medicare hospital outpatient prospective payment system conversion factor that is used to calculate the payment amount for each payment group, effective January 1, 2001. It also updates the wage index values and incorporates the year 2001 changes in the procedure codes that are used to make payments under this system. In this rule, we are also responding to public comments received on those portions of the April 7, 2000 final rule with comment period (which established the hospital outpatient prospective payment system) that implemented related provisions of the Balanced Budget Refinement Act (BBRA) of 1999. In addition, we are responding to public comments on the August 3, 2000 interim final rule with comment period that modified the April 7, 2000 final rule with comment period by revising the criteria used to define new or innovative medical devices, drugs, and biologicals eligible for transitional pass-through payments and correcting the criteria for grandfathering provider-based Federally Qualified Health Centers (FQHC) into the prospective payment system.     

Medicare program; Medicare Geographic Classification Review Board--procedures and criteria--HCFA. Final rule with comment period

This final rule with comment period responds to public comments on the September 6, 1990 interim final rule with comment period that established the Medicare Geographic Classification Review Board (MGCRB) and sets forth the criteria for the MGCRB to use in issuing its decisions concerning the geographic reclassification of hospitals for purposes of payment under the prospective payment system. In addition, this final rule with comment period implements provisions of the Omnibus Budget Reconciliation Act of 1990 concerning the MGCRB.     

Medicaid program; eligibility and coverage requirements--HCFA. Final Rule

This final rule withdraws regulations setting forth a mandatory budgetary method for determining financial eligibility for individuals who are not receiving or deemed to be receiving Federal cash assistance but whose financial eligibility for Medicaid is being determined through the application of financial criteria of the Aid to Families with Dependent Children (AFDC) program. These regulations were previously issued as part of a final rule with comment period originally published on January 19, 1993, and were to be effective October 18, 1994. This final rule also makes conforming technical changes, as a result of this withdrawal, to the remainder of the January 19, 1993, final rule and reaffirms the August 18, 1994, effective date of this remaining part. These changes are being made as a result of consideration of public comments received.     

Medicare program; changes to the inpatient hospital prospective payment system and fiscal year 1992 rates--HCFA. Final rule

We are revising the Medicare inpatient hospital prospective payment system to implement necessary changes arising from legislation and our continuing experience with the system. In addition, in the addendum to this final rule, we are describing changes in the amounts and factors necessary to determine prospective payment rates for Medicare inpatient hospital services. We are also setting forth the new target rate percentages for determining rate-of-increase limits for hospitals and hospital units excluded from the prospective payment system. This final rule also responds to the comments we received concerning changes to hospital payments made in a January 7, 1991 final rule with comment. These changes include midyear changes to the inpatient hospital prospective payment system that implemented several provisions of section 4002 of the Omnibus Budget Reconciliation Act of 1990. In addition, this final rule responds to comments received concerning changes in the procedures and criteria of the Medicare Geographic Classification Review Board (MGCRB) that were set forth in a June 4, 1991 final rule with comment period.     

Medicare program; payment for customized wheelchairs--HCFA. Final rule

This final rule responds to comments we received on an interim final rule relating to payment for customized wheelchairs that was published on December 20, 1991 (56 FR 65995). The interim rule set forth the Secretary's criteria that a wheelchair must meet to be considered a customized item and allowed for a payment for the purchase of customized items based on the carrier's case-by-case determination. This rule establishes the interim rule as a final regulation with one change. The change is based on our review and consideration of the public comments. EFFECTIVE DATE: This final rule is effective on July 30, 1993.     

Medicare and Medicaid programs; electronic health record incentive program--stage 2. Final rule

This final rule specifies the Stage 2 criteria that eligible professionals (EPs), eligible hospitals, and critical access hospitals (CAHs) must meet in order to qualify for Medicare and/or Medicaid electronic health record (EHR) incentive payments. In addition, it specifies payment adjustments under Medicare for covered professional services and hospital services provided by EPs, eligible hospitals, and CAHs failing to demonstrate meaningful use of certified EHR technology (CEHRT) and other program participation requirements. This final rule revises certain Stage 1 criteria, as finalized in the July 28, 2010 final rule, as well as criteria that apply regardless of Stage.     

Medicare program; criteria for submitting supplemental practice expense survey data under the physician fee schedule. Interim final rule with comment period

This interim final rule revises criteria that we apply to supplemental survey information supplied by physician, non-physician, and supplier groups for use in determining practice expense relative value units under the physician fee schedule. This interim final rule solicits public comments on the revised criteria for supplemental surveys.     

Medicare program; application of inherent reasonableness payment policy to Medicare Part B services (other than physician services). Final rule

This final rule finalizes the process that was set forth in an interim final rule published on December 13, 2002, for establishing a realistic and equitable payment amount for Medicare Part B services (other than physicians' services) when the existing payment amounts are inherently unreasonable because they are either grossly excessive or grossly deficient. This process does not apply to services paid under a prospective payment system, such as outpatient hospital services or home health services. The December 2002 interim final rule also described the factors we (or our carriers) will consider and the procedures we will follow in establishing realistic and equitable payment amounts for Medicare Part B services. In addition, this final rule responds to public comments we received on two provisions in the December 13, 2002 interim final rule relating to how we define grossly excessive or deficient payment amounts and to the criteria for using valid and reliable data in applying the inherent reasonableness authority.     

Tobacco products, exemptions from substantial equivalence requirements. Final rule

The Food and Drug Administration (FDA) is issuing this final rule to establish procedures for requesting an exemption from the substantial equivalence requirements of the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act). The final rule describes the process and statutory criteria for requesting an exemption and explains how FDA reviews requests for exemptions. This regulation satisfies the requirement in the Tobacco Control Act that FDA issue regulations implementing the exemption provision.     

Medicare program; rural health clinics: amendments to participation requirements and payment provisions; and establishment of a quality assessment and performance improvement program. Final rule

This final rule amends Medicare certification and payment requirements for rural health clinics (RHCs) as required by the Balanced Budget Act of 1997 (BBA). It changes the definition of a qualifying rural shortage area in which a Medicare RHC must be located; establishes criteria for identifying RHCs essential to delivery of primary care services that we can continue to approve as Medicare RHCs in areas no longer designated as medically underserved; and limits waivers of certain nonphysician practitioner staffing requirements. This final rule imposes payment limits on provider-based RHCs and prohibits "commingling" (the use of the space, professional staff, equipment, and other resources) of an RHC with another entity. The rule also requires RHCs to establish a quality assessment and performance improvement program that goes beyond current regulations. Finally, this final rule addresses public comments received on the February 28, 2002 proposed rule and makes other revisions for clarity and uniformity and to improve program administration.     

Beverages: bottled water. Direct final rule

The Food and Drug Administration (FDA) is amending its bottled water quality standard regulations by establishing an allowable level for the contaminant uranium. As a consequence, bottled water manufacturers are required to monitor their finished bottled water products for uranium at least once each year under the current good manufacturing practice (CGMP) regulations for bottled water. Bottled water manufacturers are also required to monitor their source water for uranium as often as necessary, but at least once every 4 years unless they meet the criteria for the source water monitoring exemptions under the CGMP regulations. FDA will retain the existing allowable levels for combined radium-226/-228, gross alpha particle radioactivity, and beta particle and photon radioactivity. This direct final rule will ensure that the minimum quality of bottled water, as affected by uranium, combined radium-226/-228, gross alpha particle radioactivity, and beta particle and photon radioactivity, remains comparable with the quality of public drinking water that meets the Environmental Protection Agency's (EPA's) standards. FDA is issuing a direct final rule for this action because the agency expects that there will be no significant adverse comment on this rule. Elsewhere in this issue of the Federal Register, FDA is publishing a companion proposed, rule under the agency's usual procedure for notice-and-comment rulemaking, to provide a procedural framework to finalize the rule in the event the agency receives any significant adverse comments and withdraws this direct final rule. The companion proposed rule and direct final rule are substantively identical.     

Afterschool snacks in the Child and Adult Care Food Program. Final rule

This final rule incorporates into the Child and Adult Care Food Program (CACFP) regulations the provisions of the William F. Goodling Child Nutrition Reauthorization Act of 1998, which authorized afterschool care centers meeting certain criteria to be reimbursed for snacks served to at-risk children 18 years of age and younger. This rule establishes the eligibility of at-risk afterschool care centers to serve free snacks to children who participate in afterschool programs. The centers, which must be located in low-income areas, are reimbursed at the free rate for snacks. The intended effect of this rule is to support afterschool care programs through the provision of snacks that meet CACFP meal pattern requirements. The additional benefits provided by the 1998 reauthorization act and codified by this final rule were extended to institutions and children immediately after enactment. These changes were originally proposed by the Department in a rulemaking published on October 11, 2000.     

Criteria for the release of individuals administered radioactive materials--NRC. Final rule

The Nuclear Regulatory Commission (NRC) is amending its regulations concerning the criteria for the release of patients administered radioactive material. The new criteria for patient release are based on the potential dose to other individuals exposed to the patient. The new criteria are consistent with the recommendations of the National Council on Radiation Protection and Measurements (NCRP) and the International Commission on Radiological Protection (ICRP). This final rule required the license to provide written instructions to patients on how to maintain the doses to others as low as is reasonably achievable if the total effective dose equivalent to any other individual exposed to the released patient is likely to exceed 1 milisievert (0.1 rem). This final rule responds to three petitions for rulemaking regarding the criteria for release of patients administered radioactive material.     

VA homeless providers grant and per diem program--VA. Final rule

We are, with changes, adopting as a final rule the provisions of an interim final rule promulgated pursuant to The Homeless Veterans Comprehensive Service Programs Act of 1992. The Act authorizes the Department of Veterans Affairs to assist public or nonprofit private entities in establishing new programs to furnish supportive services and supportive housing for homeless veterans through grants. The Act also authorizes VA to provide per diem payments, or in-kind assistance in lieu of per diem payments, to eligible entities that established programs after November 10, 1992 that provide supportive services or supportive housing for homeless veterans, or service centers providing supportive services. This rule contains criteria and requirements relating to the awarding of grants and relating to per diem payments. Accordingly, this rule is necessary so that grants can be awarded and per diem payments can be made.     

Medicare program; coverage of epoetin (EPO) used by competent home dialysis patients--HCFA. Final rule

This final rule adopts as final the interim final rule that provided for Medicare coverage of EPO used by ESRD beneficiaries who dialyze at home and are competent to use the drug without medical or other supervision and established criteria for selection of patients that can be considered "competent" and for monitoring of the patients who are selected. It also makes minor changes in response to public comments on the interim rule. The interim rule was necessary to implement section 4201(d)(1) of the Omnibus Budget Reconciliation Act of 1990 (OBRA '90). The purpose of the amendments is to facilitate use of EPO at home, while ensuring that such use of the drug is safe.     

Health information technology: standards, implementation specifications, and certification criteria for electronic health record technology, 2014 edition; revisions to the permanent certification program for health information technology. Final rule

With this final rule, the Secretary of Health and Human Services adopts certification criteria that establish the technical capabilities and specify the related standards and implementation specifications that Certified Electronic Health Record (EHR) Technology will need to include to, at a minimum, support the achievement of meaningful use by eligible professionals, eligible hospitals, and critical access hospitals under the Medicare and Medicaid EHR Incentive Programs beginning with the EHR reporting periods in fiscal year and calendar year 2014. This final rule also makes changes to the permanent certification program for health information technology, including changing the program's name to the ONC HIT Certification Program.     

Medicare program; changes to the inpatient hospital prospective payment system and fiscal year 1991 rates--HCFA. Final rule

We are revising the Medicare inpatient hospital prospective payment system to implement necessary changes arising from legislation and our continuing experience with the system. In addition, in the Addendum to this final rule, we are describing changes in the amounts and factors necessary to determine prospective payment rates for Medicare inpatient hospital services. In general, these changes are applicable to discharges occurring on or after October 1, 1990. We also set forth rate-of-increase limits for hospitals and hospital units excluded from the prospective payment system. This final rule also responds to comments received concerning changes to hospital payments made in an April 20, 1990 final rule with comment. These changes include mid-year changes to the inpatient hospital prospective payment system that implemented provisions of the Omnibus Budget Reconciliation Act of 1989; and adjustments applicable to prospective payment hospitals and to the target amounts of hospitals and units excluded from the prospective payment system due to the elimination of the day limitation on covered inpatient hospital days made by the Medicare Catastrophic Coverage Act of 1988 and later repealed by provisions in the Medicare Catastrophic Repeal Act of 1989. The April 20, 1990 final rule with comment also incorporated changes to these provisions made by the Family Support Act of 1988, which clarified the criteria for adjusting the target amounts and implementation date. In addition, this final rule clarifies the documentation requirements necessary to support the cost allocation of teaching physicians and the allowability of costs for rotating residents in determining payment for the direct costs of an approved graduate medical education program. This clarification is being made as a result of a September 29, 1989 final rule that made changes in Medicare policy concerning payment for the direct graduate medical education costs of providers associated with approved residency programs in medicine, osteopathy, dentistry, and podiatry.     

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.