Medicare program; solvency standards for provider-sponsored organizations. Health Care Financing Administration (HCFA), HHS. Final rule

The Balanced Budget Act of 1997 established a new Medicare+Choice (M+C) program that offers eligible individuals Medicare benefits through enrollment in one of an array of private health plans that contract with us. Among the new options available to Medicare beneficiaries is enrollment in a provider-sponsored organization (PSO). This final rule revises and responds to comments on solvency standards that certain entities must meet to contract as PSOs under the new M+C program. These standards, originally established in an interim final rule published on May 7, 1998, apply to PSOs that have received a waiver of the requirement that M+C organizations must be licensed by a State as risk-bearing entities.     

Medicare program; improvement to the Medicare+Choice appeal and grievance procedures. Final rule with comment period

This final rule with comment period responds to comments on the January 24, 2001, proposed rule regarding improvements to the Medicare+Choice (M+C) appeal and grievance procedures. It establishes new notice and appeal procedures for enrollees when an M+C organization decides to terminate coverage of provider services. The January 24, 2001 proposed rule was published as a required element of an agreement entered into between the parties in Grijalva v. Shalala, civ. 93-711 (U.S.D.C. Az.), to settle a class action lawsuit. This rule also specifies a Medicare-participating hospital's responsibility for issuing discharge or termination notices under both the original Medicare and M+C programs, amends the Medicare provider agreement regulations with regard to beneficiary notification requirements, and amends M+C enrollee grievance procedures.     

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.     

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.     

Medicare program: request for public comments on implementation of the Medicare+Choice program, and notice of timeframes for submission of applications for contracts--HCFA. Notice of intent to regulate; solicitation of comments

The Balanced Budget Act of 1997 (BBA) establishes a new Medicare+Choice program. Under this program, eligible individuals may elect to receive Medicare benefits through enrollment in one of an array of private health plans that contract with us. The BBA directs the Secretary to publish by June 1, 1998, regulations establishing standards for the Medicare+Choice program. We have already received comments and inquiries from the public on a number of issues associated with the Medicare+Choice program. This document solicits further public comments on issues related to implementation of the Medicare+Choice program. We intend to consider these comments as we develop an interim final rule to implement the Medicare+Choice program. This document also includes preliminary information regarding application procedures for organizations that intend to contract with us to participate in the Medicare+Choice program. This document also informs the public of a meeting to discuss the Medicare+Choice program.     

Medicare Program; establishment of the Medicare+Choice Program--HCFA. Interim final rule with comment period

The Balanced Budget Act of 1997 (BBA) establishes a new Medicare+Choice (M+C) program that significantly expands the health care options available to Medicare beneficiaries. Under this program, eligible individuals may elect to receive Medicare benefits through enrollment in one of an array of private health plan choices beyond the original Medicare program or the plans now available through managed care organizations under section 1876 of the Social Security Act. Among the alternatives that will be available to Medicare beneficiaries are M+C coordinated care plans (including plans offered by health maintenance organizations, preferred provider organizations, and provider-sponsored organizations), M+C "MSA" plans, that is, a combination of a high deductible M+C health insurance plan and a contribution to an M+C medical savings account (MSA), and M+C private fee-for-service plans. The introduction of the M+C program will have a profound effect on Medicare beneficiaries and on the health plans and providers that furnish care. The new provisions of the Medicare statute, set forth as Part C of title XVIII of the Social Security Act, address a wide range of areas, including eligibility and enrollment, benefits and beneficiary protections, quality assurance, participating providers, payments to M+C organizations, premiums, appeals and grievances, and contracting rules. This interim final rule explains and implements these provisions. In addition, we are soliciting letters of intent from organizations that intend to offer M+C MSA plans to Medicare beneficiaries and/or to serve as M+C MSA trustees.     

Medicare program; payment for respiratory assist devices with bi-level capability and a backup rate. Final rule

This final rule clarifies that respiratory assist devices with bi-level capability and a backup rate must be paid as capped rental items of durable medical equipment (DME) under the Medicare program and not paid as items requiring frequent and substantial servicing (FSS), as defined in section 1834(a)(3) of the Social Security Act. Before 1999, respiratory assist devices with bi-level capability (with or without a backup rate feature) were referred to as "intermittent assist devices with continuous positive airway pressure devices' under the Medicare program and in the Healthcare Common Procedure Coding System (HCPCS). This final rule responds to public comments received on a proposed rule published in the Federal Register on August 22, 2003, and finalizes the policy in that proposed rule. The rule will ensure that respiratory assist devices are consistently and properly paid under Medicare as capped rental items.     

Medicare program; changes to the Medicare+Choice program. Health Care Financing Administration (HCFA), HHS. Final rule

The purpose of this final rule is to set forth limited changes to the Medicare+Choice regulations published in our June 26, 1998 interim final rule (63 FR 34968). Those regulations implemented section 4001 of the Balanced Budget Act of 1997 (BBA), which established the Medicare+Choice (M+C) program. This final rule addresses selected issues raised by commenters on the June 26, 1998 interim final rule where we have identified the need for changes or where we believe that clarifications are needed as soon as possible. Among these issues are provider participation procedures, beneficiary enrollment options, and several access-related issues, including initial care assessment requirements, notification requirements when specialists are terminated from an M+C plan, and several coordination of care requirements.     

Medicare program; reduction in Medicare Part B premiums as additional benefits under Medicare+Choice plans. Final rule

This final rule revises the regulations to provide for a Medicare+Choice organization to offer a reduction in the standard Medicare Part B premium as an additional benefit under one or more Medicare+Choice (M+C) plans. The legislation specifies that the reduction to the Medicare Part B premium cannot exceed the standard Medicare Part B premium amount and cannot be applied to surcharges. Surcharges are increased premiums for late enrollment and for reenrollment. The Medicare Part B premium may be collected by a variety of methods: Paid directly to the Centers of Medicare & Medicaid Services by the beneficiary; collected as an adjustment to any Social Security, Railroad Retirement, or Civil Service Retirement benefits; paid by an employer as part of an annuity package; or, paid by the State for individuals enrolled in a qualifying State Medicaid program. This legislation applies to benefits under Medicare M+C plans offered by an M+C organization electing this option, beginning January 1, 2003. This final rule revises the regulations to set out the basic rules under section 606 of the Medicare, Medicaid, and SCHIP Benefits Improvement Protection Act of 2000 (BIPA) for adjustment and payment of the Medicare Part B premium.     

Medicare program; waiver requirements and solvency standards for provider-sponsored organizations--HCFA. Interim final rule with comment period

This interim final rule with a request for comments implements authority to waive, in the case of provider-sponsored organizations (PSOs) that meet certain criteria, the requirement that Medicare + Choice organizations be licensed by a State as risk-bearing entities. The waivers will be approved only under certain conditions where the State has denied or failed to act on an application for licensure. This rule also establishes solvency standards that certain entities must meet to contract as PSOs under the new Medicare + Choice program. These standards apply to PSOs that have received a waiver of the requirement that Medicare + Choice organizations be licensed by a State as risk-bearing entities.     

Medicare program; expedited determination procedures for provider service terminations. Final rule with comment period

This final rule with comment period responds to comments on one discrete aspect of the proposed rule published in the Federal Register on November 15, 2002. The portion of that proposed rule addressed here involves the expedited determination and reconsideration procedures available to beneficiaries when a provider informs them of a decision that Medicare coverage of their provider services is about to end.     

Solicitation of information and recommendations for developing OIG compliance program guidance for certain Medicare+Choice organizations--OIG, HHS. Notice

This Federal Register notice seeks the input and recommendations of interested parties into the OIG's development of a compliance program guidance for Medicare+Choice organizations that offer coordinated care plans (M+CO/CCPs). The OIG has previously developed compliance program guidances for hospitals, clinical laboratories and home health agencies in order to provide clear and meaningful guidance to those segments of the health care industry. In an effort to provide similar guidance to certain M+C organizations, we are soliciting comments, recommendations and other suggestions from concerned parties and organizations on how best to develop compliance program guidance and reduce fraud and abuse within M+CO/CCPs.     

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; revisions to payment policies under the physician fee schedule for calendar year 2001. Health Care Financing Administration (HCFA), HHS. Final rule with comment period

This final rule with comment period makes several changes affecting Medicare Part B payment. The changes include: refinement of resource-based practice expense relative value units (RVUs); the geographic practice cost indices; resource-based malpractice RVUs; critical care RVUs; care plan oversight and physician certification and recertification for home health services; observation care codes; ocular photodynamic therapy and other ophthalmological treatments; electrical bioimpedance; antigen supply; and the implantation of ventricular assist devices. This rule also addresses the comments received on the May 3, 2000 interim final rule on the supplemental survey criteria and makes modifications to the criteria for data submitted in 2001. Based on public comments we are withdrawing our proposals related to the global period for insertion, removal, and replacement of pacemakers and cardioverter defibrillators and low intensity ultrasound. This final rule also discusses or clarifies the payment policy for incomplete medical direction, pulse oximetry services, outpatient therapy supervision, outpatient therapy caps, HCPCS "G" Codes, and the second 5-year refinement of work RVUs for services furnished beginning January 1, 2002. In addition, we are finalizing the calendar year (CY) 2000 interim physician work RVUs and are issuing interim RVUs for new and revised codes for CY 2001. We are making these changes to ensure that our payment systems are updated to reflect changes in medical practice and the relative value of services. This final rule also announces the CY 2001 Medicare physician fee schedule conversion factor under the Medicare Supplementary Medical Insurance (Part B) program as required by section 1848(d) of the Social Security Act. The 2001 Medicare physician fee schedule conversion factor is $38.2581.     

Medicare and Medicaid programs; programs of all-inclusive care for the elderly (PACE); program revisions. Final rule

This rule finalizes the interim final rule with comment period published in the Federal Register November 24, 1999 (64 FR 66234) and the interim final rule with comment period published in the Federal Register on October 1, 2002 (67 FR 61496). The November 1999 interim final rule implemented sections 4801 through 4803 of the Balanced Budget Act of 1997 (Pub. L. 105-33) and established requirements for Programs of All-inclusive Care for the Elderly (PACE) under the Medicare and Medicaid programs. The interim final rule with comment period published on October 1, 2002 (67 FR 61496) implemented section 903 of the Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000 (BIPA) (Pub. L. 106-554).     

Medicare program; revisions to payment policies under the physician fee schedule for calendar year 2000. Health Care Financing Administration (HCFA), HHS. Final rule with comment period

This final rule makes several changes affecting Medicare Part B payment. The changes include: implementation of resource-based malpractice insurance relative value units (RVUs); refinement of resource-based practice expense RVUs; payment for physician pathology and independent laboratory services; discontinuous anesthesia time; diagnostic tests; prostate screening; use of CPT modifier -25; qualifications for nurse practitioners; an increase in the work RVUs for pediatric services; adjustments to the practice expense RVUs for physician interpretation of Pap smears; and revisions to the work RVUs for new and revised CPT codes for calendar year 1999 and a number of other changes relating to coding and payment. Furthermore, we are finalizing the 1999 interim physician work RVUs and are issuing interim RVUs for new and revised codes for 2000. This final rule solicits public comments on the second 5-year refinement of work RVUs for services furnished beginning January 1, 2002 and requests public comments on potentially misvalued work RVUs for all services in the CY 2000 physician fee schedule. This final rule also conforms the regulations to existing law and policy regarding: removal of the x-ray as a prerequisite for chiropractic manipulation; the exclusion of payment for assisted suicide; and optometrist services. This final rule also announces the calendar year 2000 Medicare physician fee schedule conversion factor under the Medicare Supplementary Insurance (Part B) program as required by section 1848(d) of the Social Security Act. The 2000 Medicare physician fee schedule conversion factor is $36.6137.