Medicare program; Medicare graduate medical education affiliation provisions for teaching hospitals in certain emergency situations. Interim final rule with comment period

This interim final rule with comment period will modify the current Graduate Medical Education (GME) regulations as they apply to Medicare GME affiliations to provide for greater flexibility during times of disaster. Specifically, this rule will implement the emergency Medicare GME affiliated group provisions that will address issues that may be faced by certain teaching hospitals in the event that residents who would otherwise have trained at a hospital in an emergency area (as that term is defined in section 1135(g) of the Social Security Act (the Act)) are relocated to alternate training sites.     

Medicare and Medicaid programs; surety bond requirements for home health agencies--HCFA. Final rule

This final rule revises several provisions of an earlier final rule concerning surety bond requirements published in the Federal Register on January 5, 1998 (63 FR 292). This rule also establishes the surety bond submission compliance data, as described in a notice of intent and in a final rule concerning surety bond requirements published in the Federal Register on March 4, 1998 (63 FR 10730 and 10732). The March 4 documents advised the public that we intended to make technical revisions to the January 5, 1998 final rule and extend the February 27, 1998 compliance date for all home health agencies (HHAs) to furnish a surety bond to HCFA and/or the State Medicaid agency, or both, until 60 days after the date of publication of this final rule. In this rule, for Medicare-participating HHAs, we are establishing a new compliance date to submit a surety bond that is 60 days after the date of publication of this final rule. For Medicaid-participating HHAs, we are establishing a new compliance date to furnish a surety bond that is a date established by the State Medicaid agency up to 120 days after the date of publication of this final rule. We are also responding to comments we received in response to the January 5, 1998 final rule that pertain to the technical revisions we discussed in our March 4, 1998 notice. It is our intention to respond to all comments not addressed herein in a future Federal Register document. This final rule revision does not change the beginning date of the term the initial surety bond is to cover, that is, January 1, 1998.     

Medical device reporting: manufacturer reporting, importer reporting, user facility reporting, distributor reporting--FDA. Direct final rule; withdrawal

The Food and Drug Administration (FDA) published in the Federal Register of May 12, 1998, a proposed rule (63 FR 26129) and a direct final rule (63 FR 26069) to implement amendments to the medical device reporting provisions of the Federal Food, Drug, and Cosmetic Act, as amended by the FDA Modernization Act of 1997 (FDAMA). The comment period closed July 27, 1998. FDA is withdrawing the direct final rule because the agency received significant adverse comment.     

Medicaid program; Medicaid managed care. Health Care Financing Administration (HCFA), HHS. Final rule with comment period

This final rule with comment period amends the Medicaid regulations to implement provisions of the Balanced Budget Act of 1997 (BBA) that allow the States greater flexibility by permitting them to amend their State plan to require certain categories of Medicaid beneficiaries to enroll in managed care entities without obtaining waivers if beneficiary choice is provided; establish new beneficiary protections in areas such as quality assurance, grievance rights, and coverage of emergency services; eliminate certain requirements viewed by State agencies as impediments to the growth of managed care programs, such as the enrollment composition requirement, the right to disenroll without cause at any time, and the prohibition against enrollee cost-sharing. In addition, this final rule expands on regulatory beneficiary protections provided to enrollees of prepaid health plans (PHPs) by requiring that PHPs comply with specified BBA requirements that would not otherwise apply to PHPs.     

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.     

TRICARE; Continued Health Care Benefit Program expansion. Final rule

This final rule executes the expansion of section 1078a of title 10, United States Code (U.S.C). With the recent expansions of Military Health System (MHS) coverage, particularly with the Reserve Component (RC) members, some MHS beneficiaries would not be eligible to purchase Continued Health Care Benefit Program (CHCBP) coverage under certain circumstances that terminate their MHS coverage. This provision allows the Secretary to establish CHCBP eligibility for any category of MHS beneficiaries who otherwise would lose MHS coverage with no continued care eligibility. Although the proposed rule listed each authorized category of MHS beneficiary eligible to receive care, on further examination this format for the rule appeared cumbersome and perhaps confusing. Thus this final rule contains some organizational changes to simplify the rule to enhance understanding and make clear that any category including future categories of beneficiaries are entitled to purchase this CHCBP coverage. This final rule also includes administrative changes providing clarification on eligibility notifications and the CHCBP premium rate publication process. It updates the previous final rule published in the Federal Register on September 30, 1994.     

Medicaid program; Medicaid managed care. Withdrawal of final rule with comment period

This document withdraws all provisions of the final rule with comment period on Medicaid managed care that we published in the Federal Register on January 19, 2001 (66 FR 6228) with an initial effective date of April 19, 2001. This January 19, 2001 final rule, which has never taken effect, would have combined Medicaid managed care regulations in a new part 438, implemented Medicaid managed care requirements of the Balanced Budget Act of 1997 (Pub. L. 105-33), and imposed new requirements on entities currently regulated as "prepaid health plans' (PHPs). The regulations set forth in the final rule being withdrawn have been superseded by regulations promulgated in a subsequent rulemaking initiated on August 20, 2001 (66 FR 43613). In addition, this document addresses comments received in response to an interim final rule with comment period that we published on August 17, 2001 in the Federal Register (66 FR 43090) that further delayed, until August 16, 2002, the effective date of the January 19, 2001 final rule with comment period.     

Status of certain additional over-the-counter drug category II and III active ingredients--FDA. Final rule

The Food and Drug administration (FDA) is issuing a final rule stating that certain ingredients in over-the-counter (OTC) drug products are not generally recognized as safe and effective or are misbranded. FDA is issuing this final rule after considering the reports and recommendations of various OTC drug advisory review panels and public comments on proposed agency regulations, which were issued in the form of a tentative final monograph (proposed rule). Based on the absence of substantive comments in opposition to the agency's proposed nonmonograph status for these ingredients, as well as the failure of interested parties to submit new data or information to FDA under the regulation, the agency has determined that the presence of these ingredients in an OTC drug product would result in that drug product not being generally recognized as safe and effective or would result in misbranding. This final rule is part of the ongoing review of OTC drug products conducted by FDA.     

Medicare program; revisions to payment policies under the physician fee schedule for calendar year 2003 and inclusion of registered nurses in the personnel provision of the critical access hospital emergency services requirement for frontier areas and remote locations. Final rule with comment period

This final rule with comment period refines the resource-based practice expense relative value units (RVUs) and makes other changes to Medicare Part B payment policy. In addition, as required by statute, we are announcing the physician fee schedule update for CY 2003. The update to the physician fee schedule occurs as a result of a calculation methodology specified by law. That law required the Department to set annual updates based in part on estimates of several factors. Although subsequent after-the-fact data indicate that actual increases were different to some degree from earlier estimates, the law does not permit those estimates to be revised. A subsequent law required estimates to be revised for FY 2000 and beyond. Although we have exhaustively examined opportunities for a different interpretation of law that would allow us to correct the flaw in the formula administratively, current law does not permit such an interpretation. Accordingly, without Congressional action to address the current legal framework, the Department is compelled to announce herein a physician fee schedule update for CY 2003 of -4.4 percent. Because the Department would adopt a change in the formula that determines the physician update if the law permitted it, we have examined how proper adjustments to past data could result in a positive update. The Department believes that revisions of estimates used to establish the sustainable growth rates (SGR) for fiscal years (FY) 1998 and 1999 and Medicare volume performance standards (MVPS) for 1990-1996 would, under present calculations, result in a positive update. The Department intends to work closely with Congress to develop legislation that could permit a positive update, and hopes that such legislation can be passed before the negative update takes effect. Because the Department wishes to change the update promptly in the event that Congress provides the Department legal authority to do so, we are requesting comments regarding how physician fee schedule rates could and should be recalculated prospectively in the event that Congress provides the Department with legal authority to revise estimates used to establish the sustainable growth rates (SGR) and for 1998 and 1999 and the NVPS for 1990-1996. The other policy changes concern: the pricing of the technical component for positron emission tomography (PET) scans, Medicare qualifications for clinical nurse specialists, a process to add or delete services to the definition of telehealth, the definition for ZZZ global periods, global period for surface radiation, and an endoscopic base for urology codes. In addition, this rule updates the codes subject to physician self-referral prohibitions. We are expanding the definition of a screening fecal-occult blood test and are modifying our regulations to expand coverage for additional colorectal cancer screening tests through our national coverage determination process. We also make revisions to the sustainable growth rate, the anesthesia conversion factor, and the work values for some gastroenterologic services. 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 clarifies the enrollment of physical and occupational therapists as therapists in private practice and clarifies the policy regarding services and supplies incident to a physician's professional services. In addition, this final rule discusses physical and occupational therapy payment caps and makes technical changes to the definition of outpatient rehabilitation services. In addition, we are finalizing the calendar year (CY) 2002 interim RVUs and are issuing interim RVUs for new and revised procedure codes for calendar year (CY) 2003. As required by the statute, we are announcing that the physician fee schedule update for CY 2003 is -4.4 percent, the initial estimate of the sustainable growth rate for CY 2003 is 7.6 percent, and the conversion factor for CY 2003 is $34.5920. This final rule will also allow registered nurses (RNs) to provide emergency care in certain critical access hospitals (CAHs) in frontier areas (an area with fewer than six residents per square mile) or remote locations (locations designated in a State's rural health plan that we have approved.) This policy applies if the State, following consultation with the State Boards of Medicine and Nursing, and in accordance with State law, requests that RNs be included, along with a doctor of medicine or osteopathy, a physician's assistant, or a nurse practitioner with training or experience in emergency care, as personnel authorized to provide emergency services in CAHs in frontier areas or remote locations.     

Medicare program; clarifying policies related to the responsibilities of Medicare-participating hospitals in treating individuals with emergency medical conditions. Final rule

This final rule clarifies policies relating to the responsibilities of Medicare-participating hospitals in treating individuals with emergency medical conditions who present to a hospital under the provisions of the Emergency Medical Treatment and Labor Act (EMTALA). The final rule responds to public comments received on a May 9, 2002 proposed rule (67 FR 31404) that both reiterated the agency's interpretations under EMTALA and proposed clarifying changes relating to the implementation of the EMTALA provisions. These reiterations and clarifying changes related to, among other areas, seeking prior authorization from insurers for services, emergency patients presenting at off-campus outpatient clinics that do not routinely provide emergency services, the applicability of the EMTALA provisions to hospital inpatients and outpatients, the circumstances under which physicians must serve on hospital medical staff "on-call" lists, and the responsibilities of hospital-owned ambulances. These reiterations and clarifying changes are needed to ensure uniform and consistent application of policy and to avoid any misunderstanding of EMTALA requirements by individuals, physicians, or hospital employees.     

Per diem payments for the care provided to eligible veterans evacuated from a state home as a result of an emergency. Final rule

The Department of Veterans Affairs (VA) amends its regulations concerning per diem payments to States to permit continuation of such payments in some situations for veterans who have been evacuated from a State home as a result of an emergency. Per diem is the daily rate paid by VA to a State for providing a specified level of care to eligible veterans in a facility that is officially recognized and certified by VA. This final rule authorizes VA to continue to pay per diem when veterans for whom VA is paying per diem are evacuated as a result of an emergency from a State home to a facility that is not recognized by VA as a State home. The rule requires, in order for per diem payments to continue while the veteran is relocated due to an emergency, that an appropriate VA official determine whether an emergency exists and whether the facility to which veterans may be evacuated (evacuation facility) complies with certain minimum standards. The rule establishes the minimum standards that facilities to which veterans are evacuated must meet in order for States to continue receiving per diem for relocated veterans. These standards also apply to evacuation facilities when veterans are evacuated from contract nursing homes.     

Medical devices; humanitarian use of devices--FDA. Direct final rule; withdrawal

The Food and Drug Administration (FDA) published, in the Federal Register of April 17, 1998 (63 FR 19185), a direct final rule to implement the amendments to the humanitarian use devices provision of the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Food and Drug Administration Modernization Act of 1997 (FDAMA). The comment period closed July 1, 1998. FDA is withdrawing the direct final rule because the agency received significant adverse comment.     

Administrative practices and procedures; internal agency review of decisions--FDA. Direct final rule; withdrawal

The Food and Drug Administration (FDA) published in the Federal Register of June 16, 1998 (63 FR 32733), a direct final rule to implement the new Dispute Resolution provision of the Federal Food, Drug, and Cosmetic Act, as amended by the Food and Drug Administration Modernization Act of 1997 (FDAMA). The comment period closed on August 31, 1998. FDA is withdrawing the direct final rule because the agency received significant adverse comment.     

Medicare and Medicaid programs; surety bond requirements for home health agencies--HCFA. Final rule

This final rule revised Medicare and Medicaid regulations concerning surety bond requirements published in the Federal Register (63 FR 29648) on June 1, 1998. Those regulations specified submission compliance dates for all home health agencies (HHAs) to furnish a surety bond to HCFA and/or to the State Medicaid agency. This rule removes those submission compliance dates.     

Investigational new drug applications; clinical holds; companion document to direct final rule--FDA. Proposed rule

The Food and Drug Administration (FDA) is proposing to amend its regulations governing investigational new drug applications (IND's) for human drug and biological products. This proposed action would amend the IND clinical hold requirements to state that the agency will respond in writing to a sponsor's request that a clinical hold be removed from an investigation within 30-calendar days of the agency's receipt of the request and the sponsor's complete response to the issue(s) that led to the clinical hold. This proposed action is being taken in accordance with provisions of the Food and Drug Administration Modernization Act of 1997 (the Modernization Act). This proposed rule is a companion document to a direct final rule published elsewhere in this issue of the Federal Register. If FDA receives any significant adverse comment, the direct final rule will be withdrawn, and the comments will be considered in the development of a final rule using usual notice-and-comment rulemaking based on this proposed rule.     

Medical devices; 30-day notices and 135-day PMA supplement review--FDA. Direct final rule; withdrawal

The Food and Drug Administration (FDA) published, in the Federal Register of April 27, 1998 (63 FR 20530), a direct final rule to implement the amendments to the premarket approval provisions of the Federal Food, Drug, and Cosmetic Act, as amended by the Food and Drug Administration Modernization Act of 1997 (FDAMA). The comment period closed on July 13, 1998. FDA is withdrawing the direct final rule because the agency received significant adverse comment.     

Medicare program; prospective payment system and consolidated billing for skilled nursing facilities; extension of comment period--HCFA. Notice of extension of comment period for interim final rule

This document extends the comment period for an interim final rule with comment period that was published in the Federal Register on May 12, 1998 (63 FR 26252). That interim final rule implements provisions in section 4432 of the Balanced Budget Act of 1997 related to Medicare payment for skilled nursing facility services. Those include the implementation of a Medicare prospective payment system for skilled nursing facilities, consolidated billing, and a number of related changes. The comment period is extended for 60 days.