Reflections: the challenge of biotechnology and public policy

Rapid developments in the area of biotechnology within the next decade are likely to have a significant impact on Canadian society. This article outlines the practical and ethical issues that will need to be addressed in the face of scientific advances, and contemplates the development of an appropriate policy framework in this regard. Surveying the approaches to policy development taken thus far, the author notes the underlying need for greater transparency and public participation. Rational and effective policies will only result from additional basic scientific data being made available to a more informed and engaged Canadian public.     

Pharmaceutical Reimbursement Board; maximum allowable cost (MAC) limits and announcement of public hearing--HCFA. Proposed notice

The Pharmaceutical Reimbursement Board (PRB) proposes maximum allowable cost limits on the drugs specified below and announces a public hearing with regard to these proposed MAC limits.     

CLIA program; fee schedule revision--HCFA. General notice with comment period

This notice updates the certificate fees for laboratories established under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) consistent with the methodology set forth in 42 CFR part 493. Section 353 (m) of the Public health Service Act requires that fees be collected to recoup costs of general administration of the CLIA Program. By economizing at every opportunity, the CLIA program has managed to maintain the fees established in 1992 and has absorbed all increases in costs. Revisions to the fees are necessary because the current fees are no longer sufficient to support the administration of the CLIA program. This restructuring of fees will move equitably distribute fees across all sizes and complexity of laboratories. For purposes of simplification, this notice announces a flat fee of $100 for a certificate of registration.     

Human tissue intended for transplantation--FDA. Interim rule; opportunity for public comment

The Food and Drug Administration (FDA) is issuing an interim rule to require certain infectious disease testing, donor screening, and recordkeeping to help prevent the transmission of AIDS and hepatitis through human tissue used in transplantation. The regulations are effective upon publication. FDA is taking this action in response to growing concerns that some human tissue products are being offered for transplantation use without even the minimum donor testing and screening needed to protect recipients against human immunodeficiency virus (HIV) infection and hepatitis infection. The new regulations require all facilities engaged in procurement, processing, storage, or distribution of human tissues intended for transplant to ensure that minimum required infectious disease testing has been performed and that records documenting such testing for each tissue are available for inspection by FDA. The regulations also provide authority for the agency to conduct inspections of such facilities and to detain, recall, or destroy tissue for which appropriate documentation is not available.     

Fees for certifying insulin drugs--FDA. Interim rule; opportunity for public comment

The Food and Drug Administration (FDA) is issuing interim regulations to revise the fee schedule for insulin certification services. Under the revision, FDA will charge a fixed fee for each master lot or batch submitted for certification. The changes in fee schedule reflect a change in agency testing policy for certification and release of batches of insulin. The changes in fees will allow FDA to continue to maintain an adequate insulin certification program as required by the Federal Food, Drug, and Cosmetic Act (the act). The fees are intended to recover the full costs of operation of FDA's insulin certification program, including the unfunded liability of the Civil Service Retirement Fund and appropriate overhead costs of the Public Health Service and Department of Health and Human Services.     

Preemptive public policy for genomics

To many, genomics is merely exploitable technology for the leviathan of biotechnology. This is both shallow and short sighted. Genomics is applied knowledge based on profound and evolving science about how living things develop, how healthy or sick we are, and what our future will be like. In health care, genomics technologies are disruptive yet potentially cost-effective because they enable primary prevention, the antidote to runaway costs and declining productivity. The challenges to integration are great, however, and many bioethical and social-policy implications are alarming. Because it is poorly understood today, we must debate genomics vigorously if we are to act wisely. Public policy must lead.     

Medicare program; list of covered surgical procedures for ambulatory surgical centers--HCFA. Proposed notice and request for comment

HCFA is seeking suggestions for possible additions or revisions to the current list of ambulatory surgical center (ASC) procedures covered under Medicare. Our current list of covered ASC procedures was published in the Federal Register on August 5, 1982 (47 FR 34099). In this notice we are also soliciting comments on additional ASC procedures that have been suggested by the public since publication of our current list.     

Medicare program; HCFA market research for providers and other partners--HCFA. General notice with comment period

This notice seeks public comments on information needs of Medicare risk contract health maintenance organizations (HMOs) and competitive medical plans (CMPs) and communication strategies that could improve the effectiveness and efficiency of the risk contract program. Under section 4002 of the Balanced Budget Act of 1997, and with the implementation of the Medicare + Choice program, all HMOs and CMPs will contract with HCFA under requirements of the Medicare + Choice program. The information sought in this notice will facilitate future changes in the contracting program, as well as improve information needs and communication strategies under the current risk program. Respondents should prioritize issues raised in the preliminary research and identify and additional areas of information needs and best communication strategies. This initiative is one component of our overall effort to develop a comprehensive communication strategy with Medicare providers and HMOs/CMPs and to develop innovative approaches that will assist all program participants to obtain and use information in the most accessible and effective manner. Preliminary research on the information needs of Medicare risk contract HMOs and CMPs and effective communication strategies has identified a number of areas in which we could provide additional information and potential strategies for communicating that information effectively.     

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; fee schedule for physicians' services for calendar year 1993--HCFA. Final notice with comment period

This final notice with comment period announces the final relative value units (RVUs) for Medicare payment for existing procedure codes under the physician fee schedule and interim RVUs for new and revised codes. Section 6102(a) of the Omnibus Budget Reconciliation Act of 1989, as amended by section 4118 of the Omnibus Budget Reconciliation Act of 1990, requires establishment of the physician fee schedule and periodic review and adjustment of the RVUs.