CMS has announced that the Medicare Evidence Development & Coverage Advisory Committee (MedCAC) will meet February 25, 2009 to focus on the requirements for evidence to determine if diagnostic use of genomic testing in beneficiaries with signs or symptoms of disease improves health outcomes in Medicare beneficiaries. The meeting will also discuss the various kinds of evidence that are useful to support requests for Medicare coverage in this field.
On December 18, 2008, the Congressional Budget Office (CBO) released a major report entitled “Budget Options, Volume 1: Health Care,” which sets forth 115 policy options for Congress to consider as it addresses health care system reform. The CBO points out that Medicare is expected to grow from 2.8 percent of gross domestic product (GDP) in 2008 to nearly 9 percent of GDP in 2050. This spending growth will be fueled primarily by growth in per capita medical costs, according to the CBO, with the aging of the population playing a secondary role. In light of these trends, the CBO offers specific options addressing such areas as: health insurance (market reforms, tax treatment, access to federal programs); health care quality and efficiency; geographic variation in Medicare spending; paying for Medicare services (including hospital, physician, imaging, and post-acute care, and Medicare Advantage plan services, among others); financing and paying for services in Medicaid (including drug payment revisions) and SCHIP; premiums and cost sharing in federal health programs; long-term care; health behavior and health promotion; and closing the gap between Medicare’s spending and receipts. The CBO also issued a separate report focusing on insurance reform, “Key Issues in Analyzing Major Health Insurance Proposals.” The CBO warns that without changes in policy, a substantial and growing number of nonelderly people are likely to be without health insurance. This issue cannot be addressed without making major changes in the financing or provision of health insurance and health care, which will involve "difficult trade-offs between the objectives of expanding insurance coverage and controlling both federal and total costs for health care." The report describes the assumptions that CBO would use in estimating the effects of key elements of proposals to modify the health insurance system on federal costs, insurance coverage, and other outcomes. In particular, it considers the types of issues that would arise in estimating the effects of proposals to: provide tax credits or other types of subsidies to make insurance less expensive to the purchaser; require individuals to purchase health insurance; require firms to offer health insurance to their workers or pay into a fund that subsidizes insurance purchases; replace employment-based coverage with new purchasing arrangements or provide strong incentives for people to shift toward individually purchased coverage; and provide individuals with coverage under, or access to, existing insurance plans such as the Medicare program, either as an additional option or under a “Medicare-for-all” single-payer arrangement.
On December 2, 2008, CMS proposed three national coverage determinations (NCDs) to deny Medicare coverage of certain types of serious, preventable surgical errors. Specifically, under the proposed NCDs, Medicare would not cover: (1) wrong surgical or other invasive procedures performed on a patient; (2) surgical or other invasive procedures performed on the wrong body part; or (3) surgical or other invasive procedures performed on the wrong patient. The coverage policy is intended to complement CMS’s hospital-acquired conditions policy, under which Medicare will not make higher payments to hospitals for care associated with certain reasonably-preventable conditions unless the condition were reported as present on admission. CMS will accept comments on the proposed coverage policies until January 1, 2009.
The Secretary of the Department of Health and Human Services (HHS) has submitted to Congress the Department's annual report on Medicare national coverage determinations (NCDs). The report includes detailed information on the time periods necessary for HHS to complete and implement Medicare NCDs and other background information.
On October 24, 2008, CMS issued a transmittal updating the Medicare Benefit Policy Manual to recognize the four authoritative compendia for use in the determination of a medically-accepted indication of drugs and biologicals used off-label in an anti-cancer chemotherapeutic regimen. The transmittal also modifies requirements for contractors to identify off-label uses that are supported by clinical research.
The AHRQ's Technology Assessment Program develops systematic reviews and health technology assessments at the request of CMS in order to inform national Medicare coverage policies. AHRQ has announced that beginning October 15, 2008, it will post draft Technology Assessment Program reports for public comment on its website. In a related development, on October 14, 2008, AHRQ has announced that it will be releasing for public comment a draft White Paper on "Potential Conflict of Interest in the Production of Drug Compendia" on October 22, and comments will be accepted on the draft until November 5, 2008.
CMS has issued an educational article clarifying issues related to Medicare payment of certain routine costs associated with clinical trials. The article focuses on the prohibition on payment for items or services which neither the beneficiary nor any other person or organization has a legal obligation to pay (i.e., items and services furnished gratuitously without regard to the beneficiary’s ability to pay and without expectation of payment from any source, such as free x-rays or immunizations provided by health organizations). CMS discusses the application of this policy in three scenarios: when a research sponsor says it will pay for routine costs if there is no reimbursement from any insurance company; when a research sponsor pays for the routine costs provided to an indigent non-Medicare patient; and when a research sponsor pays Medicare copayments for beneficiaries in a clinical trial.
CMS has released the “Innovator’s Guide to Navigating CMS,” which compiles key Medicare coverage, coding, and payment information in a single source. Other background information also is posted at the CMS web site.
CMS is soliciting comments regarding whether the agency should undertake Medicare national coverage determinations (NCDs) regarding a wide range of medical technologies. CMS will accept comments until September 28, 2008, on whether a review should or should not proceed prior to the formal decision to open an NCD, based on: 1) a significant number of inquiries from the public, providers, or patients; 2) new evidence or a reexamination of previously available evidence; 3) inconsistent or conflicting local coverage policies; 4) program integrity concerns; 5) substantial clinical advances; 6) technologies for which rapid diffusion could have a significant programmatic impact; or 7) significant uncertainty about the health benefit, patient selection, or appropriate facility and staffing requirements for a new technology. The specific technologies under review are as follows: thrombopoiesis stimulating agents, erythropoiesis stimulating agents, levocarnitine, parenteral iron supplementation, bisphosphonates, gene expression profiling tests, treatment of wet AMD, proton beam therapy for prostate cancer, artificial cervical discs, minimally invasive methods for bariatric surgery, biological therapies for treatment of chronic wounds, bone morphogenetic protein, hip resurfacing, ablation for atrial fibrillation, off label use of drug eluting coronary stents, vertebroplasty and kyphoplasty, lumbar fusion for degenerative disc disease, peripheral arterial stenting and vascular intervention, and pharmacogenomic testing.
CMS has posted the Medicare Evidence Development & Coverage Advisory Committee (MedCAC) Medicare Evidentiary Priorities list, which lists research topics on clinical practice for which there are significant knowledge gaps. CMS encourages researchers to consider these research priorities when designing studies for items or services that have a direct impact on the health of the elderly. CMS is working with the Agency for Healthcare Research and Quality (AHRQ) to develop a process for future revisions to the priority list. CMS is accepting comments on both the Medicare Evidentiary Priorities List and a process for revising the list, although no comment deadline is provided.
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