Health Industry Washington Watch : Washington DC Healthcare Industry Law Firm : Reed Smith : Health Industry Washington Watch : Regulations, Medicare/Medicaid, Governmental Organizations

A number of Congressional committees have held hearings recently on health policy issues. Among other things, two panels held hearings on H1N1 vaccine supply issues -- the House Energy and Commerce Committee and the Senate Homeland Security and Governmental Affairs Committee. The Energy and Commerce Health Subcommittee also held a hearing on recent breast cancer screening recommendations. Also, the Senate Energy and Natural Resources Committee held a hearing on H.R. 3276, the American Medical Isotopes Production Act of 2009.  Looking ahead, on December 8, the Energy and Commerce Health Subcommittee is holding a hearing entitled "Prescription Drug Price Inflation: Are Prices Rising Too Fast?”

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CMS has issued a Medicare Program Integrity Manual describing the “rare and unusual circumstances” in which Medicare contractors may make exceptions to clinical criteria described in an LCD during complex medical review. The transmittal is effective October 13, 2009. 

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CMS has issued an educational article on “Billing for the Administration of the Influenza A (H1N1) Vaccine,” which explains Medicare coverage and reimbursement rules for the H1N1 vaccine and also addresses seasonal flu coverage and reimbursement. 

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The Agency for Healthcare Research and Quality (AHRQ) is seeking public comment on a series of white papers to support its ongoing project on “Registries for Evaluating Patient Outcomes.”  The white papers, which address interfacing registries with electronic health records, stopping a registry, data linkage, and the use of registries in product safety assessment, eventually will be incorporated into a registries handbook. The public comment period ends on September 15, 2009.

** Note:  The comment period subsequently was extended until September 29, 2009.

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CMS has announced a series of Medicare Evidence Development & Coverage Advisory Committee (MedCAC) meetings to address specific Medicare coverage issues. MedCAC is meeting October 21, 2009 to focus on the use of catheter ablation for the treatment of atrial fibrillation.  On November 18, 2009, MedCAC will address the adequacy of the available evidence that supports the diagnostic and treatment methods used in the management of secondary lymphedema.  On January 27, 2010, the panel will review the evidence that supports the use of pharmacogenomic testing in the diagnosis and treatment of cancer. MedCAC also will meet on March 24, 2010, to examine the available evidence on the use of erythropoiesis stimulating agents (ESAs) to manage anemia in patients who have chronic kidney disease.

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The Agency for Healthcare Research and Quality (AHRQ) has announced the availability of funding for the development of a clinical registry of orthopedic devices, drugs, and procedures, with an initial focus on hip and knee replacements.  The initiative seeks to enable comparative effectiveness and safety studies regarding various orthopedic procedures and devices.

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On June 25, 2009, the Agency for Healthcare Research and Quality's (AHRQ) Technology Assessment Program will be releasing a draft technology assessment on “Use of Bayesian Techniques in Randomized Clinical Trials: A CMS Case Study.” Comments on the draft will be accepted until July 10, 2009.

*** Update:  Comment period extended until July 17.

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On March 27, CMS published a notice soliciting nominations for membership on the Medicare Evidence Development & Coverage Advisory Committee (MedCAC), which advises the HHS Secretary on whether medical items and services are “reasonable and necessary” and therefore eligible for Medicare coverage. MedCAC is looking for experts in a number of area, with the most critical needs in the following fields: experts in Bayesian statistics; clinical epidemiology; clinical trial methodology; knee, hip, and other joint replacement surgery; ophthalmology; psychopharmacology; registries; rheumatology; screening and diagnostic testing analysis; and stroke. MedCAC also needs experts in biostatistics in clinical settings, cardiovascular epidemiology, cost effectiveness analysis, dementia, endocrinology, geriatrics, gynecology, minority health, observational research design, stroke epidemiology, and women’s health. Nominations will be considered if postmarked by April 27, 2009. 

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CMS has postponed until June 17, 2009 a Medicare Evidence Development & Coverage Advisory Committee (MedCAC) meeting on the use of Bayesian statistics to interpret evidence in making coverage decisions. Bayesian analysis is a statistical technique in which prior evidence is used to update or to newly infer the probability that a hypothesis may be true. CMS encourages the participation of organizations with expertise in Bayesian statistics, meta-analyses, and clinical trial design and analyses. The meeting originally had been scheduled for March 18, 2009. 

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On May 6, 2009, MedCAC is meeting to focus on the desirable characteristics of evidence needed to evaluate screening genetic tests for Medicare coverage.

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On February 13, 2009, the House and Senate approved the conference report to accompany H.R. 1, the American Recovery and Reinvestment Act.  President Obama signed the bill into law on February 17, 2009.  The $790 billion economic stimulus package includes a number of health care policy provisions.  Among other things, the final agreement includes:

• $19 billion to accelerate the adoption of health information technology systems;
• Strengthened federal privacy and security provisions to protect personally-identifiable health information;
• Approximately $87 billion in additional federal matching funds over two years to help states maintain their Medicaid programs in the face of state budget shortfalls;
• $1.1 billion to support comparative effectiveness research;
• $1 billion for a new Prevention and Wellness Fund; and
• Provisions to help unemployed workers maintain health insurance coverage under the Consolidated Omnibus Budget Reconciliation Act (COBRA) law.
• A provision blocking a fiscal year 2009 reduction in Medicare payments to teaching hospitals related to capital payments for indirect medical education;
• A provision blocking a fiscal year 2009 Medicare payment cut to hospice providers related to a wage index payment add-on;
• Technical corrections to the Medicare, Medicaid, and SCHIP Extension Act of 2007 related to Medicare payments for long-term care hospitals;
• A temporary increase in states’ annual disproportionate share hospital allotments;
• An extension of moratoria on Medicaid regulations for targeted case management, provider taxes, and school-based administration and transportation services through June 30, 2009, and a new moratorium on a Medicaid regulation related to hospital outpatient services through June 30, 2009;
• An extension of Transitional Medical Assistance and the Qualified Individual program; and
• Medicaid prompt payment requirements for nursing facilities and hospitals.

Information on the versions of the measure approved earlier by the House and Senate is available here.    

Update:  On February 17, 2009, President Obama signed into law H.R. 1, the American Recovery and Reinvestment Act (the “ARRA”).  Reed Smith's Health Care Memorandum summarizes the major health policy provisions of the Act.

 

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The House and Senate currently are drafting major economic stimulus legislation that include a number of health care provisions. Although the details of the House and Senate versions vary, both the House and Senate packages would provide, on a temporary basis, approximately $87 billion additional federal matching funds to help states maintain their Medicaid programs during the economic downturn. Both plans also would expand federal health information technology efforts, including providing increased Medicare and Medicaid payments to certain providers using certified health information technology and establishing new privacy and security protections for health information, and increase federal funding of comparative effectiveness research, among many other things. The House of Representatives is set to vote on the bill this week. Senate panels are currently marking up various titles of the Senate package. Details on the Senate Finance Committee’s health-related provisions are available here. 

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HHS is soliciting information on how it could better use its resources and authorities to encourage the development and use of new medical technologies, consistent with the goals of maintaining and improving the quality of care, controlling overall healthcare costs, and using timely and practical administrative procedures. Comments will be accepted until April 16, 2009. 

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On January 15, 2009, CMS announced three final national coverage determinations (NCDs) to deny Medicare coverage of certain types of serious, preventable surgical errors. Specifically, CMS will no longer 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 complements CMS’s hospital-acquired conditions payment policy, under which Medicare will not make higher payments to hospitals for care associated with certain reasonably-preventable conditions unless the conditions were reported as present on admission. The NCDs are effective immediately, although implementation guidance will be issued at a later date. 

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The Practicing Physicians Advisory Council is meeting on March 9, 2009 to discuss proposed changes in regulations and manual instructions related to physicians' services. Specific Issues on the agenda include, among others, Value-Based Purchasing, Recovery Audit Contractors, the local and national coverage determination processes, and Medicare appeals.  

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The Medicare Evidence Development & Coverage Advisory Committee (MedCAC) is meeting on Wednesday, March 18, 2009 to focus on the use of Bayesian statistics to interpret evidence in making coverage decisions. Bayesian analysis is a statistical technique in which prior evidence is used to update or to newly infer the probability that a hypothesis may be true. The meeting will introduce Bayesian concepts, contrast Bayesian approaches with frequentist approaches, and provide examples of using Bayesian techniques for meta-analyses. CMS encourages the participation of organizations with expertise in Bayesian statistics, meta-analyses, and clinical trial design and analyses. 

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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.

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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.

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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.  

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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.

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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.

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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.

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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. 

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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. 

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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. 

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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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