May 2007 Practice Update
ASH Weighs in on Review of Medicare Coverage Policy for Erythropoiesis-Stimulating Agents (ESAs)
ASH submitted comments to the Centers for Medicare and Medicaid Services (CMS) and local carriers concerning the development of a Medicare coverage policy for darbepoetin alfa and epoetin alfa after recent studies linked the treatments with increased risk for serious side effects. Of particular concern to ASH are potential restrictions in the use of ESAs for the treatment of anemia in patients with hematologic malignancies who are not on chemotherapy. ASH’s comments indicate that there is data to support the use of ESAs in patients with anemia associated with low-risk myelodysplasia. ASH also recommended further studies into the use of ESAs to treat anemic patients with hematologic malignancies, and in the meantime, that coverage of these patients should be decided on a case by case basis. ASH also will be presenting comments to the FDA’s Oncologic Drugs Advisory Committee (ODAC) on May 10, 2007. In addition to meeting with CMS officials and monitoring the development of this regulatory policy, ASH is also closely monitoring this issue legislatively and members of the ASH Committee on Practice will be meeting with congressional offices in May.
Medicare Proposes Revised Clinical Trial Policy
CMS has proposed new rules to govern Medicare coverage of services provided to beneficiaries enrolled in clinical research studies. Under the Clinical Trial Policy, first developed in September 2000, Medicare pays for certain items and services for Medicare beneficiaries involved in clinical trials. The proposal includes new eligibility standards that all trials must meet to qualify for coverage that may make coverage more difficult. They are:
- "[Specify and fulfill the] method and timing of public release of all pre-specified outcomes to be measured including release of outcomes if outcomes are negative or [the] study is terminated early."
- "[Contain] a discussion of the results will generalize to the Medicare population to infer whether Medicare patients may benefit from the intervention. In particular, the protocol describes the potential impact of age-specific and other factors on outcomes and whether the research study is powered sufficiently to draw conclusions with respect to the Medicare population."
The concern is that these new requirements might deter some investigators or institutions from pursuing Medicare reimbursement for clinical services provided to patients enrolled in clinical trials and patients from participating. ASH welcomes comments on the proposal as the Society prepares its response to CMS. If you have any particular concerns or comments, please contact ASH Director of Government Relations and Practice, Mila Becker, at mbecker@hematology.org by Monday, May 7, 2007.
ASH Signs Letter Urging Physician Payment Policy Changes
ASH, along with 85 other provider groups, signed an April 20 letter urging CMS Administrator Leslie Norwalk to adopt policy changes that would provide short-term and long-term resolutions to the problematic physician update methodology.
The policy changes outlined in the letter include applying the $1.35 billion "Physician Assistance and Quality Initiatives Fund" to the CY 2008 conversion factor update. The Fund, established by the "Tax Relief and Health Care Act of 2006" (P.L. 109-432), "will help lower the cost of Congressional action" needed to lessen the projected 10 percent cut. The Medicare Payment Advisory Commission (MedPAC) made a similar recommendation in its March 2007 Report to Congress.
The letter also strongly urges the Administration to reduce the CY 2008 productivity adjustment to the Medicare Economic Index (MEI) from 1.45 percent to 0.65 percent. This would match the productivity adjustment recommended for other Medicare providers.
Reiterating the physician community’s belief that CMS should remove the cost of Part B drugs from the update methodology, the letter advises that such action would "reduce the pressure on Congress to find other offsets." The letter also reiterates previous recommendations to include national Medicare coverage determinations in the "law and regulation" portion of the update calculation. If such action is not possible, the letter suggests excluding from the calculation for at least two years all services affected by national coverage determinations.
ASH Develops Resources to Help Guide Practitioners through the Physician Quality Reporting Initiative (PQRI) – Medicare’s New Bonus Program
The 2007 PQRI provides a financial incentive for eligible professionals to participate in a voluntary quality reporting program. Eligible professionals who successfully report a designated set of quality measures on claims for dates of service from July 1 to December 31, 2007, may earn a bonus payment, subject to a cap, of 1.5 percent of total allowed charges for covered Medicare physician fee schedule services. To help hematologists/oncologists participate in this program, ASH has created on-line resources.
Special Open Door Forum on Registry-Based Reporting for the PQRI
CMS will host a Special Open Door Forum on the use of registries for reporting data on quality measures to the PQRI.
This Special Open Door Forum will take place from 1:00 p.m. – 5:00 p.m., EDT, on Monday, May 14, 2007 in the CMS auditorium, 7500 Security Blvd., Baltimore, MD. A toll-free number will be available for those who will participate by telephone.
This Special Open Door Forum will build on the broad overview of the 2007 PQRI program presented on two recent national provider conference calls by giving providers and organizations that use or produce registries and other members of the public the opportunity to discuss the potential use of registries for reporting data on quality measures to PQRI. Participants must register by May 9, 2007, at www.cms.hhs.gov/pqri/.
Medicare National Provider (NPI) Contingency Plan Roundtable Conference Call May 10, 2007
CMS will host a NPI Contingency Plan Roundtable Conference Call on May 10, 2007, from 2:00 p.m. - 3:30 p.m., EDT. Advance registration is required. To register go to www.cms.hhs.gov/NationalProvIdentStand/.
In April CMS announced a NPI contingency plan. Physicians and others who conduct claims and other transactions electronically are required to begin using their NPI, beginning May 23, 2007. The CMS contingency plan also allows each payer to decide if they will exercise any contingency plan option. Medicare will, for some period after May 23, 2007, allow the continued use of legacy numbers on claims and other transactions. As soon as the number of claims submitted with an NPI for primary providers is "sufficient" to do so, Medicare will begin rejecting claims without an NPI for primary providers following appropriate notice. Specifically, in May 2007, Medicare FFS will evaluate the number of submitted claims containing an NPI. If the analysis shows a "sufficient" number of submitted claims contain a NPI, Medicare will begin to reject claims on July 1, 2007 that do not contain NPIs. If a sufficient number of claims do not contain NPIs in the May analysis, Medicare FFS will assess compliance in June 2007 and determine whether to begin rejecting claims in August 2007. Medicare has said that after May 23, 2008, legacy numbers will not be permitted on any transactions. Legacy numbers, however, are acceptable for secondary providers until May 2008.
Medicare Trustees Annual Report Issues Funding Warning
On April 23, the Medicare Trustees released their annual report on the current and projected financial health of the program. For the first time since the passage of the 2003 Medicare Modernization Act, the Trustees have determined in two consecutive annual reports that general revenue will make up more than 45 percent of total Medicare financing within a 7-year period. This has triggered an automatic funding warning, which requires President Bush to propose legislation within 15 days of the next federal budget proposal (due in February of 2008) to bring the funding level below 45 percent. Congress is then required to consider that proposal, though it does not necessarily have to take action on it. Senate Finance Committee Chair Max Baucus (D-Mont.) has expressed concern that the funding warning "will prompt the President only to propose slashing Medicare spending, rather than to focus on the underlying factors driving costs throughout the health system." House Ways and Means Health Subcommittee Chair Pete Stark (D-Calif.) has indicated that Congress at this point is more likely to pass incremental measures to provide short-term financial relief than it is to enact sweeping reforms. According to the Trustees’ report, the Medicare hospital trust fund will become insolvent by 2019.
ASH Hosting a Lunch for State Society Executive Directors and Chief Administrators
ASH invites all state society administrators and executive directors to a lunch on Friday, July 13, 2007, at 12:30 p.m., to discuss common issues and concerns. All those who would like to attend please contact Matt Eckel at meckel@hematology.org.
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