Legislative Update
Maryland Appoints Dr. Georges Benjamin to Health Benefit Exchange Board
Several states have already passed legislation establishing health insurance exchanges under the Affordable Care Act, including the state of Maryland. In late May, Maryland Gov. Martin O’Malley appointed Dr. Georges Benjamin, executive director of the APHA, to a nine-member board that will oversee Maryland’s Health Benefit Exchange. The exchange will allow Maryland residents to compare rates, benefits and quality among health insurance plans online to help them find one that best suits their needs.
“I am honored to serve in this capacity in helping reform our nation’s health system and implement a key provision of the Affordable Care Act,” said Benjamin. “Maryland has emerged as a leader in the health reform era. The lessons we learn will serve as a model for much of the nation and will strengthen coverage and improve health. As a former health secretary of Maryland, I am particularly proud to see Maryland make such progress in working to improve the health of its residents.”
Maryland has implemented reforms that have already expanded health coverage to more than 260,000 people living in the state. This year, Gov. O’Malley signed into law legislation to establish a framework for Maryland's health benefit exchange. According to research by the independent Hilltop Institute, implementing the Affordable Care Act will save Maryland an estimated $850 million and cut the number of Marylanders without health insurance in half by 2020.
Testimony on New York’s Health Insurance Exchange
New York is lagging behind other states such as Maryland in creating its health insurance exchange under the Affordable Care Act. On May 18, Section member Mary Beth Morrissey, PhD, JD, MPH, presented testimony before the New York State Insurance Department at Baruch College, New York City, on behalf of the Women’s Bar Association of the State of New York (WBASNY) on establishing New York’s Health Insurance Exchange. WBASNY is the largest New York statewide women’s bar association, and is committed to the well-being of all women in society and to the fair and equal administration of justice. WBASNY is also a member of the 57-member New York Alliance for Women’s Health.
In her capacity as a chair of the Health Law Committee of WBASNY, Morrissey called for swift action to establish New York’s Health Insurance Exchange before the end of the 2011 legislative session. Morrissey’s testimony addressed overarching policy challenges including issues of access, health literacy and training critical to the design of a consumer-friendly structure in the exchange, and recommended steps to support the empowerment of women to make informed decisions. Morrissey also commented on expected migrations back and forth between the Medicaid program and the State Health Insurance Exchange, and the need for appropriate structures and administrative support systems to deal with rapid transitions across programs.
Other organizations that presented at the New York City public hearing were Raising Women’s Voices, the Public Health Association of the City of New York, Greater New York Hospital Association, and Health Care for All New York. There was a growing consensus among most of the organizations heard at the forum that there should be a statewide exchange in New York that would be responsive to the needs of all consumers from diverse backgrounds and communities including immigrants. By the time this newsletter is published, it is likely that New York may have passed its health insurance exchange legislation.
(Please contact Mary Beth Morrissey at mamorrissey@fordham.edu if you wish a copy of her full testimony.)
Federal Court Decision Will Increase Access to Off-Label
Prescription Drugs Under Medicare Part D
The Federal District Court in the Southern District of New York handed down a decision on March 7, 2011, holding that regulations promulgated by the U.S. Department of Health and Human Services barring coverage for medically necessary off-label prescription drugs under Medicare Part D, were unreasonable and based upon an incorrect statutory interpretation.
The Medicare Rights Center, a national, non-profit consumer service organization, filed suit over three years ago against HHS on behalf of two seriously ill plaintiffs who had been denied coverage by HHS under Medicare Part D for their medically necessary prescription drugs. The drugs had been prescribed for off-label treatments not approved by the Food and Drug Administration. Judith Layzer had been prescribed the drug Cetrotide to control her rare form of ovarian cancer, a use documented and supported in the peer-reviewed medical literature. The second Medicare beneficiary and plaintiff, Ray Fisher, had been diagnosed with myotonic muscular dystrophy type 2, and prescribed the drug Increlex to slow the deterioration of his muscle, strengthen range of motion, and improve quality of life.
The statutes in issue in this case were Title XVIII of the Social Security Act (42 U.S.C. § 1395 et seq.), establishing the Medicare program and providing health insurance to individuals aged 65 and over, as well as certain eligible individuals with disabilities; and the 2003 Medicare Prescription Drug, Improvement, and Modernization Act (“MMA”), requiring a plan sponsor to provide coverage of qualified prescription drugs. (See 42 U.S.C. §§ 1395w-102-§ 1395w-104.) Under Section 1395w-102(e) of the MMA, the definition of a “covered Part D drug” makes reference to the term “medically accepted indication” as defined at 42 U.S.C.§ 1396r-8(k)(6): “any use for a covered outpatient drug which is approved under the Federal Food, Drug, and Cosmetic Act [21 U.S.C.A § 301 et seq. (the”FDCA”)] or the use of which is supported by one or more citations included or approved for inclusion in any of [three compendia].” The implementing regulation promulgated by the Secretary of HHS imposed the requirement that to be a “covered Part D drug”, a drug must be prescribed for a “medically accepted indication.” (See 42 C.F.R. § 423.100.) According to the Court in a decision written by District Judge Harold Baer, “in this case, coverage of the Plaintiffs’ drugs was denied because the uses for which the drugs were prescribed were not approved or listed in any of these compendia.”
The Court’s conclusion in this case was based on an analysis of the statutory language defining “covered part D drug” that made clear that, “Congress did not intend to impose the Compendia requirement.” The Court ordered that appropriate coverage be provided to the Plaintiffs. This decision, and the work of the Medicare Rights Center that helped to achieve this result, have been hailed as victories for Medicare beneficiaries such as the very sick Plaintiffs in this litigation. While the Medicare Improvements for Patients and Providers Act that became effective in 2009 did make incremental progress toward establishing patient rights to coverage for off-label treatments by authorizing use of peer reviewed literature to support off-label coverage determinations, it is clear that advocacy in Congress for enactment of legislation that would establish full off-label prescription parity under the Medicare Part D Program needs to continue.