Judge Rules that CMS Misinterpreted Off-Label Drug Coverage Standard
This week, as a result of a challenge filed in court by the Medicare Rights Center in 2007, a judge held that the current interpretation of the coverage standard for drugs used off-label under the Medicare prescription drug benefit, also known as Part D, is invalid. Since Part D began, the Centers for Medicare and Medicaid Services (CMS) has not covered drugs used for off-label indications—drugs used for treatments other than those approved by the Food and Drug Administration—if the use is not listed in statutorily identified, privately owned and published drug guides known as compendia. However, Judge Harold Baer of the U.S. District Court in the Southern District of New York ruled, as Medicare Rights Center had argued, that the list of compendia in the Medicare law was not meant to be restrictive, but to be an illustrative example of materials that may be used to determine if coverage of a drug used for off-label purposes is appropriate.
Medicare Rights Center filed suit on behalf of plaintiffs Judith M. Layzer, who recently lost her battle with ovarian cancer, and Ray J. Fischer, who suffers from a rare form of muscular dystrophy. Both plaintiffs used off-label drugs as treatment for their conditions. While these uses were supported by peer-reviewed medical literature, they were not included in the compendia listed in the Medicare statute.
In addition to challenging the interpretation of the Part D statute through litigation, the Medicare Rights Center has pursued a legislative remedy, seeking clarification from Congress that off-label drug treatments can be covered under Part D if there is evidence of efficacy in peer-reviewed literature such as the New England Journal of Medicine.
That effort was successful with respect to anticancer chemotherapy drugs with the passage of the Medicare Improvements for Patients and Providers Act (MIPPA) in 2008, which clarified that peer-reviewed medical literature may be used for coverage decisions of off-label drug treatments of cancer. As a result of MIPPA, Medicare Rights Center secured coverage for Mrs. Layzer of her drug going forward, but her estate still requires reimbursement for thousands of dollars of medication she used before MIPPA took effect.
Read the Medicare Rights Center’s press release.
Read Judge Baer’s decision.
Advocates Offer Comments on 2012 Medicare Advantage and Prescription Drug Policies
Last week, the Medicare Rights Center and several other advocacy organizations submitted comments on the 2012 Advance Notice and draft Call Letter for Medicare private health plans, also known as Medicare Advantage (MA) plans, and Medicare prescription drug plans. The comments include suggested changes to the Centers for Medicare & Medicaid Services’s (CMS’s) new quality bonus payment demonstration project. The proposed demonstration would award bonuses not only to MA plans that receive the highest ratings (four or five stars), as envisioned by the Affordable Care Act (ACA), but also to plans that receive an average rating (three stars). Specifically, the comments state that if CMS decides to move forward with the demonstration, the agency should limit it to three years, as currently planned. This would give plans adequate time to transition to the new MA payment system anticipated by the ACA while ensuring that in the long term only the highest-quality plans are rewarded. The comments also question the appropriateness of allowing five-star plans to enroll Medicare consumers year-round. While such a policy might encourage more plans to aspire to receive a five-star rating, it could lead to unintended adverse consequences for consumers, such as increased marketing abuses and general confusion.
In addition, the comments call for more transparency and better oversight for Special Needs Plans (SNPS). SNPs are MA plans that exclusively or primarily serve individuals who have a particular “special need,” including people who are “dually eligible” (qualify for both Medicare and Medicaid), those with a specific chronic illnesses like diabetes and those in long-term care facilities. While SNPs were intended to better coordinate care for the enrollees they serve, little is known about individual SNP’s models of care or about whether SNPs are coordinating care as they are meant to and achieving better health outcomes and consumer experience as a result. The comments ask for SNP models of care to be made public, and ask CMS to develop SNP-specific quality measures and collect and analyze more data to determine if the current SNP program is achieving its goal.
The Call Letter is released annually and sets forth changes to bid, payment and coverage policies for private plans offered through Medicare Part C and Part D.
Read the comments.
If you have formally asked your Medicare drug plan to pay for a drug, override a restriction or move your drug to a lower cost tier (requested an “exception”), and your plan turns you down, you should appeal.
Before you can begin the appeals process, you must have already asked for an exception and been officially denied in writing. A “no” at the pharmacy is not an official denial.
The process for appealing is the same whether you are in a Medicare private health plan with drug coverage (MA-PD) or stand-alone private drug plan (PDP).
Learn how to appeal your plan’s decision at www.MedicareInteractive.org.
In a letter sent this week to Senator Max Baucus, Secretary of Health and Human Services Kathleen Sebelius described the effects of bill H.R. 1, which, if enacted, would restrict funding for health reform implementation. According to the letter, H.R. 1 would effectively halt Medicare payment to providers and jeopardize consumers’ access to important new benefits.
Read the letter.