CMA Alert | February 17, 2022

A Victory for “Off-Label” Prescription Drug Coverage

On February 11, 2022, the U.S. Court of Appeals for the 11th Circuit reversed a lower-court decision and found that Medicare must provide coverage for a beneficiary’s off-label use of a medication in Dobson v. Secretary of Health & Human Services, No. 20-11996, 2022 WL 424813 (11th Cir. Feb. 11, 2022). Florida resident Donald Dobson contacted the Center for Medicare Advocacy because his Medicare Part D plan denied coverage for dronabinol. He could not afford the medication without coverage, but he needed it critically. Since he suffered a spinal cord injury and underwent related surgeries, Mr. Dobson has experienced intractable, severe nausea and vomiting that interfere with his ability to function and other aspects of his health. After standard anti-nausea medications failed to alleviate his symptoms, Mr. Dobson’s physicians prescribed dronabinol (brand name Marinol), which worked immediately.

However, when Mr. Dobson became eligible for Medicare based on his disability, his Part D plan denied coverage of dronabinol. The denial was based on the prescription being “off-label,” meaning it was for a non-FDA approved use. Off-label prescribing is a routine, legal practice, frequently used when medications are needed to treat less-common conditions. But Medicare Part D requires more than a doctor’s prescription for off-label coverage. The program allows for coverage only if there is “support” for a particular off-label use in one of the “drug compendia” specified by Medicare law. The drug compendia are essentially reference books that summarize information on prescription medications, including chemical ingredients, potential side effects, clinical studies, and different uses for the drugs. (The compendia are also commercial publications, available only to paid subscribers, so it can be very difficult for Medicare beneficiaries to access the information they need to argue for off-label coverage of needed medications.)

Medicare agreed that dronabinol was medically necessary for Mr. Dobson. There is also a compendium entry indicating dronabinol’s off-label use for intractable nausea and vomiting that is disease-related – his very condition. Yet Medicare denied coverage on the grounds that his use was not “supported by” that compendium entry because Mr. Dobson did not share exactly the same underlying diagnosis as the patient described in the entry’s cited case study.

Conducting a thorough analysis of the Medicare Part D statute, the 11th Circuit decided that Congress’s intent was clear. For an off-label use to be “supported by” a compendium citation, the citation “must tend to show or help prove the efficacy and safety of the prescribed medication.” Furthermore, “[n]othing about the common meaning of ‘support’ means that a compendium citation must hyperspecifically identify a prescribed off-label use to tend to show or help prove its efficacy and safety.” Using this commonsense meaning of the word “support,” the court concluded that the listing in question requires Medicare to cover Mr. Dobson’s off-label use of dronabinol.

The Center for Medicare Advocacy plans to issue additional material with further details and practice tips for advocates in light of the decision, assuming it stands. The Center is grateful to co-counsel Florida Health Justice Project and Akin Gump Strauss Hauer & Feld.

• Read the full decision at https://medicareadvocacy.org/wp-content/uploads/2022/02/2-11-22-Dobson-Decision.pdf.

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Black History Month is a Good Time to Make Good Trouble

It’s understandable to be tired these days – by COVID, disinformation, the inability to pass important legislation, and inequities galore. But we remember Rep. John Lewis urging us to “find a way where there is no way.”  He knew as much as anyone how hard it is to keep fighting for what’s right.  Yet he didn’t give up.

Rep. Lewis’ message to stay the course, to speak out – and act – when something is wrong needs to ring in our ears.  We can honor his legacy by working together to advance access to quality health care, comprehensive Medicare, and health equity for all.

It’s a good time to make good trouble.

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CMS Tells Public to File Complaints About Quality of Care with CMS Locations

In a guidance document reiterating states’ obligation to conduct surveys of Medicare and Medicaid providers, the Centers for Medicare & Medicaid Services (CMS), for the first time, directly suggests that complaints about quality of care may be made directly to “locations” (formerly known as Regional Offices) if states are not conducting surveys. CMS writes:

Individuals with a quality of care complaint related to a Medicare or Medicaid health and safety regulation that the state is not surveying for may contact the CMS location, directly, at the email below [bold font in original]: 

• ROATLHSQ@cms.hhs.gov: Alabama, Florida, Georgia, Kentucky, Mississippi, North Carolina, South Carolina, and Tennessee.
• RODALDSC@cms.hhs.gov: Arkansas, Louisiana, New Mexico, Oklahoma, and Texas.
• ROPHIDSC@cms.hhs.gov: Delaware, District of Columbia, Maryland, Pennsylvania, Virginia, West Virginia, New York, New Jersey, Puerto Rico, Virgin Islands, Connecticut, Maine, Massachusetts, New Hampshire, Rhode Island, and Vermont.
• ROCHISC@cms.hhs.gov: Illinois, Indiana, Michigan, Minnesota, Ohio, Wisconsin
• ROkcmSCB@cms.hhs.gov: Iowa, Kansas, Missouri, Nebraska
• DenverLTC@cms.hhs.gov: Colorado, Montana, North Dakota, South Dakota, Utah, Wyoming
• ROSFOSO@cms.hhs.gov: Alaska, Idaho, Oregon, Washington, Arizona, California, Hawaii, Nevada, and the Pacific Territories

See: CMS, “State Obligations to Survey to the Entirety of Medicare and Medicaid Health and Safety Requirements under the 1864 Agreement,” QSO-22-12-ALL (Feb. 9, 2022), https://www.cms.gov/files/document/qso-22-12-all.pdf

While advocates have previously recommended that people contact CMS, the agency itself has never before told people to go to Regional Offices (now “locations”) to file complaints when state action is inadequate. Hopefully this new recommendation will signal a renewed interest in enforcement.

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Health Equity Reports

A round up of recent articles, reports, and issue briefs examining disparities and inequities in health care:

• Race, Racism, Civil Rights Law, And The Equitable Allocation Of Scarce COVID-19 Treatments: February 2022 Health Affairs article examining Food and Drug Administration (FDA) recommendations that clinicians use race and ethnicity, among other factors, to guide allocation and use of novel monoclonal antibodies for COVID-19 treatment. The article calls for “[s]tate and federal policymakers . . . be intentional about advancing pharmacoequity. Guidelines should clearly indicate that race is being used as a proxy for racism (i.e., as a “risk marker”).”
• House Appropriations Bills Take Steps to Use the Federal Budget as a Tool for Antiracism: February 2022 Center on Budget and Policy Priorities report focuses on three areas where funding increases in appropriations bills for fiscal year 2022 approved by the House Appropriations Committee would take important steps to support antiracist policies: K-12 funding for students from low-income backgrounds, enforcement of federal civil rights laws, and legal services for people with low incomes. The report states that “. . .these investments would have broad-based impacts, providing protections and opportunities for many people and communities, including people of color, people with disabilities, and people with low incomes living in rural and urban communities alike.”
• How Health Care Coverage Expansions Can Address Racial Equity: February 2022 The Commonwealth Fund article explains that in addition to promoting health equity, health insurance coverage is associated with improved mortality outcomes, reduced poverty, and protection from financial debt. Three policies are explored that would promote “a stronger and more equitable health insurance system,” which are: continuous postpartum coverage in Medicaid, providing coverage to individuals in the Medicaid expansion gap, and extending the increase in marketplace premium subsidies under the American Rescue Plan Act (ARPA).
• Despite Improvements, Racial and Ethnic Disparities in Cancer Mortality Rates Persist: February 2022 KFF article notes that overall cancer death rates have decreased for all racial and ethnic groups, with Black people experiencing the largest reduction. Despite these encouraging statistics, however, Black people still have the highest cancer mortality rates when compared to other populations. One reason attributed for this disparity is a diagnosis of disease occurring at a later stage. KFF also has a new brief on racial disparities in cancer outcomes, screening, and treatment.

The Center for Medicare Advocacy will add to this list as new reports become available.

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Save the Date for the 2022 National Voices of Medicare Summit & Senator Jay Rockefeller Lecture

Wednesday, May 18, 2022

Join Us for a Joyful Return to a Live Gathering

9th Annual National Voices of Medicare Summit andSen. Jay Rockefeller Lecture
Medicare at Risk – How Do We Save It?

Kaiser Family Foundation | 1330 G St. NW, Washington, DC 20005

Join us in-person or by viewing a livestream online as we convene community leaders in advocacy, policy-making, medicine, philanthropy, and academia to discuss the best practices, solutions, and opportunities in efforts to advance access to comprehensive Medicare coverage, health equity, and quality health care.All of this is inspired by, and interspersed with, the real experiences and stories of beneficiaries and caretakers. Sharing the transformative discussions of the Summit with the widest audience possible is important to us, so please save the date to engage with your colleagues and the Center for Medicare Advocacy’s community.

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Elder Justice “No Harm” Newsletter | Vol 4, Issue 1 Now Available

In the Elder Justice Newsletter, we highlight citations, including deficiencies related to abuse, neglect, and substandard care, that have been identified as not causing any resident harm. The goal of this brief newsletter is to shed light on the issue of so-called “no harm” deficiencies, which typically result in no fine or penalty to the nursing home.

This newsletter focuses on the following “no harm” violations:

• ‘It was very embarrassing’: Nursing home provides undignified treatment to residents.
• Stolen narcotics: Registered nurse steals medication from two residents.
• Begging for baths: Nursing home fails to provide appropriate hygiene care.
• Uncovered and exposed: Nursing home fails to honor residents’ right to dignity.
• Short-staffed: Call lights go unanswered.
• ‘The food was always cold’: Unpalatable meals found at nursing home.

Do YOU think these deficiencies caused “no harm”? Click to download the newsletter.

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FREE WEBINAR | Medicare Home Health and DME Update

Thursday, April 28, 2022 @ 1 – 2:30 PM EST

Sponsored by California Health Advocates

Presented by Center for Medicare Advocacy Executive Director, attorney Judith Stein, and Associate Director, attorney Kathleen Holt, the presentation includes a 30-minute live question & answer session.

Register Now:
https://attendee.gotowebinar.com/register/1457421769888387854

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THANK YOU FOR BEING PART OF OUR COMMUNITY

Thank you to everyone who generously donated to the Center this past year. Whether you are a returning or first-time donor, you energize and help sustain the Center with your support. We realize there are many urgent causes in the world today, but we also know the Center opens doors to necessary health care, which is particularly crucial now. Our unique advocacy, education, and responsiveness to the needs of families all over the country make a real difference, every day.

If you’d like to help and haven’t, click here to donate today.

If you prefer to donate offline, you can mail your check, payable to the Center for Medicare Advocacy, to: Center for Medicare Advocacy, P.O. Box 350, Willimantic, CT 06226.