Hough v. Becerra
U.S. District Court, District of New Jersey
In this case, a retired public school teacher in New Jersey seeks coverage of her “off-label” (non-FDA-approved) use of a critically-needed medication. Medicare denied coverage of the only medication that Cheryl Hough and her doctor have found to control her debilitating symptoms related to gastroparesis, a disease of the digestive system. However, the denial was based on an overly restrictive interpretation of what counts as a “medically accepted indication” under the law. After exhausting Medicare’s appeal system, Ms. Hough requested review in federal court to receive coverage of the medically necessary treatment.
The case is very similar to Dobson v. Secretary of Health and Human Services, 2022 WL 424813 (11th Cir. Feb. 11, 2022), in which the Center won coverage of the same drug for a Florida beneficiary. The Dobson court held that “support” for an off-label use means that an approved medical compendium that discusses the drug in question must tend to show or help prove the efficacy and safety of the beneficiary’s prescribed use. Support does not mean that a compendium must “hyperspecifically identify” the prescribed off-label use of the beneficiary, as Medicare is requiring. The same reasoning should apply in this case.
In May 2023, the case was settled, with Medicare agreeing to deem Ms. Hough’s off-label use a medically accepted indication and to cover the drug for her.
The Center is grateful for the generous pro bono assistance of Murphy Orlando LLC in this case.
- Read the complaint
Johnson v. Becerra
U.S. District Court, District of Columbia
The Center for Medicare Advocacy filed this proposed class action on October 6, 2022, on behalf of three individuals and two organizations. The named plaintiffs seek to represent a nationwide class of Medicare beneficiaries who rely on home health aide services to live safely in their homes and communities. They challenge the Secretary’s policies and practices that impede and restrict the availability, accessibility, and coverage of home health aide services for individuals with chronic, disabling conditions, who qualify for such services under Medicare law. Home health aides provide hands-on, personal care to assist with activities such as bathing, dressing, toileting, grooming, transferring, and walking – services that are critical to the ability of people with long-term disabilities to remain safely in their homes. Medicare-covered home health aide visits declined by 90% between 1998 and 2019. The case cites violations of the Medicare statute and regulations, as well as Section 504 of the Rehabilitation Act, which prohibits discrimination on the basis of disability. Section 504 imposes a duty on federal agencies to provide services in the most integrated setting appropriate to the needs of people with disabilities and to avoid unjustified institutionalization of disabled people. The named plaintiffs and class members they seek to represent are at risk of institutionalization for necessary care without the Medicare-covered home health aide services they require. The plaintiffs seek declaratory and injunctive relief that would remove barriers to Medicare-covered home health aide services.
In April 2023, a federal district court in D.C. dismissed the complaint on the grounds that the plaintiffs lack standing to pursue the case. In June 2023, the plaintiffs appealed the dismissal of the case to the U.S. Court of Appeals for the D.C. Circuit.
Chinatown Service Center v. U.S. Department of Health & Human Services
U.S. District Court, District of Columbia
This case challenges the elimination of key protections in health care for individuals with Limited English Proficiency (LEP). Language assistance ensures that people with LEP understand the medical information and instructions they receive. It can be the difference between getting needed health care and not even knowing one’s health care needs, especially for older adults. Language barriers also exacerbate existing health disparities in communities of color and immigrant communities. In this case, organizations that provide social services to LEP older adults allege that the Department of Health and Human Services violated the Administrative Procedure Act when it rolled back language access protections that were put in place under the Health Care Rights Law (Section 1557) of the Affordable Care Act. The protections required health plans and other entities to inform patients in their own languages of their right to interpretation, and their right to legally challenge discrimination based on language ability.
Justice in Aging and the Center for Medicare Advocacy, along with pro bono firm Stinson, LLP, filed the case in February 2021. Read the complaint.
On October 13, 2021, the court issued an order staying the case until further notice while the Department of Health and Human Services revises the current rule. It also ordered HHS to provide bi-monthly updates of its progress on revising the rule. Counsel will continue to advocate to restore meaningful language access for LEP older adults and will carefully consider any new rule proposed by HHS.
Alexander v. Becerra
(formerly Bagnall v. Sebelius; Barrows v. Burwell, Alexander v. Azar)
U.S. District Court, Connecticut; Second Circuit
This nationwide class action seeks appeal rights for Medicare beneficiaries who are placed on “observation status” at hospitals. When patients are placed on observation status, they are considered “outpatients” (covered by Medicare Part B), even though they are often on a regular hospital floor for many days, receiving the same care as inpatients. Because patients must be hospitalized as inpatients under Medicare Part A for three days to receive coverage of post-hospital nursing home care, people on observation status do not have access to nursing home coverage. They must either pay the high cost of nursing home care themselves or forgo that care altogether. The number of people placed on observation status has greatly increased in recent years as Medicare has strictly enforced its definition of what hospitals should bill as inpatient/Part A services and what they should bill as observation/Part B services. However, CMS has not allowed beneficiaries to appeal the issue of whether their hospitalizations should be classified as observation or as inpatient for Medicare coverage purposes.
The case is co-counseled by Justice in Aging and the law firm of Wilson Sonsini Goodrich & Rosati, which has provided extraordinary pro bono assistance.
- A bench trial was held in the summer of 2019. On March 24, 2020, the district court held that as a matter of constitutional due process, Medicare must allow certain patients to appeal their placement on observation status. Read the Center’s statement and FAQ page about the decision.
- The government appealed the district court’s decision to the Second Circuit in May 2020. The Second Circuit affirmed the district court’s decision in January 2022. Please see the Center’s FAQ page for additional information.
- The parties jointly proposed a clarification to the judgment on October 31, 2022. Read about the clarification here. The court approved the clarification in December 2022. Read the court’s order here.
Dobson v. Secretary of Health and Human Services
U.S. District Court, Southern District of Florida; Eleventh Circuit
In this case a beneficiary seeks Medicare Part D coverage for his “off-label” (non-FDA-approved) use of a critically needed medication. Off-label prescriptions are common (about one in five outpatient prescriptions in the U.S.) and they are often required for conditions that are rare or that have not been studied in relation to specific medications or population groups. In this case, the plaintiff is disabled from a traumatic workplace injury and experiences debilitating nausea and vomiting. Medicare has denied coverage of the only medication that provides significant relief. There is no dispute about the medical necessity of the drug. Medicare claims, however, that the beneficiary’s use is not “supported by” one of the commercial drug compendia specified by the statute – another requirement for off-label coverage. The agency states that there can be no coverage because the plaintiff does not have exactly the same underlying diagnoses as the patient cited in the relevant compendium entry. Medicare’s reading of the statute is inappropriately narrow and disregards the palliative purpose for which the drug was prescribed. The beneficiary’s doctor has confirmed that his use of the medication is supported by one of the drug compendia.
In March 2020 the district court issued a decision denying Medicare Part D coverage of the medication. In February 2022 the U.S. Court of Appeals for the 11th Circuit overturned summary judgment entered by the district court and found that Medicare must provide coverage for the beneficiary’s off-label use of the medication. The appeals court found that “nothing 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.” Read the decision.
The Center thanks co-counsel Florida Health Justice Project and the law firm of Akin Gump Strauss Hauer & Feld LLP.
Jimmo v. Sebelius
U.S. District Court, Vermont
The landmark Jimmo settlement was approved in 2013. The nationwide class action challenged Medicare’s use of an “Improvement Standard” to inappropriately deny coverage to beneficiaries who are not improving or making progress. The standard, which is erroneous under the Medicare statute, has operated to deny needed care to thousands of people with long-term, chronic, or debilitating conditions. Under the settlement, CMS clarified that coverage is available for skilled maintenance services in the home health, nursing home, and outpatient therapy settings, and to a certain extent in the inpatient rehabilitation facility setting. The settlement explains that coverage “does not turn on the presence or absence of a beneficiary’s potential for improvement…but rather on the beneficiary’s need for skilled care.”
As a result of continued court enforcement, CMS published a dedicated webpage containing important information about the settlement. The webpage reinforces the fact that Medicare does cover skilled nursing and skilled therapy services needed to maintain a patient’s function or to prevent or slow decline. Improvement or progress is not necessary as long as skilled care is required. The page contains an “Important Message About the Jimmo Settlement,” in which court-approved language emphasizes that the settlement “may reflect a change in practice” for providers and Medicare decision-makers who erroneously believed that the Medicare program covers nursing and therapy services only when a beneficiary is expected to improve.
Vermont Legal Aid and Wilson Sonsini Goodrich & Rosati were co-counsel with the Center. Class counsel continues to work on ensuring that access to skilled maintenance nursing and therapy for Medicare beneficiaries is not inappropriately denied or terminated because their conditions are “chronic,” “not improving,” “plateaued,” or “stable.” For more information on the Improvement Standard, visit the Center’s website here.
McKee v. Azar
U.S. District Court, Vermont
This case, brought by Vermont Legal Aid and the Center, sought Medicare coverage of home health services that were denied to a beneficiary who required skilled nursing visits to assess and treat her multiple serious medical conditions. It challenged the Medicare agency’s failure to follow applicable law, including the standard clarified in the Jimmo v. Sebelius settlement. Under Jimmo, the determination of whether individuals are eligible for Medicare coverage is to be made on the basis of beneficiaries’ need for skilled care, not on their potential for improvement. In this case, the plaintiff challenged Medicare’s conclusion that her “stable” condition meant that she did not require skilled care and thus did not qualify for Medicare coverage of home health services. In addition, she challenged the agency’s failure to afford appropriate weight to the opinion of her treating physician about her need for skilled care.
In July 2020, Medicare agreed to pay Ms. McKee’s home health claim in full. Advocates should continue to be alert for inappropriate denials of coverage based on lack of improvement or on “stability” – particularly for individuals with chronic conditions.