- MEDICARE and the RECONCILIATION PACKGE
Over the last several months, Congress has been debating a legislative package called the Build Back Better Act (BBB) to be passed through the reconciliation process in order to avoid a filibuster in the Senate. The reconciliation package initially included a broad range of health provisions that would have expand access to coverage under the Affordable Care Act (ACA) and Medicaid, increased funding for Home and Community Based Services (HCBS) and expanded Medicare coverage to include dental, hearing and vision. The scope of these health care improvements hinged, in part, on the extent of projected prescription drug savings for the Medicare program that are included in the reconciliation package.
Due to negotiations between different factions of policymakers, many of these provisions and/or their scope have been scaled back as the topline number, or size of the package, has shrunk from $3.5 trillion (already a compromise figure for some) to $1.75 trillion. Legislative text for BBB (H.R. 5376), the current package, is available from the House Rules Committee (Nov. 3, 2021) here. The framework of the bill released by the White House (Oct. 28, 2021) is available here. The Kaiser Family Foundation released a report titled “Potential Costs and Impacts of Health Provisions in the Build Back Better Act” (Nov. 16, 2021) available here.
As it stands today (November 17, 2021), the Congressional Budget Office (CBO) is expected to produce a score of the bill by week’s end, a House vote is imminent, and the Senate is poised to begin various processes required to consider the bill under the reconciliation process, with a vote likely sometime after Thanksgiving.
Medicare – What’s In v. What’s Out
Of the initial proposed additions of coverage for dental, hearing and vision benefits to Part B of Medicare, as of now, only the hearing benefits have survived in the current draft. BBB would invest $35 billion in a new hearing benefit, effective 2023. As noted by the Kaiser Family Foundation, it “would include hearing rehabilitation and treatment services by qualified audiologists, and hearing aids.” Hearing aids would be available every five years for beneficiaries diagnosed with moderately severe, severe or profound hearing loss in one or both ears, and would be subject to the 20% Part B coinsurance. The coverage would be for devices prescribed by a physician, not currently for over-the-counter hearing aids that the Food and Drug Administration is moving to make available. See, e.g., a recent Kaiser Health News article discussing the hearing benefit (Nov. 5, 2021).
The package would also produce significant prescription drug savings – also scaled back from broader provisions previously in H.R. 3 – and make changes to the Part D benefit. AARP recently outlined the prescription drug proposals in an article entitled “How Congress Plans to Lower Drug Prices and Out-of-Pocket Costs” (Nov. 10, 2021), noting that “[t]he bill will lower drug prices for millions of seniors by finally allowing Medicare to negotiate certain drug prices, penalizing drug companies that increase their prices faster than inflation, and adding a hard out-of-pocket cap to Medicare Part D.” The article describes the phase-in of these changes, including:
- 2023: $35 copays for insulin under Part D (and for many private health plans)
- 2024: Part D benefit redesign, including $2,000 out-of-pocket cap (AARP notes that in 2019, 1.2 million Part D enrollees spend more than $2,000 out-of-pocket)
- 2025: Prices for certain drugs negotiated by the Department of Health & Human Services (HHS), starting in 2023, will start providing negotiated prices for selected drugs in Part D (and Part B drugs in 2027); AARP further notes:
- “All of the selected drugs must be single source, meaning there is no generic or biosimilar competitor on the market.”
- “The negotiation process will include no more than 10 drugs in 2025, no more than 15 drugs in 2026 and 2027, and no more than 20 drugs in 2028 and beyond. This means that as many as 60 drugs could be selected and negotiated by 2028.”
Together with a broad coalition of oral health advocates, including dentists and other providers, the Center for Medicare Advocacy continues to push for inclusion of a comprehensive oral health benefit in Part B in the Build Back Better legislation. The latest framework of the reconciliation package does not include Medicare oral health expansion, but negotiations are ongoing. There continues to be a critical need for oral health expansions in Medicare and comprehensive oral health coverage in Medicare is widely supported in polling. We remain hopeful that Congress will address this urgent need, and finally act to improve quality of life and overall health.
Additionally, the Center for Medicare Advocacy continues to work with advocates to encourage CMS to recognize its authority to cover medically necessary oral health care immediately. The administrative efforts will be even more crucial if the final legislation leaves out oral health expansions in Medicare.
Critical Nursing Home Provisions in the Build Back Better Act
Since the beginning of the pandemic in 2020, COVID-19 has claimed the lives of over 140,000 nursing home residents and staff, while infecting almost 1.4 million more. The Center has been covering pending nursing home legislation in Congress throughout the pandemic. Lawmakers have an important opportunity with the Build Back Better Act to pass provisions to address longstanding nursing home issues that were exacerbated by the pandemic. The reconciliation bill includes five interconnected provisions from the Nursing Home Improvement and Accountability Act, sponsored in the Senate by Senator Ron Wyden, and co-sponsored by Senators Richard Blumenthal, Bob Casey, Michael Bennet, Sheldon Whitehouse, and Sherrod Brown, and sponsored in the House by Representative Richard Neal, and co-sponsored by Representatives John Larson, Frank Pallone, and Conor Lamb.
Those provisions would:
- Improve the accuracy and reliability of certain skilled nursing facility data. Data submitted through the Minimum Data Set (MDS), skilled nursing facility (SNF) value-based purchasing program, and the Payroll Based Journal (PBJ) staffing data set would be validated for accuracy. Based on this validation, if SNFs submitted inaccurate information, payments made to them would be reduced by two percentage points.
- Ensure accurate information on cost reports. This provision would require auditing of the Medicare cost reports that SNFs submit to CMS to help guarantee that tax dollars are spent appropriately.
- Make improvements to survey and enforcement practices. The goal of this provision is to improve existing surveys and enforcement processes to increase compliance with SNF Requirements of Participation. The provision also requires a review of the ability of state survey agencies to identify infection control and emergency preparedness deficiencies. Furthermore, it will strengthen the ability to sufficiently hire, train, and retrain individuals to conduct surveys.
- Establish minimum staffing for nursing homes. This provision will require a study to be conducted to determine the appropriate staffing levels for registered nurses, licensed practical nurses / licensed vocational nurses, and certified nursing assistants. The recommended minimum staffing levels must then be reported. CMS will translate these recommendations into regulations. The surveys will be repeated no less than every five years to ensure that minimum staffing levels are in line with the acuity levels in nursing homes. The regulations will be updated to reflect the most current staffing needs.
- Require nursing homes have a registered nurse on staff 24 hours per day, seven days a week. Currently, nursing homes are only required to have a registered nurse on staff eight hours per day. This provision provides a long-needed update.
Other Nursing Facility Update – “Visitation Is Now Allowed for All Residents at All Times”
Citing high vaccination rates for residents (86%) and staff (74%); interim final rules with comment (published at 86 Fed. Reg. 61555 (Nov. 4, 2021)) requiring staff to be vaccinated against COVID-19; federal regulations (42 C.F.R. §483.10(f)(2), confirming residents’ right to make choices about issues of importance to them, and §483.10(f)(4)(ii) and (iii), confirming residents’ right to deny or withdraw consent for visits); and the physical and emotion toll that social isolation during the pandemic has caused residents, the Centers for Medicare & Medicaid Services (CMS) has revised its visitation guidance to provide that “Visitation is now allowed for all residents at all times.” CMS, “Nursing Home Visitation – COVID019 (REVISED), QSO-20-39-NH (Revised Nov. 12, 2021), https://www.cms.gov/files/document/qso-20-39-nh-revised.pdf. CMS explicitly states that “facilities can no longer limit the frequency and length of visits for residents, the number of visitors, or require advance scheduling of visits.”
The new visitation policy applies to all residents and in all situations, including residents on transmission-based precautions (TBP) or quarantine, unvaccinated residents, and residents in facilities that are having an outbreak investigation.
As the Center for Medicare Advocacy has written about extensively, people who legally qualify for Medicare coverage frequently have great difficulty obtaining and affording necessary home care. There are legal standards that define who can obtain coverage, and what services are available. However, the criteria are often narrowly construed and misrepresented by providers and policy-makers, resulting in inappropriate barriers to Medicare coverage for necessary care. See, e.g., a Center issue brief from April 2021.
In July 2021, the Centers for Medicare & Medicaid Services (CMS) issued a notice of proposed rulemaking (NPRM) including home health payment updates for 2022 (see File Code CMS-1747-P; Federal Register, Volume 86, No. 127 (July 7, 2021)). In August 2021, the Center for Medicare Advocacy submitted comments to the proposed rule, available here. Among other things, the Center’s comments focused on how payment incentives in the Patient Driven Grouping Model (PDGM), including proposed changes, disincentivize home health agencies from taking on patients who have chronic, long-term needs. While CMS acknowledged and solicited comments on the diminishing access to home health aides, the proposed rule did not offer meaningful avenues towards strengthening such coverage.
Further, the Center’s comments highlighted how quality measures in the Home Health Value Based Purchasing (HHVBP) Model – which financially rewards or penalizes home health agencies based upon performance on such measures – appear to discriminate against Medicare beneficiaries with longer-term, chronic conditions who require skilled care but are not expected to improve – patients covered by the Jimmo class action settlement.
On November 9, 2021, CMS issued a final rule – CY 2022 Home Health Prospective Payment System Rate Update 86 Fed Reg 62240 (Nov. 9, 2021) available here. Most of the proposed changes from the NPRM were finalized in the rule. Further, CMS announced that they were expanding the HHVBP model nationwide starting in 2023.
- ANNUAL ENROLLMENT PERIOD
Medicare’s Open Enrollment period – also known as the Annual Election Period (AEP) or Annual Coordinated Election Period – runs from October 15 through December 7. During this time all Medicare beneficiaries can reevaluate their coverage, and make changes, whether they are in Original/Traditional Medicare with separate Part D drug coverage, or in a private Medicare Advantage plan. Beneficiaries should review their coverage every year to determine if their current options meet their specific health care needs.
During the Medicare Open Enrollment Period, Medicare beneficiaries can:
- Change from a private Medicare Advantage plan and move to traditional Medicare, or vice-versa;
- Change from one private Medicare Advantage plan to another;
- Join a Medicare Part D prescription drug plan;
- Change from one Part D plan to another; or
- Drop Medicare Part D coverage entirely (provided they have other creditable coverage).
The Kaiser Family Foundation recently released reports on Medicare Advantage (MA) and Part D plan offerings in 2022. The MA report notes that “[f]or 2022, the average Medicare beneficiary has access to 39 Medicare Advantage plans, more than double the number of plans per person in 2017, and the largest number of options available in more than a decade”. This amount varies: “On average, beneficiaries in metropolitan areas can choose from many more Medicare Advantage plans than beneficiaries in non-metropolitan areas (42 plans versus 25 plans, respectively).” With respect to Part D plans, the Part D report notes, among other findings, that “[t]he average Medicare beneficiary has a choice of 54 Medicare plans with Part D drug coverage in 2022, including 23 Medicare stand-alone drug plans and 31 Medicare advantage drug plans.”
Limitations on Consumer Choice
As discussed in a recent CMA Special Report, broadly speaking, this annual exercise of comparison is flawed in many ways, including that it relies on savvy consumers to make complicated choices in order to optimize their coverage – which most people do not do.
In previous CMA Alerts (here, here and here), we have described the myriad, complicated choices Medicare beneficiaries must make among unequal options, such as the disparate enrollment rights and opportunities between Medicare Advantage and Medigap plans, and the barriers standing in the way of informed decision-making. “Choice” is actively promoted when someone is searching for and selecting a plan, but the concept of choice changes once someone is actually enrolled in a private plan, including who provides the care and what services you can get.
Highlighting a recent report by the Kaiser Family Foundation, the CMA Special Report outlines how most people don’t review their coverage options on an annual basis. Among other things, the Report also notes that plan quality ratings, which are supposed to be a guidepost for consumers comparing their plan options, are rendered largely unusable due to near ubiquitous “high” quality ratings.
Beware of Marketing Misconduct
As discussed in another recent CMA Alert, the AEP is also a period of time during which many interested parties, including insurance plan sponsors and agents and brokers, are vying for peoples’ attention in order to convince them to enroll in a product(s) they are selling. Misconduct and misinformation during such sales attempts, either intentional or not, is common. In the Alert, we offer warnings about general agent/broker conduct, misleading TV advertisements, educational events that turn into marketing events, and potential recourse for those who are negatively impacted by these things.
Note that CMS has recently updated their flyer entitled “Agent/Broker Dos & Don’ts (updated Sept. 2021), available at: https://www.cms.gov/files/document/agentbroker-dos-donts-92021.pdf and has translated it in 17 languages: Armenian, Arabic, Chinese, Farsi, German, Haitian-Creole, Italian, Japanese, Korean, Polish, Portuguese, Russian, Vietnamese, French, Greek, Spanish and Tagalog.
Potential Recourse – Special Enrollment Period (SEP)
Medicare provides certain rights to use Special Enrollment Periods (SEPs) to change or get out of a Medicare Advantage or Part D plan in certain circumstances. This includes when someone receives inaccurate or misleading information from the Medicare Plan Finder, customer service representatives at 1-800-MEDICARE, or an MA or Part D plan (or its agents). See, e.g., a “Note” on the www.medicare.gov webpage describing SEPs: “If you believe you made the wrong plan choice because of inaccurate or misleading information, including using Plan Finder, call 1-800-MEDICARE and explain your situation. Call center representatives can help you throughout the year with options for making changes.”
For a full list of available SEPs, see, e.g., for MA SEPs: Medicare Managed Care Manual, Chapter 2 (2021 update available here) and Title 42, Code of Federal Regulations §422.62(b); for Part D SEPs see Medicare Prescription Drug Manual, Chapter 3 (2021 update available here) and Title 42, Code of Federal Regulations §423.38.
Webinar Recording: “Medicare Enrollment Issues for 2022”
On October 20, 2021 the Center for Medicare Advocacy presented a webinar that included a discussion of the 2022 Annual Coordinated Election Period (ACEP), including outreach and education materials issued by the Medicare program, Medicare Plan Finder updates, common enrollment pitfalls, options when you miss your Initial Enrollment Period, and other considerations for Medicare beneficiaries and those who assist them. Policy changes, potential helpful legislation, and other updates for 2022 were also discussed, including Medicare Advantage network adequacy and other changes made by final regulations.
A recording of the webinar can be accessed here:
On November 12, 2021, the Centers for Medicare & Medicaid Services (CMS) released 2022 Medicare cost-sharing, premium and copay amounts. Most significantly, the monthly Part B premium is increasing from $148.50 in 2021 to $170.10 in 2022. The Part B deductible is increasing $30 to $233. All of the 2022 figures are available in a CMS Fact Sheet posted here.
According to Inside Health Policy (Nov. 12, 2021), “CMS says half of the reason for the largest Medicare Part B premium increase in 15 years is due to building up the Part B Medicare trust fund to take into account the potential cost of the controversial drug Aduhelm — in case CMS approves its coverage — while the other half is due to usual cost growth combined with the need to make up for Congress’ move to decrease premiums in 2021.”
Inside Health Policy notes that senior CMS officials explained that “the 5.9% adjustment in 2022 Social Security benefits will more than cover the increase for most Medicare beneficiaries.”
The day that CMS released these figures, House Energy & Commerce Chair Frank Pallone issued a statement calling for addressing the high cost of prescription drugs: “Today’s announcement from CMS confirms the need for Congress to finally give Medicare the ability to negotiate lower prescription drug costs and establish a rebate for drugs that increase faster than inflation. Skyrocketing drug prices not only make it harder for seniors to afford the lifesaving drugs they need, but also drive up their health care premiums for doctor’s visits and outpatient care. This double financial whammy simply cannot continue, and that’s why Congress must pass the bicameral Medicare prescription drug agreement that was included in the Build Back Better Act last week. We simply cannot wait any longer to provide real relief to seniors.”
When assessing rising Medicare costs, policymakers continue to ignore the fact that overpayments to Medicare Advantage (MA) plans continue to negatively impact Medicare’s finances. The Medicare Payment Advisory Commission (MedPAC) noted in a March 2021 report to Congress that Medicare payments to MA plans average 104% of spending in traditional Medicare. The Kaiser Family Foundation (KFF) released a report in August 2021 outlining how Medicare spending is higher and growing faster per person for beneficiaries in MA than in traditional Medicare. Despite most plans submitting bids below the local benchmarks, KFF notes that the MA program “has never generated savings relative to traditional Medicare” and while higher payments have led to coverage of some limited extra benefits for plan enrollees, “the higher payments have also led to higher Medicare spending than would have occurred under traditional Medicare and higher Medicare Part B premiums paid by all beneficiaries, including those in traditional Medicare.”
In short, by addressing the high cost of prescription drugs and reining in overpayments to private Medicare Advantage plans, policymakers can keep Medicare costs – including those borne by beneficiaries – lower. They must, though, find the will to do so.
- LITIGATION UPDATE
Center for Medicare Advocacy Cases
- Alexander v. Azar (formerly Bagnall v. Sebelius, Barrows v. Burwell), No. 3:11-cv-1703 (D. Conn.), No. 13-4179 (2d Cir.); Bagnall v. Becerra, No. 20-1642 (2d Cir., second appeal) (Beneficiary Appeals of Observation Status). In November 2011, the Center for Medicare Advocacy and Justice in Aging filed a proposed class action lawsuit on behalf of individuals who have been denied Medicare Part A coverage of hospital and nursing home stays because their care in the hospital was considered “outpatient observation” rather than an inpatient admission. When hospital patients are placed on observation status, they are labeled “outpatients,” 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 for three consecutive days to receive Medicare Part A coverage of post-hospital nursing home care, people on observation status do not have access to nursing home coverage. They must either privately pay the high cost of nursing care or forgo that skilled care. The number of people placed on observation status has greatly increased in recent years, as CMS has strictly enforced its definition of which services hospitals should bill as inpatient/Part A and which services they should bill as observation/Part B. 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.
In September 2013, a federal judge in Connecticut granted the government’s motion to dismiss the lawsuit. Plaintiffs appealed, but limited the appeal to the issue of the right to an effective notice and review procedure for beneficiaries placed on observation status. In January 2015, the U.S. Court of Appeals for the Second Circuit decided that Medicare patients who are placed on observation status in hospitals may have an interest, protected by the Constitution, in challenging that classification. The panel held that the district court erred when it dismissed the plaintiffs’ due process claims, and it sent the case back to that court for further proceedings. Barrows v. Burwell, 777 F.3d 106 (2d Cir. 2015).
Substantial motion practice and more discovery occurred (for details see previous issue briefs). The law firm of Wilson Sonsini Goodrich & Rosati joined as representatives of the plaintiffs during this phase and has provide extraordinary and invaluable pro bono assistance. A bench trial on the merits of the due process issue was then held in August 2019. The plaintiffs presented several witness who were affected by observation status, an expert witness, and also several witnesses from the government. The government also examined several witnesses from CMS as well as their own expert. The parties then submitted post-trial briefing.
In March 2020, the court issued a decision. Alexander v. Azar, — F. Supp. 3d –, 2020 WL 1430089 (D. Conn. Mar. 24, 2020). It held that the Secretary of Health and Human Services violates the Fifth Amendment Due Process Clause by not allowing certain patients to appeal their placement on observation status. Thus, as matter of constitutional due process, patients who are admitted as inpatients by a physician, but whose status is changed to observation by their hospital, have the right to appeal to Medicare and argue for coverage as hospital inpatients. In this ruling, the court held that there is a protected property interest in Medicare Part A coverage, meaning that an individual cannot be deprived of that coverage without procedural safeguards. The court did not, however, find a due process violation for patients whose doctors never order inpatient status, or whose status is switched only from observation to inpatient. It drew a distinction between the actions of doctors and the actions of hospital utilization review staff. It decided that doctors’ decisions to admit patients as inpatients are not attributable to the government and thus not “state action,” a required component of a due process claim. But it held that then when a hospital’s utilization review staff finds that patient should be in observation status rather than an inpatient, that is due to Medicare’s billing rules and therefore does constitute state action.
The court modified the existing class definition accordingly. It is now:
All Medicare beneficiaries who, on or after January 1, 2009: (1) have been or will
have been formally admitted as a hospital inpatient, (2) have been or will have
been subsequently reclassified as an outpatient receiving “observation services”;
(3) have received or will have received an initial determination or Medicare
Outpatient Observation Notice (MOON) indicating that the observation services
are not covered under Medicare Part A; and (4) either (a) were not enrolled in Part
B coverage at the time of their hospitalization; or (b) stayed at the hospital for
three or more consecutive days but were designated as inpatients for fewer than
three days, unless more than 30 days has passed after the hospital stay without the
beneficiary’s having been admitted to a skilled nursing facility. Medicare
beneficiaries who meet the requirements of the foregoing sentence but who
pursued an administrative appeal and received a final decision of the Secretary
before September 4, 2011, are excluded from this definition.
The court ordered that the agency establish an appeals process for class members, under which they can argue that their inpatient admission satisfied the relevant criteria for Part A coverage—for example, that the medical record supported a reasonable expectation of a medically necessary two-midnight stay at the time of the physician’s inpatient order. Patients will be able to pursue these appeals in an expedited manner while still hospitalized. The court also ordered the agency to provide notice of these procedural rights.
In May 2020, the government appealed the district court’s trial decision to the Second Circuit. A status conference was held with the district court in October 2020 at plaintiffs’ request, during which they explained that they had received no indicia of implementation of the court’s order other than that the agency was analyzing the decision and coordinating among its personnel. The court requested that plaintiffs submit proposed measures the agency could take while the case is on appeal. In November 2020, plaintiffs offered several suggestions for implementation, including posting of notice on CMS’s website and development of a form for class members to submit their appeals. The government filed its response in December 2020, and also indicated that it intended to seek a stay of the court’s decision. The government stated that plaintiffs’ proposed implementation measures were unworkable and did not offer any counterproposals. The court ordered another status conference for January 2021.
The government’s opening appellate brief in the Second Circuit was filed in October 2020. It challenges the district court’s decisions regarding standing, class certification, and the merits of the due process claim. Plaintiffs’ response was filed in February 2021. Three amicus briefs in support of plaintiffs were also filed on March 5: one from AARP and Disability Rights Connecticut, one from the American Medical Association and the Connecticut State Medical Society, and one from the American Health Care Association. The government’s reply brief was filed with Second Circuit in April 2021.
At the district court, the government filed a motion for a stay of the judgment on January 11, 2021, stating that it would be irreparably harmed by implementing the court’s order, and that there are serious questions about the district court’s decision, indicating likelihood of success on appeal. Because of the pending stay motion, the status conference in January did not address proposed implementation measures, as the district court indicated that it wished to rule on the stay motion first. The stay motion was fully briefed as of February 2021. Plaintiffs argued against a stay based on a lack of irreparable harm to the government (demonstrated in part by its delay in requesting a stay) and a lack of likelihood of success of the government’s appeal to the Second Circuit. When the district court did not act on the stay motion, the government moved for a stay in the Second Circuit on June 22, 2021, and that motion was fully briefed as of July 8. On July 16, a single judge of the Second Circuit granted a temporary stay of implementation while it refers the government’s motion for stay to be considered by the panel of judges that retained consideration of the case.
Update: The Second Circuit held oral argument on the government’s appeal on October 6, 2021.
For answers to frequently asked questions from people who think they may be class members, please see the Center’s website here.
- Dobson v. Secretary of Health and Human Services, No. 4:18-cv-10038-JLK (S.D. Fla.), No. 20-11996 (11th Cir.) (Part D Off-Label Drug). On April 6, 2018, the Center for Medicare Advocacy and Florida Health Justice Project filed a lawsuit in the United States District Court for the Southern District of Florida on behalf of a Medicare beneficiary seeking Part D coverage for the “off-label” (non-FDA-approved) use of a critically needed medication. The plaintiff is disabled from a traumatic workplace injury that damaged his spinal cord. As a result of severe pain and multiple surgeries, he suffers daily from debilitating nausea and vomiting. After numerous medications failed to provide relief, his doctor prescribed Dronabinol, which significantly relieved his nausea and vomiting and allowed him to resume many activities of a normal life.
When Mr. Dobson became eligible for Medicare Part D, his plan denied coverage because his particular use of Dronabinol is not FDA-approved. However, the Part D plan should cover the medication because Mr. Dobson’s use of the drug is supported by one of the “compendia” (DRUGDEX) of medically-accepted indications listed in the Medicare law. Medicare looks to the compendia for acceptable off-label uses of medications, and the symptoms of nausea and vomiting are listed in an entry for Dronabinol. The plaintiff’s position is strongly supported by a federal court decision granting Part D coverage of the same medication for a beneficiary with very similar symptoms (Tangney v. Burwell, 186 F. Supp. 3d 45 (D. Mass. 2016)). In spite of this, Mr. Dobson was denied coverage at each level of administrative review. In appealing his claim to federal court, Mr. Dobson contests the agency’s use of an inappropriately restrictive reading of the law to claim that coverage cannot be granted.
Briefing on cross-motions for summary judgment was completed and a hearing was held in September 2019 in Miami before a magistrate judge.
The judge issued a decision on March 31, 2020, finding that Mr. Dobson’s medication cannot be covered by Medicare Part D. She credited the government’s argument that Mr. Dobson’s use was not a “medically accepted indication,” “supported by citation” in DRUGDEX. The judge’s reasoning was that Mr. Dobson does not have the identical diagnosis as the patient in the study contained within the DRUGDEX citation for disease-related, treatment-refractory nausea and vomiting. The judge rejected the reasoning of the Tangney court. In May 2020 the plaintiff appealed the district court’s decision to the 11th Circuit.
In the appellate briefing, Mr. Dobson argues that the Medicare statute mandates coverage of his medication because his use is “supported by” the Drugdex citation in question and that the Secretary’s interpretation is erroneous under any standard. The American Medical Association and Greater Boston Legal Services (which litigated the Tangney case) also filed amicus briefs in support of Mr. Dobson. The case was fully briefed in the 11th Circuit as of February 11, 2021. The Center is grateful for the pro bono assistance of Akin Gump Strauss Hauer & Feld at the appellate stage of this case.
Update: The 11th Circuit held oral argument on the plaintiff’s appeal on September 21, 2021.
- Chinatown Service Center v. Cochran, No. 1:21-cv-00331 (D.D.C.) (LEP Protections under Section 1557 of the ACA). Justice in Aging and the Center for Medicare Advocacy, along with pro bono firm Stinson LLP, filed this case on February 5, 2021 on behalf of two community-based organizations that provide social services to Limited English Proficient (LEP) older adults. In the waning days of the Trump Administration, the federal government eliminated protections for LEP individuals in health care by rolling back regulations that were put in place as part of Section 1557 of the Affordable Care Act. The protections were intended to target health disparities by requiring health plans and other entities to inform patients both of their right to interpretation, and their right to legally challenge discrimination based on language ability. But, in 2020, the Trump Administration issued a rule that eliminated these language access protections (as well as many others affecting LGBTQ people, immigrants, and women). The plaintiffs are asking the court to vacate the 2020 rule and enjoin its implementation.
The parties agreed to stay all proceedings in the matter until July 16, 2021, at which point they filed a joint status report. The court then requested briefing on whether the case should be remanded voluntarily or further stayed based on the administration’s representation that it will be revisiting the Section 1557 regulations and expects to commence a rulemaking proceeding to revise or replace the 2020 rule that eliminated the relevant language access provisions. On August 18, 2021, the government moved for voluntary remand or in the alternative a stay of proceedings. Plaintiffs filed an opposition requesting that if the case is going to be remanded, the rule should be vacated in the meantime to avoid further harm to plaintiffs and others, and that if the case is stayed in the alternative it should be time-limited with reporting requirements. The government’s motion was fully briefed as of October 8.
Update: 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. The court decided to follow the same approach it had followed in a related case, Whitman-Walker Clinic, Inc. v. HHS, No. 20-1630, 2021 WL 4033072 (D.D.C. Sept. 3, 2021), which challenges several aspects of the 2020 rule, and in which the court had found that a stay was appropriate. The court also ordered HHS to provide bi-monthly updates on its proposed rulemaking, starting on November 30, 2021.
 CMS. COVID-19 Nursing Home Data. (Updated Oct. 31, 2021). Centers for Medicare & Medicaid Services Data. Available at: https://data.cms.gov/covid-19/covid-19-nursing-home-data
 S.2694. Nursing Home Improvement and Accountability Act of 2021. Congress.gov. Available at: https://www.congress.gov/bill/117th-congress/senate-bill/2694/all-actions?r=11&q=%7B%22action-by%22%3A%22all%22%7D
 H.R.5169. Nursing Home Improvement and Accountability Act. Congress.gov. Available at: https://www.congress.gov/bill/117th-congress/house-bill/5169