- MEDICARE and the RECONCILIATION PACKGE
Congress is currently debating a $3.5 trillion legislative package that, according to the New York Times (Aug. 11, 2021) “is aimed at creating the largest expansion of the federal safety net in nearly six decades.” The package, in the form of a budget reconciliation bill which avoids a filibuster in the Senate, requiring only 51 votes, is tied to a bipartisan infrastructure bill that the Senate has passed but that the House has not yet voted on. According to Inside Health Policy (9/17/21), “House Speaker Nancy Pelosi (D-CA) plans to keep her promise of holding a Sept. 27 vote on the bipartisan infrastructure bill, but she expects it to fail because it won’t be coupled with reconciliation, and she plans to bring infrastructure back for a second vote in the fall after negotiating a reconciliation deal with the Senate, lobbyists say. Pelosi wants to tie infrastructure to reconciliation to force moderate Democrats who support the infrastructure bill to also vote for reconciliation.”
The reconciliation package includes a range of health provisions that would expand access to coverage under the Affordable Care Act (ACA) and Medicaid, increase funding for Home and Community Based Services (HCBS) and expand Medicare coverage to include dental, hearing and vision. The scope of these health care improvements hinges, in part, on the extent of projected prescription drug savings for the Medicare program that are included in the reconciliation package. The mechanisms for addressing prescription drug prices, and how much corresponding savings might be achieved as result, is a current sticking point in the debate over the reconciliation package.
Medicare – Expanding Dental, Hearing and Vision Coverage
When assessing ways in which the Medicare program should be improved, advocates have several priorities (see, e.g., this July 2021 letter from 10 advocacy organizations outlining priorities for modernizing and strengthening the Medicare program). In addition to lowering prescription drug prices paid by Medicare beneficiaries (and the program itself), Congress is currently focusing on adding dental, vision and hearing benefits – long-time goals for many advocates. The House Ways & Means and Energy & Commerce Committees have both recently approved similar bills that outline the scope of new dental, hearing and vision benefits (see, e.g., here) that are broadly similar to the provisions of H.R. 3, a bill that passed the House, but not the Senate, in 2019 (see CMA Alert discussing passage of H.R. 3 here).
The Senate has not yet weighed in with their version of the reconciliation package, and the House version can still change prior to it being finalized. While advocates hope that these landmark proposals to add dental, hearing and vision benefits can be improved even further, there is broad support for the proposals’ addition of these benefits to Part B of Medicare, meaning they would be available to all Medicare beneficiaries, rather than a separate, stand-alone part(s) like the Part D prescription drug benefit.
As the Center outlined in recent CMA Alert, opponents of this historic opportunity to add these benefits are circulating various myths about Medicare and Medicare beneficiaries. Contrary to these myths:
- Critical Dental, Hearing and Vision Services Are Needed and Largely Unaffordable for Most Medicare Beneficiaries;
- Dental, Vision and Hearing Benefits Should be Comprehensive and Available for all Beneficiaries, Not Just Through Private Plans (such benefits are not “extra” or “duplicative”); and
- Now is the time to expand coverage – Medicare is not going “broke”, and the addition of these benefits to Part B don’t impact the Part A Trust Fund.
As outlined in another recent CMA Alert, the Center has written extensively on the need for a dental benefit in Medicare, including fact sheets that address the relationship between oral health and particular chronic conditions. We also drafted a fact sheet and FAQ with Families USA and Justice in Aging highlighting why a dental benefit must be in Part B. In addition, we have highlighted the need for hearing and vision care, including a recent article in STAT news about the need for hearing aid and hearing services.
In order to weigh in with members of Congress, see the following Action Alerts that call for broad improvements to the Medicare program, and a specific request for a comprehensive dental benefit. In addition, see this new Action Alert specifically for dental professionals who support a comprehensive benefit added to Part B.
Update: Crisis Standards of Care & COVID-19
Recent surges of COVID-19 cases are overwhelming hospital intensive care units (ICUs) around the nation. According to data from the Department of Health and Human Services, eight states have reached a critical level of having 10 percent or fewer ICU beds available. Idaho activated Crisis Standards of Care statewide on September 16, 2021, due to the “massive increase of COVID-19 patients requiring hospitalization in all areas of the state.”
In response to concerns about limited supplies of life saving resources due to the pandemic, some states and medical professionals developed protocols for rationing acute medical care,
often called Crisis standards of care (CSC). CSC can be triggered when there is a significant resource scarcity during times when crisis conditions exist. The CSC provide a standard guide for medical providers when resources become scarce and providers are forced to ration life-saving treatment, such as ICU care. The American Medical Association (AMA) notes that these standards of care might need to be utilized when the commitment to a patient is “counterbalanced by the need to protect the welfare of a population of patients.” While the AMA does not define specific clinical protocols for making medical rationing decisions, the organization provides guidance based on its Code of Medical Ethics, which includes making decisions based on medical need, instead of criteria such as a patient’s perceived social worth.
The Center for Medicare Advocacy (Center) has been monitoring the issue of medical rationing since the beginning of the pandemic. COVID-19 highlighted structural inequalities in the nation’s health care system and disproportionately impacted racial and ethnic minorities, along with older adults. The Center reported in July, 2020 that many plans include criteria based on disability, which “have the effect of discriminating against people with disabilities in violation of Section 1557 of the Affordable Care Act and Section 504 of the Rehabilitation Act.” Evidence of discrimination was seen when Utah issued its CSC. It authorized a medical provider, when assessing two patients with the same health status, to use age as a tiebreaker in determining which one received lifesaving care if there were only enough resources to treat one. The Center joined colleagues at Justice in Aging and the American Society on Aging in opposing the HHS Office of Civil Rights endorsement of Utah’s standards as discriminatory against older adults in violation of the Age Discrimination Act of 1975 (Age Act) and Section 1557. Utah, subsequently, removed the provision that the tiebreaker would be based solely on the patient’s age.
Centers for Disease Control and Prevention. CDC COVID Data Tracker. Retrieved September 16, 2021. Available at: https://covid.cdc.gov/covid-data-tracker/#county-view
McCausland, P. “Idaho declares statewide hospital resource crisis amid Covid surge” NBCNews.com. (Sept. 16, 2021). Available at: https://www.nbcnews.com/news/us-news/idaho-hospitals-west-face-covid-surge-struggle-transfer-patients-rcna1997
LaVito, A., Levin, J., & Maglione, F. “Delta Forces Hospitals Across U.S. to Ration Scarce ICU Beds.” Bloomberg.com. (Aug. 10, 2021). Available at: https://www.bloomberg.com/news/articles/2021-08-10/delta-strains-hospitals-across-u-s-as-unvaccinated-fill-icus
U.S. Department of Health & Human Services. Covid-19 Reported Patient Impact and Hospital Capacity by State. HealthData.gov. (Updated Sept. 15, 2021). Available at: https://healthdata.gov/dataset/COVID-19-Reported-Patient-Impact-and-Hospital-Capa/6xf2-c3ie
Association of American Medical Colleges. “COVID-19 Crisis Standards of Care: Frequently Asked Questions for Counsel.” (Updated Dec. 18, 2020). Available at: https://www.aamc.org/coronavirus/faq-crisis-standards-care
Sun, A., & Heyward, G. “American Hospitals Buckle Under Delta, With I.C.U.s Filling Up” The New York Times. (Aug. 17, 2021). Available at: https://www.nytimes.com/interactive/2021/08/17/us/covid-delta-hospitalizations.html
Stone, W. “A COVID Surge Is Overwhelming U.S. Hospitals, Raising Fears Of Rationed Care” NPR. (Sept. 5, 2021). Available at: https://www.npr.org/sections/health-shots/2021/09/05/1034210487/covid-surge-overwhelming-hospitals-raising-fears-rationed-care
American Medical Association. Crisis Standards of Care: Guidance from the AMA Code of Medical Ethics. AMA. (April 5, 2020). Available at: https://www.ama-assn.org/delivering-care/ethics/crisis-standards-care-guidance-ama-code-medical-ethics
Deam, J. “A Boy Went to a COVID-Swamped ER. He Waited for Hours. Then His Appendix Burst.” ProPublica. (Sept. 15, 2021). Available at: https://www.propublica.org/article/a-boy-went-to-a-covid-swamped-er-he-waited-for-hours-then-his-appendix-burst
Miller WD, Han X, Peek ME, Charan Ashana D, & Parker WF. “Accuracy of the Sequential Organ Failure Assessment Score for In-Hospital Mortality by Race and Relevance to Crisis Standards of Care.” JAMA Netw Open. 2021;4(6):e2113891. doi:10.1001/jamanetworkopen.2021.13891
U.S. Department of Health & Human Services. Hospital Utilization. HHS Protect Public Data Hub. (Updated Sept. 13, 2021). Available at: https://protect-public.hhs.gov/pages/hospital-utilization
U.S. Department of Health & Human Services. COVID-19 Reported Patient Impact and Hospital Capacity by State. HealthData.gov. (Updated Sept. 15, 2021). Available at: https://healthdata.gov/dataset/COVID-19-Reported-Patient-Impact-and-Hospital-Capa/6xf2-c3ie
Center for Medicare Advocacy. “Utah’s Crisis Standards of Care: Discriminatory Medical Rationing” CMA. (Oct. 29, 2020). Available at: https://medicareadvocacy.org/utahs-crisis-standards-of-care-discriminatory-medical-rationing/
Kertesz, K. “Advocacy Update: Medical Rationing” Center for Medicare Advocacy. (July 16, 2020). Available at: https://medicareadvocacy.org/advocacy-update-medical-rationing/?emci=fc880dd4-071a-eb11-96f5-00155d03bda0&emdi=ea000000-0000-0000-0000-000000000001&ceid=
Idaho Department of Health & Welfare. Idaho Expands Crisis Standards of Care Statewide Due to Surge In COVID-19 Patients Requiring Hospitalization. (Sept 16, 2020). Available at: https://healthandwelfare.idaho.gov/news/idaho-expands-crisis-standards-care-statewide-due-surge-covid-19-patients-requiring-0
Kornfield, M., Firozi, P., Pietsch, B., Timsit, A., Beachum, L., & Knowles, H. “Idaho allows rationing of medical care statewide amid surge in covid hospitalizations.” The Washington Post. (Sept.16, 2021). Available at: https://www.washingtonpost.com/nation/2021/09/16/covid-delta-variant-live-updates/
Hick, J., Hafling, D., Wynia, M., & Toner, E. “Crisis standards of care and COVID-19: What Did We Learn? How Do We Ensure Equity? What Should We Do?” National Academy of Medicine. (Aug. 30, 2021). Available at: https://nam.edu/crisis-standards-of-care-and-covid-19-what-did-we-learn-how-do-we-ensure-equity-what-should-we-do/
Cleveland Manchanda EC, Molina MF, & Rodriguez RM. “Racial Equity in Crisis Standards of Care—Reassuring Data or Reason for Concern?” JAMA Netw Open. 2021;4(3):e214527. doi:10.1001/jamanetworkopen.2021.4527
Cha, A. E., & Kornfield, M. Four patients, Two dialysis machines: Rationing medical care becomes a reality in hospitals overwhelmed with covid patients. The Washington Post (2021, September 17). Available at: https://www.washingtonpost.com/health/2021/09/17/hospitals-ration-care-covid/
Provisions in Reconciliation Package: Build Back Better Act
Nursing Home Improvement and Accountability Act of 2021, 60-page bill introduced in Senate, Aug. 10, 2021; in the House, Sep. 3, 2021, https://waysandmeans.house.gov/sites/democrats.waysandmeans.house.gov/files/documents/SNF-PKGE_03_xml_Introduction_signed.pdf Discussed in “Senators Introduce Nursing Home Legislation to Improve Quality of Care” (CMA Alert, Aug. 12, 2021), https://medicareadvocacy.org/senators-introduce-nursing-home-legislation-to-improve-quality-of-care/
- Requires 24-hour a day registered nurse coverage in all facilities
- Requires the Secretary of the Department of Health and Human Services to study, submit periodic reports to Congress, and implement nurse staffing ratios, and requires facilities to meet staffing ratios
- Requires all facilities to have an infection preventionist at least 40 hours per week
- Requires the Secretary to review and improve survey and enforcement practices to ensure their effectiveness, appropriate classification of deficiencies, timely correction of deficiencies, timely investigation of complaints and reported allegations of abuse and neglect, the ability of state survey agencies to hire, train, and retain surveyors, and more
- Provides enhanced Medicaid funding to support staffing (higher wages and benefits) and quality of care, with independent evaluations of and reports to Congress about the increased funding
- Enhances the accuracy and reliability of nursing home data, requiring audits and financial penalties for the submission of inaccurate data
- Prohibits pre-dispute arbitration agreements
Due to reconciliation rules, only four provisions are included:
- Improving the accuracy and reliability of certain SNF data ($50 million available until fiscal year 2031 to conduct data validation of MDS (resident assessment) data, staffing data, and Value-Based Purchasing Program data; reduce SNF payments by 2% beginning in fiscal year 2025 for submitting false data in any of the 3 categories)
- Ensuring accurate information on cost reports ($250 million to audit Medicare costs reports, beginning in calendar year 2022 and ending in 2031)
- Survey improvements ($325 million for fiscal years 2022-2031 to improve survey and enforcement processes to improve facility compliance)
- Nurse staffing requirements ($50 million for HHS for fiscal years 2022-2033 to conduct studies on the appropriateness of minimum staffing levels for nursing staff (no later than 3 years after law is passed and then at least every 5 years) and to write regulations (within 2 years of each study) mandating facility staffing levels based on the recommended staffing minimums identified in the studies
Temporary Nurse Aides (TNAs)
Temporary Nurse Aides, an Update, “Who Provides Care for Nursing Home Residents? An Update on Temporary Nurse Aides” (CMA Report, Sep. 15, 2021), https://medicareadvocacy.org/wp-content/uploads/2021/09/SNF-TNA-Report-09-2021.pdf
March 2020: As part of the long list of blanket waivers and flexibilities granted to nursing facilities as a result of the public health emergency (PHE), CMS waived the requirement (from the 1987 Nursing Home Reform Law) that facilities not use individuals as nurse aides for more than four months unless they are trained in a state-approved nurse aide training program of least 75 hours. CMS did not waive the competency requirement.
American Health Care Association developed a free eight-hour on-line training course for a “temporary position intended to address the current state of emergency.” Many states explicitly adopted the program.
April 2021: CMS said that “the four-month regulatory timeframe will be reinstated when the blanket waiver ends,” but then, gratuitously suggested “that states evaluate their NATCEP [Nurse Aide Training and Competency Evaluation Program] and consider allowing some of the time worked by the nurse aides during the PHE to count toward the 75-hour training requirement.”
CMA report looks at how states are implementing the CMS suggestion. CMS’s “suggestion” has in fact encouraged states to allow workers to continue providing care to residents now and after the pandemic, even when they have less training than the state required of all aides before the pandemic and less training than the 75 hours that the federal government has required for decades as the minimum.
States are most commonly counting time worked as temporary nurse aides as if it were actual training and many are requiring few, if any, hours of additional training beyond the eight hours received on-line – essentially, they are grandfathering temporary aides into permanent certified nurse aides.
- UPCOMING ANNUAL ENROLLMENT PERIOD
Medicare’s Open Enrollment period – also known as the Annual Election Period 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).
It is important to note when determining your best coverage options that open enrollment does not generally apply to Medigap plans, which are only guaranteed issue in most states during a beneficiary’s initial enrollment period, and during limited special enrollment periods.
Determining the coverage that is best for your specific health care needs can be complex, but here are several simple tips to help beneficiaries with their coverage decisions.
- Be ready with a list of all your health care conditions, prescription needs, and desired/necessary providers when you review your options.
- Make a note of any changes to income that might help you qualify for extra help with drug costs or Medicare co-pays.
- Watch your email for important notices from Medicare and Social Security. Read them carefully to be sure they are legitimate notices, and not private plan marketing junk mail.
- Review the 2022 Medicare & You handbook (discussed below) – a new Chinese version is now available, with translations in Vietnamese and Korean coming in early October.
- If you are considering private plans for your coverage, rather than the universally accepted traditional Medicare program, be sure to review plan options on the Medicare Plan Finder.
- Finally, there is help available to navigate these decisions from your State Health Insurance Assistance Program (SHIP). Find contact information for your SHIP program at https://www.shiphelp.org/ (In CT, known as CHOICES, at (800) 994-9422.)
Above all, be sure to make the decisions that will best meet your health care coverage needs for the coming year. Remember that your status in October may not be where you find yourself next July.
Updates for 2022
During a recent CMS National Medicare Education Program (NMEP) webinar, CMS outlined recent and pending changes to the Medicare Plan Finder (MPF), including:
- Ability to save drugs and pharmacies
- Ability to save selected pharmacies
- New in-network pharmacy finder
- Plan results filter updates
- Plan compare updates – easier to quickly view key costs
- Plan details update – new drug cost comparison table
- Prescription Drug Assistance (PAP) data source updated more frequently
Starting the 2022 plan year, Part D plans can use a second, preferred specialty tier (for more information, including several changes that will be effective in 2023, see this CMA Alert discussing the most recent final Part C and D rules).
- Still not subject to tiering exception
- CMS will codify a maximum allowable cost sharing permitted for the specialty tiers of between 25 and 33%
- If there are two specialty tiers, one must be a ‘‘preferred’’ tier that offers lower cost sharing than the proposed maximum allowable cost sharing
Medicare & You 2022 – Center for Medicare Advocacy Report Examines Bias Towards Medicare Advantage (MA)
Background of Bias Towards MA in Recent Medicare Materials
Starting in the Fall of 2017, the Center for Medicare Advocacy (the Center) and other advocacy organizations highlighted that, in a marked change from previous practice, the Trump Administration’s Centers for Medicare & Medicaid Services’ (CMS) outreach and enrollment materials promoted enrollment in private Medicare Advantage (MA) plans, while downplaying the drawbacks of such plans. At the same time, these materials – including revisions to recent editions of Medicare & You, online comparison tools (including the Medicare Plan Finder and associated materials), and education and outreach materials – tended to downplay (or in the case of some email campaigns, entirely leave out), the option of traditional/Original Medicare. Instead of objectively presenting enrollment options, some of this material went as far as encouraging beneficiaries to choose a private MA plan over traditional Medicare.
While there were some general improvements in the 2021 Medicare & You handbook, bias towards Medicare Advantage remained, and in some ways, was worse. Enrollment in MA plans was promoted at the same time that important restrictions and challenges faced when enrolling in MA plans were downplayed or omitted. Regrettably, when we had an opportunity to review the 2022 draft – along with a number of other stakeholders – we found that much of this bias remained.
CMS recently posted the final Medicare & You 2022 Handbook on their website. We reviewed the new handbook with an eye toward assessing the balance of information provided about traditional Medicare vs. Medicare Advantage, and the accuracy of information regarding coverage. We are pleased to report that while there is still work to do, the new Handbook makes important strides towards reversing the bias in favor of MA that was prevalent in recent editions.
With 2022 Handbook, CMS Takes an Important First Step Towards Reversing Bias in Favor of Medicare Advantage
In a report issued today by the Center for Medicare Advocacy, we examine the improvements, and highlight where more attention is needed. In the final version of Medicare & You 2022, it is evident that CMS has given greater attention to objectivity rather than painting Medicare Advantage in the most favorable light. This change is clear when reviewing the comparison charts at the beginning of the Handbook, a section readers are most likely to pay attention to, and, because of its brevity, is most susceptible to improper shortcuts or abbreviation of critical information.
For example, information about limited provider networks, extra benefits and other areas and much improved. The Handbook still needs work with respect to describing the prevalence of prior authorization, and accurate descriptions of out-of-pocket costs, even with MOOP.
The report “MEDICARE & YOU 2022 – An Important First Step Towards Reversing Bias in Favor of Medicare Advantage” provides a detailed analysis of these changes, along with an Addendum that catalogues bias in favor of Medicare Advantage in Medicare materials over the last few years. The full report is available here.
- 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).
Several dispositive motions 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. It did not request a stay at the time. A status conference was held with the district court in October 2020 at plaintiffs’ request. Plaintiffs 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. Since the order has no timeline for implementation, class members have been left wondering when they will be able to submit claims. This is urgent due to the age of many class members. The court requested that plaintiffs submit proposed measures the agency could take while the case is on appeal. That proposal was filed in November 2020, and plaintiffs offered several ideas 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, meaning the appeal is now fully briefed.
At the district court, the government filed a motion for a stay of the judgment on January 11, 2021, claiming that it would be irreparably harmed by implementing the court’s order, and that there are serious questions about the district court’s decision, which indicates a 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 wishes to rule on the stay motion first. The stay motion was fully briefed as of February 2021. Plaintiffs have 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. After 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.
Update: On July, 16, 2021, 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. Meanwhile the government’s appeal of the trial decision is pending and scheduled for oral argument 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 49-year-old 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 case is scheduled for argument in the 11th Circuit 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.
Update: 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. On September 17, 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 reply brief is due October 8, 2021.
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