- FEDERAL UPDATE
Medicare and Build Back Better
During the last Alliance webinar in November 2021, we discussed the legislative package Congress was debating called the Build Back Better Act (BBB) that was 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 were included in the reconciliation package.
In late December 2021, negotiations over the BBB act stalled when Senator Joe Manchin (D-WV) announced that he would not vote for the package that had emerged from both the House and Senate over the previous months. As of this January 2022 Alliance webinar, negotiations are on hold.
As previously discussed, here are some of the Medicare provisions that remained in BBB before negotiations stalled:
- Hearing Benefit – 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).
- Prescription Drug Savings and Changes to Part D Benefit – As noted in an AARP article that outlined the prescription drug proposals entitled “How Congress Plans to Lower Drug Prices and Out-of-Pocket Costs” (Nov. 10, 2021), “[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.”
- Nursing Home Provisions – 5 nursing home-related provisions were included in the House-passed bill, including: data validation; auditing of cost reports; improvements to survey and enforcement practices; establish minimum staffing for nursing homes; and a requirement that nursing homes have a registered nurse on staff 24 hours per day, seven days a week. The draft Senate Finance Committee bill language released on December 11, 2021 added 2 new provisions aimed at increasing the number of facilities that participate in the Special Focus Facility program and providing $800 million in grant funding to states to improve staffing and infection control in long-term care institutional settings. The Senate version, however, removed the mandate that CMS update staffing regulations to reflect the minimum staffing ratios from survey findings and recommendations. See this CMA Alert (Dec. 16, 2021) for a side-by-side comparison of the House and Senate nursing home provisions.
Part C and D Proposed Rule
On January 6, 2022, CMS released CY 2023 Medicare Advantage and Part D Proposed Rule (CMS-4192-P) and an accompanying Press Release describing the overall rule, and a separate Press Release focusing on Part D prescription drug costs. The proposed rule, available here, will be published in the Federal Register on January 12, 2022. Comments to the proposed rule are due March 7, 2022.
According to the summaries issued by CMS, the proposed rule includes a range of provisions, including the following:
- based on past performance;
- (D-SNPs) – proposals include establishment of enrollee advisory committees, simplify plan materials for enrollees, further streamline grievance and appeal systems, solicitation of information concerning social determinants of health, and changes in cost-sharing rules that will lead to more equitable payments to providers and state expenditures; and
- – “CMS is proposing to redefine the negotiated price as the baseline, or lowest possible, payment to a pharmacy, effective January 1, 2023. This policy would reduce beneficiary out-of-pocket costs and improve price transparency and market competition in the Part D program”.
CMA Home Health Survey: Medicare Beneficiaries Likely Misinformed and Underserved
Home health services as authorized by Medicare law, regulations, and policies are too often unavailable in practice. For example, for patients who meet qualifying criteria, Medicare law authorizes up to 28 to 35 hours a week of home health aide personal hands-on care and nursing services combined, as well as therapies and medical social services. “Personal hands-on care” as defined by law includes many services. While bathing is included, it also includes dressing, grooming, feeding, toileting, transferring and other key services that help an individual remain healthy and safe at home. Unfortunately, patients can rarely access this level of Medicare-covered care. As reflected in a recent study by the Center for Medicare Advocacy, access problems are especially true for beneficiaries with chronic and longer-term conditions who need services to maintain or slow decline.
From April 28, 2021-November 19, 2021, the Center for Medicare Advocacy (the Center/CMA) conducted a survey of 217 Medicare-certified home health agencies (HHA) in 20 states to learn what beneficiaries may experience when seeking home care. The agencies were identified through the Care Compare search tool at www.medicare.gov. The Center inquired about home health services available from each agency for a hypothetical patient with an authorized practitioner’s order certifying one hour of physical therapy per week, one hour of skilled nursing per week, and 20 hours of home health aide services per week.
All agencies indicated that they would be able to provide one hour of physical therapy per week, and 99% said they could provide one hour of skilled nursing care per week. Responses about home health aide services, however, were very different. 15% of agencies did not provide a clear answer regarding available home health aide services. Those that did provide an answer demonstrated overwhelmingly that home health aide services are not available in an amount even approaching the benefit as defined by Medicare law. This trend was present in rural and urban areas across all 20 surveyed states.
Further, in order to see if accurate information about the Medicare home health benefit is available from the Centers for Medicare & Medicaid (CMS) – the federal Medicare agency – the Center made 10 calls to the official CMS Medicare help line, 1-800-MEDICARE. Center staff asked the same questions regarding services available for the same hypothetical patient as they asked home health agencies in the survey. Unfortunately, the information provided by 1-800-MEDICARE was inconsistent and often inaccurate.
- Download and read the full report at: https://medicareadvocacy.org/wp-content/uploads/2021/12/CMA-Survey-Medicare-Home-Health-Underservice.pdf
Implementation of New Payment Rule in the New Year
As discussed during the last Alliance call, 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.
Reminder: CMA Webinar: “Medicare Coverage of Home Health Services” Wednesday January 12, 2022 @ 2 – 3:00 EST – register here: https://attendee.gotowebinar.com/register/7879007285776193551
- NURSING FACILITY UPDATES
Revision of Visitation Guidance
At the beginning of the coronavirus pandemic in March 2020, the Centers for Medicare & Medicaid Services (CMS) totally barred visitors. Since then, it has issued multiple revisions to its guidance, most recently, as follows:
Nov. 12, 2021: Citing high vaccination rates for residents (86%) and staff (74%); interim final rule with comment (86 Fed. Reg. 61555 (Nov. 4, 2021)) requiring staff to be vaccinated; residents’ rights to make choices about issues of importance to them and confirming residents’ right to deny withdraw or consent for visits; and the physical and emotional that social isolation during the pandemic caused residents, CMS revised its visitation guidance to provide that “Visitation is now allowed for all residents at all times.” CMS, “Nursing Home Visitation – COVID-19 (REVISED), QSO-20-39-NH (Revised Nov. 12, 2021), https://www.cms.gov/files/document/qso-20-39-nh-revised.pdf. CMS wrote, “facilities can no longer limit the frequency and length of visits for residents, the number of visitors, or require advance scheduling of visits.” See CMA, “CMS Revises Visitation Rules for Nursing Facilities” (CMA Alert, Nov. 18, 2021), https://medicareadvocacy.org/cms-revises-visitation-rules-for-nursing-facilities/
Dec. 17, 2021: The American Health Care Association, LeadingAge, and AMDA – The Society for Post-Acute and Long-Term Care Medicine (medical directors association) wrote a letter to CMS Administrator Chiquita Brooks-LaSure asking CMS to revise its November guidance to give facilities “More flexibility to temporarily limit, restrict, or prohibit visitors from entering the facility.” Letter at https://paltc.org/sites/default/files/Joint%20letter%20on%20Visitation%20AHCA-AMDA-LeadingAge.pdf. The three associations argued that the Public Health Emergency, the expected surge in the Omicron variant, hospital surges, and “[nursing home] staffing shortages [that] may lead to the inability to ensure that safe visiting policies are being followed” are factors supporting the need “to temporarily restrict access” to facilities.
Dec. 23, 2021: CMS issued Frequently Asked Questions (FAQs) to allow “very limited and rare exceptions” to “the bottom line,” which is “visitation must be permitted at all times.” Contradicting the November guidance, CMS wrote, “facilities may restructure the visitation policy, such as asking visitors to schedule their visit at staggered time-slots throughout the day, and/or limiting the number of visitors in the facility or a resident’s room at any time.” CMS wrote, “the facility must demonstrate that good faith efforts were made to facilitate visitation,” but provided no guidance on the exceptions to visitation or what efforts facilities must make before limiting visitors. See CMA, “CMS Revises November Visitation Guidance after Nursing Home Industry Calls on CMS to Allow Facilities to ‘Limit, Restrict, or Prohibit Visitors’” (CMA Alert, Dec. 23, 2021), https://medicareadvocacy.org/cms-revises-november-visitation-guidance-after-nursing-home-industry-calls-on-cms-to-allow-facilities-to-limit-restrict-or-prohibit-visitors/
Jan. 6, 2022: CMS revised the Dec. 23 FAQs. CMS, “Nursing Home Visitation: Frequently Asked Questions (FAQs)” (Jan. 6, 2022), https://www.cms.gov/files/document/nursing-home-visitation-faq-1223.pdf. CMS confirms that facilities must “continue to permit visitation,” despite the spikes in infections caused by the Omicron variant, although it allows states to “instruct nursing homes to take additional measures to make visitation safer, while ensuring visitation can still occur.” CMS also encourages facilities “to consult with state and local health departments when outbreaks occur to determine when modifications to visitation policy would be appropriate.” Question 10 essentially summarizes CMS’s current position:
While CMS is concerned about the rise of COVID-19 cases due to the Omicron variant, we’re also concerned about the effects of isolation and separation of residents from their loved ones. Earlier in the pandemic we issued guidance for certain limits to visitation, but we’ve learned a few key things since then. Isolation and limited visitation can be traumatic for residents, resulting in physical and psychosocial decline. So, we know it can lead to worse outcomes for people in nursing homes. Furthermore, we know visitation can occur in a manner that doesn’t place other residents at increased risk for COVID-19 by adhering to the practices for infection prevention, such as physical distancing, masking, and frequent hand hygiene. There are also a variety of ways that visitation can be structured to reduce the risk of COVID-19 spreading. So, CMS believes it is critical for residents to receive visits from their friends, family, and loved ones in a manner that does not impose on the rights of another resident. Lastly, as indicated above, facilities should consult with their state or local public health officials, and questions about visitation should be addressed on a case by case basis.
Posting of Unpaid Civil Monetary Penalties
In response to questions from two reporters – Clark Kauffman of Iowa Capital Dispatch and Jocelyn Wiener of CalReports – who had been told by CMS that the agency does not post civil money penalties against nursing facilities if the facilities do not pay them, CMS changed its policy and told both reporters it would now post unpaid fines. See CMA, “CMS Will Now Post All Civil Money Penalties Imposed against Nursing Facilities” (CMA Alert, Dec. 18, 2021), https://medicareadvocacy.org/cms-will-now-post-all-civil-money-penalties-imposed-against-nursing-facilities/
Nov. 5, 2021: CMS publishes an interim final rule with comment (86 Fed. Reg. 61555 (Nov. 5, 2021)) requiring 100% of staff with direct patient contact at 14 categories of Medicare- and Medicaid-certified health care providers and suppliers to be vaccinated for coronavirus, https://www.govinfo.gov/content/pkg/FR-2021-11-05/pdf/2021-23831.pdf
Four States sued, representing 25 states. As a result of appellate court decisions in the Eighth, Eleventh, and Fifth Circuit Courts of Appeals, the two District Court injunctions against the mandate were narrowed to the 25 states that were parties to the litigation. The U.S. Supreme Court heard oral argument on Jan. 7, 2022.
Dec. 28, 2021: CMS issued guidance on the 100% staff vaccination mandate for the 25 states not covered by the injunctions. The guidance includes a memorandum applicable to all providers, with separate attachments for each of the 14 categories of providers and suppliers. Staff vaccination rates under 100% constitute non-compliance. However, non-compliance will not necessarily lead to termination from Medicare and Medicaid. CMS will generally give providers and suppliers opportunities to come into compliance. CMS, “Guidance for the Interim Final Rule – Medicare and Medicaid Programs; Omnibus COVID-19 Health Care Staff Vaccinations,” QSO-22-07-ALL (Dec. 28, 2021), https://www.cms.gov/medicareprovider-enrollment-and-certificationsurveycertificationgeninfopolicy-and-memos-states-and/guidance-interim-final-rule-medicare-and-medicaid-programs-omnibus-covid-19-health-care-staff-0
See CMA, “U.S. Supreme Court Will Hear Appeals of Vaccination Mandate for Health Care Providers on January 7; CMS Moves Ahead on Mandate in States Not Under Injunction” (CMA Alert, Dec. 30, 2021), https://medicareadvocacy.org/vax-mandates-in-court/
- PREVIEW: CENTER FOR MEDICARE ADVOCACY’S TELEHEALTH REPORT
Two years ago, the Centers for Disease Control and Prevention (CDC) confirmed the first cast of COVID-19 in the United States. By March 2020, the Centers for Medicare & Medicaid Services (CMS) increased access to Medicare covered telehealth services with the aim of reducing exposure to COVID-19 that would come from in-person doctor visits. CMS expanded regulatory flexibilities and the range of providers that could be reimbursed for services. The CMS actions resulted in a 6,000 percent increase in the use of telehealth by Medicare beneficiaries, the number of visits jumped from 840,000 in 2019 to almost 52 million in 2020.
The Center for Medicare Advocacy has closely watched the telehealth expansion with an eye on ensuring that beneficiaries are able to continue to access quality health care. In July 2020, the Center, along with the Medicare Rights Centers, issued guiding principles for legislators focused on telehealth expansion. Furthermore, the Center has conducted an in-depth analysis of telehealth that it will publish shortly. The goal of the report is to identify ways to utilize telehealth services, while also ensuring that Medicare beneficiaries will receive the best quality health care. Through interviews with experts around the nation and deep research, the upcoming report will also examine gaps that currently exist in accessibility, along with infrastructure needs that should be addressed by lawmakers to ensure equitable access to telehealth services.
- 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. At plaintiffs’ request, a status conference was held with the district court in October 2020 regarding implementation of the court’s order. The court ordered submissions on proposed measures the agency could take while the case is on appeal and ordered another status conference for January 2021.
The government’s opening appellate brief in the Second Circuit was filed in October 2020. It challenged 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 filed in March: 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 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. When the district court did not act on it, the government moved for a stay in the Second Circuit in June 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.
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.
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.
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 in November.
Update: The government’s first status report was filed on November 30, 2021, stating that in continues to expect to issue a Notice of Proposed Rulemaking no later than April 2022.
 Medicare Act Home Health provisions are available at 42 USC §1361(m); implementing federal regulations are at 42 CFR 409 et seq; CMS home health benefit policy is available at Medicare Benefit Policy Manual (cms.gov) .
 42 U.S.C. §1395x(m)(1)-(4). Receipt of skilled therapy can also trigger coverage for home health aides.
 42 CFR §409.45(b)(1)(i)-(v). See also, Medicare Benefits Policy Manual, Chapter 7, §§50.1 and 50.2.
 From 4/28/21-7/26/21, calls were made to agencies in the following 19 states: AZ, CA, CT, FL, GA, IL, KS, LA, MD, MA, MN, NY, OH, OR, PA, TX, UT, WV, WY. To confirm that findings are persistent and widespread, on 11/19/21 additional calls were made to agencies in MI.
 Results are based on information communicated directly by agency representatives. The actual provision of services as stated by agencies has not been independently verified. While we originally planned to produce a directory of care available from surveyed home health agencies, the results of the survey demonstrated that available care is so limited, a directory does not seem useful.
 CMS. Medicare Telemedicine Health Care Provider Fact Sheet. CMS. (March 17, 2020). Available at: https://www.cms.gov/newsroom/fact-sheets/medicare-telemedicine-health-care-provider-fact-sheet
 Wong Samson, L., Tarazi, W., Turrini, G., & Sheingold, S. Medicare Beneficiaries’ Use of Telehealth in 2020: Trends by Beneficiary Characteristics and Location. ASPE. (December 3, 2021). Available at: https://aspe.hhs.gov/reports/medicare-beneficiaries-use-telehealth-2020
 CMA, & Medicare Rights Center. Telehealth – Recognize the Benefits, But Proceed with Caution. Center for Medicare Advocacy. (July 23, 2020). Available at: https://medicareadvocacy.org/joint-principles-from-center-for-medicare-advocacy-and-medicare-rights-center-medicare-expansion-of-telehealth-helps-beneficiaries-access-care-during-the-pandemic-but-caution-is-needed-bef/