Issue Brief 84 | May 2024 – New Health Care Rules & Other Issues

I. NEW HEALTH CARE RULES  

Special Guest Speaker: Jennifer Lav, Senior Attorney, National Health Law Program (NHeLP) will discuss the recently issued final rule under Section 1557 of the Affordable Care Act (ACA), which would strengthen anti-discrimination protections in health programs and activities, and the recently finalized rule under Section 504 of the Rehabilitation Act that prohibits discrimination on the basis of disability in programs and activities that receive funding from HHS, such as private Medicare Advantage plans and Part D plans.

Also see Center for Medicare Advocacy CMA Alert (May 9. 2024): HHS Final Rules Strengthen Anti-Discrimination Protections in Health Care – Center for Medicare Advocacy.

II. NURSING HOME UPDATES

CMS releases final nurse staffing ratio rule

See “CMS Publishes Final Rule On Nursing Staffing Standards” (CMA Alert, May 23, 2024)

CMS, Medicare and Medicaid Programs; Minimum Staffing Standards for Long-Term Care Facilities and Medicaid Institutional Payment Transparency Reporting, 89 Fed. Reg. 40876 (May 10, 2024), as promised by President Biden’s nursing home reform agenda (Feb. 2022).

The final rules establish three separate and independent nurse staffing requirements:

Exemptions process, §483.35(h)

CMS Fact Sheet (Apr. 10, 2024) says the final staffing rule also creates “a temporary hardship exemption from the minimum nurse staffing HPRD [hours per resident day] standards and the 24/7 RN requirement only if they meet the following criterion for geographic staffing unavailability, financial commitment to staffing, and good faith efforts to hire.” Facilities are eligible for a hardship exemption only if the ratio of the requirement (for example, 24/7 RN coverage) to the population in the facility’s area is 20% below the national average.

A survey must first find that a facility is not in compliance with staffing requirements. Then the facility may, if eligible, request a hardship exemption by showing good faith efforts to hire and retain staff (§483.25(h)(2)) and its financial commitment to staffing (§483.35(h)(3)). Documentation of compliance with the exemption requirements must be supplied, but only on request (§483.35(h)(6)).

A facility is ineligible for a hardship exemption if

• it failed to submit staffing data to the Payroll-Based Journal System
• is a Special Focus Facility, or
• within the preceding months, was cited with widespread or pattern insufficient staffing resulting in actual harm to a resident (§483.35(h)(5)(i)-(iii))

New in the final rule: a facility granted a hardship exemption must

• post a notice of its exemption status “in a prominent and publicly viewable location in each resident facility”
• provide notice of its exemption status to each current and prospective resident, and
• send a notice to the state long-term care ombudsman program

§483.35(h)(4)(i)-(iii). Exemptions continue until the next standard recertification survey and may be extended indefinitely, unless the facility meets one of the criteria for ineligibility (§483.35(h)(7)).

Facility assessment process, 42 C.F.R. §483.71, goes into effect August 8, 2024

• Facility assessment is not a new requirement; it was included in 2016 revisions to Requirements of Participation at 42 C.F.R. §483.70(e), instead of nurse staffing ratios

• But facility assessment has rarely been cited; and only a handful of deficiencies are called harm or jeopardy level (so, essentially, there has been no enforcement)

• Facility assessment is made a new regulatory provision, both to emphasize the importance of the process and to complement the minimum numerical standards (89 Fed. Reg., 40906)

• As in the 2016 rule, facilities must

• conduct and document a facility-wide assessment to determine the resources (including staff numbers, competencies, and skill sets) that are needed to care for its residents during both day-to-day operations and emergencies
• review and update annually, as necessary, and whenever the facility plans for or has any change in the facility or resident population that would require a substantial change (e.g., adding dialysis services or admitting bariatric residents)

include nursing home leadership, direct care staff

• New in 2024:

• facilities “must also solicit and consider input received from residents, resident representatives, and family members” (§483.71(b)(1)(iii))
• facilities must use “evidence-based data-driven methods” to determine the staffing needs of their residents and that the assessment be “consistent with and informed by individual resident assessments as required under §483.20.”

Preamble to final rule includes multiple statements that “many” facilities will find from their facility assessment that they need to staff at higher levels than the numerical standards, which will not go into effect for years.

“when assessing the sufficiency of a facility’s staffing it is important to note that any numeric minimum staffing requirement is not a target and facilities must assess the needs of their resident population and make comprehensive staffing decisions based on those needs. Often, that will require higher staffing than the minimum requirements. The additional requirements in this rule to bolster facility assessments are intended to address this need and guard against any attempts by LTC facilities to treat the minimum staffing standards included here as a ceiling, rather than a floor (baseline).” 89 Fed. Reg., 48883

“We expect that many facilities will need to staff above the minimum standards to meet the acuity needs of their residents depending on case-mix and as mandated by the facility assessment required at § 483.71.” 89 Fed. Reg. 40891

“We emphasized in the proposed rule and reiterate here that facilities are also required to staff above the minimum standard, as appropriate, to address the specific needs of their resident population (88 FR 61369). We expect that most facilities will do so in line with strengthened facility assessment requirements at § 483.71 (88 FR 61368).” 89 Fed. Reg., 40892

“all LTC facilities must provide adequate staffing to meet their specific population’s needs based on their facility assessments. In many cases, facilities will need higher levels of staffing as a result.” 89 Fed. Reg., 40948.

Higher staffing levels for many facilities will reflect their residents’ acuity:

  “if the facility assessment was conducted according to the requirements finalized in this rule, LTC facilities should know the number of staff, the competencies, skill sets they need, and the other resources needed to care for residents in their facilities. This should enable LTC facilities to adjust their staffing and other resources to compensate for resident acuity and changes needed in daily staffing.” 89 Fed. Reg., 40908

“LTC facilities should continue using the facility assessment to determine staffing needs above the finalized minimum standards to provide safe and quality care based on resident acuity.” 89 Fed. Reg., 40912

Despite positive statements in the preamble, CMS’s current implementation plans appear limited:

• CMS is apparently allowing facilities to develop their own assessment process; it rejected, for now, commenters’ suggestion that CMS specify an assessment process (such as the methodology developed by Charlene Harrington and colleagues, the Patient-Driven Payment Model (PDPM) (the Medicare prospective payment reimbursement system for skilled nursing facilities that includes 25 case-mix adjusted nurse staffing groups), or another recognized evidence-based data-driven methodology. CMS will provide a “template” for the facility assessment process.
• CMS is using the standard survey and enforcement systems to determine compliance and to sanction noncompliance.

Industry lawsuit challenges final rule

The American Health Care Association, the Texas Health Care Association, and three Texas nursing facilities filed a lawsuit to overturn the final staffing rule. American Health Care Association v. Xavier Becerra, Case 2:24-cv-00114-Z (N.D. Texas May 23, 2024).

The hyperbolic language in the Complaint repeats arguments that AHCA has been making since President Biden first announced his nursing home reform agenda in February 2022 – no one to hire, unfunded mandate, nursing homes will close. The Center for Medicare Advocacy published an Alert challenging these arguments, “Residents’ Advocates Reject Industry Complaints About Nursing Home Staffing Rule” (CMA Alert, May 9, 2024).

Paragraph 12 of the Complaint summarizes these arguments:

12. To be clear, all agree that nursing homes need an adequate supply of well-trained staff. But imposing a nationwide, multi-billion-dollar, unfunded mandate at a time when nursing homes are already struggling with staffing shortages and financial constraints will only make the situation worse. If CMS’s new standards are permitted to take effect, hundreds of nursing homes will likely be forced to downsize or close their doors entirely. That threatens to displace tens of thousands of nursing home residents from their current facilities, while forcing countless other seniors and family members to wait longer, search farther, and pay more for the care they need. The Final Rule thus promises to be a nightmare not only for owners and operators of nursing homes, but also for the vulnerable residents they serve, in direct derogation of CMS’s statutory mandate.

The Complaint provides an “Overview of the Medicare and Medicaid Programs,” ¶¶26-28; “Historical Federal Regulation of Nursing Home Staffing,” ¶¶29-38 (arguing that Congress, not the federal agency, determined staffing rules); “Statutory Staffing Requirements for Nursing Homes,” ¶¶39-45; “The Final Rule,” ¶¶46-59 (discussing the rule and staffing study); “Harms to Plaintiffs and the Communities They Serve,” ¶¶60-66 (“massive, unfunded mandate;” four-fifths of all facilities will need to increase staffing levels; nursing home closures).

There are two Claims for Relief, both based on the Administrative Procedures Act:

Count One: APA, Lack of Statutory Authority. ¶¶67-81 (CMS lacks authority to promulgate these rules, including Major Questions Doctrine, ¶¶78-81)

Count Two: APA, Arbitrary and Capricious Agency Action. ¶¶82-95 (“One-Size-Fits-All Standards,” ¶¶84-89; “Unachievable Requirements,” ¶¶90-95

Plaintiffs seek declaratory and permanent injunctive relief

Congress

See Nursing Home Roundup, May, 2024 (CMA Alert, May 23, 2024)

But see Congress: H.J. Res 139, filed May 10, 2024 under the Congressional Review Act, disapproves the final minimum staffing rule for nursing homes. However, the bill will not be passed in the Senate and would be vetoed by President Biden, if it got to his desk.

Nurse aide training rules are under attack.

• H.R. 468, Building America’s Health Care Workforce Act. The bill would reinstate for two years the pandemic-era waiver of federal nurse aide training requirements that expired on May 11, 2023 and would allow for time worked under the waiver to count toward the 75 hours’ minimum nurse aide training requirements. On May 16, 2024, the Health Subcommittee of the Energy and Commerce Committee, on a party-line vote, forwarded H.R. 468 to the full Committee.

• H.R. 3227, the Ensuring Seniors’ Access to Quality Care Act, would reduce the number of nursing facilities that are barred for two years from conducting their own nurse aide training programs (not imposing the aide training ban if the deficiency did not involve “quality of care”). The Health Subcommittee passed H.R. 3227 on a party-line vote. On a party-line vote on May 8, the House Ways & Means Committee approved a similar bill, H.R. 8244, also named the Ensuring Seniors Access to Quality Care Act.

Residents’ advocates and unions and other members of an ad hoc coalition supporting nursing home reform opposed the bills weakening longstanding nurse aide training rules.

CMS: Risk-Based Survey

Meanwhile, the ad hoc coalition supporting nursing home reform wrote to CMS Administrator Chiquita Brooks-LaSure expressing concerns with the Risk-Based Survey process that the Centers for Medicare & Medicaid Services is currently testing.

• In April, CMS described, in a single paragraph, a risk-based survey (RBS) that it is testing to provide shorter, “more focused” surveys for “consistently higher-quality facilities” in response to a federal survey budget that has not been increased in nine years. 

• Concerns include:

• Questions about legality (1987 Nursing Home Reform Law states at 42 U.S.C. §§1395i-3(g)(2)(A)(i), 1396r(g)(2)(A)(i), Medicare and Medicaid, respectively, “Each skilled nursing facility shall be subject to a standard survey.” 

• Questions about process. How many states will test RBS? How many facilities? Is the same process with the same types of surveyors being used consistently in all RBS surveys? Who will determine whether RSB is valid and on what basis?

• Questions about criteria for selection of facilities for RBS

• A history of fewer citations for noncompliance is not a meaningful criterion when many facilities have not had a standard (recertification) survey in two to three years (or more).

• Decades of reports by the Government Accountability Office confirm that many deficiencies are missed and that when deficiencies are cited, they are undercoded as less significant with respect to scope and severity than they actually are.^[1]

• “No pending investigations for residents at immediate jeopardy” reflects the 2% of facilities with the most serious deficiencies; it is not a criterion reflecting high quality.

• How is “higher staffing” defined?

• How does “compliance with staffing and data submission requirements” reflect higher quality facilities?

• Identifying “consistently higher-quality facilities” is difficult, if not impossible. Prominent nursing home researchers Charles D. Phillips, Catherine Hawes, Trudy Lieberman, and Mary Jane Koren confirmed the difficulty of identifying consistently high quality facilities. Describing “the multidimensional nature of nursing homes and their residents” in “Where Should Momma Go? Current nursing home performance measurement strategies and a less ambitious approach,” they concluded that performance measurement systems are better at identifying problem facilities than good facilities.

• The “ multidimensional nature of nursing homes and their residents” means that facilities can provide good care to some residents and, simultaneously, poor care to other residents. RBS’s apparent focus on how a nursing home generally performs would violate the Nursing Home Reform Law’s recognition of an entitlement in each resident to high quality care (“A nursing facility must provide services and activities to attain or maintain the highest practicable physical, mental, and psychosocial well-being of each resident, in accordance with a written plan of care . . . . [bold font supplied], 42 U.S.C. §§1395i-3(b)(2), 1396r(b)(2).)

• Finally, the quality of care in nursing homes can change rapidly and dramatically, for better or worse, following changes in key staff, such as the Administrator and Director of Nursing. The quality of care in a nursing home is not immutable. Even though CMS’s description of RBS states that a survey would be expanded “[i]f any concern about resident safety were encountered during the RBS,” that promise is not sufficient. CMS should not wait for resident harm to occur; the regulatory system should take appropriate action to prevent avoidable harm to residents. CMS’s promise also fails to address resident welfare and rights. The Reform Law provides:

It is the duty and responsibility of the Secretary to assure that requirements which govern the provision of care in skilled nursing facilities under this subchapter, and the enforcement of such requirements, are adequate to protect the health, safety, welfare, and rights of residents and to promote the effective and efficient use of public moneys.

42 U.S.C. §1395i-3(f)(1) (Medicare); the Medicaid law is substantively identical, 42 U.S.C. §1396r(f)(1).

III. LITIGATION UPDATE  

• Johnson v. Becerra, No. 1:22-cv-03024 (D.D.C.) (Challenge to Deprivation of Home Health Aide Services by Disabled Medicare Beneficiaries). The Center filed this proposed class action on October 6, 2022, on behalf of two individuals and two organizations. The named plaintiffs seek to represent a nationwide class of Medicare beneficiaries who rely on home health aide services to live safely in their homes and communities. They challenge the Secretary’s policies and practices that impede and restrict the availability, accessibility, and coverage of home health aide services for individuals with chronic, disabling conditions who qualify for such services under Medicare law. These practices include the failure to properly oversee and enforce Conditions of Participation for Medicare-certified home health agencies. They also include auditing and reviewing systems and quality rating systems that discourage the provision of aide services for plaintiffs and proposed class members. The case cites violations of the Medicare statute and regulations, as well as Section 504 of the Rehabilitation Act, which prohibits discrimination on the basis of disability. Section 504 imposes a duty on federal agencies to administer programs in the most integrated setting appropriate to the needs of people with disabilities and to avoid unjustified institutionalization of disabled people. The named plaintiffs and class members they seek to represent are at risk of institutionalization for necessary care without the Medicare-covered home health aide services they require. The plaintiffs seek declaratory and injunctive relief that would remove barriers to Medicare-covered home health aide services.

On April 5, 2023, the court granted the government’s motion to dismiss and denied plaintiffs’ class certification motion as moot. Johnson v. Becerra, 668 F. Supp. 3d 14 (D.D.C. 2023). The court found that all plaintiffs had adequately presented their claims to the Secretary, and it waived the requirement of exhaustion of administrative remedies. However, the court held that the plaintiffs lack standing to challenge the Secretary’s policies because they failed to plausibly allege redressability. Assuming that plaintiffs’ injuries were caused by the Secretary, the court found that it is “purely speculative” that their injuries would be redressed by a favorable court decision. It emphasized that Medicare-certified home health agencies are “third parties,” and doubted that the requested policy changes would alter the home health agencies’ behavior with regard to provision of aide services. The plaintiffs appealed the district court’s dismissal of the case to the U.S. Court of Appeals for the D.C. Circuit in June 2023.

UPDATE: Oral argument on the appeal was held on March 14, 2024.

• Beitzel v. Becerra, No. 2:23-cv-01932 (E.D. Cal.) (Self-Administered Drug List). The Center for Medicare Advocacy and Community Legal Services at the McGeorge School of Law filed this class action on September 8, 2023, on behalf of beneficiaries who have lost coverage for medically necessary, expensive drugs with no warning. The lead named plaintiff requires an injectable drug that – for years – was administered to him in a clinic by health care professionals to treat symptoms of Crohn’s disease. He also has Parkinson’s disease and cannot administer the drug himself due to his disability. The drug was covered under a provision that allows Medicare Part B to pay for drugs that are furnished “incident to the services of a physician.” Then, unbeknownst to the plaintiff, Medicare deemed the drug to be “usually self-administered by the patient,” meaning it would no longer be covered for him as it had been, under Part B.

Medicare provided no notice of this change in coverage and does not require medical practitioners to provide notice. Only after the plaintiff received several additional scheduled injections from the clinic did he learn that the drug was no longer covered by Part B and that Medicare held him responsible for its full cost, which was over $40,000 per injection. The plaintiffs challenge Medicare’s policy of providing no notice when a drug that was excluded by Part B is added to the “self-administered drug list” (SAD List) and thus excluded from such coverage. They raise due process and statutory claims to ensure that beneficiaries can make informed decisions about how to receive these medications when there has been a change in Medicare’s coverage terms. Plaintiffs filed an amended complaint with an additional plaintiff on December 26, 2023, and a motion to certify a nationwide class on January 30, 2024. The government filed a motion to dismiss the amended complaint on January 31, 2024.

UPDATE: A hearing on the government’s motion to dismiss was held on April 15, 2024. The judge granted the motion, signing the opinion on April 19, 2024 and entering it onto the docket on April 22. The judge held that he lacked jurisdiction under 42 U.S.C. 405(g) over the claims of two Plaintiffs because they had not exhausted administrative remedies. He held that Beitzel, the remaining Plaintiff, lacked Article III standing to seek prospective relief, and had failed to state a claim for which relief could be granted for all of his claims (due process and statutory). Plaintiffs appealed to the Ninth Circuit on June 3, 2024, with briefing commencing this summer.

Read the News Release

Read the First Amended Complaint

• Barrows v. Becerra, 24 F.4^th 116 (2d Cir. 2022) (Beneficiary Appeals of Observation Status). In November 2011, the Center for Medicare Advocacy and Justice in Aging filed a 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 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.

After a dismissal by the district court, a remand by the Second Circuit, substantial motion practice and discovery, a bench trial on the merits of the due process claim was held in August 2019. In March 2020, the trial court issued a decision. Alexander v. Azar, 613 F. Supp. 3d 559 (D. Conn. 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. 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. The court modified the existing class definition accordingly.

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. Certain 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. On January 25, 2022 the Second Circuit affirmed the trial court’s decision in full. Barrows v. Becerra, 24 F.4^th 116 (2d Cir. 2022). The court found that one of the named plaintiffs who paid over $10,000 for nursing home care after an observation stay had standing to sue. It found that decisions by hospital personnel to reclassify a patient from inpatient to an outpatient receiving observation services constituted state action. Finally, it conducted an analysis under Mathews v. Eldridge and agreed with the trial court that the Secretary violates Due Process by offering no procedural protections for beneficiaries whose status is reclassified from inpatient to observation through the hospital utilization review process.

In October 2022, the parties jointly requested a clarification of the judgment in the interest of facilitating and streamlining certain retrospective appeals and reducing administrative burden. The parties asked the court to clarify that if a class member who was enrolled in Part B at the time of their hospitalization prevails in appealing a retrospective claim, Medicare is not required to “unwind” and readjust the hospital claim, but may make Part A payment for the covered nursing home services without adjusting the underlying claim. On December 9, 2022, after a class notification process, the court issued an order clarifying the judgment as the parties had requested.  Information about the clarification can be found here.

The government is implementing the court’s injunction via a Notice of Proposed Rulemaking. After substantial delays, class counsel requested a status conference with the court, which was held on August 9, 2023. In light of the significant delays in implementation and ongoing harm to class members, the judge ordered the government to take the next step in the rulemaking process (submission of a draft rule to the Office of Management and Budget (“OMB”)) by October 1, 2023. It also ordered the government to submit monthly status reports on the progress of the implementation process.

The government reported to the court that CMS had issued a Notice of Proposed Rulemaking (NPRM) on December 21, 2023, which was published in the Federal Register on December 27, 2023. The court issued an order stating that the government may submit a final status report on May 1, 2024.

UPDATE: Class counsel Center for Medicare Advocacy, Justice in Aging, and Wilson Sonsini Goodrich & Rosati submitted detailed comments on the NPRM, as did a broad coalition of 75 national as well as state and local beneficiary advocacy organizations. Along with the Center and co-counsel Justice in Aging, organizations that signed on to the coalition’s letter include AARP, the ALS Association, the Medicare Rights Center, the National Committee to Preserve Social Security and Medicare, the National Disability Rights Network, and the National Health Law Program. The comments support CMS’s general approach to the court-ordered appeal procedures and strongly urge the agency to finalize and implement the rule as quickly as possible. The coalition of advocates support that the proposed observation status appeals will be largely similar to existing Medicare appeals. The advocates also support provisions that aim to minimize burden on beneficiaries. However, they made several recommendations to improve the procedures. For instance, the organizations advise extending the time period in which eligible class members can file retrospective appeals for coverage of past claims; providing additional clarity and guidance to beneficiaries on submission of supporting medical records; and conducting additional education and outreach to ensure beneficiaries and their families are aware of the new appeal procedures. Another coalition, which focused on observation status, submitted comments as well. All of these aforementioned comments emphasized the need for CMS to finalize the rule and implement the appeals process as soon as possible. The public comment period closed on February 26, 2024.

In its status report of May 1, 2024, the government noted that it received 51 comments from commenters and is now working on the final rule. It stated that it anticipates publishing the final rule “before the end of the year.” It also summarized some of the comments by providers, government, advocates, and other communities. Plaintiffs submitted a response to this status report, pointing out that 1. the chief requests of advocates’ comments on the NPRM is finalizing and implementing the rule as quickly as possible, and 2. 51 comments is not a large number to respond to, and Plaintiffs are concerned that stretching publication of the final rule until “the end of the year” could significantly and unnecessarily delay relief. They noted instances when agencies had responded to many thousands of comments in much shorter periods of times. Plaintiffs requested a status conference in August to ensure sufficient progress is being made on the final rule. After initially requiring only an additional status report after which the he would assess whether a status conference is necessary, the judge ultimately decided to require a status conference on July 19, 2024, and noted that CMS has responded to thousands of comments in a matter of a few months in past rulemakings.

• For answers to frequently asked questions from people who think they may be class members, please see the Center’s website here.

• Chinatown Service Center v. U.S. Dep’t of Health & Human Servs., 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 ask the court to vacate the 2020 rule and enjoin its implementation.

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 Section 1557 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. On July 25, 2022, HHS publicly released a proposed rule implementing Section 1557 of the Affordable Care Act. The proposed regulation was published in the Federal Register on August 4, 2022. On November 20, 2022, the government filed a status report noting that the public comment period on the proposed regulation closed on October 3, 2022, and that HHS had received more than 85,000 comments.

During a status conference held in June 2023, the government clarified that it expects the new Section 1557 rule to issue not later than “this winter.” The court ordered the government to continue filing monthly status reports. In the filing from July 31, 2023, the government indicated that the agency “aspires to the submit the rule to the Office of Information and Regulatory Affairs for final clearance before the end of this calendar year.”

UPDATE: HHS published the final Section 1557 rule on May 6, 2024. The Rule reinstates and expands on the 2016 regulations and it cites Chinatown Service Center as an example of the need to provide individuals with LEP notice of the availability of language assistance. Examples: covered entities and providers are required to provided qualified interpreters; people with LEP cannot be required to provide their own interpreters; notices and taglines are required in the top 15 languages spoken by people with LEP in each state. The new rule addresses the emerging area of machine/AI interpretation and translation, and it also expressly accounts for intersectional discrimination (based on multiple protected characteristics). In light of the new rule, the case was voluntarily dismissed on June 3, 2024.

• Drug Price Negotiation Lawsuits – Inflation Reduction Act

The Center has joined a coalition of advocacy organizations, led by AARP, that is urging federal courts to uphold Medicare’s drug price negotiation program. The program, created by the Inflation Reduction Act, allows Medicare to use its bargaining power to negotiate prices and reduce the cost of expensive drugs for the first time. Drug companies and their allies have filed multiple lawsuits around the country attempting to strike down or limit the program.

The coalition has filed amicus briefs supporting the government in these lawsuits, explaining that the negotiation program is urgently needed because it will help older adults and people with disabilities afford life-saving prescription drugs. Medicare Many Medicare beneficiaries are directly affected by high drug prices because they are responsible for Part D “coinsurance” amounts, based on a percentage of the drug’s price. Sadly, many beneficiaries still leave drugs at the pharmacy, skip doses, or forgo other necessities due to drug costs. Non-adherence to prescribed treatments can endanger beneficiaries’ health, result in costly hospitalizations, and even cause premature deaths. All Medicare beneficiaries are affected by high drug prices to some degree because monthly premiums for Medicare drug plans take prices into consideration.

The amicus briefs also explain that the drug price negotiation program will protect the financial integrity of Medicare and save taxpayers billions of dollars. Before the IRA, Medicare was prohibited by law from negotiating the price of drugs directly with manufacturers. This amounted to a special exemption for drug companies that other medical providers and suppliers do not have. Hospitals, nursing facilities, and physicians participating in Medicare have all faced limits on payments for decades, ensuring that their services are affordable for beneficiaries and taxpayers. But drug companies received a special carve-out. The Medicare negotiation program begins to bring payment for prescription drugs in line with Medicare’s payment for other items and services.

• Read an amicus brief filed in a case brought by a Connecticut drug manufacturer here. This brief features stories the Center collected from Connecticut residents about their experiences with prescription drug prices.
• Ongoing updates on the Medicare drug price negotiation cases can be viewed at the O’Neill Institute Health Care Litigation Tracker here.

[1] E.g., Nursing Homes: Improved Oversight Needed to Better Protect Residents from Abuse, GAO-19-433 (Jun. 13, 2019), https://www.gao.gov/products/gao-19-433; Nursing Homes: More Reliable Data and Consistent Guidance Would Improve CMS Oversight of State Complaint Investigations, GAO-11-280 (May 9, 2011), https://www.gao.gov/products/gao-11-280; Nursing Homes: Some Improvement Seen in Understatement of Serious Deficiencies, but Implications for the Longer-Term Trend Are Unclear, GAO-10-434R (May 27, 2010), https://www.gao.gov/products/gao-10-434r; Poorly Performing Nursing Homes: Special Focus Facilities Are Often Improving, but CMS’s Program Could Be Strengthened, GAO-10-197 (Apr. 19, 2010), https://www.gao.gov/products/gao-10-197; Nursing Homes: Addressing the Factors Underlying Understatement of Serious Care Problems Requires Sustained CMS and State Commitment, GAO-10-70 (Dec. 28, 2009), https://www.gao.gov/products/gao-10-70; Nursing Homes: Federal Monitoring Surveys Demonstrate Continued Understatement of Serious Care Problems and CMS Oversight Weaknesses, GAO-08-517 (May 15, 2008), https://www.gao.gov/products/gao-08-517; Nursing Homes: Federal Actions Needed to Improve Targeting and Evaluation of Assistance by Quality Improvement Organizations, GAO-07-373 (Jun. 29, 2007), https://www.gao.gov/products/gao-07-373; Nursing Homes: Efforts to Strengthen Federal Enforcement Have Not Deterred Some Homes from Repeatedly Harming Residents, GAO-07-241 (Apr. 23, 2007), https://www.gao.gov/products/gao-07-241; Nursing Homes: Despite Increased Oversight, Challenges Remain in Ensuring High-Quality Care and Resident Safety, GAO-06-117 (Jan. 17, 2006), https://www.gao.gov/search?keyword=%22nursing%20homes%22%201998-2000&page=2; Nursing Homes: Prevalence of Serious Quality Problems Remains Unacceptably High, Despite Some Decline, GAO-03-1016T (Jul. 17, 2003), https://www.gao.gov/products/gao-03-1016t; Nursing Homes: Sustained Efforts Are Essential to Realize Potential of the Quality Initiatives, HEHS-00-197 (Sep. 28, 2000), https://www.gao.gov/products/hehs-00-197; Nursing Homes: HCFA Should Strengthen Its Oversight of State Agencies to Better Ensure Quality Care, %-HEHS-00-27 (Nov. 4, 1999), https://www.gao.gov/products/t-hehs-00-27; Nursing Homes: CMS’s Special Focus Facility Methodology Should Better Target the Most Poorly Performing Homes, Which Tended to Be Chain Affiliated and For-Profit, GAO-09-689 (Sep. 28, 2009), https://www.gao.gov/products/gao-09-689; Nursing Homes: Proposal To Enhance Oversight of Poorly Performing Homes Has Merit, HEHS-99-157 (Jun. 30, 1999), https://www.gao.gov/products/hehs-99-157; Nursing Homes: Complaint Investigation Processes Often Inadequate to Protect Residents, HEHS-99-80 (Mar. 22, 1999), https://www.gao.gov/products/hehs-99-80; Nursing Homes: Additional Steps Needed to Strengthen Enforcement of Federal Quality Standards, HEHS-99-46 (Mar. 18, 1999), https://www.gao.gov/products/hehs-99-46; Nursing Homes: Quality of Care More Related to Staffing than Spending, GAO-02-431R (Jul. 15, 2002), https://www.gao.gov/products/gao-02-431r; Nursing Homes: More Can Be Done to Protect Residents from Abuse, GAO-02-312 (Mar. 5, 2002), https://www.gao.gov/products/gao-02-312; California Nursing Homes: Care Problems Persist Despite Federal and State Oversight, HEHS-98-202 (Jul. 27, 1998), https://www.gao.gov/products/hehs-98-202;