- Updates on Payment v. Coverage – Access To Care Threats
As discussed on previous Alliance calls, the Center for Medicare Advocacy has been drawing attention to changes in two new Medicare payment systems that pose significant threats to beneficiaries’ access to care:
- The Patient Driven Payment Model (PDPM) for Skilled Nursing Facility care (effective October 1, 2019) and;
- The Patient Driven Groupings Payment Model (PDGM) for Home Health care (effective January 1, 2020);
While there has been no reduction in Medicare coverage under the law for these care settings, the new payment models have changed financial incentives for providers. In turn, these payment changes are leading to diminished access to certain kinds of care and for certain kinds of individuals.
The Centers for Medicare & Medicaid Services (CMS) — the federal agency responsible for administering the Medicare program — has begun implementing new Medicare payment models for both home health and skilled nursing facility care. These payment models create a different set of financial incentives for Medicare providers. Although the payment models pose a substantial risk to beneficiaries, especially those with chronic conditions and longer-term needs, CMS has made clear that PDGM and PDPM do not change Medicare coverage criteria. Thus, Medicare beneficiaries who meet the coverage criteria for home health and skilled nursing facility care must continue to receive medically reasonable and necessary services tailored to their individual needs.
- Read the full Center for Medicare Advocacy Issue Brief at: https://www.medicareadvocacy.org/wp-content/uploads/2020/03/Issue-Brief.-Medicare-Payment-vs.-Coverage.pdf
- The Issue Brief includes a link to a CMS Medicare Learning Network (MLN) article re: Home Health (Feb. 10, 2020): https://www.cms.gov/files/document/se20005.pdf. (Reiterating that the new Medicare payment system did not changed home health coverage standards.
- Updates on Coronavirus
- CMS Press Release re: Agency Response to Coronavirus (March 5, 2020): https://www.cms.gov/newsroom/press-releases/cms-develops-additional-code-coronavirus-lab-tests
- Impact on Nursing Facility Residents
- Long-Term Community Coalition – Fact Sheet on Infection and Control in Nursing Homes: https://nursinghome411.org/fact-sheet-infection-control-prevention/
- CMS Documents: Advance Notice and Proposed Rule re: Parts C & D
In past years, CMS has issued a draft Advanced Notice to Part C and D insurers who plan to contract with the Medicare program in the following year. The Advanced Notice generally outlines payment and quality requirements, and is usually accompanied by a “Call Letter” addressing other policy issues. After a comment period, CMS finalizes the letter by early April prior to plans submitting their contract bids. These and other documents, including Medicare Manuals, are considered to be non-regulatory (or sub-regulatory) guidance that do not have the legal weight of regulations. Often, but not always, CMS also issues annual proposed rules (regulations) impacting Parts C and D that are finalized after a public comment period.
Pursuant to a Supreme Court decision decided in June 2019, CMS is changing its approach to issuing sub-regulatory guidance. Azar v. Allina Health Services, 139 S. Ct. 1804 (2019), available here, addressed the Department of Health and Human Services’ (HHS), and by extension, CMS’ ability to change a hospital reimbursement formula without notice and comment period. In response to the Allina decision, HHS issued an internal memo dated October 31, 2020 stating that the holding of the decision is that, under the Medicare Act, “any Medicare issuance that establishes or changes a ‘substantive legal standard’ governing the scope of benefits, or eligibility of individuals, entities, or organizations to furnish services, must go through notice-and-comment rulemaking.” The memo declared that if CMS “intends for a particular guidance document to be used in enforcement actions, then the guidance must comply with Allina.” As a result, CMS is seeking to both codify existing guidance and largely issue new policy proposals via regulations, following public comment.
2021 Medicare Advantage and Part D Advance Notice Part II
According to a CMS fact sheet dated Feb. 5, 2020, “CMS will not be publishing a Call Letter for 2021. CMS is proposing to codify much of the guidance typically included in the annual Call Letter through the CY 2021 and 2022 MA and Part D Proposed Rule. CMS will also separately issue Part C and Part D bidding instructions and information previously provided through the Call Letter.” Part I of the Advanced Notice, issue in January 2020, largely addressed MA payment issues. The Advanced Notice Part II, issued Feb 5, 2020, similarly contained MA and Part D payment updates and some sections on quality measures. It did not contain other policy updates typically included in previous Call Letters.
Proposed C & D Rule
On February 18, 2020, CMS published in the Federal Register a proposed rule entitled “Medicare and Medicaid Programs; Contract Year 2021 and 2022 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicaid Program, Medicare Cost Plan Program, and Programs of All-Inclusive Care for the Elderly” (CMS-4190-P) at 85 Fed Reg 9002 (Feb. 18, 2020). On Feb. 5, 2020, CMS published a fact sheet outlining some of the contents of the proposed rule.
There are a number of issues addressed in the proposed rule that might be of interest to advocates, including the following (note that this is only a partial list):
- Part C and D Star Ratings – CMS proposes to increase the weight of beneficiaries’ experiences, complaints and access on star ratings;
- Medicare Advantage network adequacy – CMS seeks to ease the network adequacy requirements for telehealth in rural areas, as well as incentivize offering specialists via telehealth;
- Dual Eligible Special Needs Plans (D-SNP) “Look Alike” plans – CMS proposes not to enter or renew a contract for MA plans that are not SNPs and that project or show high dual eligible enrollment; CMS says plans that exceed the threshold for duals enrollment would be able to transition their membership into a D-SNP or another zero premium plan offered by the MA organization;
- Allow Part D Plans to Add a 2nd Specialty Tier – plans would be able to offer a second, “preferred” specialty tier with lower cost-sharing than the current specialty tier;
- Real Time Benefit Tool (RTBT) – CMS proposes that each Part D plan implement a beneficiary RTBT “that will allow enrollees to view plan-provided, patient-specific, real-time formulary and benefit information by January 1, 2021”;
- Codify Rules Concerning Enrollment of Individuals with ESRD in MA plans in 2021; and
- Codify Marketing Guidelines – as discussed in a previous Center Alert, advocates complained to CMS that they significantly revised the contents of the 2020 Medicare Communications and Marketing Guidelines (MCMG), the set of rules that govern the selling and promotion of Medicare Advantage and Medicare Prescription Drug plans, without any advance notice or opportunity to provide comment. In this proposed rule, CMS appears to be codifying some, but not all, of the consumer protections they removed. Perhaps most alarmingly, CMS does not reverse their previous revision to the guidelines that weakened the distinction between “marketing” events, which are designed to steer or attempt to steer potential enrollees, or the retention of current enrollees, toward a plan or limited set of plans; and “educational” events, which are designed to inform beneficiaries about MA, Part D or other Medicare programs.
Comments on the proposed rule are due April 6, 2020.
- Updates on Plan Finder, Medicare Advantage
Medicare Plan Finder Updates
As discussed during previous Alliance calls, CMS introduced a new, updated Medicare Plan Finder (MPF) in late August 2019. In addition to the timing of the roll out and other MPF challenges identified prior to the annual enrollment period, since the introduction of the updated MPF, there were also a number of functional problems identified. These problems included: inaccurate information about covered drugs and costs, non-formulary drugs, dosage options, copays for individuals with the Part D Low Income Subsidy (LIS), problems creating a MyMedicare account and the listing of plan choices by premium rather than total cost.
While CMS addressed some of these problems during the ACEP, challenges persisted and many individuals made coverage decisions based on incomplete or inaccurate information. While those enrolled in MA plans currently have an additional opportunity to change plans between January and March through the Medicare Advantage Open Enrollment Period (MA OEP), those enrolled in stand-alone PDPs do not have such options. Further, problems might not arise or be identified until later in the year.
While CMS blog posts – which are unlikely to be read by many Medicare beneficiaries – do reference the availability of an SEP (see, e.g., the January 10, 2020 blog post), CMS continues to both downplay problems with the Plan Finder and largely fails to directly connect such problems with an SEP right. The Center asserts that this may serve as a deterrent to seek an SEP for those who are unsure about, don’t recall or don’t have evidence about the inaccurate information they obtained through the Plan Finder.
On February 19, 2020, CMS convened a group of stakeholders representing advocacy organizations, insurance plans, agent/broker representatives and the Administration for Community Living (ACL). There were a number of CMS staff present.
The meeting did not allow for a dialogue with CMS staff, nor did CMS provide any concrete next steps concerning further updating the Plan Finder. There was an opportunity, though, for pre-assigned groups of stakeholders to discuss what is and is not working with the Plan Finder, and report the results of such discussions to CMS staff. There seemed to be general agreement in the room about the problems with the Plan Finder, including: inaccuracies in data; the fact that searches sort plans based on premiums (rather than total out-of-pocket cost cost) needs to change; CMS seems to be actively promoting MA plans over other options; and the need to further promote or advertise the availability of a Special Enrollment Period (SEP) for exceptional circumstances and directly tie it to problems with the Plan Finder.
Special Enrollment Period (SEP)
As noted during the last Alliance call, sometime towards the end of (or after) the ACEP, the Medicare.gov website was updated to include reference to an SEP for Special Circumstance: https://www.medicare.gov/sign-up-change-plans/when-can-i-join-a-health-or-drug-plan/special-circumstances-special-enrollment-periods.The website notes:
You can make changes to your Medicare Advantage and Medicare prescription drug coverage when certain events happen in your life, like if you move or you lose other insurance coverage. These chances to make changes are called Special Enrollment Periods (SEPs). Rules about when you can make changes and the type of changes you can make are different for each SEP.
Note: If you believe you made the wrong plan choice because of inaccurate or misleading information, including using Plan Finder, call 1-800-MEDICARE and explain your situation. Call center representatives can help you throughout the year with options for making changes.
For a brief period early this year, the landing page at www.medicare.gov had a direct link to the SEP page above, but as of the date of this Alliance call, it is no longer featured on the homepage. Advocates assert that CMS must do more to promote the availability of this SEP and directly relate such availability to problems people experienced with the Plan Finder during the annual enrollment period.
Medicare Advantage Updates
The Center has recently written several Alerts drawing attention to various issues surrounding Medicare Advantage (MA) plans, including:
- The Myth of “Choice” in Private Insurance, Including Medicare Advantage (March 5, 2020) – drawing from a recent op-ed in the New York Times by Wendell Potter, this Alert discusses how policy makers often promote the concept of “choice” as a key pillar of health care and insurance, including within the Medicare program. The importance and availability of “choice” becomes less clear, however, the closer one examines what choice actually means with respect to health insurance coverage – including in the Medicare program.
- Articles Highlight Medicare Advantage Concerns (Feb. 27, 2020) – A recent article in the New York Times highlights a number of concerns about the Medicare Advantage (MA) program, many of which have been raised by the Center for Medicare Advocacy. The concerns include the growing imbalance between MA and traditional Medicare, the limitations on consumer choice and ability to purchase Medigap plans, and efforts by the Centers for Medicare & Medicaid Services (CMS) to steer people towards enrollment in MA plans. “Medicare’s Private Option Is Gaining Popularity, and Critics” by Mark Miller, appeared in the Times online on Feb. 21, 2020, and in print on February 22. Similarly, a recent article by Bob Herman published by Axios highlights both the growing enrollment in, and cost of, the MA program.
- Medicare Advantage Continues to Drive Up Medicare Costs – Congress Must Act to Level the Playing Field with Traditional Medicare (Feb. 4, 2020) – This Alert discusses how recent projections by the Congressional Budget Office (CBO) show that Medicare Advantage will cost the Medicare program even more than previously thought. As pressure grows on the federal budget – and Medicare specifically – indiscriminate cuts to the program would inevitably harm beneficiaries. A recent Health Affairs Blog by researcher Dr. Ricard Kronick outlines a policy change Congress can enact that would both rein in wasteful payments to MA plans and help level the playing field between MA and traditional Medicare.
- LITIGATION UPDATE
Affordable Care Act Case
On December 18, 2019, the Fifth Circuit issued a decision in the lawsuit brought by several states and supported by the Trump administration that seeks to dismantle the entire Affordable Care Act (ACA). A divided panel of the appeals court ruled that the ACA’s individual mandate is now unconstitutional because the Congress reduced the penalty for remaining without insurance to $0. Then, although it was clear that Congress did not intend to strike down the entire ACA when it eliminated the penalty (because, among other things, it left the rest of the law in place), the Fifth Circuit concluded that many of the ACA’s provisions may not be “severable” from the mandate and therefore must also be struck down. It ordered the same lower-court judge who struck down the entire law last year to parse through all of the hundreds of the ACA’s provisions with a “finer-toothed comb” to determine which can survive. The Center had filed an amicus brief along with AARP and Justice in Aging highlighting the critical protections the law provides for older Americans and people with disabilities.
The Fifth Circuit ruling threatens the entire ACA: protections for pre-existing conditions, the expansion of Medicaid, and, critically for older adults and people with disabilities, many provisions that improved Medicare. The ACA closed the donut hole in Part D, saving beneficiaries millions on prescription drugs. It eliminated out-of-pocket costs for preventive services, such as mammograms and diabetes screenings. It extended the solvency of the Part A Trust Fund for many years. Simply put, the ACA is woven into Medicare, including over 165 provisions that help beneficiaries and strengthen the program’s financial well-being. Striking down the ACA would have disastrous ramifications for Medicare beneficiaries and the U.S. health care system as a whole.
Update: On January 15, 2020, the Center joined AARP and Justice in Aging in filing an amicus brief in the Supreme Court in support of the states defending the law, urging the Court to grant immediate review of the lawsuit rather than allow it to be remanded to the district court and appealed again. The brief highlights the ACA’s key protections for older adults and the devastating consequences of nullifying the law. It also emphasized that prolonged uncertainty will harm millions of older Americans and people with disabilities who rely on the ACA.
While the Court denied expedited review, as of March 2, 2020, it granted California’s petition for certiorari on a standard timeline. This means it will likely be argued in the fall of 2020, with a decision to issue by the end of June 2021. The Center is pleased that the Supreme Court has granted review and we will continue to urge a decision that the ACA remains constitutional and should not be struck down.
For more information, see these resources from the Kaiser Family Foundation:
- “Explaining Texas v. U.S.: A Guide to the 5th Circuit Appeal in the Case Challenging the ACA” (July 2019) https://www.kff.org/health-reform/issue-brief/explaining-texas-v-u-s-a-guide-to-the-5th-circuit-appeal-in-the-case-challenging-the-aca/
- “Potential Impact of Texas v. U.S. Decision on Key Provisions of the Affordable Care Act” (Jan. 2020): https://www.kff.org/health-reform/fact-sheet/potential-impact-of-texas-v-u-s-decision-on-key-provisions-of-the-affordable-care-act/
Center for Medicare Advocacy Cases
- Alexander v. Azar (formerly Bagnall v. Sebelius, Barrows v. Burwell), No. 3:11-cv-1703 (D. Conn.) (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.
On September 23, 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. On January 22, 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).
The parties completed discovery on the issue ordered by the Second Circuit: whether plaintiffs have a “protected property interest” in Part A coverage of their hospital stays, which depends on whether CMS has “meaningfully channeled” discretion on the question of patient status determinations. If the Secretary has established criteria for inpatient hospitalization, plaintiffs have an interest that is protected by the Due Process Clause and thus they may be entitled to notice and an opportunity to appeal their placement on observation. Plaintiffs received voluminous documentation from the government and conducted depositions of witnesses from the Department of Health and Human Services, Medicare contractors, and some of the hospitals that treated the named plaintiffs. The law firm of Wilson Sonsini Goodrich & Rosati, which has helped the Center in previous litigation, joined as representatives of the plaintiffs during this phase and is continuing to provide invaluable pro bono assistance.
After briefing and a hearing on the protected property interest issue and defendant’s supplemental motion to dismiss, the court issued a decision on February 8, 2017, denying both parties’ motions for summary judgment and largely denying the government’s motion to dismiss. The court found that all named plaintiffs have standing and none of their claims was moot, even though some have passed away and some have resolved their underlying individual claims. It decided that factual disputes precluded summary judgment on the property interest question, though it did note that CMS considers the billing of hospitalizations as inpatient or observation to be a regulatory matter, under the authority of the Secretary, as opposed to a clinical decision. The court also found that while a treating physician’s status order plays a “role” in Medicare’s review of a hospital claim, it is not dispositive or even presumed to be correct.
As for the motion to dismiss, the court found that plaintiffs had plausibly alleged the other two aspects of a due process claim: state action (in the form of pressure on providers by CMS) and inadequacy of existing procedures (it is undisputed that there is currently no appeal method for patients placed on observation status). The court found that plaintiffs’ claim for expedited notice is now moot due to the new requirements being implemented under the NOTICE Act (“MOON” notice).
Plaintiffs then filed a renewed motion for class certification, and on July 31, 2017, the court issued a decision certifying a nationwide class of Medicare beneficiaries who have received “observation services” in a hospital since January 1, 2009, and have received an “initial determination” that such services were covered, or subject to coverage, under Medicare Part B. In response to a motion for reconsideration filed by plaintiffs, the court issued a decision October 16, 2017 redefining the class to specifically include beneficiaries who have received a MOON notice. The court declined to include beneficiaries who do not have Part B, as plaintiffs had requested, but stated that it may revisit the class definition as more evidence is presented.
A second round of discovery closed on June 15, 2018, with both parties having conducted numerous depositions and exchanging documents. The government filed for summary judgment for a second time on July 30, 2018, this time on the “what process is due” element of plaintiffs’ claim. The government focused on the three factors from Mathews v. Eldridge, 424 U.S. 319 (1976), which determine what procedural safeguards are due – with a particular focus on the risk of erroneous deprivation of the private interest at stake under the current procedures used (note: there are currently no procedures for beneficiaries to appeal their hospital status) The government also filed a motion to decertify the class on August 24, 2018.
A hearing was held on November 26, 2018 to address the motion for summary judgment on the Eldridge factors, the motion to decertify the class, and the court’s own question on whether it should bifurcate the trial to deal with the protected property interest separately. However, the hearing focused mostly on the court’s questions about the criteria plaintiffs rely on for a protected property interest, in particular CMS’s “Two-Midnight Rule,” which plaintiffs have argued is the governing standard for inpatient admission since it was introduced in 2013. The court gave plaintiffs an opportunity to amend their complaint as it relates to the Two-Midnight Rule, which plaintiffs declined because the second complaint in intervention (filed in 2015) already makes sufficient allegations about the Rule. The court decided that the government should have an additional opportunity to address whether the Two-Midnight Rule can create a protected property interest. It removed the scheduled trial from the calendar and directed the government to file another, supplemental summary judgment motion specifically on whether the Two-Midnight Rule can serve to create a protected property interest. It also directed the government to address how the court should treat the remaining claims from the original complaint and first complaint in intervention if it grants summary judgment with respect to the property interest theory based on the Two-Midnight Rule. On December 6, 2018, the government alerted the court and plaintiffs that in addition to the supplementary summary judgment motion, it would also file a motion to dismiss claims from the first two complaints for lack of subject matter jurisdiction pursuant Fed. R. Civ. P. 12(h)(3).
The case was initially stayed during the partial government shutdown of late 2018 and early 2019, which delayed the briefing schedule. But the court eventually put the schedule back in motion despite the shutdown. On January 30, 2019, the government filed its supplemental summary judgment motion regarding a protected property interest based on the Two-Midnight Rule, and a motion to dismiss based on lack of subject matter jurisdiction (claiming that all of the named plaintiffs lack standing and that their claims are moot). The motions were fully briefed as of March 6, 2019.
On March 27, 2019, the court issued a ruling denying the government’s motion for summary judgment, motion to decertify the class, and motion to dismiss. Alexander v. Azar, 370 F. Supp. 3d 302 (D. Conn. 2019). The judge concluded that evidence submitted by the plaintiffs could reasonably establish that physician decisions about whether to classify beneficiaries as inpatients are “meaningfully constrained” by criteria set by Medicare, including the Two-Midnight Rule since it came into effect in 2013, and class members may therefore possess a property interest in the inpatient Medicare coverage they seek. It also found that a trial was necessary to balance the evidence submitted about the three Mathews v. Eldridge factors. The court declined to dismiss the case, finding that the plaintiffs continue to have standing and that their claims are not moot. The court also did not take the drastic step of decertifying the nationwide class, but did modify the class definition to target individuals who, in the court’s view, are more certain to experience harm from the observation designation. The definition is now:
All Medicare beneficiaries who, on or after January 1, 2009: (1) have received or will have received “observation services” as an outpatient during a hospitalization; (2) 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 (3) 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. 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 requested additional briefing from the parties on whether it should create two subclasses, consisting of people whose hospitalizations occurred before the Two-Midnight Rule came into effect in October 2013, whose assertion of a protected property interest relies on the application of commercial screening tools in determining patient status, and those whose hospitalizations occurred after the Two-Midnight Rule came into effect, who rely on the Rule itself. The court inquired whether the subclasses may require separate counsel, or whether they should be created solely for “case management” purposes.
The court held a telephonic status conference on April 3, 2019 to discuss scheduling, and subsequently issued an order setting trial to bring on August 12, 2019. On the same day, the government also filed a motion for clarification and reconsideration of the court’s March 27 ruling. It asked the court to identify what the criteria for admission are under the Two-Midnight Rule and the “legal framework” the court applied in determining that such criteria would give rise to a protected property interest. The government also requested that the court reconsider the new class definition on the grounds that not everyone who is hospitalized for three days requires follow-up SNF care. (This issue was addressed by the parties in previous briefing.) On June 4, 2019, the court issued a ruling denying the government’s motion for reconsideration, meaning the class definition remained the same. The court also declined to further detail its reasoning on the issue of a protected property interest. Additionally, the court decided that it would not subdivide the class, formally or otherwise. A joint trial memorandum was filed on July 12. The government also filed an “omnibus” motion in limine seeking to exclude some of plaintiffs’ evidence.
A pretrial conference was held on July 29, 2019, during which the government’s motion in limine was addressed. A bench trial was then held from August 12 – 20, 2019. The plaintiffs presented several witness who were affected by observation status (two beneficiaries, a family member of a named plaintiff, a doctor), 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 court then set a post-trial briefing schedule and issued an order containing five questions it requested the parties to address in their post-trial briefing. Post-trial briefing was complete as of November 26, 2019. The parties each submitted proposed findings of fact and conclusions of law, as well as responses to the court’s questions and to the other party’s submission.
Update: On January 28, 2020, the court issued an order requesting additional briefing on four questions. Indicating that the parties should not infer anything from the inquiries, the court asked about whether it should find a property interest in Medicare Part A coverage for the periods both before and after the Two-Midnight Rule went into effect, whether that interest should be found for patients whose status is initially inpatient but later switched to observation, and how a successful appeal should affect class members’ eligibility for SNF care. The parties submitted responses to the questions on February 14, 2020 and replies to each other’s briefs on February 28. Plaintiffs indicated why the court should find an interest in Part A coverage and should not limit that finding to beneficiaries who are switched from inpatient to observation. In short, Medicare’s rules regarding patient status apply equally to people who are initially designated as observation as to those who are switched from inpatient, creating a legitimate claim of entitlement. There is also state action in both situations as it is Medicare rules being applied.
As class counsel receives inquiries from people asking whether they can “join” the case, we advise them that no action is required of class members, but they should save any paperwork relating to their hospitalization and costs resulting from it. We also encourage them to share their observation status story on the Center’s website here.
- For more information about observation status, including pending legislation see: https://www.medicareadvocacy.org/medicare-info/observation-status/.
- McKee v. Azar, No. 2:19-cv-114-cr (D. Vt.) (coverage of home health services). On July 2, 2019, Vermont Legal Aid and the Center for Medicare Advocacy filed a lawsuit in federal court in Vermont, on behalf of a Medicare beneficiary whose was denied coverage of home health services. The beneficiary required skilled nursing visits to assess and treat her multiple serious medical conditions. The case challenges the Medicare agency’s failure to follow applicable law, including the standard clarified in the Jimmo v. Sebelius settlement, which requires the determination of whether individuals are eligible for Medicare coverage to be made on the basis of beneficiaries’ need for skilled care, not on their potential for improvement. This determination should be based on each beneficiary’s unique condition and individual needs. In this case, the plaintiff challenges the Secretary’s conclusion that her “stable” condition precludes a determination that she required skilled care and qualified for Medicare coverage of home health services. In addition, she challenges the agency’s failure to afford appropriate weight to the opinion of her treating physician about her need for skilled care.
The government filed an Answer and the administrative record on September 3, 2019, and the plaintiff filed a motion requesting reversal of the coverage decision on November 4, 2019. She argued that the coverage decision violated the standard clarified by the Jimmo settlement, and that she was eligible for home health coverage based on skilled observation and assessment as well as patient education services.
In December 2019 the government filed an unopposed request for a 30-day extension of the deadline for its response to the plaintiff’s motion, based on the fact that the parties may seek to resolve the matter and require time to confer.
Update: The parties continue to negotiate possible settlement of the case. The government’s deadline to respond to plaintiff’s opening brief is now extended until April 3, 2020.
- Dobson v. Azar, No. 4:18-cv-10038-JLK (S.D. Fla.) (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 recent federal 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, we will contest the agency’s use of an inappropriately restrictive reading of the law to claim that coverage cannot be granted. The goal is to get Mr. Dobson the medication he desperately needs, and help ensure appropriate application of the law governing off label uses in other cases.
The parties consented to proceed before a magistrate judge on June 13, 2018. Briefing on cross-motions for summary judgment was complete as of December 3, 2018. On January 10, 2019, the court alerted the parties that the case had been reassigned to a different magistrate judge. The parties consented to jurisdiction by the new magistrate judge on February 7, 2019.
Oral argument on the cross-motions for summary judgment was held on September 25, 2019 in Miami, Florida. The judge took the matter under advisement and will issue a ruling.
- Jimmo v. Sebelius, No. 5:11-cv-17 (D. Vt.) (Improvement Standard). The settlement in Jimmo was approved on January 24, 2013. CMS issued revisions to its Medicare Benefit Policy Manual to clarify that Medicare coverage is available for skilled maintenance services in the home health, nursing home and outpatient settings. CMS also implemented a nationwide Educational Campaign for all who make Medicare determinations to ensure that beneficiaries with chronic conditions are not denied coverage for critical services because their underlying conditions will not improve. Pursuant to the settlement, counsel for the parties met twice a year to discuss problems with implementation and possible solutions.
After three years of urging CMS to fulfill its obligation to end continued application of the “Improvement Standard,” the Center and Vermont Legal Aid filed a Motion for Resolution of Non-Compliance with the settlement agreement. The court announced its decision on the Motion on August 18, 2016. The Order required CMS to remedy the inadequate Educational Campaign that was a cornerstone of the original Settlement Agreement. As the judge stated, “Plaintiffs bargained for the accurate provision of information regarding the maintenance coverage standard and their rights under the Settlement Agreement would be meaningless without it.” The parties negotiated but could not come to agreement on what a Corrective Action Plan should entail. The court then ordered each party to submit a brief explaining and justifying their proposed corrective action plans, as well as a response to the other party’s plan.
On February 2, 2017, the court released a decision ordering CMS to carry out a Corrective Action Plan to remedy noncompliance with the Settlement. Jimmo v. Burwell, 2017 WL 462512 (D. Vt. Feb. 1, 2019) The plan includes a new webpage by CMS dedicated to the Jimmo settlement with frequently asked questions and a statement (which the court largely adopted from plaintiffs’ suggested language) that affirmatively disavows the Improvement Standard; new training for Medicare contractors making coverage decisions; and a new National Call for Medicare contractors and adjudicators to correct erroneous statements that had been made on a previous call. On February 16, 2017, the court approved the final wording of the statement to be used by CMS to affirmatively disavow the use of an Improvement Standard. Importantly, the statement notes that the “Jimmo Settlement may reflect a change in practice for those providers, adjudicators, and contractors who may have erroneously believed that the Medicare program covers nursing and therapy services under these benefits only when a beneficiary is expected to improve.”
In late August 2017 the government published the new Jimmo-webpage on the CMS website to comply with the Corrective Action Plan. The webpage includes court-approved affirmative disavowal of the Improvement Standard in a blue box titled “Important Message About the Jimmo Settlement.” The webpage also contains links to Jimmo-related documents, such as the transmittals of the revised Manual provisions, and a new set of Frequently Asked Questions. The imprimatur of CMS on these materials will help beneficiaries and their advocate who are arguing against inappropriate coverage denials or service terminations.
The court case has now concluded, but class counsel continues to work on ensuring that access to skilled maintenance nursing and therapy for older adults and people with disabilities is not inappropriately denied or terminated because their conditions are “chronic,” “not improving,” “plateaued,” or “stable.”
For more information on the Improvement Standard, visit the Center’s website, www.MedicareAdvocacy.org.