Issue Brief – January 2019 – Medicare Advocacy: Highlights from 2018 and Looking Forward in 2019

Disclaimer: the views expressed in this Issue Brief and during the Alliance call are solely those of the Center for Medicare Advocacy.

1. ACCESS TO CARE   

Home Health

Between April 2017 and October 2018, the Center completed the “CMA Issue Brief Series: Medicare Home Health Crisis” – a ten-part series examining the growing crisis in access to Medicare home health coverage and necessary care – and outlining the Center for Medicare Advocacy’s work to address these issues.  The issue briefs are available online here: https://www.medicareadvocacy.org/cma-issue-brief-series-medicare-home-health-care-crisis/.

The following is an excerpt from Plans to Address and Resolve the Medicare Home Care Crisis, the last in the series, published October 18, 2018.

Plans to Address and Resolve the Medicare Home Health Crisis

There is a crisis in access to Medicare-covered home health care. Earlier editions of this Issue Brief Series have detailed the home health benefit and the access obstacles facing patients, particularly those with longer term and chronic conditions. This Brief summarizes what is at stake, some of what’s been done thus far, and what’s needed to remove the obstacles.

Under the law, beneficiaries qualify for home health coverage when they are under the care of a physician, are homebound, and need skilled nursing or therapy care. There is no required end-point to coverage; it can continue so long as the beneficiary meets the coverage criteria. In practice, however, beneficiaries are regularly unable to obtain the coverage, and care, provided by law.

In recent years, access to the benefit has rapidly diminished and a growing number of beneficiaries have been unable to obtain home health services, even when they meet Medicare coverage criteria, (See CMA Issue Brief #5). While the Centers for Medicare & Medicaid Services (CMS) online and print materials now more accurately reflect Medicare home health coverage law, (See CMA Issue Brief #4), CMS continues to administer the benefit as if it is for patients with acute care needs. Further, although some beneficiary protections have been expanded, (See CMA Issue Brief #6), CMS payment policies, quality measures, and fraud investigations create disincentives for home health agencies to provide care to all who qualify; patients with longer-term needs are particularly disfavored, (See CMA Issue Brief #7). Recently proposed rules would only accelerate this trend towards turning Medicare home health coverage into a short-term, post-acute care benefit – contrary to clearly expressed Congressional intent, (See CMA Issue Brief #8).

The Center for Medicare Advocacy (the Center) continues to develop strategies to raise awareness about the crisis in access to Medicare home care and to seek solutions. A combination of actions are necessary, including Administrative and Congressional, strategic collaboration with providers, development of stories and media attention, and, potentially, litigation.

• The Administration and CMS should rescind proposed payments rules and develop a model intended to effectuate coverage laws, by giving home health providers appropriate financial incentives to serve all qualifying Medicare beneficiaries. Quality measures and fraud investigation triggers should also be redesigned to ensure that all patients who qualify under the law have equal access to care. The Administration, and those who advise CMS, including the Medicare Payment Advisory Commission (MedPAC), should fully understand Medicare coverage law and work to ensure the benefit is administered to implement the promise of the law: to allow homebound patients to receive necessary care at home. Oversight of the program must aim to ensure equal access to coverage for all who qualify, regardless of their conditions or ability to improve. Underserving patients who qualify should cause as much concern as overserving. Considerations should include capping maximum allowable profit margins, thus removing incentives to serve some beneficiaries who are more profitable than others.
• Members of Congress should recognize that constituents are losing access to legally covered home care and act to ensure that coverage laws are implemented as intended – for all who qualify. Congress should insist that CMS corrects policies that restrict access to such services. Congress and the Administration should ensure that Medicare-certified home health agencies are ready to provide all services covered under the Medicare benefit. Congress should also consider lifting the 2.5% statutory cap on provider access to outlier payments.
• Home health agencies are generally willing to provide services to all beneficiaries when they are properly reimbursed. While some Medicare-certified agencies provide services to beneficiaries with longer-term and chronic conditions, many will not for fear of claim denials, fraud investigations, audits, and financial penalties. Too often, agencies lose money, get reduced quality measures, and are targeted by audits based on criteria that do not accurately reflect the Medicare law. As a result, providers turn away beneficiaries who have chronic conditions in favor of more profitable short-term, acute care cases. Equalizing access to care may not be the home health industry’s primary concern, but the industry should join with beneficiary advocates to oppose these policies that lead to inequities in access to care. The Center will continue to work with home health agencies to understand and honor coverage laws, to gain more confidence that care provided to people with longer-term conditions will be covered, and to help prevent unfair oversight practices.
• Media stories have helped raise awareness about the crisis in access to home health care. Some published articles have generated responses from CMS, such as a recommendation (made in the Federal Register) that agencies use outlier payments to cover higher-cost patients. While it may be appropriate in some cases to use outlier payments, they are currently underfunded and statutorily capped at 2.5% of all Medicare home health expenditures (already maximized by home health agencies). Additionally, outlier payments are not appropriate for all beneficiaries who have longer-term or chronic conditions. Many of these patients are actually less costly to agencies than short-term acute care patients.
• Finally, as we strategize ways to resolve the inequities in access to Medicare-covered home care, the Center must also consider the possibility of strategic litigation. Some of the identified access barriers may conflict with Medicare law, the Administrative Procedures Act, and/or anti-discrimination laws. The Center for Medicare Advocacy is committed to doing all we can to advance fair access to Medicare home care.​

The Center for Medicare Advocacy welcomes assistance and inquiries from other advocates concerned about the crisis in access to Medicare-covered home care. We encourage beneficiaries to appeal denials when they are not able to obtain coverage for all the home health services they need and for which they qualify under the law. We also urge beneficiaries to let us know about their difficulties, and success, in accessing care at https://www.medicareadvocacy.org/submit-your-home-health-access-story/. Working together, we will achieve appropriate and fair access to Medicare home health care.

Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Updates

All Competitive Bid Program Contracts ended on December 31, 2018.

What Beneficiaries Should Know:

• Equipment in process under the 13 month capped rental program should continue “business as usual”.
• While providers who do not accept Medicare assignment cannot charge more than 15% higher than Medicare’s allowed charge. There is no such restriction (no limiting charge) for DME suppliers. (See Resource 7, below.) A Medicare enrolled supplier that does not accept assignment can charge without a prescribed limit. The beneficiary is responsible for the difference between what Medicare will pay and what the supplier will charge. Competitive Bid Program Contractors were required to accept assignment. Now that there are no contracts, fewer suppliers are accepting assignment. Make sure to ask if the supplier accepts assignment. Then get the answer in writing. If the answer is “no”, the beneficiary should confirm in writing what the charges will be.
• If a supplier accepts assignment, the supplier should not be charging for delivery, set up or training (this cost is included in the Medicare payment). (See Resource 6, below.)
• Repairs – CMS has “disassociated” the purchase of equipment by Medicare to require repairs and is now allowing for repairs to “stand on their own merit”, despite whether Medicare paid for the equipment originally. Beneficiaries should ensure the continued need for the equipment is updated in the medical record and ensure the need for the repair is also documented. The repair may be performed by any “authorized” repair place (CMS recommends working with the DMACs (Durable Medical Equipment Medicare Administrative Contractors) and suppliers to find an authorized repair place. (See Resource 4, below.)
• The CBICs (Competitive Bid Implementation Contractors) are no longer available for oversight of suppliers. The DMACs will continue to pay claims based on rules and policies. Generally, the NSC (National Suppliers Clearinghouse) is responsible for oversight of Medicare enrolled suppliers adherence to “supplier standards”.
• The first point of contact to resolve issues should be 1-800-MEDICARE. If a beneficiary is trying to resolve a problem, the caller should ask for the call to be “escalated”.
• Second point of contact would be the DMACs. (See Resource 4, below.)
• Third point of contact The Competitive Bidding Program Ombudsman’s Office is still active to monitor inquiries, to establish a baseline for a complaints process, and to inform CMS of beneficiary access problems. (See Resource 8, below.)
• Why has CMS abruptly allowed all Competitive Bidding Contracts to expire after building the program for more than a decade, rather than extend the contracts? CMS states that, “this Administration wishes to pursue improvements to the program via rulemaking”. CMS further states they, “anticipate no negative implications for beneficiaries.” It already appears too late for that.

To help the Center for Medicare Advocacy track, report on, and seek resolution to access barriers, please report any problems obtaining DMEPOS to DMEPOS@MedicareAdvocacy.org

DMEPOS Resources:

1. CMS Fact Sheet on the Temporary Gap Period, Effective January 1, 2019 through December 31, 2020. https://www.cms.gov/Outreach-and-Education/Outreach/Partnerships/Downloads/DMEPOS-Temporary-Gap-Period-Fact-Sheet.pdf
2. Final Rule, published November 14, 2018. https://www.govinfo.gov/content/pkg/FR-2018-11-14/pdf/2018-24238.pdf
3. Medicare supplier directory www.medicare.gov/supplier, or to locate a supplier, ask a question or file a complaint, call 1-800-MEDICARE (1-800-633-4227).
4. To locate the correct DMAC for each state, see https://www.cms.gov/medicare-coverage-database/indexes/contacts-durable-medical-equipment-medicare-administrative-contractor-index.aspx
5. Contact a state SHIP to help resolve local/state problems. https://www.shiptacenter.org/
6. The Medicare Claims Processing Manual, for questions about payment for DMEPOS, including delivery and services charges (Section 60 of the Manual) https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/clm104c20.pdf
7. For questions about assignment (and the lack of a limiting charge on some supplies and on Durable Medical Equipment) see https://www.medicare.gov/your-medicare-costs/part-a-costs/lower-costs-with-assignment
8. For further assistance after 1-800-MEDICARE and DMACs, contact the Office of the Competitive Bidding Acquisition Ombudsman at CompetitiveAcquisitionOmbudsman@cms.hhs.gov
9. Watch out for aggressive marketing by suppliers. Report suspected fraud for investigation via online form https://forms.oig.hhs.gov/hotlineoperations/report-fraud-form.aspx or phone 1-800-HHS-TIPS (1-800-633-4227)(TTY 1-877-486-2048).

Observation Status

Recently, the Center for Medicare Advocacy laid out our Medicare Platform for the New Congress (see below). One of the core considerations to improve Medicare for all beneficiaries, now and in the future, is the need to reduce ongoing barriers to coverage and care. One of the key issues impeding access to Medicare coverage is the continued, and growing, use of “outpatient” observation status.

Hospital patients in “outpatient” observation status often receive care in acute care hospitals that is indistinguishable from the care patients receive when they are formally admitted to hospitals as inpatients.[1]  The consequences of outpatient status are considerable, however, especially for patients who need post-hospital care in a skilled nursing facility (SNF). Since Medicare was enacted more than 50 years ago, Medicare Part A has covered SNF care only for patients who were hospitalized as inpatients for at least three consecutive days, not counting the day of discharge (since Medicare counts days by midnights, not by 24-hour periods, a shorthand for this statutory requirement is three inpatient midnights). Unless covered by Medicaid, hospital patients who were in observation or other outpatient status must pay for their SNF stay entirely out-of-pocket, or forego this necessary care.

A recent analysis of Medicare spending on post-acute care documents the steep decline in inpatient hospital admissions since 2010.[2] Many of these patients actually were in the hospital, but in “outpatient” observation (rather than inpatient) status. Declining inpatient stays covered by Medicare has resulted in a decline in Medicare-covered SNF stays – and in a parallel reduction in access to necessary SNF care.

Legislation introduced in the 113^th, 114^th, and 115^th Congresses would have counted all time in the hospital, whether called inpatient or outpatient, for purposes of satisfying Medicare’s three-day inpatient requirement for SNF coverage. Although a broad coalition of organizations[3] supported the legislation, the legislation has not been enacted. 

For the 116^th Congress, there are several alternative approaches to address the issue of observation status and reduce the harm it causes beneficiaries. Congress could:

• Reintroduce S.568/H.R. 1421, The Improving Access to Medicare Coverage Act of 2017,[4] as is.
• Reintroduce the 2017 legislation, but add a right to appeal a patient’s classification as observation or other outpatient status. (As a result of the Notice of Observation in Treatment and Implications for Care Eligibility (NOTICE) Act,[5] hospitals must inform patients, orally and in writing (using the Medicare Outpatient Observation Notice, MOON[6]) that they are in observation status if that status continues for 24 hours. However, the federal regulations implementing the NOTICE Act explicitly deny patients the right to appeal their classification as observation status patients.[7])
• Amend the Medicare statute to authorize patient appeals of observation status. (All Medicare notices except the MOON authorize patient appeals, as a matter of due process.)
• Amend the Medicare statute to allow for Part A coverage of SNF care if a patient is hospitalized as an inpatient for one day. (The Medicare Payment Advisory Commission made this recommendation in January 2015 as a less costly proposal than either counting all time in the hospital or waiving the three-day requirement entirely.[8])
• Amend the Medicare statute to allow for Part A coverage of SNF care if a patient is hospitalized, as an inpatient or outpatient, for one day. 
• Amend the Medicare statute to eliminate the 3-day inpatient requirement for Part A coverage of a stay in a SNF. (Multiple reasons support this approach, although it may be the most expensive approach.  Medical practice is different today than it was in 1965; many procedures are now performed on an outpatient basis that required extended periods of hospitalization in 1965. When Medicare was enacted, the average length of stay in a hospital for patients age 65 and over was 13 days; the average length of stay for all patients now is five days.  Medicare Shared Savings Program, such as Accountable Care Organizations, may waive the three-day inpatient requirement.[9]  Medicare Advantage plans may also waive the three-day requirement, and most do.[10])

Conclusion

Observation status has created an enormous hardship for Medicare patients who need post-hospital care in a SNF. It also creates unwanted and unnecessary conflicts between patients and providers. One or more of the alternatives identified above could help reduce the harm of observation status and help Medicare patients get the care they need. 

Nursing Home Issues

The following statement was drafted by the Center for Medicare Advocacy, the Long-Term Care Community Coalition, Consumer Voice, Justice in Aging, and California Advocates for Nursing Home Reform.

Nursing Home Residents at Risk:                                                                                                                                 A Briefing for Members of Congress

The Nursing Home Reform Law requires every nursing home to provide residents with the services they need to attain and maintain their “highest practicable physical, mental, and psychosocial well-being.” To ensure that residents receive the care that they need and deserve, the law and its implementing regulations detail specific resident rights and protections that all nursing homes must adhere to when they voluntarily participate in Medicare and/or Medicaid. Unfortunately, the Centers for Medicare & Medicaid Services (CMS) has been rolling back these resident rights and protections, often at the request of the nursing home industry, for the purpose of reducing so-called provider “burdens.”

The following actions represent only a few of CMS’s deregulatory efforts over the past two years:

1. CMS placed an 18-month moratorium on the full enforcement of eight standards of care. These standards relate to important resident protections, such as baseline care planning, staff competency, antibiotic stewardship, and psychotropic medications. The moratorium means that nursing homes will not be financially penalized when these safeguards are violated.
2. CMS shifted the default civil money penalty (CMP) from per day (for the duration of a violation) to per instance. The New York Times reported that “the change means that some nursing homes could be sheltered from fines above the maximum per-instance fine of $20,965 even for egregious mistakes.”
3. CMS issued a notice of proposed rulemaking (NPRM) to roll back emergency preparedness requirements. Most notably, the proposed rule would allow nursing homes to review their programs and train staff every two years instead of annually.
4. In response to industry lobbying, CMS is carrying out plans to revise the federal nursing home Requirements of Participation to “reform” standards that have been identified as “excessively burdensome” for the nursing home industry. The Requirements were recently revised in 2016 (for the first time in 25 years) to better address longstanding problems, including persistent abuse and neglect. These standards need to be implemented, not watered down.

Nursing home residents are some of the most vulnerable individuals in the nation. CMS’s deregulatory agenda puts residents in danger of experiencing harm or being placed in immediate jeopardy of health, safety, or well-being. This potential for resident harm is in direct opposition to the HHS Secretary’s duty under the law. The law makes clear that the Secretary is responsible for assuring the “requirements which govern the provision of care in skilled nursing facilities…, 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.” CMS’s actions indicate that the Secretary is ignoring this long-standing mandate.

CMS’s efforts are even more dangerous because they exacerbate existing problems in nursing homes. Multiple reports from the HHS Office of the Inspector General (OIG) and the Government Accountability Office (GAO) document persistent and widespread problems facing nursing home residents. For instance, a 2014 OIG report found that one-third of Medicare beneficiaries experienced harm within, on average, 15.5 days of entering a nursing home; the OIG stated that 59 percent of these events were preventable. Similarly, a 2008 GAO report highlighted that studies since 1998 indicate state surveyors “sometimes understate the extent of serious care problems in homes because they miss deficiencies . . . .” Such persistent problems over the years have created greater insecurity for residents, requiring additional legislation and regulations, not less.

The following problems indicate only some of the ongoing concerns:

1. Citations. More than 95 percent of all citations for violations of the federal minimum standards of care result in findings of no resident harm. A “no harm” citation does not mean that the resident did not, in fact, experience pain, suffering, or humiliation. However, a finding of “no harm” all too often does mean that the nursing home is not penalized for poor care.
2. Staffing. Staffing is essential to resident care and quality of life. Too often, insufficient staffing is the underlying cause of other health violations. By law, nursing homes must have a registered nurse on duty for eight consecutive hours and 24-hour licensed nurse services every single day. This is recognized as the minimum necessary to ensure that residents receive the “skilled nursing” care and monitoring that they need and which facilities are paid to provide. However, CMS noted in a 2017 memorandum that about six percent of nursing homes that submitted nurse staffing data for the third quarter of 2017 had seven or more days with no reported RN hours and that 80 percent of these days were on weekends. The New York Times further found that, for at least one day in the last quarter of 2017, 25 percent of nursing homes reported no registered nurses at work.
3. Antipsychotic Drugs. About 20 percent of nursing home residents are administered antipsychotic drugs every day. However, less than two percent of the population will ever have a diagnosis for a clinical condition (e.g., Schizophrenia) identified by CMS when it risk-adjusts for potentially appropriate uses of these drugs. In a 2011 statement addressing widespread and inappropriate use of antipsychotic drugs in nursing homes, the HHS Inspector General stated that “[g]overnment, taxpayers, nursing home residents, as well as their families and caregivers should be outraged – and seek solutions.” Nevertheless, seven years later, in the absence of meaningful enforcement the problem is still widespread.
4. Transfer and Discharge. CMS has stated that “facility-initiated discharges continue to be one of the most frequent complaints made to State Long Term Care Ombudsman Programs.” Although the Nursing Home Reform Law places specific restrictions on when and how a resident can be transferred or discharged, many residents fall victim to inappropriate and unsafe discharges. Residents have been discharged to unsafe and inappropriate settings, such as homeless shelters, storage units, and motels. 
5. Ownership. The buying and selling of nursing homes and the transfer of licenses to new managers raise questions about who these operators are and whether there are sufficient state and federal law, regulations, and practices in place, and meaningfully enforced, to protect residents. For instance, Skyline Healthcare took over 100 nursing homes across the country starting in 2015 before ultimately collapsing in 2018. Officials from various states indicated that Skyline was at imminent risk of running out of necessary food and medication, and was unable to meet payroll. Many of Skyline’s nursing homes were acquired from Golden Living, another chain that was sued by the Pennsylvania Attorney General in 2015 for providing poor care to residents.

Nursing home residents are in need of urgent action to protect their quality of care and quality of life. Given the ongoing problems that already exist in nursing homes, CMS’s deregulation places residents at an even greater risk of experiencing harm. Our organizations would like the opportunity to work with you to address the needs of this exceptionally vulnerable population. Please do not hesitate to contact us if you have any questions or concerns about long-term care issues.

2. LEVELING THE PLAYING FIELD – TRADITIONAL MEDICARE AND MEDICARE ADVANTAGE

Policy Changes and CMS Efforts Favoring Medicare Advantage (MA)

Over last several years, there has been a pattern among policymakers and the Administration to favor the MA program over traditional Medicare.  Legislative changes that have worked to tip the scales include – MACRA (2015) which will prohibit people eligible for Medicare on or after January 1, 2020 from purchasing a Medigap policy that covers the Part B deductible (sometimes referred to as policies that offer “first dollar coverage”); the CURES Act (2016) which reinstated the Medicare Advantage Open Enrollment Period (MA-OEP) and expanded MA to ESRD without corresponding Medigap rights; and the Bipartisan Budget Act (BBA) of 2018 which expands supplemental benefits in MA to individuals with chronic conditions, but not, correspondingly, in trad. Medicare.

• See CMA Weekly Alert re: Tipping the Scales Towards MA Plans (March 2018): https://www.medicareadvocacy.org/tipping-the-scales-toward-medicare-advantage/

Administrative actions have also tipped the scales – In the current climate of “deregulation” a number of policies are being implemented that favor MA plan sponsor “flexibility” in a way that will make things more complex, not less, for Medicare beneficiaries, at the same time those in traditional Medicare are being left behind.

• See the Center’s “Special Report: Recent Changes in Law, Regulations and Guidance Relating to Medicare Advantage and the Prescription Drug Benefit Program”(September 2018), available at: https://www.medicareadvocacy.org/special-report-recent-changes-in-law-regulations-and-guidance-relating-to-medicare-advantage-and-the-prescription-drug-benefit-program/

In addition to new rules and regulations issued by the Administration, over the last two years we have seen CMS engaged in explicit bias, or steering towards MA plans. In helping people figure out their options within Medicare, any good, unbiased counselor will point out pluses and minuses of different options.  Instead, CMS is overplaying the pluses of MA and downplaying any minuses in a manner that is highly misleading, at best – including revisions to Medicare & You, online comparison tools, and education and outreach materials, including an enrollment period email campaign that downplayed or eliminated explanation of the option of traditional Medicare altogether.   

• See the Center’s Weekly Alert “As Medicare Enrollment Period Draws to a Close, MA Steering Continues – Advocates & Members of Congress Write Letters of Concern to CMS” (October 2018): https://www.medicareadvocacy.org/as-medicare-enrollment-period-draws-to-a-close-ma-steering-continues-advocates-members-of-congress-write-letters-of-concern-to-cms/

Promoting Free Choice  

Recently, the Center for Medicare Advocacy laid out our Medicare Platform for the New Congress (see below). One of the core considerations to improve Medicare for all beneficiaries, now and in the future, is the need to preserve and expand consumer protections and quality coverage for all Medicare Beneficiaries – including parity between traditional Medicare and private Medicare plans. One of the key issues currently limiting choice and coverage for Medicare beneficiaries is limited access to Medigap plans.

Medicare Supplement Insurance, more commonly referred to as Medigap, is insurance that helps pay for “gaps” in Medicare payment. Medigap does not generally pay for gaps in services not covered by traditional Medicare, but rather for cost-sharing when coverage is provided by Medicare Parts A and B. Given the high costs of health care and Medicare cost-sharing, Medigap policies are key to affording care for people in traditional Medicare.

Unfortunately, however, there are limitations on accessing these important plans:

• Federal law requires Medigap “guaranteed issue” protections for people age 65 and older only during the first six months of their Medicare Part B enrollment and certain other limited situations, including during a “trial” Medicare Advantage enrollment period. Beneficiaries who miss these windows of opportunity may not be able to purchase a Medigap policy later in life if their needs or priorities change.
• Beneficiaries under age 65 with disabilities who qualify for Medicare have no guaranteed issue at all. (Individual states may offer varying degrees of consumer protection, but many do not).

Rights to purchase Medigap supplemental insurance policies should be expanded to people under 65 and should include ongoing access for all in order to provide real, meaningful choices for all Medicare beneficiaries.  Similarly, an out-of-pocket cap on beneficiary expenses should be added to traditional Medicare, just as Medicare Advantage plans are required to provide for their enrollees.

3. IMPROVING AND EXPANDING MEDICARE

Core Considerations for Medicare for Today & Tomorrow – A Medicare Platform for the New Congress

The Center for Medicare Advocacy works for a comprehensive Medicare program and quality health coverage and care for all people. To accomplish these goals for current and future beneficiaries in the changing health care environment, we seek to:

• Improve Medicare for current and future beneficiaries.
• Support the development of the best method possible to increase access to quality health coverage and care for the most people.

Medicare Platform to Improve Medicare for all beneficiaries, now and in the future:

1. Consumer Protections and Quality Coverage for All Medicare Beneficiaries (Including Parity Between Traditional Medicare and Medicare Advantage)

• Cap out-of-pocket costs in traditional Medicare
• Require Medigap plans to be available to all individuals in traditional Medicare, regardless of pre-existing conditions and age (“Guarantee Issue” and “Community Rating”)
• Ensure all benefits in Medicare Advantage are also available in traditional Medicare
  • For example, include all MA “supplemental benefits,” waiver of 3-day prior hospital stay requirement for SNF coverage, coverage for home health aides, coordinated care
• Simplify enrollment in traditional Medicare, Part D and Medigap, and ease transitions from other insurances to Medicare
• Improve consumer protections in Medicare Advantage
  • Standardize benefit packages,
  • Strengthen network adequacy requirements
  • Strengthen plan oversight
  • Strengthen marketing protections
• Ensure the Medicare appeals system is cost-effective, accessible and fair

2. Reduce Ongoing Barriers to Care  

• Eliminate the harm of hospital “Observation Status”
• Home Health – Ensure access to coverage is actually available for all beneficiaries who meet coverage criteria, ensure access to legally authorized home health aides, resolve conflicts between payment models and coverage laws
• Jimmo Implementation – Ensure beneficiaries with longer-term, chronic, and/or debilitating conditions have full access to skilled nursing, therapy and related care needed to maintain their conditions or slow decline

3. Improve Traditional Medicare  

• Add oral health, audiology, vision coverage
• Restructure Medicare to make it comprehensive, simpler and  affordable
• Increase Low-Income Protections in the Medicare Savings Program (at least on par with ACA subsidies)
• Long-term Care – Add coverage over time. For now, make incremental improvements (For example, repeal homebound requirement for home health coverage, repeal requirement that individual need skilled care and be homebound to qualify for home health aide coverage, repeal requirement that DME generally be needed in the home)

Coverage Highlight: Oral Health

Senator Cardin Introduces Bill to Add Oral Health Coverage to Medicare

In the opening days of the new Congress, Senator Ben Cardin (Maryland) introduced the Medicare Dental Benefit Act of 2019 (S. 22).  According to a January 4, 2019 press release issued by the senator’s office, the proposed bill “would repeal the statutory exclusion on Medicare coverage of dental care and dentures” in the Medicare statute, and would expand “Part B benefits to cover dental and oral health services, including routine cleanings and exams, fillings and crowns, major services such as root canals and extractions, emergency dental care, and other necessary services.”

One of the Center’s top priorities is to expand Medicare coverage to include oral and dental care, as well as push for coverage of medically necessary oral health care which is currently supported by the Medicare statue but is significantly limited in practice due to Medicare policy.   

The Center joined Families USA, Justice in Aging, and Oral Health America in offering support for this legislation.

Enrollment

In October 2018, the Kaiser Family Foundation (KFF) released an issue brief that examined eight legislative proposals introduced in the last Congress that would create a Medicare for All or public plan buy-in program.  The issue brief is available here: https://www.kff.org/medicare/issue-brief/medicare-for-all-and-public-plan-buy-in-proposals-overview-and-key-issues/

KFF also released an accompanying interactive comparison tool: https://www.kff.org/interactive/compare-medicare-for-all-public-plan-proposals/

4. LITIGATION UPDATE

• Alexander v. Azar (formerly Bagnall v. Sebelius, Barrows v. Burwell), No. 3:11-cv-1703 (D. Conn.) (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 cross motions for summary judgment 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 have 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). The parties filed an updated plan for further discovery.

Plaintiffs filed a renewed motion for class certification on March 3, 2017. 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.

The 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, although the court had discouraged it.

Update: A hearing was held on November 26, 2018, which was supposed to address the pending motion for summary judgment on the Eldridge factors, the pending motion to decertify the class, and whether the court should bi-furcate the trial to deal with the protected property interest separately. The hearing instead focused mostly on the court’s questions about what criteria plaintiffs rely on to create 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. Over the objection of plaintiffs, the court decided that the government should have an additional opportunity to address whether the Two-Midnight Rule can create a protected property interest. The court removed the trial, which had been scheduled for February 2019, from the schedule and directed the government to file another, supplementary 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 will 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 government’s briefs were due January 3, 2019, however due to the “lapse in appropriations” (government shutdown), the briefing was stayed by the court on December 27 until the government re-opens. The court will eventually have four pending motions to address (two for summary judgment, one for class decertification, and one to dismiss).

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: https://www.medicareadvocacy.org/submit-your-observation-status-story/

• For more information about observation status, including pending legislation   see: https://www.medicareadvocacy.org/medicare-info/observation-status/.

• 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. The judge set a briefing schedule for cross motions for summary judgment.

Update: The 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 assigned to a different magistrate judge.

• 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.

On March 1, 2016, the Center and its co-counsel, Vermont Legal Aid, filed a Motion for Resolution of Non-Compliance with the settlement agreement. The filing came after three years of urging the Centers for Medicare & Medicaid Services (CMS) to fulfill its obligation to end continued application of an “Improvement Standard” by Medicare providers, contractors and adjudicators to deny Medicare coverage for skilled maintenance nursing and therapy.

The court announced its decision on the Motion for Resolution of Non-Compliance 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. 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. The government was given an opportunity to object to the language of the corrective statement, and the parties negotiated final wording which was submitted to the court.  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 can be found here.  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, see the Center’s website at: https://www.medicareadvocacy.org/medicare-info/improvement-standard/.

• Exley v. Burwell (formerly Lessler v. Burwell), No. 3:14-cv-1230 (D. Conn.) (ALJ Delays) The Medicare statute and regulations require that an administrative law judge (ALJ) issue a decision within 90 days the filing of a request for hearing. While the Chief ALJ has stated that individual beneficiary cases should not be delayed, still most of the Center’s cases were exceeding statutory timelines for decisions.

On August 26, 2014, the Center filed a nationwide class action lawsuit in United States District Court in Connecticut. The named plaintiffs, from Connecticut, New York and Ohio, all waited longer than the statutory 90-day limit for a decision on their Medicare appeals. On January 29, 2015, defendant’s motion to dismiss was denied.  On June 10, 2015, the court granted the plaintiffs’ motion for certification of nationwide class of Medicare beneficiaries who have been or will be waiting more than 90 days for a decision on their timely-filed request for an ALJ hearing. The parties also conducted discovery. In March 2016 the court preliminarily approved a settlement and notice to the class was posted.

A Fairness Hearing was held on August 1, 2016 and the Court granted final approval of the settlement agreement. The settlement calls for the Office of Medicare Hearings and Appeals (OMHA) to continue its policy of providing beneficiary appellants with priority over other appellants in receiving ALJ decisions, to designate a Headquarters Division Director to oversee inquiries about appeals initiated by beneficiary appellants, and to address any complaints or questions concerning the processing of those appeals. OMHA will also introduce a new, more user-friendly ALJ hearing request form that allows beneficiaries to self-identify, and will also publish data about the length of processing time for beneficiary appeals.

On September 1, 2016 as part of the settlement, OMHA established a toll-free Beneficiary Help Line: (844) 419-3358.  This line, which is staffed by representatives of OMHA, will address inquiries about ALJ appeals being pursued by Medicare beneficiaries. The Center urges anyone pursuing a beneficiary appeal who believes the appeal is not receiving timely attention to call the Beneficiary Help Line. The expectation is that a call to this line will help resolve delays in cases that are eligible to be prioritized. The Beneficiary Help Line is staffed from 8:00 a.m. to 4:30 p.m., Eastern Time. If calling at other times or if the OMHA Beneficiary Help Line staff are assisting other callers, OMHA instructs callers to leave a voicemail. Please report your experiences using the Help Line to the Center at: abers@medicareadvocacy.org.

As of November 1, 2016 CMS updated scripts for 1-800-Medicare to highlight the OMHA beneficiary prioritization policy for beneficiary callers and to refer them to the toll-free OMHA Beneficiary Help Line if they have questions about filing appeals with OMHA or about ALJ appeals that are pending with OMHA. OMHA also posted the beneficiary appeals data required by the settlement on their website at http://www.hhs.gov/about/agencies/omha/about/current-workload/beneficiary-appeals-data/index.html. The data shows beneficiary appeals now being processed within or very close to the 90-day statutory time period.

In late January 2017 the Office of Medicare Hearings and Appeals issued a new ALJ request form, the OMHA-100, which is a unified request for hearing and review and can be used for all appeals to OMHA.  As part of the settlement, the form allows beneficiaries and enrollees to self-identify, making it easier for these claims to be classified as beneficiary appeals and given priority for processing. CMS has also issued instructions to appeal contractors that deal with reconsiderations (the level below ALJ hearings) the begin using revised appeal instructions that include plain-language instructions about OMHA’s beneficiary mail-stop as well as information on the beneficiary help-line that has been established at OMHA.  The OMHA-100 is available at: https://www.hhs.gov/sites/default/files/OMHA-100.pdf

• For information about and a copy of the Exley settlement, see:  https://www.medicareadvocacy.org/exley-v-burwell-settlement-in-medicare-appeals-delay-case-granted-final-approval/

• Ryan v. Price, No. 5:14-cv-269 (D. Vt.) (Prior Favorable Homebound Determination) On December 19, 2014, the Center for Medicare Advocacy and Vermont Legal Aid filed a class action lawsuit against Sylvia Mathews Burwell, the Secretary of Health and Human Services, to stop Medicare’s practice of repeatedly denying coverage for home health services for beneficiaries on the basis that they are allegedly not homebound, when Medicare has previously determined them to be homebound. (Ryan v. Burwell). The lawsuit was filed in the United States District Court in Burlington, Vermont on behalf of two Vermont residents, Marcy Ryan and John Herbert, as a regional class action lawsuit covering New England and New York.

On March 25, 2015, the government filed a motion to dismiss on the grounds that plaintiffs lack standing, that the court lacks subject matter jurisdiction, and that plaintiffs have failed to state claim on which relief may be granted.  On July 27, 2015, the court denied the government’s motion to dismiss, finding four separate grounds on which the dually eligible plaintiffs have standing. The court also found that it had subject matter jurisdiction and that plaintiffs had stated a claim on which relief could be granted.

On December 2, 2015, the court granted plaintiffs’ motion for class certification and, at request of the plaintiffs, issued clarification on the class definition on February 23, 2016.  The regional class is defined as all beneficiaries of Medicare Part A or B in Connecticut, Maine, Massachusetts, New Hampshire, New York, Rhode Island, and Vermont (Medicare Administrative Contractor Jurisdiction K): (a) who have received a “favorable final appellate decision” that he or she was “confined to the home,” i.e. homebound, in the appeal of a home health nursing or therapy claim denial; (b) who have subsequently been denied, or will be denied, coverage for additional service on the basis of not being homebound, on or after January 1, 2010; (c) who had a non-lapsed, viable appeal of the subsequent denial for coverage of additional home health services as of March 5, 2015, or had a particularized individual basis for tolling of any applicable appeal deadline; and (d) for whom the claim for Medicare home health coverage was filed on or before August 2, 2015.

Written discovery was served. The government filed a motion for summary judgment in November 2016 and plaintiffs filed a cross motion and responded in December.  However, the parties then entered settlement talks and postponed further briefing while those negotiations proceeded.

On October 11, 2017, the parties filed a joint motion for preliminary approval of a proposed settlement agreement and notice to the class, which the court approved on October 27, 2017. Notice to the class was posted and is available here. The notice explains that The proposed settlement applies to Medicare beneficiaries in the northeast United States whose appeals for coverage of home health services were denied between January 1, 2010 and March 5, 2015 on the basis of not being homebound, and who had previously received a favorable appeal decision determining that they were homebound. More details on the class definition can be found in the notice to class members. The agreement will allow class members to have their eligible claims for home health services reviewed under the Prior Favorable Homebound provision, which directed that when a beneficiary had previously been found to be homebound in a Medicare appeal, that conclusion should be given “great weight” in any subsequent appeal for home health services, provided there had not been a significant change in the beneficiary’s condition.

A final fairness hearing was held at the court in Rutland, Vermont on January 11, 2018. No objections were received, and the court granted final approval of the settlement. CMS will be publishing on their website an application process for eligible class members to have their claims re-reviewed under the correct standard. Eligible class members will be required to identify themselves and their eligible claim to CMS no later than one year after the settlement application process is published. The settlement, available here, contains details on which beneficiaries are eligible for re-review and the procedural requirements.

CMS has published the application process on its website. Eligible class members must identify themselves and their eligible claims to the CMS by completing and submitting the “Ryan Re-Review Form,” along with any supporting documentation, no later than August 1, 2019.  The form provides information to assist in determining whether the beneficiary’s claims qualify for re-review under the settlement (for example, the home health services have to have been received on or before August 2, 2015, and denied on or after January 1, 2010). The re-review form and other important information about the settlement are published on CMS’s website here. Please contact Vermont Legal Aid or the Center for Medicare Advocacy with questions about the settlement.

• Ryan Re-Review Form: https://www.cms.gov/Center/Special-Topic/Ryan-Settlement/Ryan-Re-Review-Form.pdf