The ICYMI CMS 2020 Blog

Background

The Center for Medicare & Medicaid Services (CMS), an agency within the Health & Human Services Administration (HHS), is responsible for oversight and regulatory compliance in health care programs such as Medicare, Medicaid, the Children’s Health Insurance Program (CHIP), the Patient Protection & Affordable Care Act (ACA), and state and federal health insurance marketplaces. CMS collects and analyzes data, produces research reports, and works to eliminate instances of fraud and abuse within the health care system. They also support the development and testing of innovative health care payment and service delivery models through the Center for Medicare & Medicaid Innovation (CMMI) which began under the Obama Administration.   

CMS is responsible for proposed rules, ensuring implementation of regulatory changes, providing guidance, and other press items that are relevant to health policy.  Keep an eye on this blog post as it will get updated as CMS proposes changes to the programs, we, and our partners, care about.

December

CMS announced a new voluntary payment model that builds on CMS’ focus to deliver Medicare beneficiaries value through better care and improved quality. The Geographic Direct Contracting Model (the “Model”) will test an approach to improving health outcomes and reducing the cost of care for Medicare beneficiaries in multiple regions and communities across the country. Through the model, participants will take responsibility for beneficiaries’ health outcomes, giving participants a direct incentive to improve care across entire geographic regions. Within each region, organizations with experience in risk-sharing arrangements and population health will partner with health care providers and community organizations to better coordinate care.

CMS is finalizing policy changes that will give Medicare patients and their doctors greater choices to get care at a lower cost in an outpatient setting. The Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) final rules will increase value for Medicare beneficiaries and reflect the agency’s efforts to transform the healthcare delivery system through competition and innovation. 

In Week Four of the 2021 Open Enrollment period, 523,020 people selected plans using the HealthCare.gov platform.

CMS finalized updates to Medicare coverage policies for artificial hearts and ventricular assist devices (VADs), both of which are used to treat patients with life-threatening advanced heart failure.

November

In Week Three of the 2021 Open Enrollment period, 758,421 people selected plans using the HealthCare.gov platform. 

CMS announced a set of new flexibilities to increase the capacity of the American health care system to provide care to patients outside a traditional hospital setting amid a rising number of coronavirus disease 2019 (COVID-19) hospitalizations across the country. These flexibilities include allowances for safe hospital care for eligible patients in their homes and updated staffing flexibility designed to allow ambulatory surgical centers (ASCs) to provide greater inpatient care when needed. Building on CMS’s previous actions to expand the availability of telehealth across the nation, these actions are aimed at allowing health care services to be provided outside a hospital setting while maintaining capacity to continue critical non-COVID-19 care, allowing hospitals to focus on the increased need for care stemming from public health emergency (PHE).

In Week Two of the 2021 Open Enrollment period, 803,741 people selected plans using the HealthCare.gov platform. As in past years, enrollment weeks are measured Sunday through Saturday. 

CMS is finalizing a rule that is designed to increase the supply of lifesaving organs available for transplant in the United States by requiring that the organizations responsible for organ procurement be transparent in their performance, highlighting the best and worst performers, and requiring them to compete on their ability to successfully facilitate transplants.

CMS announced today that the Medicare Fee- For-Service (FFS) improper payment rate has continued to decline. The Medicare FFS estimated improper payment rate decreased to 6.27% in FY 2020, from 7.25% in FY 2019, the fourth consecutive year the Medicare FFS improper payment rate has been below the 10% threshold for compliance established in the Payment Integrity Information Act of 2019. This year’s decrease was driven largely by progress in the following important areas:

Every week during Open Enrollment, CMS will release enrollment snapshots for the HealthCare.gov platform, which is used by the Federally-facilitated Exchange and some State-based Exchanges. These snapshots provide point-in-time estimates of weekly plan selections, call center activity, and visits to HealthCare.gov or CuidadoDeSalud.gov.

HealthCare.gov Platform Snapshot Week 1: November 1 – 7

CMS released the 2020 Medicaid and Children’s Health Insurance Program (CHIP) Managed Care final rule. The final rule fulfills one of the Trump Administration’s earliest commitment to states by reducing unnecessary administrative burden and federal regulatory barriers. The purpose of the rule is to ensure state Medicaid and CHIP agencies are able to work effectively to develop and implement managed care programs that better serve each state’s growing number of Medicaid and CHIP beneficiaries.

CMS announced the 2021 monthly Medicare Parts A and B premiums, deductibles, and coinsurance amounts in which the Medicare Part B monthly premium remains steady. This news comes as Medicare Open Enrollment started on October 15, 2020 running through December 7, 2020, and follows the announcement that Medicare Advantage (or private Medicare health plans) and Part D prescription drug plan premiums are at historic lows, with hundreds of Medicare Advantage and Part D plans now offering $35 monthly co-pays for insulin starting in January 2021.

CMS finalized policies that allow certain new and innovative equipment and supplies used for dialysis treatment of patients with End-Stage Renal Disease (ESRD) in the home to qualify for an additional Medicare payment. The final rule encourages the development of new and innovative home dialysis machines that give Medicare beneficiaries with ESRD more dialysis treatment options in the home that can improve their quality of life. 

CMS launched a new toolkit designed for state Medicaid agencies to strengthen their infrastructure and develop robust home and community-based services (HCBS) for eligible beneficiaries. This toolkit is the latest in a series of CMS efforts to promote high quality, person-centered HCBS to safely transition older adults and individuals with disabilities back to their homes and communities, and decrease reliance on nursing home care.  

CMS released the third annual update to its Medicaid and Children’s Health Insurance Program (CHIP) Scorecard. The Scorecard is the signature Medicaid accountability initiative that highlights state and federal performance on the administration and health outcomes of the Medicaid and CHIP programs that collectively account for approximately $600 billion in annual spending and serve over 74 million Americans. For the first time, the Scorecard now provides identified per capita spending data across all states, highlighting variation in program costs alongside the quality and performance data.

October

CMS announced that the Open Enrollment Period for the Federal Health Insurance Exchange will officially begin at HealthCare.gov on Sunday, November 1 and will run through Tuesday, December 15. Consumers will be able to log in to HealthCare.gov and CuidadodeSalud.gov or call 1-800-318-2596 to fill out an application and enroll in a 2021 Exchange health plan for coverage starting as soon as January 1, 2021.

CMS announced the seven finalists who will advance to the final round of the Artificial Intelligence (AI) Health Outcomes Challenge.  This multi-stage competition launched last year with more than 300 entities proposing AI solutions for predicting patient health outcomes aimed at revolutionizing healthcare for potential use by the CMS Center for Medicare and Medicaid Innovation.

The Finalists are:

• Ann Arbor Algorithms (Sterling Heights, MI)
• ClosedLoop.ai (Austin, TX)
• Deloitte Consulting, LLP (Arlington, VA)
• Geisinger (Danville, PA)
• Jefferson Health (Philadelphia, PA)
• Mathematica Policy Research, Inc. (Princeton, NJ)
• University of Virginia Health System (Charlottesville, VA)

CMS released a set of toolkits for providers, states and insurers to help the health care system prepare to swiftly administer the vaccine once it is available. CMS released an Interim Final Rule with Comment Period (IFC) today that establishes that any vaccine that receives Food and Drug Administration (FDA) authorization, either through an Emergency Use Authorization (EUA) or licensed under a Biologics License Application (BLA), will be covered under Medicare as a preventive vaccine at no cost to beneficiaries. 

CMS is proposing new changes to Medicare Durable Medical Equipment, Prosthetics, Orthotic Devices and Supplies (DMEPOS) coverage and payment policies. This rule would provide more choices for beneficiaries with diabetes, while streamlining the process for innovators in getting their technologies approved for coverage, payment, and coding by Medicare. The proposed rule would expand the interpretation regarding when external infusion pumps are appropriate for use in the home and can be covered as DME under Medicare Part B, increasing access to drug infusion therapy services in the home. 

CMS announced today that average 2021 premiums for Medicare Advantage plans are expected to decline 34.2 percent from 2017 while plan choice, benefits, and enrollment continue to increase. The Medicare Advantage average monthly premium will be the lowest in 14 years (since 2007) for the over 26 million Medicare beneficiaries projected to enroll in a Medicare Advantage plan for 2021. Additionally, for the first time, seniors who use insulin will have over 1,600 Medicare Advantage and Part D prescription drug plans to choose from that will offer insulin at no more than a $35 monthly copay beginning in January.  

CMS announced new actions to pay for expedited coronavirus disease 2019 (COVID-19) test results. CMS previously took action in April 2020 by increasing the Medicare payment to laboratories for high throughput COVID-19 diagnostic tests from approximately $51 to $100 per test. Today, CMS is announcing that starting January 1, 2021, Medicare will pay $100 only to laboratories that complete high throughput COVID-19 diagnostic tests within two calendar days of the specimen being collected.  Also effective January 1, 2021, for laboratories that take longer than two days to complete these tests, Medicare will pay a rate of $75. CMS is working to ensure that patients who test positive for the virus are alerted quickly so they can self-isolate and receive medical treatment.

CMS announced the approval of Georgia’s new Medicaid section 1115 demonstration called “Pathways to Coverage.”  The demonstration is designed to provide coverage for a limited set of working-age Georgia adults who are ineligible for Medicaid to opt into Medicaid coverage however, the waiver contains work, premium, and specific income requirements to gain coverage. The waiver is approved through 2025.

CMS expanded the list of telehealth services that Medicare Fee-For-Service will pay for during the coronavirus disease 2019 (COVID-19) Public Health Emergency (PHE). For the first time using a new expedited process, CMS is adding 11 new services to the Medicare telehealth services list since the publication of the May 1, 2020, COVID-19 Interim Final Rule with comment period (IFC).  Additionally, CMS released a  preliminary Medicaid and CHIP data snapshot on telehealth utilization during the PHE. This snapshot shows, among other things, that there have been more than 34.5 million services delivered via telehealth to Medicaid and CHIP beneficiaries between March and June of this year, representing an increase of more than 2,600% when compared to the same period from the prior year. The data also shows that adults ages 19-64 received the most services delivered via telehealth, although there was substantial variance across both age groups and states.  

CMS announced amended terms for payments issued under the Accelerated and Advance Payment (AAP) Program. CMS expanded the AAP Program on March 28, 2020 and gave these loans to healthcare providers and suppliers in order to combat the financial burden of the pandemic. Providers were required to make payments starting in August of this year, but with this action, repayment will be delayed until one year after payment was issued.  After that first year, Medicare will automatically recoup 25 percent of Medicare payments otherwise owed to the provider or supplier for eleven months.  At the end of the eleven-month period, recoupment will increase to 50 percent for another six months.

CMS shared a fact sheet with a snapshot of the data from the Accountable Health Communities (AHC) Model. The fact sheet provides information on how the model is implemented and a snapshot of data on demographics of beneficiaries participating in the model as well as their self-reported health-related social needs. The first AHC Model evaluation report is anticipated in 2021 and will include a more in-depth analysis of data from the AHC Model. Some data highlights of this report include: One in three beneficiaries (33 percent) reported at least one core health-related social need. Food needs were the most commonly reported (67 percent of those reporting at least one need), followed by housing (47 percent), transportation (41 percent), and utility assistance (28 percent). Of those screened, 18 percent were eligible for community navigation services, and 76 percent of eligible beneficiaries accepted the navigation assistance.

CMS sent guidance to State Survey Agencies and local emergency response entities regarding testing exercise requirements for activities associated with the COVID-19 PHE. The guidance includes:

• Testing exercise definitions highlighting the differences between workshops, table-top exercises, mock disaster drills, functional exercises, and full-scale exercises;
• Changes to specific testing exercise requirements for inpatient and outpatient providers and suppliers;
• Exemptions from testing due to the presence of an actual emergency; and
• Information regarding the documentation of all drills, tabletop exercises, and any activation of an emergency plan, in addition to documentation showing any revisions to a facility’s emergency plan as a result of an after-action review process.

CMS announced an update to August 26^th guidance for COVID-19 testing in nursing homes. CMS is adjusting the color-coded assessment methodology that the agency uses to determine the rate of county-level COVID-19 positivity in the following manner:

• Counties with 20 or fewer tests over 14 days will now move to “green.”
• Counties with both fewer than 500 tests and fewer than 2,000 tests per 100,000 residents, and greater than 10% positivity over 14 will now move to “yellow.”

September

CMS released new tools to reduce paperwork and authorization delays for laboratories seeking Clinical Laboratory Improvement Amendments (CLIA) certification to test for coronavirus disease 2019 (COVID-19).  CMS’s quick-start guide helps laboratories with the application process for CLIA certification and includes information on the expedited review process implemented at the beginning of the public health emergency that allows labs to start COVID-19 testing before the official paper certificate arrives by postal mail.  Laboratories also have a new option to pay CLIA certification fees on the CMS CLIA Program website.  Online payments are processed overnight, which is substantially faster than hard-copy checks. 

CMS announced today that average 2021 premiums for Medicare Advantage plans are expected to decline 34.2 percent from 2017 while plan choice, benefits, and enrollment continue to increase. The Medicare Advantage average monthly premium will be the lowest in 14 years (since 2007) for the over 26 million Medicare beneficiaries projected to enroll in a Medicare Advantage plan for 2021. Additionally, for the first time, seniors who use insulin will have over 1,600 Medicare Advantage and Part D prescription drug plans to choose from that will offer insulin at no more than a $35 monthly copay beginning in January.  

CMS released preliminary Medicaid and Children’s Health Insurance Program (CHIP) data revealing that, during the coronavirus disease 2019 (COVID-19) public health emergency (PHE), rates for vaccinations, primary, and preventive services among children in Medicaid and CHIP have steeply declined. This decline may have significant impacts on long-term health outcomes for children, as Medicaid and CHIP cover nearly 40 million children, including three quarters of children living in poverty and many with special health care needs that require health services. 

CMS today announced the availability of up to $165 million in supplemental funding to states currently operating Money Follows the Person (MFP) demonstration programs. This funding will help state Medicaid programs jump-start efforts to transition individuals with disabilities and older adults from institutions and nursing facilities to home and community-based settings of their choosing.

CMS  announced that it will expand the Medicare Prior Authorization Model for Repetitive, Scheduled Non-Emergent Ambulance Transport (RSNAT) nationwide. The model has saved Medicare about $650 million over four years while preserving quality of care and access to essential services. The RSNAT Prior Authorization Model tests whether prior authorization—or advanced approval of a service before the service is furnished and before a claim is submitted for payment—helps save Medicare money while maintaining or improving the quality of care for repetitive, scheduled non-emergency ambulance transportation. 

CMS announced it has finalized the End-Stage Renal Disease (ESRD) Treatment Choices (ETC) Model, to improve or maintain the quality of care and reduce Medicare expenditures for patients with chronic kidney disease. The ETC Model encourages an increased use of home dialysis and kidney transplants to help improve the quality of life of Medicare beneficiaries with ESRD. The ETC Model will impact approximately 30 percent of kidney care providers and will be implemented on January 1, 2021 at an estimated savings of $23 million over five and a half years. A fact sheet on the model can be found here. 

CMS released their FEMA SEP in early May, however it is only now coming to the forefront of attention. The SEP announcement was intended to clarify for Medicare Advantage (MA) and Part D plan sponsors that the exceptional conditions Special Enrollment Period (SEP) adopted under 42 CFR 422.62(b)(4) and 423.38(c)(8)(ii) for Individuals Affected by a FEMA-Declared Weather Related Emergency or Major Disaster is applicable and is available for beneficiaries who were eligible for — but unable to make — an election because they were affected by the COVID-19 pandemic and meet the terms of the SEP listed below. Consistent with the President’s emergency declaration pursuant to section 501 (b) of the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121-5207 (the “Stafford Act”) on March 13, 20201 , and the President’s subsequent approval of major disaster declarations in all 50 states and the District of Columbia, this SEP is available nationwide to residents of all states, tribes, territories, and the District of Columbia effective March 1, 2020, as these entities are eligible to apply for Public Assistance.

CMS released the Direct Contracting (DC) Global and Professional Financial Methodology papers, which provide an overview of each component of the financial methodologies of the Direct Contracting model, such as the calculation of the benchmark and other relevant components. Aspects of the papers include:

• A high-level description of the risk arrangements and payment mechanisms that are available to a DCE;
• The DC financial settlement and reconciliation process;
• A background on DC benchmarking components such as risk adjustment and the use of a modified MA Rate Book;
• The decision not to use 2020 data as a reference year due to the COVID-19 public health emergency (PHE), and instead use 2019 data for both 2021 and 2022;
• Methods used to cap risk adjustment growth at 3%, limit risk score growth through retrospective review, and the exceptions to these controls;
• Details for the calculation of the Performance Year (PY) Benchmark, including the development of the historical baseline expenditures, the prospective trend, the geographic adjustment factors, the regional rate, and the blended Benchmark calculation;
• An overview of financial settlement and reconciliation policies, including the application of risk mitigation mechanisms and the timing of the preliminary and final Financial Reconciliation; and
• An overview of the changes to the financial methodology for PY1 to account for the off-cycle performance period running from April through December 2021.

CMS Administrator Seema Verma announced  that the agency is officially withdrawing the proposed Medicaid Fiscal Accountability Regulation (MFAR) rule from the regulatory agenda, citing state and provider partners’ concerns about “potential unintended consequences” of the proposed rule, which require further study. 

CMS released Part I of the 2022 Advance Notice of Methodological Changes for Medicare Advantage (MA) Capitation Rates and Part C and Part D Payment Policies (the Advance Notice). This is being released earlier than usual to accommodate the potential for an earlier release of Part II of the Advance Notice in the Fall, and the release of the Rate Announcement in January instead of April. In Part I, to implement requirements of the 21st Century Cures Act, CMS is proposing to:

• Fully phase in the 2020 CMS-Hierarchical Condition Categories (HCC) model;
• Discontinue using Risk Adjustment Processing System (RAPS) inpatient diagnoses to supplement encounter / Encounter Data Submission data;
• End the blending of encounter data-based and RAPS-based risk scores; and
• Use 100% of the risk score calculated using the 2020 CMS-HCC model and diagnoses from MA encounter data and fee-for-service FFS claims.

CMS received the final report from the independent Coronavirus Commission for Safety and Quality in Nursing Homes (Commission), which was facilitated by MITRE.  CMS also released an overview of the public health actions the agency has taken to date to combat the spread of the coronavirus disease 2019 (COVID-19) in nursing homes. The Commission emerged from its convenings with 27 recommendations and accompanying action steps organized into 10 themes. These themes intersect with the Commission’s four objectives, and reflect responses to:

• Ongoing supply and affordability dilemmas related to testing, screening, and personal protective equipment (PPE).
• Tension between rigorous infection control measures and quality of life issues that exist in cohorting and visitation policies.
• A call for transparent and accessible communications with residents, their representatives and loved ones, and the public.
• Urgent need to train, support, protect, and respect direct-care providers
• Outdated infrastructure of many nursing-home facilities.
• Opportunities to create and organize guidance to owners and administrators that is more actionable and to obtain data from nursing homes that is more meaningful for action and research.
• Insufficient funding for quality nursing home operations, workforce performance, and resident safety.

Each of the 27 Principal Recommendations are deliberately paired with specific action steps. The intent is that CMS would implement each principal recommendation in conjunction with its associated action steps to understand and realize the Commission’s vision. 

CMS released updated Medicaid and Children’s Health Insurance Program (CHIP) data that is used for monitoring program performance and analyzing state and federal payments for services. The Transformed Medicaid Statistical Information System (T-MSIS) data provides information on key topics including service utilization and spending, and supports research and analysis that helps improve quality of care for beneficiaries.

CMS issued guidance to state Medicaid directors designed to advance the adoption of value-based care strategies across their healthcare systems and align provider incentives across payers. Under value-based care, providers are reimbursed based on their ability to improve quality of care in a cost-effective manner or lower costs while maintaining standards of care, rather than the volume of care they provide.  Value-based care arrangements may also permit providers to address social determinants of health, as well as disparities across the healthcare system.  Moving toward a more value-driven healthcare system allows states to provide Medicaid beneficiaries with efficient, high quality care, while improving health outcomes. 

Today CMS launched Care Compare, a streamlined redesign of eight existing CMS healthcare compare tools available on Medicare.gov. Care Compare provides a single user-friendly interface that patients and caregivers can use to make informed decisions about healthcare based on cost, quality of care, volume of services, and other data. With just one click, patients can find information that is easy to understand about doctors, hospitals, nursing homes, and other health care services instead of searching through multiple tools.

August

In late August, CMS issued a proposed rule, the  Medicare Coverage of Innovative Technology (MCIT) (CMS-3372-P). eliminate this lag time for both seniors and innovators. It would create a new, accelerated Medicare coverage process for innovative products that the FDA deems “breakthrough,” which FDA approves on an expedited basis and could include devices harnessing new technologies like implants or gene-based tests to diagnose or treat life-threatening or irreversibly debilitating diseases or conditions like cancer and heart disease. Under the proposal, Medicare would provide national coverage simultaneously with FDA approval, for a period of four years. After that time, CMS may reevaluate the device based on clinical and real-world evidence of improvement in health outcomes among Medicare beneficiaries. This four-year timeline would incentivize the manufacturers of these breakthrough devices to develop additional evidence regarding the applicability of their products to the Medicare population, so they might continue Medicare coverage beyond the initial four years.

CMS today announced efforts underway to support Louisiana and Texas in response to Hurricane Laura. On August 26, 2020, Department of Health and Human Services (HHS) Secretary Alex Azar declared public health emergencies (PHEs) in these states, retroactive to August 22, 2020 for the state of Louisiana and to August 23, 2020 for the state of Texas. 

CMS announced today that it will be implementing a national nursing home training program for frontline nursing home staff and nursing home management. The training is designed to equip both frontline caregivers and their management with the knowledge they need to stop the spread of coronavirus disease 2019 (COVID-19) in their nursing homes. The training announced today will be available immediately to staff of America’s 15,400 Medicare and Medicaid certified nursing homes and focuses on critical topics like infection control and prevention, appropriate screening of visitors, effective cohorting of residents, safe admission and transfer of residents, and the proper use of personal protective equipment (PPE) 

CMS announced it will resume routine inspections of all Medicare and Medicaid certified providers and suppliers to improve the safety and quality of life of patients and residents. CMS had previously suspended certain routine inspections as part of its response to the coronavirus disease 2019 (COVID-19) pandemic to prioritize infection control and immediate jeopardy situations and to give health care providers and suppliers time needed to respond to the spread of COVID-19.

CMS directed the resumption of onsite revisit surveys, non-immediate jeopardy complaint surveys and annual recertification surveys as soon as resources are available. In addition, CMS is providing guidance on resolving enforcement cases that were previously on hold because of survey prioritization changes. The agency will also temporarily expand the desk review policy, when state surveyors ensure that facilities return back into compliance with Federal requirements without an onsite survey, to include all noncompliance reviews except for immediate jeopardy citations that have not been removed.

CMS today announced that the agency has imposed more than $15 million in civil money penalties (CMPs) to more than 3,400 nursing homes during the public health emergency for noncompliance with infection control requirements and the failure to report coronavirus disease 2019 (COVID-19) data. 

CMS proposed updates to coverage policies for artificial hearts and ventricular assist devices (VADs), both of which are used to treat patients with life-threatening advanced heart failure.

Medicare currently covers artificial hearts under the “coverage with evidence development” paradigm when beneficiaries are enrolled in a clinical study. The proposed decision memorandum would eliminate the “coverage with evidence development” requirement and provides for coverage determinations for artificial hearts to be made by local Medicare Administrative Contractors (MACs).  Although a small number of Medicare beneficiaries receive artificial hearts, the technology can save the lives of certain end-stage heart failure patients awaiting heart transplantation. CMS is seeking comments on this proposed national coverage determination.

CMS announced new funding opportunities that will increase access and improve quality in rural health care. The Community Health Access and Rural Transformation (CHART) Model delivers on President Trump’s Executive Order from last week on Improving Rural Health and Telehealth Access as well as the President’s Medicare Executive Order and CMS’s Rethinking Rural Health initiative. 

Per the President’s Executive Order, the CHART Model  is also intended to tie payment to value, increases choice and lowers costs for patients. CHART will empower rural communities to develop a system of care to deliver high quality care to their patients by providing support through new seed funding and payment structures, operational and regulatory flexibilities and technical and learning support.

CMS announced a policy that will allow issuers to offer temporary premium reductions for individuals with 2020 coverage in the individual and small group markets. CMS is providing this additional flexibility to help ensure that consumers struggling to pay their premiums can continue to be covered and receive the care they may need during this time.

CMS is proposing several policies that would give Medicare beneficiaries more choices in where they seek care and lower their out-of-pocket costs for surgeries. The proposed rule takes steps that would allow hospitals and ambulatory surgical centers to operate with better flexibility and patients to have what they need to make informed decisions on where they receive care.

CMS proposes to expand the number of procedures that Medicare would pay for when performed in an ambulatory surgical center (ASC), which would give patients more choices in where they receive care and ensure CMS does not favor one type of care setting over another. For CY 2021, we propose to add eleven procedures that Medicare would pay for when provided in an ASC, including total hip arthroplasty. Since 2018, CMS has added 28 procedures to the list of surgical services that can be paid under Medicare when performed in ASCs.

Additionally, we propose two alternatives that would further expand our goals of increasing access to care at a lower cost. Under the first alternative, CMS would establish a process where the public could nominate additional services that could be performed in ASCs based on certain quality and safety parameters. Under the other proposed alternative, we would revise the criteria used to determine the procedures that Medicare would pay for in an ASC, potentially adding approximately 270 procedures that are already payable when performed in the hospital outpatient setting to the ASC list.

CMS proposed a rule to modify the Medicare Diabetes Prevention Program Expanded Model (MDPP) that would allow the agency to  determine whether an 1135 waiver event could disrupt in-person MDPP services, if MDPP suppliers are unable to conduct classes in-person, or if MDPP beneficiaries would be unable to attend in-person classes, for reasons related to health, safety, or site availability or suitability.

CMS is proposing changes to expand telehealth permanently, consistent with the Executive Order on Improving Rural and Telehealth Access. The Executive Order and proposed rule is intended to improve access and convenience of care for Medicare beneficiaries, particularly those living in rural areas. Additionally, the proposed rule implements a multi-year effort to reduce clinician burden under our Patients Over Paperwork initiative and to ensure appropriate reimbursement for time spent with patients.

July

At the tail-end of July CMS announced three final Medicare payment rules intended to align payment for inpatient psychiatric facilities (IPF), skilled nursing facilities (SNF) and hospices.

• Inpatient Psychiatric Facilities: The final rule updates Medicare payment policies and rates for the IPF Prospective Payment System (PPS) for Fiscal Year (FY) 2021.  In this final rule, CMS is finalizing a 2.2 percent payment rate update and finalizing its proposal to adopt revised Office of Management and Budget (OMB) statistical area delineations resulting in wage index values being more representative of the actual costs of labor in a given area. CMS is finalizing updates to allow advanced practice providers, including physician assistants, nurse practitioners, psychologists, and clinical nurse specialists, to operate within the scope of practice allowed by state law by documenting progress notes in the medical record of patients, for whom they are responsible, receiving services in psychiatric hospitals.

• Skilled Nursing Facilities: The final rule updates the Medicare payment rates and the quality programs for SNFs. These updates include routine technical rate-setting updates to the SNF PPS payment rates, as well as finalizes adoption of the most recent OMB statistical area delineations and applies a 5 percent cap on wage index decreases from FY 2020 to FY 2021. CMS is also finalizing changes to the ICD-10 code mappings that would be effective beginning in FY 2021, in response to stakeholder feedback. CMS projects aggregate payments to SNFs will increase by $750 million, or 2.2 percent, for FY 2021 compared to FY 2020. 

• Hospice: For FY 2021, hospice payment rates are updated by the market basket percentage increase of 2.4 percent ($540 million). Hospices that fail to meet quality reporting requirements receive a 2 percentage point reduction to the annual market basket percentage increase for the year. The hospice payment system includes a statutory aggregate cap. The aggregate cap limits the overall payments made to a hospice annually. The final hospice cap amount for the FY 2021 cap year is $30,683.93, which is equal to the FY 2020 cap amount ($29,964.78) updated by the final FY 2021 hospice payment update percentage of 2.4 percent.

CMS announced the average basic premium for Medicare Part D prescription drug plans, which cover prescription drugs that beneficiaries pick up at a pharmacy. The average basic Part D premium will be $30.50 in 2021. The 2021 and 2020 average basic premiums are the second lowest and lowest, respectively, average basic premiums in Part D since 2013. This trend of lower Part D premiums, which have decreased by 12 percent since 2017, means that beneficiaries have saved nearly $1.9 billion in premium costs over that time. Further, Part D continues to be an extremely popular program, with enrollment increasing by 16.7 percent since 2017.

CMS released its first monthly update of data that provides a snapshot of the impact of COVID-19 on the Medicare population. For the first time, the snapshot includes data for American Indian/Alaskan Native Medicare beneficiaries. The new data indicate that American Indian/Alaskan Native beneficiaries have the second highest rate of hospitalization for COVID-19 among racial/ethnic groups after Blacks. Previously, the number of hospitalizations of American Indian/Alaskan Native beneficiaries was too low to be reported.

The updated data on COVID-19 cases and hospitalizations of Medicare beneficiaries covers the period from January 1 to June 20, 2020. It is based on Medicare claims and encounter data CMS received by July 17, 2020.

Other key data points:

• Black beneficiaries continue to be hospitalized at higher rates than other racial and ethnic groups, with 670 hospitalizations per 100,000 beneficiaries.

• Beneficiaries eligible for both Medicare and Medicaid – who often suffer from multiple chronic conditions and have low incomes – were hospitalized at a rate more than 5 times higher than beneficiaries with Medicare only (719 versus 153 per 100,000).

• Beneficiaries with end-stage renal disease (ESRD) continue to be hospitalized at higher rates than other segments of the Medicare population, with 1,911 hospitalizations per 100,000 beneficiaries, compared with 241 per 100,000 for aged and 226 per 100,000 for disabled.

• CMS paid $2.8 billion in Medicare fee-for-service claims for COVID-related hospitalizations, or an average of $25,255 per beneficiary.

CMS announced that  the U.S. Department of Health and Human Services (HHS) will devote $5 billion of the Provider Relief Fund authorized by the Coronavirus Aid, Relief, and Economic Security (CARES) Act to Medicare-certified long term care facilities and state veterans’ homes (“nursing homes”), to build nursing home skills and enhance nursing homes’ response to COVID-19, including enhanced infection control. This funding could be used to address critical needs in nursing homes including hiring additional staff, implementing infection control “mentorship” programs with subject matter experts, increasing testing, and providing additional services, such as technology so residents can connect with their families if they are not able to visit. Nursing homes must participate in the Nursing Home COVID-19 Training (described below) to be qualified to receive this funding. This new funding is in addition to the $4.9 billion previously announced to offset revenue losses and assist nursing homes with additional costs related to responding to the COVID-19 public health emergency (PHE) and the shipments of personal protective equipment (PPE) provided to nursing homes by the Federal Emergency Management Agency (FEMA).

Building on the initiative HHS announced last week, in which rapid point-of-care diagnostic testing devices will be distributed to nursing homes, and the new funding from the Provider Relief Fund, CMS will begin requiring, rather than recommending, that all nursing homes in states with a 5% positivity rate or greater test all nursing home staff each week. This new staff testing requirement will enhance efforts to keep the virus from entering and spreading through nursing homes by identifying asymptomatic carriers.

More than 15,000 testing devices will be deployed over the next few months to help support this mandate, with over 600 devices shipping this week. Funds from the Provider Relief Fund can also be used to pay for additional testing of visitors.

CMS announced new flexibilities for Federally Qualified Health Centers (FQHCs) and Rural Health Clinics (RHCs) including updated guidance on telehealth payment and how they can apply the Cost Sharing (CS) modifier to preventive services furnished via telehealth.

CMS announced the agency’s targeted approach to provide additional resources to nursing homes in coronavirus disease 2019 (COVID-19) hotspot areas.  Specifically, CMS plans to deploy Quality Improvement Organizations (QIOs) across the country to provide immediate assistance to nursing homes in the hotspot areas as identified by the White House Coronavirus Task Force. QIOs are CMS contractors who work with healthcare providers to help them improve the quality of healthcare they provide to Medicare Beneficiaries.

June

CMS announced a new blanket waiver for the SNF benefit period due to disruptions caused by COVID-19. Such disruptions can affect the benefit by:

• Prevent a beneficiary from having the Qualifying Hospital Stay (QHS)

• Disrupt the process of ending the beneficiary’s current benefit period and renewing their benefits

Emergency waivers of QHS and benefit period requirements under §1812(f) of the Social Security Act help restore SNF coverage that beneficiaries affected by the emergency would be entitled to under normal circumstances.

CMS announced plans to end the emergency blanket waiver requiring all nursing homes to resume submitting staffing data through the Payroll-Based Journal (PBJ) system by August 14, 2020. The PBJ system allows CMS to collect nursing home staffing information which impacts the quality of care residents receive. The blanket waiver was intended to temporarily allow the agency to concentrate efforts on combating COVID-19 and reduce administrative burden on nursing homes so they could focus on patient health and safety during this public health emergency. A memo on the announcement can be found here.

CMS announced the creation of the Office of Burden Reduction and Health Informatics to unify the agency’s efforts to reduce regulatory and administrative burden and to further the goal of putting patients first. The new office is an outgrowth of the agency’s Patients over Paperwork (PoP) Initiative, which is the cornerstone of CMS’s ongoing efforts to implement President Trump’s 2017 executive order to “Cut the Red Tape” and eliminate duplicative, unnecessary, and excessively costly requirements and regulations.

CMS is calling for a renewed national commitment to value-based care based on Medicare claims data that provides an early snapshot of the impact of the coronavirus disease 2019 (COVID-19) pandemic on the Medicare population. Key data points includes:

• End-stage renal disease (ESRD) patients (individuals with chronic kidney disease undergoing dialysis) had the highest rate of hospitalization among all Medicare beneficiaries, with 1,341 hospitalizations per 100,000 beneficiaries. Patients with ESRD are also more likely to have chronic comorbidities associated with increased COVID-19 complications and hospitalization, such as diabetes and heart failure.

• The second highest rate was among beneficiaries enrolled in both Medicare and Medicaid (also known as “dual eligible”), with 473 hospitalizations per 100,000 beneficiaries.

• Among racial/ethnic groups, Blacks had the highest hospitalization rate, with 465 per 100,000. Hispanics had 258 hospitalizations per 100,000. Asians had 187 per 100,000 and whites had 123 per 100,000.

• Beneficiaries living in rural areas have fewer cases and were hospitalized at a lower rate than those living in urban/suburban areas (57 versus 205 hospitalizations per 100,000).

The MITRE Corporation has published the membership of the independent Coronavirus Commission on Safety and Quality in Nursing Homes. CMS, under the leadership of President Trump and his Plan to Open Up America Again, seeks an independent review and comprehensive assessment of the nursing home response to the Coronavirus Disease 2019 (COVID-19) pandemic. The agency tasked MITRE to solicit membership applications, select the members, and facilitate the Commission’s work. The Commission’s review will help inform current and future responses to COVID-19 and potential future infectious disease outbreaks within nursing homes. MITRE will convene and moderate the Commission throughout the summer of 2020. CMS anticipates the Commission’s final report in fall of 2020.

The Commission will conduct a comprehensive assessment of the overall response to the COVID-19 pandemic in nursing homes. Based on its assessment, the Commission will make recommendations on actions and best practices for immediate and future actions.  Three key areas of focus for the Commission include:

• Ensuring nursing home residents are protected from COVID-19 and improving the responsiveness of care delivery to maximize the quality of life for residents;

• Strengthening efforts to enable rapid and effective identification and mitigation of COVID-19 transmission (and other infectious disease) in nursing homes; and

• Enhancing strategies to improve compliance with infection control policies in response to COVID-19.

CMS has instructed Medicare Administrative Contractors and notified Medicare Advantage plans to cover coronavirus disease 2019 (COVID-19) laboratory tests for nursing home residents and patients. This instruction follows the Centers for Disease Control and Prevention’s (CDC) recent update of COVID-19 testing guidelines for nursing homes that provides recommendations for testing of nursing home residents and patients with symptoms consistent with COVID-19 as well as for asymptomatic residents and patients who have been exposed to COVID like in an outbreak. Original Medicare and Medicare Advantage plans will cover COVID-19 lab tests consistent with CDC guidance.

Medicare Advantage plans must continue not to charge cost sharing (including deductibles, copayments, and coinsurance) or apply prior authorization or other utilization management requirements for COVID-19 tests and testing-related services.

CMS released the Establishing Minimum Standards in Medicaid State Drug Utilization Review (DUR) and Supporting Value- Based Purchasing (VBP) for Drugs Covered in Medicaid, Revising Medicaid Drug Rebate and Third Party Liability (TPL) Requirements (CMS 2482-P).  This proposed rule advances CMS’ efforts to support state flexibility to enter innovative value-based purchasing arrangements (VBPs) with drug manufacturers for new expensive therapies, and to provide manufacturers with regulatory flexibility to enter into VBPs with commercial payers, which will benefit Medicaid programs. It also creates minimum standards in state Medicaid Drug Utilization Review (DUR) programs designed to reduce opioid-related fraud, misuse and abuse

CMS issued a proposed rule that would start to remove barriers to the development of payment models based on value for innovative new therapies, particularly those involved in precision medicine. The proposed rule is a bundle of proposals aimed mostly at Medicare Part D in order to provide additional regulatory flexibility to drug manufacturers, with the hope that they will eventually lower drug prices.

These proposals build on the steps that the Trump Administration has already taken to lower drug prices including the following actions:

• In Medicare Part D, which covers prescription drugs that beneficiaries pick up at the pharmacy, the average basic premium for Medicare Part D prescription drug plans was projected to decline 13.5 percent since 2017 to the lowest level in seven years, saving beneficiaries about $1.9 billion in premium costs over that time.

• Announced the Senior Savings Model where, starting in 2021, participating enhanced Part D prescription drug plans across the country will provide Medicare beneficiaries access to a broad set of insulins at a maximum $35 copay for a month’s supply, saving beneficiaries on average $446 for their insulins.

• Allowing Part D plans to substitute certain generic drugs to onto plan formularies more quickly during the year, so beneficiaries immediately have lower cost sharing for these drugs.
• Increasing competition among plans by removing the requirement that certain Part D plans have to “meaningfully differ” from each other, making more plan options available for beneficiaries.

• Providing more information on out-of-pocket costs for prescription drugs to beneficiaries by requiring Part D plans to adopt tools that provide clinicians with information that they can discuss with patients on out-of-pocket drug costs at the time a prescription is written.

• Implementing Part D legislation signed by President Trump to prohibit “gag clauses”, which keep pharmacists from telling patients about lower-cost ways to obtain prescription drugs.

• Approved state plan amendments from eight states to negotiate supplemental rebate agreements involving innovative value-based payment arrangements with drug manufacturers, so states can demand results from manufacturers in exchange for payment.

• Issued guidance intended to help states monitor and audit Medicaid and CHIP managed care plans to identify spread pricing when calculating their medical loss ratio (MLR).

With encouragement from the Trump Administration, CMS released a guide for patients and beneficiaries as they consider their in-person care options. During the height of the pandemic, many healthcare systems and patients postponed non-emergency, in-person care in order to keep patients and providers safe and to ensure capacity to care for COVID-19 patients. 

 The U.S. Department of Health and Human Services (HHS) announced new guidance that specifies what additional data must be reported to HHS by laboratories along with Coronavirus Disease 2019 (COVID-19) test results. The guidance standardizes reporting to ensure that public health officials have access to comprehensive and nearly real-time data to inform decision making in their response to COVID-19. 

CMS posted the first set of underlying coronavirus disease 2019 (COVID-19) nursing home data. On April 19, 2020, CMS announced the requirement that nursing homes to inform residents, their families, and their representatives of COVID-19 cases in their facilities. In addition to this, nursing homes are required to report COVID-19 cases and deaths directly to the Centers for Disease Control and Prevention (CDC) and today CMS is making this data publicly available.

The Trump Administration released new enforcement actions for Nursing Homes with records of persistent infection control issues. The enforcement actions against these Nursing Homes are mostly increasing Civil Monetary Penalties (CMPs) for Nursing Homes with serious and long-standing violations, as well as requiring lower-level violations to file corrective actions plans to CMS.

May

CMS today finalized requirements that will increase access to telehealth for seniors in Medicare Advantage (MA) plans, expand the types of supplemental benefits available for beneficiaries with an MA plan who have chronic diseases, provide support for more MA options for beneficiaries in rural communities, and expand access to MA for patients with End Stage Renal Disease (ESRD). CMS is giving MA plans more flexibility to count telehealth providers in certain specialty areas (such as Dermatology, Psychiatry, Cardiology, Ophthalmology, Nephrology, Primary Care, Gynecology, Endocrinology, and Infectious Diseases) towards meeting CMS network adequacy standards. A fact sheet on the final rule can be found here.

CMS developed two additional codes that laboratories can use to bill for certain COVID-19 lab tests, including serology tests. CMS has updated its guidance to include payment details for additional CPT codes created by the American Medical Association. There is no cost-sharing for Medicare patients.

CMS released additional blanket waivers for hospitals and ground ambulance organizations to:

• Modify existing physical environment waivers to allow for increased flexibilities for surge capacity and patient quarantine at hospitals, psychiatric hospitals, and critical access hospitals as a result of COVID-19; and
• Modify the data collection period and data reporting period for ground ambulance organizations.

CMS announced new guidance for state and local officials to ensure the safe reopening of nursing homes across the country. The guidance details critical steps nursing homes and communities should take prior to relaxing restrictions implemented to prevent the spread of COVID-19, including rigorous infection prevention and control, adequate testing, and surveillance. 

CMS is announced a call for nominations for the new contractor-led Coronavirus Commission on Safety and Quality in Nursing Homes to help inform immediate and future responses to the Coronavirus Disease 2019 (COVID-19) within these facilities. In addition, the agency released a list of FAQs for Nursing Homes re-opening which can be found here.

The independent contractor, MITRE is not-for-profit organization based in Bedford, Massachusetts, and McLean, Virginia. It manages federally funded research and development centers supporting several U.S. government agencies. They are intended to convene the commission and manage all aspects of the process, including nomination and selection of members, facilitating meetings, and independently producing a final report to CMS Administrator Verma regarding findings and recommendations. 

MITRE is soliciting nominees for the commission from health industry professional, clinical, advocacy and consumer organizations known for their nursing home focus and expertise. The contractor is accepting nominations on their Nursing Home Commission Nomination website, where additional information about the Commission and its purpose can also be found.  

CMS released a new toolkit developed to aid nursing homes, Governors, states, departments of health, and other agencies who provide oversight and assistance to these facilities, with additional resources to aid in the fight against the coronavirus disease 2019 (COVID-19) pandemic within nursing homes. The toolkit builds upon previous actions taken by the Centers for Medicare & Medicaid Services (CMS), which provide a wide range of tools and guidance to states, healthcare providers and others during the public health emergency.

CMS recently released additional blanket waivers for Medicare providers to:

• Expand hospitals’ ability to offer long-term care services (“swing beds”);
• Waive distance requirements, market share, and bed requirements for Sole Community Hospitals;
• Waive certain eligibility requirements for Medicare-Dependent, Small Rural Hospitals (MDHs); and
• Update specific life safety code requirements for hospitals, hospice, and long-term care facilities.

The full list of updated blanket waivers for Medicare providers can be found here.

 CMS recently released an Interim Final Rule with Comment Period (IFC) building on the agency’s efforts to give the American healthcare system maximum flexibility to respond to the coronavirus disease 2019 (COVID-19) pandemic. Below is a summary of resources and information available on the rule. View the full rule here.

Updated guidance on reporting requirements for Nursing Homes to provide notifications of confirmed and suspected among residents and staffing was issued by CMS in early May, as part of the agency’s ongoing effort to increase oversight and support the nation’s 15,000 Nursing Homes. The guidance builds upon existing regulation that requires Nursing Homes to report cases of communicable disease to the appropriate local and state health authorities, now however, they must also report the first week of case data to the Centers for Disease Control and Prevention (CDC) beginning May 8 but no later than May 17. For the first time, all 15,000 nursing homes will be reporting this data directly to the CDC through its reporting tool. This reporting requirement is the first action of its kind in the agency’s history. 

As of May 5th, CMS has approved over 145 requests for state relief in response to the COVID-19 pandemic, including recent approvals for Kansas, Maryland, Minnesota, Missouri, Nebraska, Rhode Island, and Wyoming.  24 states have been approved for a Disaster Relief State Plan Amendment (SPA), all 50 states have been approved for at least one 1135 waiver, 37 states have received approval for a 1915(c) Appendix K waiver, and only state each have received approval for a regular SPA and an emergency 1115 waiver (Virginia and Washington respectively).

CMS issued a second set of sweeping regulatory changes that was aimed at providing Medicare telehealth flexibilities for providers and suppliers. In response to requests and clarifications from providers such as physical and occupational therapists, and accountable care organizations CMS released these additional flexibilities to provide regulatory relief. Providers  previously restricted from providing telehealth services for reimbursement can now do so, and CMS is also upping payments for telephone-only telehealth visits. 

Accountable Care Organizations (ACOs)  were also addressed in the changes, with CMS pledging not to financially penalize them for for lower-than-expected health outcomes in their patient populations from COVID-19. Other major changes are related to COVID-19 testing for Medicare and Medicaid beneficiaries. A written practitioner’s order is no longer needed for diagnostic testing for Medicare payment purposes. The agency also said it will cover serology, or antibody testing, including certain FDA-authorized tests that patients self-collect at home. A full press release and list of changes can be found here.

April

Centers for Medicare & Medicaid Services (CMS) announced that it is reevaluating payments Accelerated Payment Program and suspending its Advance Payment Program to Part B suppliers effective immediately. The agency made this announcement following the successful payment of over $100 billion to healthcare providers and suppliers through these programs and in light of the $175 billion recently appropriated for healthcare provider relief payments.

CMS had expanded these temporary loan programs to ensure providers and suppliers had the resources needed to combat the beginning stages of the 2019 Novel Coronavirus (COVID-19). Funding will continue to be available to hospitals and other healthcare providers on the front lines of the coronavirus response primarily from the Provider Relief Fund.

 The Trump Administration released a new toolkit for states to help accelerate adoption of broader telehealth coverage policies in the Medicaid and Children’s Health Insurance Programs (CHIP) during the 2019 Novel Coronavirus (COVID-19) pandemic.  This release builds on the agency’s swift actions to provide states with a wide range of tools and guidance to support their ability to care for their Medicaid and CHIP beneficiaries during this public health emergency. 

CMS and the Assistant Secretary of Preparedness and Response (ASPR)  released a new toolkit for state and local healthcare providers and facilities for workforce flexibilities in the face of COVID-19. This toolkit includes a full suite of available resources to maximize responsiveness based on state and local needs, building on President Trump’s commitment to a COVID-19 response that is locally executed, state managed, and federally supported. This work was developed by the Healthcare Resilience Task Force as part of the unified government’s response to COVID-19. 

CMS announced a host of guidance and press releases this week including guidance on providing essential non-COVID-19 care to patients without symptoms of COVID-19 in regions with low and stable incidence of COVID-19. This is part of Phase 1 in the Trump Administration’s Guidelines for the “Opening Up America” plan. The recommendations update earlier guidance provided by CMS on limiting non-essential surgeries and medical procedures and can be found here.

CMS released a list of new blanket waivers to  support Long-Term Care Hospitals Rural Health Clinics (RHCs), Federally Qualified Health Centers (FQHCs), and Intermediate Care Facilities. Congress and CMS made changes to requirements and payments during the COVID-19 Public Health Emergency, including:

• New payment for telehealth services, including how to bill Medicare
• Expansion of virtual communication services
• Revision of home health agency shortage requirement for visiting nursing services
• Consent for care management and virtual communication services
• Accelerated/advance payments

Additionally, the Administration released new regulatory requirements for Nursing Homes to increase reporting and transparency during COVID-19. CMS will now require nursing homes to report cases of COVID-19 directly to the Centers for Disease Control and Prevention (CDC). This information must be reported in accordance with existing privacy regulations and statute. This measure augments longstanding requirements for reporting infectious disease to State and local health departments. CMS will also require nursing homes to fully cooperate with CDC surveillance efforts around COVID-19 spread. The reporting requirements can be found here.

The Trump Administration announced that Medicare will nearly double payment for certain lab tests that use high-throughput technologies to rapidly diagnose large numbers of 2019 Novel Coronavirus (COVID-19) cases. Medicare will pay laboratories for the tests at $100 effective April 14, 2020, through the duration of the COVID-19 national emergency. Increasing Medicare payment for these tests will help laboratories test in nursing home communities that are vulnerable to the spread of COVID-19. A copy of the official ruling can be found here.

The Center for Medicare and Medicaid Services issued updated infection control guidance in early April for several inpatient and outpatient settings. The new guidance details protocols for nursing homes, hospice facilities, dialysis facilities, home health agencies, Program of All-Inclusive Care for the Elderly (PACE), hospital discharges, and a variety of additional settings. CMS will continue to monitor and review the impact of COVID-19 on clinicians and patients and will update the guidance regularly with new information for current and additional providers and facilities. A full of the updated guidance can be found here.

The Center for Medicare and Medicaid Services Medicare Learning Network hosted a call for Medicare providers and interested stakeholders in early April to go over the basics of 1135 waivers. This call was intended to provide information on how, when, and why providers and/or states should be requesting an individual waiver from the agency to provide services during COVID-19 or when to utilize the blanket waiver authority, as well as considerations the agency makes when approving individual applications.

As of April 8th, CMS has approved 53 1135 waivers in response to COVID-19. The Trump Administration released an array of templates for states including an 1135 template to facilitate rapid request and approval of waiver authorities for State Medicaid, Medicare & CHIP programs in order to respond swiftly to the crisis.

The first week of April saw nearly $34 billion delivered to Medicare providers through expansion of the Accelerated/Advance Payment Program during the COVID-19 crisis. The Accelerated/Advance Payment Program is a loan program funded through the Part A (Hospital Insurance) and Part B (Supplementary Medical Insurance) trust funds to provide immediate relief for providers and suppliers. The payments are available to Part A providers, including hospitals, and Part B suppliers, including doctors, non-physician practitioners and durable medical equipment (DME) suppliers. While most of these providers and suppliers can receive three months of their Medicare reimbursements, certain providers can receive up to six months. A fact sheet about the expanded use of the Accelerated/Advance Payment Program can be found here.

In conjunction with the Trump Administration, CMS released a set of key recommendations for state and local governments to slow the transmission of COVID-19 in nursing facilities. The guidance issued by the Administration seeks to provide  government officials with tools to  increase screening and prevention measures in nursing homes as well as treatment. The recommendations focus on staffing separation, conservation of Personal Protective Equipment (PPE), and regular symptom screening for residents and staff. The full list of recommendations in the guidance can be found here.

March

In late March the Trump Administration released their final interoperability and patient access rules, that focus on increasing data exchange and transparency between providers, payers, and patients. The timeline for these rule changes to take place start in January 2021, and require payers to contract with a third-party developer to create apps where patients can more readily access their health data. A fact sheet about the final rules can be found here.

The Trump Administration released a sweeping array of regulatory changes allowing for hospitals and healthcare facilities to temporarily exercise flexibility in providing care to patients during the COVID-19 crisis. These changes are four-fold; permitting non-hospital buildings and spaces to be used for providing care and quarantine sites to increase hospital capacity, removing healthcare workforce requirement barriers such as in-state license requirements to rapidly increase the workforce, eliminate paperwork and auditing requirements to prioritize patient care, and prioritize telehealth by allowing more than 80% of Medicare services be provided using telehealth channels. Additional information on the new changes from the Administration to address patient surge can be found here. 

CMS released a host of FAQs regarding specific provisions in the Families First Coronavirus Response Act that affects state Medicaid programs such as the enhanced Federal Medical Assistance Percentage Matching (FMAP), as well as on payment guidance and grace periods for issuers offering coverage on the Federally-Facilitated and State-Based Exchanges. While legislation is pending in the House to pass a $2 trillion stimulus package, the Families First Coronavirus Response Act, provided increased match (6.2% from existing match) for all states and territories. A summary of the Families First Coronavirus Response Act can be found here. 

The Trump Administration announced in mid-March as COVID-19 has spread throughout the United States, that it was declaring a state of emergency. In a press release, the Administration stated they were taking “aggressive actions and regulatory flexibilities to help healthcare providers and states respond to and contain the spread of 2019 Novel Coronavirus Disease (COVID-19).” The state of emergency will allow flexibility for state Medicaid agencies, Medicare provider enrollment flexibilities, and waiver flexibilities for hospital and other healthcare facilities.

Through an 1135 waiver, which are used to temporarily modify components of Medicare, Medicaid, and Children’s Health Insurance Program (CHIP) in order to best serve delivery health care products and services to enrollees in these programs during times and locations of an emergency or disaster, states can more rapidly address crisis situations such as COVID-19.[3] A fact sheet about the state of emergency declaration can be found here.

CMS released two virtual toolkits in mid-March for general providers as well as those that provide care to patients with End-Stage Renal Disease. These toolkits are intended to cut down the time that providers take searching for answers to telehealth questions and spend more time with their patients. These guides also provide information on developing telehealth documentation tools, monitoring, and telehealth evaluation processes. The virtual toolkit for general providers can be found here, while the toolkit for ESRD providers can be found here.

CMS released the second phase of the 21^st Century Cures Act, the final HHS Interoperability & Patient Access Rules as part of the Trump Administration’s MyHealthEData initiative in an effort to give patients more control over their health data. The announcement contains two rules, released in conjunction with the National Coordinator for Health Information Technology (ONC) which focuses on giving patients secure access to their health information through standardizing application program interfaces (APIs) to reduce information blocking. This rule contains eight exceptions for payers to utilize the new standardized APIs which can be found here, and is expected to go into full effect January 1^st, 2021.

CMS released an FAQ for Medicaid and CHIP agencies regarding COVID-19. The information highlights the resources available to states, such as the Disaster Preparedness Toolkit developed by CMS specifically for state Medicaid and CHIP agencies, to address a variety of policy and program topics related to eligibility and enrollment, benefits and cost sharing, healthcare workforce, and telehealth. Guidance from the FAQ can be found here.

CMS announced that the Medicare Advantage (MA) Value-Based Insurance Design (VBID) application deadline has been moved to April 24^th, 2020. Value-Based Insurance Design model tests a broad array of MA service delivery and/or payment approaches and contributes to the modernization of MA through increasing choice, lowering cost, and improving the quality of care for Medicare beneficiaries. The VBID Model is intended to allow MA organizations to further target benefit design to enrollees based on chronic condition but also certain socioeconomic characteristics, such as low-income status, including dually eligible beneficiaries. More information on the VBID model can be found here.

February

February started with proposed changes to Medicare Advantage Part D to drug pricing transparency, a central tenet of the Trump Administration’s health care agenda. This proposed rule will require Part D plans to offer real-time drug price comparison tools by 2022. The presumed intent is that Part D plan beneficiaries will be able to achieve lower prescription drug prices by utilizing these comparison tools or find the most-cost effective medication that’s covered under their plan.[2] The associated fact sheet with this proposed rule that provides a summary of the key changes can be found here.

CMS also released a proposed methodology to calculate civil monetary penalties for group and non-group health plans that fail to comply with Medicare Secondary Payer reporting requirements. This methodology was released as part of the Trump Administration’s data policy agenda in respect to health care to protect taxpayers from fraud and abuse. CMS is currently soliciting feedback on the proposed methodology, closing on April 20^th,  which can be found here.

The remainder of February was dominated by COVID-19 (Coronavirus) preparation and announcements. CMS announced in mid-February that HHS and the Office of the Assistant Secretary for Preparedness and Response (ASPR) have partnered with Janssen Research & Development a subsidiary of Johnson & Johnson, to rapidly develop COVID-19 therapeutics.

January

The first week of January saw the final federal exchange enrollment snapshot released, with a total of 8.3 million people enrolled in health coverage for 2020, either through automatic re-enrollment or by selecting a new plan. This fact sheet was followed quickly by the announcement of Federal Health Strategic IT Plan, and its release for public comment. This plan lays out the goals and objectives to ensure that individuals have access to own electronic health information and can utilize it to better manage their own health care. The plan is currently still open for public comment here and is open for submissions until March 18^th.

The end of January contained the major announcements from the agency, with CMS announcing their “Healthy Adult Opportunity Guidance” and the 2021 Notice of Benefit & Payment Parameters (NBPP). The Healthy Adult Opportunity Guidance (HAO) was issued by the Trump Administration in a letter to State Medicaid Directors to encourage states to utilize this demonstration initiative to drastically alter their Medicaid program. The most striking component of the guidance is the proposed option to alter Medicaid’s financing structure from an entitlement program to a block grant where states transition to receiving limited from unlimited match.[1] A fact sheet on the key changes the guidance proposes State’s consider for their Medicaid program can be found here.

In addition to the HAO guidance, the NBPP updates the regulatory and financial standards applied to issuers and exchanges as well as set parameters for the remaining premium stabilization program, risk adjustment. The major changes proposed in the NBPP are as follows:

1. Adjustment to the automatic re-enrollment process so that any enrollee whose premium tax credit (PTC) would be enough to cover their entire premium would be automatically re-enrolled without any PTC unless they returned to their Marketplace for a new eligibility determination.
2. Retaining user fees for Federally Facilitated Marketplaces (FFMs) at 3.0% and 2.5% for State-Based Exchanges using the federal platform (SBM-FPs). HHS sought public comment on whether to reduce these fees to better reflect 2021 premium and enrollment projections as well as lower operational costs due to cuts in outreach, marketing, consumer assistance and plan oversight.
3. New annual reporting obligation on benefit mandates that would require states to report to HHS any additional benefits outside of the Essential Health Benefits (EHBs) that would trigger the ACA requirement of states to defray cost.
4. Retain risk adjustment user fees (about $2.28 per billable member per year) for 2021 based on 2020 data. The risk adjustment model predicts plan liability for an average enrollee based on risk scores.

The changes proposed in the NBPP closed public comment on March 2^nd, as of the 2^nd, 1,086 comments were posted and will be reviewed by CMS in the coming weeks. The public comments on the proposed NBPP can be seen here.

ICYMI

At the end of the last decade, CMS issued a proposed rule called the Medicaid Fiscal Accountability Rule (MFAR) which will drastically alter the way that states can provide local match which is a portion of the non-federal share of spending for state Medicaid budgets. Part of the rule seeks to restructure plan and health-care related taxes which generate the local match that states can put forth to receive matching dollars from the federal government. Therefore, if CMS does not allow provider donations or create a permissible tax class for plans this greatly reduce taxes on plans and providers which generate the local match, potentially leading to a smaller Medicaid budget. A fact sheet on MFAR can be found here.

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Check back here for more updates as CMS continues to release updates, proposed rules.

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Contact Us

To work with us or learn more about Transform Health contact Heather Bates at heather@transformhc.com .

[1] Health Affairs, “The Problematic Law And Policy Of Medicaid Block Grants”, 2019

[2] “Proposed Changes to Medicare Advantage and Part D Will Provide Better Coverage, More Access and Improved Transparency for Medicare Beneficiaries”, 2020

[3] Center for Medicare & Medicaid Services, 1135 Waivers, 2020