Washington Healthcare Update

November 2, 2020

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This week in Washington: Washington is relatively quiet because of Election Day on Tuesday, Nov. 3rd.

Congress 

Senate

Administration

Proposed Regulations/Guidance

Final Regulations/Guidance

Senate

Grassley, Hassan Introduce Bipartisan Legislation to Increase Transparency and Accountability within the Federal Government

On Oct. 26, Sens. Chuck Grassley (R-IA) and Maggie Hassan (D-NH), along with Reps. Ted Lieu (D-CA) and Jody Hice (R-GA), introduced bipartisan legislation to increase transparency and accountability within the federal government. The Oversight.gov Authorization Act would formally authorize the establishment and maintenance of a website to help the public more easily access reports that have been generated by the independent work of Inspectors General (IGs). Additionally, the bill would improve accountability over funds related to COVID-19 federal spending and the work of the Pandemic Response Accountability Committee by bolstering the webpage dedicated to housing this information as mandated under the CARES Act.

Find the bill here.

Administration

CMS Advances Seven Finalists in Artificial Intelligence Health Outcomes Challenge

On Oct. 29, the Centers for Medicare and Medicaid Services (CMS) announced seven finalists who will advance to the final round of the Artificial Intelligence (AI) Health Outcomes Challenge. This multistage competition launched last year with more than 300 entities proposing AI solutions for predicting patient health outcomes aimed at revolutionizing health care for potential use by the CMS Center for Medicare and Medicaid Innovation. 

In this last stage of the competition, the seven finalists will further develop algorithms that demonstrate how AI tools can be used to predict unplanned hospital and skilled nursing facility admissions and adverse events, and also will develop predictive algorithms for a standard target to be selected by CMS. CMS will announce the grand prize winner (who will receive up to $1 million in prize money) and runner-up (who will receive up to $230,000 in prize money) by the end of April 2021.

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 to Make COVID-19 Vaccines, Treatments Free for Medicare Beneficiaries

On Oct. 28, the Centers for Medicare and Medicaid Service (CMS) announced that the COVID-19 vaccines would be free to all Medicare beneficiaries. Medicare will cover, in entirety, the up to $2.6 billion cost of paying doctors to administer coronavirus vaccines, and doctors will bill traditional Medicare for all beneficiaries so private Medicare Advantage plans do not need to cover the cost. CMS will also make antibodies and other COVID-19 treatments free to seniors by paying hospitals extra for using newly approved or authorized COVID-19 treatments and by paying outpatient providers for those products separately from bundled payments.

Medicare will pay doctors $28.39 to administer coronavirus vaccines. For vaccines that require two doses, Medicare will pay $16.95 for the first dose and $28.39 for the second dose. These rates will be geographically adjusted and recognize the costs involved in administering the vaccine, according to an interim final rule.

HHS Rewards 10,000-Plus Nursing Homes for COVID-19 Mitigation

On Oct. 28, the Department of Health and Human Services (HHS) announced more than $330 million will be distributed this week to nursing homes that HHS determined made significant reductions in COVID-19 cases and deaths in their facilities between August and September. There will be four more opportunities for nursing homes to qualify for the incentive funds.

Find more information here.

Round 2021 of Competitive Bidding Will Only Include Knee, Back Braces

On Oct. 27, the Centers for Medicare and Medicaid Services (CMS) announced it is only awarding competitive bidding contracts to durable medical equipment (DME) suppliers for off-the-shelf back and knee braces. CMS announced that it is not delaying the 2021 competitive bidding program for other DME categories and left them out for now because their inclusion would not save enough money. The announcement came the same day CMS released the proposed 2021 DME pay rule, but that rule did not include information on when competitive bidding would go back into effect for the product areas left out of the 2021 bidding round.

2021 Contract for Federal Exchange Plans Includes “Exit” Clause

On Oct. 26, the Centers for Medicare and Medicaid Services (CMS) released an overview of the Federal Health Insurance Exchange Open Enrollment Period that runs from Nov. 1, 2020, to Dec. 15, 2020, for coverage starting on Jan. 1, 2021. The contract between the federal government and insurers who will be selling plans on the federal exchange in 2021 includes a new clause that says the plans might have cause to end their agreement if the Affordable Care Act (ACA) ends the tax credits.

Find more information here.

FDA Lists Essential Medicines Required by Trump’s “Buy American” Executive Order

On Oct. 30, the Food and Drug Administration (FDA) released a list of essential medicines to ensure the U.S. has adequate supplies for treating severe injuries or illnesses during a public health emergency, such as an infectious disease outbreak or chemical, biological or nuclear attack. The FDA’s list includes 223 drugs and biologics, including the active ingredients in Tylenol and Advil; pain drugs like morphine; rabies and tetanus vaccines; and multiple antibiotics to treat infections. Medical devices are also on the list, including 96 considered to be medical countermeasures, such as instruments for monitoring vital signs and vaccine delivery devices.

Find the list here.

FDA Will Use Organ-Chips to Study COVID-19 Severity, Immunity

On Oct. 29, the Food and Drug Administration (FDA) entered into a three-year collaborative agreement with Emulate under which multiple centers within FDA will study the biotechnology company’s Organ-Chips technology to evaluate COVID-19 vaccines and therapies. The centers will also study the human immune response to SARS-CoV-2, and will use the Organ-Chips technology for other key areas of drug research, including Alzheimer’s, microbiome health and liver-induced toxicity. This Cooperative Research and Development Agreement is separate from the 2017 CRADA under which FDA used the Organ-Chips technology to simulate and monitor human organs’ reactions to ingredients in foods, cosmetics and supplements.

FDA Clears AstraZeneca to Resume U.S. COVID-19 Vaccine Trials

On Oct. 23, the Food and Drug Administration (FDA) cleared AstraZeneca to restart its phase 3 COVID-19 vaccine trial, which was put on hold in early September after a trial participant in the United Kingdom experienced a serious neurological adverse event. Though the company resumed its trials in several other countries last month, the U.S. trials remained on hold as FDA expanded its investigation. AstraZeneca is one of two leading COVID-19 vaccine makers that had trials put on hold. The second company, Johnson & Johnson, has yet to resume its trials, which were put on hold in mid-October, but reports have indicated the company expects the trials will soon be given the go-ahead to resume.

FDA Vaccine Panel Argues Against Unblinding COVID-19 Vaccine Trials

On Oct. 22, the Food and Drug Administration (FDA) vaccine advisors panel disagreed with COVID-19 vaccine manufacturers who claim they might have to unblind their placebo-controlled phase 3 trials should a vaccine become available through emergency use authorization (EUA). In siding with FDA, which has said trials should remain blinded for as long as possible even after an EUA is issued, the panel said that limited vaccine availability coupled with targeted distribution and low vaccine confidence make it unlikely there will so much demand for an initial vaccine that trials would need to be unblinded.

Proposed Regulations/Guidance

Fourth COVID-19 Interim Final Rule with Comment Period

On Oct. 28, the Centers for Medicare and Medicaid Services (CMS) released another interim final rule in anticipation of the COVID-19 vaccine. The interim final rule announces that states must maintain enrollment only of validly enrolled beneficiaries in one of three tiers of coverage, with coverage maintained through the end of the month in which the COVID-19 public health emergency ends. The rule also allows that states seeking a 1332 waiver during the COVID-19 pandemic could request an expedited review of their application, and a shortened public comment period.

The Section 1332 waivers allow states to request exemptions from various Affordable Care Act (ACA) requirements and implement their own reforms. The interim final rule lays out CMS’s plan to provide free coverage of COVID-19 vaccines and therapeutics, and also lets the Department of Health and Human Services (HHS), the Department of Treasury and states modify the requirement to hold public comment periods to discuss the progress of a 1332 waiver. This rule is meant to prevent the spread of COVID-19 by limiting the need for the states to hold the public hearings required as part of the waiver application. The policy is effective immediately, although the Trump administration will be taking comments for 60 days.

Find the interim final rule here.

Medicare CY 2021 Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) Policy Issues and Healthcare Common Procedure Coding System (HCPCS) Level II Proposed Rule

On Oct. 27, the Centers for Medicare and Medicaid Services (CMS) proposed a durable medical equipment (DME) pay rule that would permanently increase pay for rural areas, expand coverage of continuous glucose monitors (CGMs), codify procedures for determining pay for new DME and expand coverage of external infusion pumps for certain drugs. The proposed rule asks for feedback on whether CMS should continue its current pay method for DME equipment that has essentially been removed from the bid program until that equipment goes back into bidding. If finalized, the rule would classify all CGMs as DME and establish payment amounts for the items and related supplies.

Find the proposed rule here, which will be posted on the Federal Register on Nov. 4, 2020.

Courts

Find a comprehensive look at “Courts and Healthcare Policy in 2020” here.

Final Regulations/Guidance

CMS: Transparency in Coverage Final Rule

On Oct. 29, the Department of Health and Human Services (HHS), the Department of Labor and the Department of the Treasury released the Transparency in Coverage final rule. Under the new rule, a process is set up to allow plans that encourage consumers to shop for services from lower-cost providers to share the resulting savings with consumers, and to take credit for those shared savings payments in their medical loss ratio (MLR) calculations.

In the new rule, most non-grandfathered group health plans and insurers offering such coverage in the individual and group markets will be required to make personalized out-of-pocket cost information and underlying negotiated rates for all covered items and services available to enrollees through an internet-based self-service tool, as well as through a paper form upon request. Pricing information on an initial list of 500 services, determined by the Departments of Labor, Treasury and HHS that finalized the rule, will need to be available on such a tool by the start of 2023. Information on all other services and items will need to be available to enrollees by 2024.

Find the final rule here.

CMS Finalizes Calendar Year 2021 Payment and Policy Changes for Home Health Agencies and Calendar Year 2021 Home Infusion Therapy Benefit

On Oct. 29, the Centers for Medicare and Medicaid Services (CMS) finalized routine updates to the home health payment rates for calendar year (CY) 2021, and finalized the regulatory changes related to the use of telecommunications technology in providing care under the Medicare home health benefit. This rule adopts the revised Office of Management and Budget (OMB) statistical area delineations as described in OMB Bulletin 18-04, and finalizes a 5 percent cap on wage index decreases in CY 2021.

This rule also finalizes Medicare enrollment policies for qualified home infusion therapy suppliers, updates the home infusion therapy services payment rates for CY 2021 and finalizes a policy excluding home infusion therapy services from home health services as required by law. The rule also finalizes policies under the Home Health Value-Based Purchasing Model published in the May 8, 2020, interim final rule with comment period, as required by law.

Find the final rule here.

If you have any questions, contact the following individuals atMcGuireWoods Consulting:

Stephanie Kennan, Senior Vice President
Mariam Eatedali, Research Associate

Founded in 1998,McGuireWoods Consulting LLC(MWC) is a full-service public affairs firm offering infrastructure andeconomic development, strategic communications & grassroots, and governmentrelations services. McGuireWoods Consulting is a subsidiary of theMcGuireWoods LLPlaw firm and has been named in The National Law Journal’s special annualreport, “The Influence 50,” for the past several years. In the most recentreport, McGuireWoods Consulting was ranked 15th of the 1,900 governmentrelations firms in Washington, D.C.

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