Washington Healthcare Update - May 2020 #4

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This week in Washington: The House and Senate are out of session for Memorial Day Weekend. The House returns Wednesday, May 27.

Upcoming Hearings/Markups

Congress

Hearings/Markups

  • House Committee on Appropriations: “Department of Veterans Affairs - Response to COVID-19”
  • Senate Committee on Aging: “Caring for Seniors Amid the COVID-19 Crisis”

House

  • Carter Introduces Bill for 30 Percent Tax Credit to U.S.-Manufactured Drugs, Medical Equipment
  • Energy and Commerce Committee Probes Administration’s COVID-19 Response

Senate

  • Senate Democrats Release Plan to Expand Health Care Coverage & Affordability During COVID-19

Administration

  • HHS: Contract with Phlow for American-Made Drugs to Avoid Shortages
  • FDA, Aetion to Collaborate on Real-World Evidence to Address COVID-19

Proposed Regulations/Guidance

  • FDA: Change in Safety Requirements for Diabetic Drugs
  • CMS: Coordinating Care from Out-of-State Providers for Medicaid-Eligible Children with Medically Complex Conditions – Reopened Comment Period
  • CMS Proposes 2.9 Percent Pay Increase for Inpatient Rehab Facilities

Final Regulations/Guidance

  • CMS: Contract Year 2021 Medicare Advantage and Part D Final Rule
  • CMS: Nursing Home Reopening Recommendations for State and Local Officials
  • CMS: Partnering for Impact: Early Insights from the Accountable Health Communities Model
  • FDA Removes 27 Antibody Tests From the Market

Other

  • MedPac: New Appointments

Reports

  • GAO: Medicare – CMS Should Provide Beneficiaries More Information about Substance Use Disorder Coverage
  • GAO: Science and Tech Spotlight – COVID-19 Testing
  • GAO: Infection Control Deficiencies Were Widespread and Persistent in Nursing Homes Prior to COVID-19 Pandemic

Upcoming Hearings/Markups

Wednesday, May 27, 2020

House Ways and Means Committee: “ The Disproportionate Impact of COVID-19 on Communities of Color”

The House Ways and Means Committee will hold a hearing on how the COVID-19 pandemic is affecting American communities of color. This hearing will take place remotely via Cisco Webex video conferencing.

Find more details on the hearing here.

Hearings/Markups

House Committee on Appropriations: “Department of Veterans Affairs - Response to COVID-19”

Tuesday, May 19: The House Committee on Appropriations, subcommittee on Military Construction, Veterans Affairs, and Related Agencies held a hearing on the response to COVID-19 by the Department of Veterans Affairs, with a witness panel of officials from the VA.

Find more details on the hearing here.

Senate Committee on Aging: “Caring for Seniors Amid the COVID-19 Crisis”

Thursday, May 21: The Senate Committee on Aging held a hearing on caring for senior citizens during the ongoing COVID-19 pandemic.

Find more details on the hearing here.

House

Carter Introduces Bill for 30 Percent Tax Credit to U.S.-Manufactured Drugs, Medical Equipment

On May 22, Rep. Buddy Carter (R-GA) introduced a bill to give a 30 percent tax credit to drug manufacturers and makers of medical gear and diagnostics that are manufactured in the United States. The Manufacturing API, Drugs, and Excipients (MADE) in America Act is sponsored by Reps. Morgan Griffith (R-VA), David McKinley (R-WV), Eric Crawford (R-AR) and Darren Soto (D-FL).

Energy and Commerce Committee Probes Administration’s COVID-19 Response

The House Energy and Commerce oversight subcommittee announced they will spend the next few months investigating the Trump administration’s response to the coronavirus pandemic. The investigation will focus on COVID-19 testing, contact tracing, the supply chain for personal protective gear and vaccine development. The goal is to outline ways to improve the response moving forward.

Senate

Senate Democrats Release Plan to Expand Health Care Coverage & Affordability During COVID-19

On May 22, Sens. Jeanne Shaheen (D-NH) and Tina Smith (D-MN), with Senate Finance Committee Ranking Member Ron Wyden (D-OR) and Senate Health, Education, Labor, and Pensions (HELP) Committee Ranking Member Patty Murray (D-WA), released a plan to expand health care coverage and affordability during the COVID-19 pandemic. In a white paper, the senators outline a series of common sense legislative priorities that the Senate should take up immediately, including expanding premium support through subsidies and tax credits, incentivizing Medicaid expansion in hold-out states and having a special open enrollment period. Their proposal also calls for all COVID-19 treatment costs to be covered, including for the uninsured.

Find the plan here.

Administration

HHS: Contract with Phlow for American-Made Drugs to Avoid Shortages

On May 19, the Department of Health and Human Services (HHS) announced it was awarding a contract up to $812 million to Richmond, VA-based Phlow Corporation to manufacture pharmaceutical ingredients, chemical compounds and generic drugs needed to soften or prevent drug shortages in the U.S. Phlow Corporation is partnering with Civica Rx, Virginia Commonwealth University’s Medicines for All Institute and AMPAC Fine Chemicals. Under the federal contract, Civica Rx will be building its own factory to make more sterile injected drugs at the same site in Virginia where Phlow will have its factory.

FDA, Aetion to Collaborate on Real-World Evidence to Address COVID-19

On May 19, the Food and Drug Administration (FDA) and Aetion, a health care technology company, announced they are working together to study how real-world data can be used to stem the COVID-19 pandemic. The company and FDA will use Aetion’s Evidence Platform to analyze fit-for-purpose data sources to characterize COVID-19 patient populations and their medication use, identify risk factors for COVID-19-related complications and contribute to research on potential interventions. Aetion’s research is to support the FDA’s objectives to explore the natural history of the disease, as well as treatment and diagnostic patterns.

Find more details here.

Proposed Regulations/Guidance

FDA: Change in Safety Requirements for Diabetic Drugs

On March 9, the Food and Drug Administration (FDA) released a draft guidance to no longer require drug manufacturers to conduct large cardiovascular safety studies for all new type 2 diabetes therapies. The FDA is recommending new safety requirements that will focus on evaluations that are broader than heart disease. Companies will need to include at least 4,000 patients exposed to the drug in phase III clinical trials, with at least 1,500 patients exposed to the drug for at least one year and 500 patients exposed to the drug for at least two years.

Find the draft guidance here. Public comments are due by June 8, 2020.

CMS: Coordinating Care from Out-of-State Providers for Medicaid-Eligible Children with Medically Complex Conditions – Reopened Comment Period

As of today, May 4, the Centers for Medicare and Medicaid Services (CMS) reopened the comment period for the request for information (RFI), Coordinating Care from Out-of-State Providers for Medicaid-Eligible Children with Medically Complex Conditions, by 30 additional days. The RFI is to address access to care across state lines in Medicaid for children with medical complexity.

Find the proposed rule here. The new comment period deadline is June 3, 2020.

CMS Proposes 2.9 Percent Pay Increase for Inpatient Rehab Facilities

On April 16, the Centers for Medicare and Medicaid Services (CMS) released a proposal to increase pay for inpatient rehabilitation facilities in fiscal 2021, lift the requirements for postadmission evaluations and allow nonphysician practitioners to provide more services. CMS proposes to increase the inpatient rehabilitation facility payment by 2.9 percent, and proposes to maintain outlier payments at 3 percent of total payments. CMS says this would be an overall $270 million increase in fiscal 2021 relative to fiscal 2020. The proposal includes adoption of the Office of Management and Budget’s (OMB) statistical area delineations and would apply a 5 percent cap on wage index decreases from fiscal 2020 to fiscal 2021.

Find the proposed rule here. Public comments are due by June 15, 2020.

Final Regulations/Guidance

CMS: Contract Year 2021 Medicare Advantage and Part D Final Rule

On May 22, the Centers for Medicare and Medicaid Services (CMS) released a final rule to implement certain changes before the contract year 2021 bid deadline. CMS plans to address the remaining proposals for plan year 2022 later this year. This rule allows Medicare Advantage (MA) plans to increase their telehealth benefits and increase plan options for beneficiaries living in rural areas. MA plans can count telehealth providers in certain specialty areas (such as dermatology, psychiatry, cardiology,ophthalmology, nephrology, primary care, gynecology, endocrinology and infectious diseases) toward meeting CMS network adequacy standards.

The rule implements changes made by the 21st Century Cures Act to permit all beneficiaries with end-stage renal disease (ESRD) the option to enroll in an MA plan starting in 2021. Previously, beneficiaries with ESRD were only allowed to enroll in MA plans in limited circumstances.

CMS is also finalizing proposals to enhance the MA and Part D Star Ratings System to further increase the impact that patient experience and access measures have on a plan’s overall Star Rating.

Find the final rule here.

CMS: Nursing Home Reopening Recommendations for State and Local Officials

On May 18, the Centers for Medicare and Medicaid Services (CMS) announced new guidance for state and local officials for the safe reopening of nursing homes across the country. The guidance details steps nursing homes and communities should take prior to relaxing restrictions implemented to prevent the spread of coronavirus disease 2019 (COVID-19), including infection prevention and control, adequate testing and surveillance.

Find the full guidance here.

CMS: Partnering for Impact: Early Insights from the Accountable Health Communities Model

On May 18, the Centers for Medicare and Medicaid Services (CMS) released a brief on the “Partnering for Impact: Early Insights from the Accountable Health Communities Model.” The Accountable Health Communities (AHC) Model assesses whether joining clinical care and social services can reduce health care utilization and costs for high-risk Medicare and Medicaid beneficiaries. In November 2019, CMS convened 29 bridge organizations participating in the AHC Model and key partners for the second annual AHC meeting to brainstorm and share strategies to address beneficiaries’ health-related social needs. This report includes an overview of those insights and strategies.

Find the report here.

FDA Removes 27 Antibody Tests From the Market

On May 21, the Food and Drug Administration (FDA) removed 27 COVID-19 antibody tests from the market that had been authorized under the March 16 policy that allowed tests to be marketed and distributed without FDA authorization, as long as FDA received notification from manufacturers. The list includes tests that were voluntarily withdrawn by the manufacturers, as well as those for which there are no pending Emergency Use Authorization requests or issued EUAs. The tests on the removal list will not be marketed or distributed.

Find the list here.

Courts

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

Other

MedPac: New Appointments

On May 21, the Government Accountability Office (GAO) announced Michael Chernew will be the new chairman of the Medicare Payment Advisory Commission (MedPac). Chernew is a professor of health care policy at Harvard Medical School and is a member of the National Bureau of Economic Research. Betty Rambur, a professor of nursing, and Wayne Riley, the president of a New York City medical center, are also joining MedPAC as new members.

Three MedPAC members, Kathy Buto, Warner Thomas and Francis Crosson, are leaving the commission as their terms expire this year. Two members whose terms are expiring, David Grabowski and Dana Gelb Safran, were reappointed for another term.

Reports

GAO: Medicare – CMS Should Provide Beneficiaries More Information about Substance Use Disorder Coverage

On May 22, the Government Accountability Office (GAO) released a report on the 5 million Medicare beneficiaries using behavioral health services that the program covers, which include treatments for mental health and substance use disorders. Medicare wants to expand access to substance use disorder treatment, but some beneficiaries may not know these services are covered. Medicare’s coverage of these treatments is not explicitly outlined in the Medicare & You publication, according to the report. GAO recommends that Medicare include in this publication explicit information on covered services for beneficiaries with substance use disorders.

Find the full report here.

GAO: Science and Tech Spotlight – COVID-19 Testing

On May 20, the Government Accountability Office (GAO) released a spotlight on the three types of FDA-authorized COVID-19 tests. Molecular and antigen tests help diagnose active infections. Molecular tests look for the virus’s genetic material, while antigen tests look for unique parts of the virus. Results can be used for quarantines, routing supplies, etc. Serology tests look for antibodies in the blood to help determine prior exposure. So far, FDA has authorized at least 56 molecular tests and 12 serology tests for emergency use. It recently authorized one antigen test as well. Accuracy varies among all of the tests.

Find the full report here.

GAO: Infection Control Deficiencies Were Widespread and Persistent in Nursing Homes Prior to COVID-19 Pandemic

On May 20, the Government Accountability Office (GAO) released a report that prior to the COVID-19 pandemic, most nursing homes were cited for infection prevention and control deficiencies (82 percent of those surveyed from 2013-2017). About half of these homes had persistent problems and were cited across multiple years. The report is a response to an inquiry by Sen. Ron Wyden (D-OR), ranking member of the Senate Finance Committee.

Find the full report here.


If you have any questions, contact the following individuals at McGuireWoods 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 and economic development, strategic communications & grassroots, and government relations services. McGuireWoods Consulting is a subsidiary of the McGuireWoods LLP law firm and has been named in The National Law Journal's special annual report, "The Influence 50," for the past several years. In the most recent report, McGuireWoods Consulting was ranked 15th of the 1,900 government relations firms in Washington, D.C.

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