Washington Healthcare Update

March 1, 2021

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This week in Washington: The House votes on budget reconciliation while the Senate ponders the Byrd Rule; Senate committees hold hearings on HHS Secretary-designate Becerra’s confirmation.

Congress

Hearings/Markups

House

Senate

Administration

Courts

Reports

Congress

Hearings/Markups

Committee on Budget Marks Up Budget Reconciliation COVID Package

February 22, 2021: The committee marked up legislation from other committees to create the Budget Reconciliation package. The legislation was sent to the House Rules Committee to determine the rule by which the floor would debate the legislation.  

Why this is important: The committee’s role is to take the different pieces passed by other committees and create one bill. This is part of the reconciliation process.

House Energy and Commerce Committee’s Subcommittee on Oversight Hearing: “Pathway to Protection Expanding Availability of COVID-19 Vaccines”

February 23, 2021: The committee reviewed the issues and barriers to creating a larger vaccine supply and getting the supply into the arms of the American people with manufacturers of COVID-19 vaccines.

Find more information and view the hearing here.

Senate Health Equation Labor and Pensions Committee Hearing on the Nomination of Xavier Becerra to be the Secretary of Health and Human Services

February 23, 2021: The committee held a hearing with the nominee to discuss his views on health policy.

Senate Finance Committee Hearing on the Nomination of Xavier Becerra to be the Secretary of Health and Human Services

February 24, 2021: The committee held a hearing with the nominee to discuss his views on health policy. This committee is responsible for reporting the nomination to the full Senate for consideration.

House

House Passes COVID Relief Through Budget Reconciliation

On February 27, the House of Representatives passed 219- 212 the American Rescue Plan, H.R. 1319, a sweeping $1.9 trillion stimulus plan, and sent it to the Senate. Two Democrats joined all of the House Republicans in opposing the legislation. The bill includes $350 billion in aid to states, cities, U.S. territories and tribal governments and increases funding for vaccine distribution and coronavirus testing among many other measures, such as nutritional assistance, housing assistance and $1400 stimulus payments to millions of Americans.   

Prior to consideration, a provision in the Energy and Commerce Committee’s section of the package was removed. That provision allocated $1.8 billion to assisted living centers and other congregate settings to procure tests and other supplies and for vaccines for staff. An amendment offered in House Rules Committee by the Chairman of the House Budget Committee John Yarmuth (D-KY) was incorporated in the legislative text prior to consideration by the full House.

Section by section breakdown of the legislation.

Text of the legislation and amendment made in Rules Committee.

Senate

HELP and Finance Committees Hold Hearings with HHS Secretary-designate Becerra

On Feb. 23, the Senate Health, Education, Labor and Pension Committee (HELP) held a hearing to discuss health policy with the U.S. Health and Human Services Secretary-designate, Xavier Becerra. Republican members questioned his ability to lead the department because he is not a health professional. Despite arguments, many assume he will be confirmed. Issues raised ranged from 340B policies, organ transplant policy and the Affordable Care Act. While the HELP committee held a hearing, the committee does not vote on the nomination.

The Finance Committee held its hearing on Feb. 24. Many members addressed drug prices, drug shortages and the need to address mental health issues as well as positions he took as California’s attorney general in lawsuits addressing contraceptive coverage and the Affordable Care Act. His nomination is expected to be reported favorably to the full Senate for consideration.

Senate Faces Byrd Rule Issues in Advance of Consideration of the American Rescue Plan

On Feb. 26, the U.S. Senate parliamentarian ruled that a provision in the American Rescue Plan does not meet the Byrd Rule test. In essence, the Byrd Rule says that in using budget reconciliation to pass legislation, provisions must have a direct impact – either positive or negative – on federal spending. Budget Reconciliation allows for the Senate to pass legislation with a simple majority and not the usual 60 votes required to pass legislation. The Byrd Rule may be raised against other provisions including subsidies for insurance provided through COBRA. The legislation can only pass in the Senate if all democrats stay united and Vice President Harris breaks the tie vote. Read more about the Byrd Rule here.

The Senate is expected to wrap up consideration of the COVID legislation over the next two weeks. If provisions are stripped out of the House passed package, the House will have to consider the Senate version. The goal of the leadership is to have the bill before the President for signing by March 14.

Drug Importation Legislation Introduced

On Feb. 25, Sens. Grassley (R-IA) and Klobuchar (D-MN) reintroduced the Safe and Affordable Drugs from Canada Act, which would allow individuals to safely import prescription drugs from Canada. This legislation is cosponsored by Sens. Tammy Baldwin (D-WI), Susan Collins (R-ME), Sherrod Brown (D-OH), Maggie Hassan (D-NH), Angus King (I-ME), Patrick Leahy (D-VT), Jeff Merkley (D-OR), Jeanne Shaheen (D-NH), Sheldon Whitehouse (D-RI), Ron Wyden (D-OR) and Gary Peters (D-MI). Companion legislation was introduced in the House of Representatives by Reps. Chellie Pingree (D-ME) and Jaime Herrera Beutler (R-WA).

Administration

Biden Signs Executive Order on Supply Chain

On Feb. 24, President Biden signed an executive order calling for a 100-day review of the U.S. pharmaceutical supply chain to protect finished drug products and active pharmaceutical ingredients against a range of vulnerabilities, including overreliance on foreign competitors and diminished capacity.

The order requires federal agencies to consult with industry and academia as part of the initial review, which White House officials told reporters should help strengthen the supply chain in the long term.

White House to Send Masks to Communities Hit Hard by Pandemic

On Feb. 24, the administration announced plans to distribute free cloth face masks to organizations serving some of the nation’s most vulnerable populations in an effort to help curb COVID-19 infections among underserved communities disproportionately hit by the pandemic. The administration estimates that it will send out 25 million masks at a cost of $68 million for the purpose of getting them to 15 million low-income people from March through May.

HHS Office of Minority Health Holds First Meeting of COVID-19 Health Equity Task Force

On Feb. 26, the HHS Office of Minority Health held the first meeting of the COVID-19 Health Equity Task Force. The COVID-19 Health Equity Task Force was established by Executive Order 13995 and is part of the government-wide effort to identify and eliminate health and social disparities that result in disproportionately higher rates of exposure, illness, hospitalization and death related to COVID-19 in minority populations.

Centers for Medicare and Medicaid Services to Take Action in Texas after Public Health Emergency

On Feb. 17, Health and Human Services Acting Secretary Norris Cochran declared a public health emergency (PHE) for Texas retroactive to Feb. 11, 2021. This action cleared the way for CMS to take several actions. 

Waivers and Flexibilities for Hospitals and other Health Care Facilities: CMS has already waived many Medicare, Medicaid and CHIP requirements for facilities because of the pandemic. The CMS Dallas Survey and Enforcement Division, under the Survey Operations Group, will consider other provider-specific requests for healthcare facilities in Texas. These waivers work to provide continued access to care for beneficiaries. CMS announced last month a new web-based tool that streamlines access for providers in documenting and submitting waiver requests and PHE-related inquiries. 

Dialysis Care: CMS is helping patients obtain access to critical lifesaving services. The Kidney Community Emergency Response (KCER) program has been activated and is working with the End Stage Renal Disease (ESRD) Network (Network 14 –Texas) to assess the status of dialysis facilities in potentially impacted areas. The program will assess issues such as generators, alternate water supplies, education and materials for patients, and more. Patients are educated to have an emergency supply kit on hand, in a waterproof bag, including important personal, medical and insurance information; contact information for their facility; the ESRD NW hotline number; and contact information of those with whom they may stay or for out-of-state contacts. They have also been instructed to have on hand supplies for a three-day emergency diet. The ESRD NW 14 (TX) toll-free hotline number is 877-886-4435, and the KCER hotline number is 866-901-3773. Additional information about the ESRD Network 14 Texas Emergency can be found here.

Ensuring Access to Care in Medicare Advantage and Part D: During a PHE, Medicare Advantage organizations must take steps to maintain access to covered benefits for beneficiaries in affected areas. These steps include allowing Parts A and B and supplemental Part C plan benefits to be furnished at specified non-contracted facilities and waiving, in full, requirements for gatekeeper referrals where applicable. Part D plan sponsors are allowed to take certain actions to ensure pharmacy access during a disaster or state of emergency. 

Special Enrollment Opportunities: CMS encourages people who are seeking health insurance coverage to take advantage of the Federal Health Insurance Exchange special enrollment period currently available now through May 15 on HealthCare.gov. Find more information here. Additionally, individuals who were eligible for another special enrollment period during the Federal Emergency Management Agency (FEMA)-declared emergency period may also qualify for another SEP to gain coverage based on when their coverage could have started if they had been able to enroll sooner. For more information, please visit CMS or FEMA.

Medicare regulations provide a special enrollment period for certain Medicare beneficiaries who reside in the area where an emergency/disaster declaration has been made (or rely on help making health care decisions from someone who lives in the affected area). Medicare beneficiaries who were eligible for another enrollment period, but did not make an election as a result of the emergency, will be able to make the missed enrollment election during the declared emergency/disaster or up to two months after the end of the emergency/disaster. 

Medical equipment and supplies replacements: Under the COVID-19 waivers, CMS suspended certain requirements necessary for Medicare beneficiaries who have lost or had damage to their durable medical equipment, prosthetics, orthotics and supplies because of the PHE. This will help to make sure that beneficiaries can continue to access the medical equipment and supplies they rely on each day. Medicare beneficiaries can contact 1-800-MEDICARE (1-800-633-4227) for assistance. 

Current COVID-19 Waivers: CMS has compiled a list of current waivers already available for health care providers to use during the COVID-19 PHE. These waivers remain available to providers in the state of Texas who have been affected by the consequences of the winter storm. The New 1135 Emergency Waiver and Public Health Emergency (PHE)-related Inquiries Web Tool launched on the CMS Waiver and Flexibilities webpage.

Disaster Preparedness Toolkit for State Medicaid and CHIP Agencies: CMS developed an inventory of Medicaid and CHIP flexibilities and authorities available to states in the event of a disaster. CMS will provide technical assistance to the state upon request in accessing any needed flexibilities. The toolkit also includes resources for Medicaid beneficiaries to assist them in connecting to helpful resources during the emergency. CMS is working closely with the Texas state Medicaid agency to ensure the Medicaid and CHIP beneficiaries have access to care and their needs are being met during these winter storms.

Nursing Home Reporting to the National Healthcare Safety Network (NHSN): CMS expects that nursing home providers will continue to accurately report COVID-19 cases to the NHSN. However, in light of the public health emergency in Texas, CMS will not impose civil money penalties for non-reporting through March 4, 2021, as residents continue to be displaced amid power and water concerns. Any facility that requires extended repairs or arrangements should contact its state survey agency to ensure proper coordination with CMS.

Three-Day Prior Hospitalization: Using the authority under Section 1812(f) of the act, CMS is issuing a separate waiver of the statutory requirement for a three-day prior inpatient hospitalization for coverage of a Skilled Nursing Facilities (SNF) Part A stay, which provides temporary emergency coverage of SNF services without a qualifying inpatient hospital stay, for those people who experience dislocations, or are otherwise affected by the public health emergency.

Emergency Preparedness Requirements: Providers and suppliers are expected to have emergency preparedness programs based on an all-hazards approach. CMS has prepared webinars on emergency preparedness requirements, including topics such as emergency power supply; 1135 waiver process; Best Practices & Lessons Learned from past disasters; Helpful Resources; and more. The webinars are available here.

CMS also compiled a list of Frequently Asked Questions (FAQs) and useful national emergency preparedness resources to assist State Survey Agencies (SAs); their state, tribal, regional, local emergency management partners; and health care providers to develop effective and robust emergency plans and toolkits to assure compliance with the EP rules. 

The tools can be located here and here.

Additional information on the emergency preparedness requirements can be found here.

FDA Approves Johnson & Johnson Vaccine for Emergency Use

On Feb. 24, the Food and Drug Administration (FDA) confirmed the safety of the Johnson & Johnson vaccine against COVID-19, ahead of the meeting to determine whether to grant emergency use authorization.  On Feb. 26, the FDA approved the vaccine for emergency use. 

Find more information here.

The letter authorizing emergency use can be found here.

FDA Releases Guidance for Modifying COVID-19 Vaccines

On Feb. 23, the FDA released guidance for modifying COVID-19 vaccines and tests to target virus variants. In the guidance, the FDA says that clinical trials for booster shots targeting emergence of COVID-19 strains can be narrower than the trials for the original vaccine as long as they demonstrate that the booster provides an immune response.  

The FDA also released guidance on how the variants will impact the agency’s evaluation of COVID-19 tests.   

Find more information:

Emergency Use Authorization for Vaccines to Prevent COVID-19; Guidance for Industry

Policy for Evaluating Impact of Viral Mutations on COVID-19 Tests – Guidance for Test Developers and Food and Drug Administration Staff

Courts

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

U.S. Supreme Court to Take Up Decision to Uphold Trump Administration’s “Gag Rule”

On Feb. 22, the U.S. Supreme Court said it will take up the 9th Circuit Court’s decision to uphold the Trump administration’s so-called “gag rule” that blocks Title X grantees from talking about or referring patients for abortion.

Oral Arguments Unlikely to be Heard on Public Charge Rule

On Feb. 22, the U.S. Supreme Court agreed to hear oral arguments in a case challenging the Trump-era public charge rule, but observers say it is likely the Biden administration will rescind the Trump administration policy before arguments are heard.

Reports

GAO Testimony Before Senate Budget Committee, Low-Income Workers: Millions of Full-time Workers in the Private Sector Rely on Federal Health Care and Food Assistance Programs

The GAO was asked to examine several aspects of working adult Medicaid enrollees and SNAP recipients, including the employers for whom they work. The testimony summarizes the findings from the GAO’s October 2020 report, which examined (1) what is known about the labor characteristics of wage-earning adult Medicaid enrollees and SNAP recipients and (2) what is known about where wage-earning adult Medicaid enrollees and SNAP recipients work.

For more information: GAO-21-410T, LOW-INCOME WORKERS: Millions of Full-Time Workers in the Private Sector Rely on Federal Health Care and Food Assistance Programs

GAO-21-396T, COVID-19: Key Insights from GAO’s Oversight of the Federal Public Health Response

Five relief laws, including the CARES Act, have appropriated $3.1 trillion to address the public health and economic threats posed by COVID-19. The CARES Act also includes a provision for GAO to report on its ongoing monitoring and oversight efforts related to COVID-19. This testimony summarizes GAO’s insights from its oversight of the federal government’s pandemic response in a series of comprehensive reports issued from June 2020 through January 2021. In particular, the statement focuses on the public health response, including testing, vaccines and therapeutics, medical supply chain, health disparities and health data.

For more information: GAO-21-396T, COVID-19: Key Insights from GAO’s Oversight of the Federal Public Health Response

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

Stephanie Kennan, Senior Vice President

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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