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Sep 28, 2020

Washington Healthcare Update

This week in Washington: House passes bipartisan continuing resolution (CR) to avoid government shutdown; Senate set to pass the CR this Tuesday.

Upcoming Hearings/Markups

Congress

Hearings/Markups

House

Administration

Proposed Regulations/Guidance

Other

Reports


Upcoming Hearings/Markups

Sept. 30, 2020

House Committee on Energy and Commerce: Pathway to a Vaccine – Ensuring A Safe and Effective Vaccine People Will Trust

The Subcommittee on Oversight and Investigations of the Committee on Energy and Commerce will hold a hearing with status updates on the COVID-19 vaccine’s development.

Find more information on meeting here.

Oct. 2, 2020

Select Subcommittee on the Coronavirus Crisis: Hybrid Hearing With Secretary Of Health And Human Services Alex M. Azar II

The Select Subcommittee on the Coronavirus Crisis, chaired will hold a hearing with Secretary Alex Azar on the Department of Health and Human Services’ response to the coronavirus pandemic. The hearing will examine the Trump Administration’s handling of scientific studies at the Centers for Disease Control and Prevention (CDC) and Food and Drug Administration (FDA), transparency concerns and critique of the national plan to contain the coronavirus.

Find more information on meeting here.

Hearings/Markups

House Committee on Rules: Legislative Meeting

Sept. 21, 2020: The House Committee on Rules met to discuss the rule by which the continuing resolution will be considered on the floor of the House.

  • H.R. 8337 — Continuing Appropriations Act, 2021 and Other Extensions Act

Find more information on meeting here.

Why this is important: The continuing resolution (CR) passed the House, 359-57. The bill is set to be considered by the Senate on Tuesday.

Senate Committee on Health, Education, Labor and Pensions: COVID-19: An Update on the Federal Response

Sept. 23, 2020: The Senate Committee on Health, Education, Labor and Pensions held a hearing for a COVID-19 federal response update.

Find more information on the hearing and panel here.

Why this is important: This hearing took place as the Government Accountability Office’s (GAO) latest report showed that the Department of Health and Human Services (HHS) federal response to COVID-19 needs improvement.

House

House Passes Bipartisan Continuing Resolution (CR) to Fund Government

On Sept. 22, the House passed a continuing resolution (CR) to avoid a government shutdown, 359-57. The bipartisan CR will fund the government until Dec. 11. The CR is scheduled to be voted on in the Senate on Sept. 29, the day before the funding deadline. It is expected to pass the Senate.

The CR includes a number of health care provisions. The legislation funds community health centers, national health services corps and teaching hospitals that operate graduate medical education programs. The legislation also provides clarification that drugs used in medication-assisted treatment can continue to get Medicaid rebates and provides an increase in funding for the Medicaid improvement fund, protection of Medicare beneficiaries from an expected Part B premium hike and extension of FDA’s rare pediatric disease priority review voucher program.

In addition, the legislation includes Medicare and Medicaid extenders including delaying cuts in Medicaid disproportionate share hospitals, the Money Follows the Person demonstration and the Community Mental Health demonstration. 

The legislation also provides some relief for Medicare providers by extending the deadline and lowering interest for certain COVID-19 provider relief payments.

Find H.R. 8337 (Continuing Resolution) here.

House Passes 10 Health Care-Related Bills

On Sept. 21, the House passed 10 bills that had been reported to the House for consideration from the House Energy and Commerce Committee. All passed on a voice vote. The bills address the maternal mortality crisis, study and prevention of sudden infant and child death, ensure Medicaid beneficiaries have access to non-emergency medical transportation and support programs to prevent self-harm and suicide. In addition, the legislation includes efforts to strengthen the Strategic National Stockpile and legislation to further develop a national continuous pharmaceutical manufacturing industry and permit the Food and Drug Administration to destroy unsafe medical devices. The bills passed are:

  • H.R. 4866, the “National Centers of Excellence in Continuous Pharmaceutical Manufacturing Act of 2019,” introduced by Chairman Pallone and Rep. Brett Guthrie (R-KY). The legislation would amend the 21st Century Cures Act to direct FDA to designate National Centers of Excellence (NCEs) in Continuous Pharmaceutical Manufacturing. NCEs would work with FDA and industry to craft a national framework for continuous manufacturing implementation, including supporting additional research and development of this technology, workforce development, standardization and collaborating with manufacturers to support adoption of continuous manufacturing. The bill authorizes $80 million to be appropriated for NCEs each year from fiscal year (FY) 2021 through FY 2025.
  • H.R. 7574, the “Strengthening America’s Strategic National Stockpile Act of 2020,” introduced by Reps. Elissa Slotkin (D-MI) and Susan Brooks (R-IN). The legislation would make several improvements to the Strategic National Stockpile (SNS) and incorporates language from a number of bipartisan bills introduced in the 116th Congress. Specifically, the bill would improve the financial security of the SNS by authorizing the sale of products to other federal departments or agencies from within six months of product expiration. It would also improve the ability of the SNS to maintain and procure medical supplies by requiring the Secretary of Health and Human Services (HHS) to ensure that the contents of the SNS are in good working order and, as necessary, conduct maintenance on contents of the stockpile, among other provisions.
  • H.R. 2271, the “Scarlett’s Sunshine on Unexpected Death Act,” introduced by Reps. Gwen Moore (D-WI), Tom Cole (R-OK) and Jamie Herrera Beutler (R-WA). The legislation would require the Centers for Disease Control and Prevention (CDC) to revise the Sudden Unexplained Infant Death Investigation Reporting Form, authorize CDC to award grants to improve the completion of comprehensive death scene investigations for sudden unexplained infant death (SUID) and sudden unexplained death in children (SUDC), to increase the rate of comprehensive, standardized autopsies in cases of SUID and SUDC and to train medical examiners, coroners, death scene investigators, law enforcement and health professionals on standard death scene investigation protocols. The bill authorizes grants through the Health and Resources and Services Administration (HRSA) related to SUD and SUID.
  • H.R. 4995, the “Maternal Health Quality Improvement Act of 2019,” introduced by Reps. Eliot Engel (D-NY), Larry Bucshon (R-IN), Xochitl Torres Small (D-NM), Bob Latta (R-OH), Alma Adams (D-NC) and Steve Stivers (R-OH). The legislation creates new programs in the Public Health Service Act to improve maternal health, including programs to strengthen maternal health quality and access to care in rural areas, programs to address racial and ethnic disparities in maternal health outcomes, and grants to implement best practices in maternal health care and strengthen training programs.
  • H.R. 3935, the “Protecting Patients Transportation to Care Act,” introduced by Reps. Buddy Carter (R-GA), Tony Cárdenas (D-CA), Tom Graves (R-GA) and Sanford Bishop of (D-GA). The legislation would amend the Medicaid statute to include non-emergency medical transportation (NEMT) in the list of mandatory Medicaid benefits by codifying current Medicaid NEMT regulations. The bill would also require state Medicaid programs to have in place a utilization management process for the benefit.
  • H.R. 1646, the “Helping Emergency Responders Overcome Act of 2019” or the “HERO Act of 2019,” introduced by Rep. Ami Bera (D-CA). The legislation would create a data system at CDC to capture public safety officer suicide incidences and study successful interventions, authorize grants for peer support behavioral health and wellness programs within fire departments and emergency medical service agencies and require the development of best practices for addressing post-traumatic stress disorder (PTSD) in public safety officers and educational materials.
  • H.R. 4564, the “Suicide Prevention Lifeline Improvement Act of 2019,” introduced by Reps. John Katko (R-NY), Don Beyer (D-VA) and Grace Napolitano (D-CA). The legislation would increase the authorization funding level of the National Suicide Prevention Lifeline program to $50 million each year, from FY 2020 through FY 2022. The bill also directs HHS to establish a plan for maintaining the program and includes a pilot program to research, analyze and employ various innovative technologies and platforms for suicide prevention.
  • H.R. 4585, the “Campaign to Prevent Suicide Act,” introduced by Reps. Beyer and Greg Gianforte (R-MT). The legislation would direct HHS, in coordination with CDC and the Substance Abuse and Mental Health Services Administration (SAMHSA), to carry out a national suicide prevention media campaign to advertise the new 9-8-8 number, when it becomes effective, raise awareness for suicide prevention resources and cultivate a more effective discourse on how to prevent suicide. The bill would also provide guidance to TV and social media companies on how to talk about suicide by creating a best practices toolkit.
  • H.R. 5619, the “Suicide Prevention Act,” introduced by Reps. Chris Stewart (R-UT) and Matsui. The legislation would establish two grant programs to prevent self-harm and suicide. The first program would authorize CDC to award grants to state, local and tribal health departments to expand surveillance of self-harm and the second program would authorize SAMHSA to award grants to hospital emergency departments for programs to prevent self-harm and suicide attempts among patients after discharge.
  • H.R. 5663, the “Safeguarding Therapeutics Act,” introduced by Reps. Guthrie and Eliot Engel (D-NY). The legislation would extend FDA’s administrative destruction authority to medical devices, which would allow FDA to destroy certain imported medical devices, such as diagnostic tests or surgical masks in instances where FDA believes such medical devices are adulterated, misbranded or unapproved and may pose a threat to the public health, as the agency currently does with regard to drugs. 

Administration

President Trump Signs Two Executive Orders on “An America-First Healthcare Plan”

On Sept. 25, President Donald Trump announced two new health care executive orders. The orders seek to protect pre-existing conditions and prevent surprise billing. However, the orders will have minimal impact. The surprise billing order requires Congress to pass legislation. Pre-existing conditions are protected under the Affordable Care Act, legislation the president is currently fighting to end through the courts.  

Find the executive order on pre-existing conditions here.

Trump Administration Announces Low Medicare Advantage Premiums

On Sept. 24, the Centers for Medicare and Medicaid Services (CMS) announced Medicare Advantage premiums are set to be at their lowest rate since 2007. Premiums are expected to decline 11 percent in 2021 compared to plan year 2020, decreasing from $23.63 to an estimated $21 per month on average, according to the Centers for Medicare & Medicaid Services (CMS). Medicare Advantage premiums have decreased by an estimated 34.2 percent since 2017, according to CMS.

The announcement comes weeks before the annual open enrollment period for Medicare. About 26 million people are projected to enroll in Medicare Advantage. The trending lower Medicare Advantage premiums have saved beneficiaries nearly $1.5 billion since 2017, CMS said.

In addition, more than 1,600 Medicare Advantage and Part D prescription plans will cap insulin monthly copays at no more than $35.

Trump Administration to Give Medicare Beneficiaries Drug Discount Cards Before Election

On Sept. 24, the Trump administration announced it plans to hand out $200 discount cards to help Medicare Part D beneficiaries cover their copays in the coming weeks. Aides suggested that the nearly $7 billion cost of the plan could be paid for by the president’s proposal to lower drug costs, a program that has not been implemented.

Trump Administration: Public Charge Rule to Be Enforced Retroactively

On Sept. 23, the Department of Homeland Security announced it will resume implementing its public charge rule nationwide, including applying it retroactively. This announcement came after the U.S. Court of Appeals for the Second Circuit ruled that a stay on the rule in three states can be lifted. The rule expands federal immigration authorities’ ability to deny green cards or visas to legal immigrants based on their potential use of government benefits, including Medicaid.

CMS Announces New Federal Funding for 33 States to Support Transitioning Individuals From Nursing Homes to the Community

On Sept. 23, the Centers for Medicare and Medicaid Services (CMS) 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.

Find more information here.

HHS Rejects GAO’s Finding That COVID-19 Supply Chain Issues Persist

On Sept. 22, the Department of Health and Human Services (HHS) dismissed the Government Accountability Office’s (GAO) findings that COVID-19 supply chain issues persist and that there is a need for coordination and transparency. The GAO reported that personal protective equipment and testing supplies are still in short supply due to the country’s limited domestic production and high global demand. The report recommends HHS and Federal Emergency Management Agency (FEMA) work together to help states track their supply request status so they know which orders are pending and what else they need to order.

OMB Starts Reviewing Second Part of 2022 MA, Part D Advance Notice

On Sept. 22, the Office of Management and Budget (OMB) started reviewing the second part of the Medicare Advantage and Part D rate notice and pay policies for 2022.

Proposed Regulations/Guidance

CMS Releases Guidance to Drug Manufacturers Participating in the Medicaid Drug Rebate Program on the Importation of Certain Drugs

On Sept. 24, the Centers for Medicare and Medicaid Services (CMS) released guidance to drug manufacturers that participate in the Medicaid Drug Rebate Program (MDRP) on the MDRP requirements relating to the importation of certain drugs under the Federal Food, Drug, and Cosmetic Act (FFDCA) Section 801 importation guidance. The guidance answers questions regarding the Food and Drug Administration’s (FDA) final guidance titled “Importation of Certain FDA-Approved Human Prescription Drugs, Including Biological Products, and Combination Products.”

Find more information here.

CMS Proposes to Expand Telehealth Benefits Permanently for Medicare Beneficiaries Beyond the COVID-19 Public Health Emergency

On Aug. 4, the Centers for Medicare and Medicaid Services (CMS) proposed permanently extending the availability of certain telemedicine services after the COVID-19 public health emergency (PHE) ends, giving Medicare beneficiaries access to health care particularly in rural areas where access to health care providers may otherwise be limited. CMS is proposing to permanently allow some telehealth services, including home visits for the evaluation and management of a patient (in the case where the law allows telehealth services in the patient’s home), and certain types of visits for patients with cognitive impairments. CMS is seeking public input on other services to permanently add to the telehealth list.

The billing and coding requirements for Evaluation and Management (E/M) (or office/outpatient visits) make up 20 percent of the spending under the Physician Fee Schedule. Simplified coding and billing requirements for E/M visits will go into effect Jan. 1, 2021. In this rule, CMS is proposing to increase the value of many services that are comparable to or include office/outpatient E/M visits such as maternity care bundles, emergency department visits, end-stage renal disease capitated payment bundles, physical and occupational therapy evaluation services and others.

Find the proposed rule here. Public comments are due by Oct. 5, 2020.

Courts

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

Other

New Expanded Access eRequest App Allows Physicians to Submit EA Requests Online

On Sept. 23, the Reagan-Udall Foundation for the Food and Drug Administration (FDA), with input from experts at FDA, launched Expanded Access eRequest to streamline expanded access for individual patients in non-emergency settings. The eRequest online app walks physicians and other health care providers screen-by-screen through the expanded access process—from determining if expanded access is appropriate for their patient to submitting the request to FDA. Physicians can identify potential investigational therapies; access sponsor information; complete, sign and submit FDA Form 3926; upload supporting documentation; and review additional resources, all in one place.

Reports

GAO: VA Vet Centers - Evaluations Needed of Expectations for Counselor Productivity and Centers’ Staffing

On Sept. 23, the Government Accountability Office (GAO) released a report on the Department of Veterans Affairs’s (VA) operating 300 Vet Centers throughout the U.S. that provide counseling services to military veterans and their families. The VA has changed how it assesses Vet Center counselors’ productivity and its expectations for the number of clients that the counselors see each week. However, the GAO found that the VA has not evaluated how these new expectations may affect veteran care or counselor practices. For example, counselors told GAO that these changes could negatively affect client care, such as spending less time with them to be able to fit more clients into their schedules.

Find GAO’s recommendations here, and full report here.

GAO: COVID-19 - Federal Efforts Could Be Strengthened by Timely and Concerted Actions

On Sept. 21, the Government Accountability Office (GAO) released a report that updates GAO’s oversight of federal actions to support public health, individuals and the economy during the COVID-19 pandemic.

Findings include:

  • There have been shortages of personal protective equipment and testing supplies because very few of them are made in the U.S. and global demand for them is high;
  • The Department of Health and Human Services (HHS) may be able to collect more complete data on COVID-19 cases, hospitalizations and deaths among racial and ethnic minority groups; and
  • The Department of the Treasury and the IRS do not know how many eligible people have yet to receive an economic impact payment.

Find GAO’s recommendations here, and full report here.

GAO: VA Disability Benefits - VA Should Continue to Improve Access to Quality Disability Medical Exams for Veterans Living Abroad

On Sept. 21, the Government Accountability Office (GAO) released a report on how, of about 1 million disability claims in 2019 to the Veterans Benefits Administration (VBA) processed, about 18,000 were for veterans living abroad. The VBA often uses medical exams to determine if disability benefits are warranted. Claims from veterans living abroad increased 14 percent from FY2014 to FY2019. In this period, claims processing times improved.

Veterans’ access to disability exams abroad also improved as VBA increased the number of countries using VBA-contracted medical examiners instead of embassy-referred examiners. However, travel costs and other factors sometimes hinder access to quality exams.

Find GAO’s recommendations here, and 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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