This Week in Washington: Waiting for the election results from Georgia Senate race; mental health legislation continues to be discussed and CBO publishes option book

Congress

House

House Rules Committee Meets to Determine Rule for House Consideration of the Jackie Wolerski Maternal and Child Home Visiting Reauthorization Act of 2022

On Nov. 29, the House Rules Committee met to determine the rule by which the Jackie Walorski Maternal and Child Home Visiting Reauthorization Act of 2022 will be considered on the House floor. The legislation reauthorizes MIECHV for five years, increasing the annual funding level to $800 million in 2027 and providing increased investment in home visiting in every state and territory. It also updates program policies to provide an even stronger focus on improving outcomes for families and to provide clarity and stability for successful state and territorial programs.

Senate

Senate Finance Committee Looks at Medicare Advantage and Medicaid Managed Care “Ghost Networks”

On Dec.1, the Senate Finance Committee released its fifth and final mental health discussion draft. The draft would eliminate “ghost networks” by requiring Medicare Advantage (MA) plans and Medicaid managed care organizations to regularly update their provider directories. The draft legislation would also require the Government Accountability Office (GAO) to compare Medicaid payments for behavioral health services with reimbursement for medical or surgical services, as well as compare MA mental and physical health benefits. Additionally, the bill would require MA plans to update a provider’s status in the insurer’s directory within two days and have the Centers for Medicare and Medicaid Services (CMS) collect those directories to post on a public website.

For more information, click here.

Sen. Mike Lee (R-UT) Introduces Bill to Increase Competition in Biological Drug Market

On Nov. 17, Sen. Mike Lee (R-UT) introduced the Biosimilar Red Tape Elimination Act to increase competition in the biological drug market. The bill would prohibit the FDA from requiring biosimilars to undergo switching studies to receive an “interchangeable” designation.

Unlike generic drugs, many states will not allow pharmacists to substitute a biosimilar unless the FDA declares it to be “interchangeable.” The legislation would allow pharmacists to substitute biosimilars in lieu of the branded version.

Read more on healthcare policy in McGuireWoods Consulting’s Washington Healthcare Update.

This Week in Washington: Congress returns to complete appropriations and year-end legislation.

Congress

House

Expected Committee Changes in Health-Related Committees

With party control changing in the House, there will be changes in who leads the health-related committees. At the House Ways and Means Committee, now-Chair Richard Neal (D-MA) will become the ranking member. Rep. Vern Buchanan (R-FL) is expected to become chair. For the last year, he has been the ranking member of the committee’s subcommittee on Health.

At the House Energy and Commerce Committee, now-Chair Frank Pallone (D-NJ) will become the ranking member, and the current ranking member, Rep. Cathy McMorris Rodgers (R-WA), will become chair. These changes will have to be approved by the Republican caucus.

The Senate will see some changes despite Democrats’ remaining in control. Sen. Patty Murray (D-WA) is expected to take the chairmanship of the Senate Appropriations Committee. That means that Sen. Bernie Sanders is next in line to be chair of the Health, Education, Labor and Pensions Committee. Because the current ranking member, Sen. Richard Burr (R-NC), is retiring, Sen. Bill Cassidy (R-LA) is expected to become ranking member of the HELP Committee. Sen. Cassidy is a physician and also serves on the Senate Finance Committee.

Senate

Senate Finance Committee Releases Discussion Draft on Mental Health

On Nov. 10, the Senate Finance Committee released its fourth discussion draft concerning mental health provisions for possible inclusion in an end-of-year bill.

The draft legislation would:

  • Clarify that peer support specialists can provide behavioral health integration services to Medicare beneficiaries
  • Increase Medicare payment rates for behavioral health integration services from 2026 through 2027
  • Direct CMS to create a single global payment under the physician fee schedule to fund mobile crisis response team services including screening and assessment
  • Require CMS to create bundled payments for crisis stabilization services for Medicare beneficiaries

For more information, click here.

Senate Finance Committee Democrats Urge CMS to Release New Medicare Advantage Marketing Rules Quickly

On Nov. 15, Democratic Senate Finance Committee members, led by Chair Ron Wyden (D-OR) and Bob Casey (D-PA), urged CMS to release regulations as soon as possible to enhance oversight of Medicare Advantage marketing. Earlier, the committee released a report revealing instances of Medicare Advantage marketing fraud in 14 states. Senate Democrats are urging CMS to increase consumer protections through notice-and-comment rulemaking as soon as possible. They are also calling on Congress to fully fund the Medicare State Health Insurance Assistance Program (SHIP) and the Senior Medicare Patrol (SMP).

For more information, click here.

Read more on healthcare policy in McGuireWoods Consulting’s Washington Healthcare Update.

This Week in Washington: Countdown to Election Day- Focus on polls, campaigns and who will be in control of the House and Senate

Congress
House

The House is in recess until Nov. 14

Senate

The Senate is in recess until Nov. 14

Senators Write USTR to Urge Protection of American Innovation in Therapeutics and Diagnostics

U.S. Senators Tom Carper (D-Del.) and Pat Toomey (R-Pa.) led a bipartisan group of senators in writing U.S. Trade Representative Katherine Tai to urge the Biden Administration to safeguard American innovation in the World Trade Organization’s (WTO) negotiations on whether to expand its waiver of IP rights enforcement for COVID-19 vaccines to also include therapeutics and diagnostics. Senators Bill Cassidy (R-La.), Chris Coons (D-Del.), John Barrasso (R-Wyo.), Kyrsten Sinema (D-Ariz.), Thom Tillis (R-N.C.), Robert Menendez (D-N.J.), Richard Burr (R-N.C.), and Jon Tester (D-Mont.) also signed onto the letter.

In June 2022, WTO members agreed to waive obligations under the WTO’s Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement for COVID-19 vaccine patent subject matter for a five-year period. This requires the United States to not enforce certain IP rights on behalf of U.S.-based companies at the WTO. The expansion under consideration would enable eligible WTO member countries to ignore otherwise enforceable intellectual property (IP) protections for therapeutics and diagnostics that treat COVID-19.

GOP Senators Ask FDA to Increase Focus Non-Opioid Pain Medication

On Oct. 19, Sens. James Lankford (R-OK), Roger Marshall (R-KS), Shelley Moore Capito (R-WV) and Marsha Blackburn (R-TN) wrote the Food and Drug Administration Commissioner Robert Califf asking that the FDA increase focus on development of non-opioid pain medication. They note that no non-opioid alternative for pain management was approved in 2021. In 2018, the SUPPORT for Patients and Communities Act required FDA issue guidance addressing challenges in non-addictive pain therapies and to assist drug developers in creating non-opioid alternatives for acute and chronic pain management. The FDA did publish draft guidance in February, but the senators state the FDA has not met the requirements of the legislation fully. The senators asked that they be responded to by Nov. 9.

CBO Looks At Doctors’ Reimbursement and Access

The Congressional Budget Office (CBO) included “analyzing how the amount physicians are paid for services affects access to care for dual-eligible beneficiaries (people dually enrolled in Medicare and Medicaid) compared with Medicare-only beneficiaries” on a recently released list of its ongoing projects.

This comes as MedPAC, the congressional advisory panel on Medicare reimbursement, is also looking at how to raise reimbursement for safety net doctors. At its most recent meeting, MedPAC discussed four ways to target funds for providers caring for patients with low-income subsidies.

Read more on healthcare policy in McGuireWoods Consulting’s Washington Healthcare Update.

This Week in Washington: Treasury Finalizes “Family-Glitch” Fix

Congress

House

Progressive Caucus Members Announce Bill to Rename Medicare Advantage

Two members of the House Progressive Caucus announced they will introduce legislation that would change the name of Medicare Advantage (MA) in order to make clear that MA plans are offered by private insurers. They believe that seniors may be misled into enrolling into MA plans.

The bill is sponsored by Rep. Mark Pocan (D-WI), a former chair of the caucus, and Rep. Ro Khanna (D-CA). In addition to changing the name of the program, the legislation would impose financial penalties on private insurers using the term “Medicare” in plan names.

The bill comes as the issue of how best to strengthen Medicare is already shaping up to be a midterm election issue. The administration has been promoting the Medicare drug-price controls included in the recently enacted Inflation Reduction Act as a major effort to strengthen the program, while Republican lawmakers blast the IRA provisions as anti-competitive.

A majority of Medicare beneficiaries are projected to be enrolled in Medicare Advantage by next year.

Senate

The Senate is in recess and will return Nov. 14.

Read more on healthcare policy in McGuireWoods Consulting’s Washington Healthcare Update.

This Week in Washington: Congress Passes Continuing Resolution until Dec. 16; House Leaves Until After Election; Senate to be Back Mid-October. 

Congress

House

Following the Senate’s vote on Sept. 29, a Continuing Resolution funding the government through Dec 16 passed the House on Sept. 30 by 230-201. Ten Republicans joined Democrats to pass the legislation to fund the government through Dec. 16. The Senate passed the legislation 72-25.

The CR was stalled in the Senate because of provisions related to speed up permitting for energy projects, which had been included because a vote on the provisions had been promised to Sen. Joe Manchin (D-WV). After Sen. Manchin requested the provisions be removed so they did not stall the CR further, the bill gained bipartisan support.

Included in the CR were an additional $62 million for the 9-8-8 Suicide and Crisis Lifeline’s prevention and behavioral health services, and an extension of enhanced Medicaid federal matching assistance program for Puerto Rico and other territories. Extensions were also included for the Medicare low-volume payment program, and the drug user fees for the Food and Drug Administration. 

Mental Health Matters Act Passes

In a mostly party line 220-205 vote, the House passed the Mental Health Matters Act, which addresses the “severe impact” COVID-19 had on students, educators and families by putting more mental health experts in schools and expanding that pipeline of school-based professionals. 

One Republican, Rep. Brian Fitzpatrick (R-PA), voted for the legislation, which would provide grants to establish a pipeline for school-based mental health service professionals. The Department of Education would administer the grants.

Read more on healthcare policy in McGuireWoods Consulting’s Washington Healthcare Update.

This Week in Washington: Congress Comes Down to the Finish Line

 

Congress

House

Health Legislation

On Sept. 21, the House Ways & Means Committee passed two bills to improve Medicare’s inpatient psychiatric facility payment system and add intensive inpatient program coverage for beneficiaries with mental health and substance use disorders who need it. The legislation would also direct HHS to conduct two outreach campaigns related to opioid treatment programs and behavioral health integration codes as well as require Medicare to cover marriage and family therapists and mental health counselor services.

In addition, the committee reported out legislation to improve accuracy of private insurance provider directories and to note whether telehealth services are offered, and sent directly to the floor a bill named in memory of Rep. Jackie Walorski (R-IN) that reauthorizes a program that provides in-home services to vulnerable families and doubles the annual funding over five years.

The committee also approved several bipartisan bills to help consumers access mental health services and better understand covered benefits. The committee passed legislation that would ensure victims of sexual assault do not have to pay out-of-pocket costs for forensic exams. Prior to the vote, members agree that before the legislation is considered on the House floor, it will be revised to ensure assault victims do not face cost sharing for any of the medical treatment they may need beyond rape test kits and that benefit should be extended to apply to victims of domestic violence.

The committee also approved the Machine-Readable Coverage Expansion Act that requires plans to submit their Summary of Benefits and Coverage documents to the Department of Health and Human Services (HHS) for posting in a centralized location that is accessible to researchers and other stakeholders who want to analyze the data and identify potential gaps.

Last, the committee passed legislation that requires the Department of Health and Human Services and the U.S. Treasury to create a star rating or other similar system to measure the availability of mental health and substance abuse providers compared to other products in the same area.

The following legislation passed out of the Ways and Means Committee:

  • H.R. 8876, The Jackie Walorski Maternal and Child Home Visiting Reauthorization Act of 2022
  • Committee Print 117-1. Improvements to Medicare Inpatient and Outpatient Mental Health Services
    • H.R. 8879 (introduced by Reps. Dwight Evans and Jodey Arrington)
    • H.R. 8878 (introduced by Reps. Judy Chu, Bill Pascrell and Adrian Smith)
  • Committee Print 117-2. Improvements to the Medicare Program Related to Physician Services and Education.
    • H.R. 432 (introduced by Rep. Mike Thompson)
    • H.R. 8910 (introduced by Reps. Jason Smith, Brad Schneider and Drew Ferguson)
    • H.R. 8884 (introduced by Reps. Mike Kelly and Brian Higgins)
    • H.R. 8890 (introduced by Reps. Raul Ruiz, Greg Murphy, Don Beyer and Larry Buschon)
    • H.R. 8908 (introduced by Reps. Ron Estes and Jimmy Panetta)
  • Committee Print 117-3. Requiring Coverage of Forensic Medical Exams with No Cost Sharing
    • H.R. 8891 (introduced by Reps. Linda Sánchez, Gwen Moore and Carol Miller)
  • Committee Print 117-4. Improved Information in Provider Directories, Plan Definitions, and Crisis Services for Private Insurance Plans
    • H.R. 8885 (introduced by Reps. Dan Kildee, Brad Wenstrup and Kevin Hern)
    • H.R. 8886 (introduced by Reps. Gwen Moore and David Schweikert)
    • H.R. 8892 (introduced by Reps. Terri Sewell, Darin LaHood and David Kustoff)
  • Committee Print 117-5. Improved Information for Network Coverage and Plan Documents in Private Insurance Plans
    • H.R. 8881 (introduced by Reps. Steven Horsford and Vern Buchanan)
    • H.R. 8889 (introduced by Reps. Stacey Plaskett, Tom Rice and Lloyd Smucker)

House Select Subcommittee on the Coronavirus Crises Issues Report on For-Profit Nursing Homes and COVID

The House Select Subcommittee on the Coronavirus Crisis released a new report concerning the conditions inside for‑profit nursing home chains during the early months of the pandemic, including severe and allegedly deliberate understaffing, a lack of personal protective equipment from staff and residents and a lack of quarantine protocol for COVID-19–positive employees. The report is the select subcommittee’s latest update on its investigation into large for-profit nursing home chains and their response to the COVID-19 pandemic.

On Sept. 21, the subcommittee held a hearing and released its report. At the hearing, witnesses urged the subcommittee to focus on six issues as federal and state legislators work with nursing homes, including: addressing the workforce crisis through workforce development and funding; improving state survey processes for oversight of nursing homes; strengthening nursing home transparency; reimbursing the cost of care and reducing purchasing costs; prioritizing equity among racial and ethnic groups; and incentivizing adoption of certified electronic health records and information technology interoperability in nursing homes. Other witnesses also suggested following the recommendations of the National Academies of Sciences, Engineering and Medicine for both short-term and long-term solutions to understaffing. Those recommendations focused on improving pay, sick leave and benefits as well as career advancement opportunities, childcare access and access to training for workers.

Rep. Carter Introduces Legislation to Permit Pharmacists to Refuse Filling Medications

Rep. Buddy Carter (R-GA) introduced a bill that would permit pharmacists to refuse to fill prescriptions for medications they believe could be used to end a pregnancy. The bill is counter to the U.S. Department of Health and Human Services guidance for pharmacies.

The Pharmacist Conscience Protection Act is cosponsored by 26 other House Republicans.

Rural Access to Telehealth Services

A bipartisan group of legislators sent a letter praising the Centers for Medicare and Medicaid Services proposal to continue rural access to behavioral telehealth services after the COVID-19 public health emergency ends. CMS is proposing to allow permanent access to telehealth behavioral health care provided by the clinical staff of hospitals after the PHE ends. The representatives also have introduced legislation, the Rural Behavioral Health Access Act, to do the same as the proposed rule. The letter’s signatories include Reps. Daniel Kildee (D-MI), Brad Wenstrup (R-OH), Brian Fitzpatrick (R-PA), Adrian Smith (R-NE), Jared Huffman (D-CA), Ashley Hinson (R-IA), Elise Stefanik (R-NY), Troy Balderson (R-OH) and Ron Kind (D-WI).

Senate

Funding the Government: Continuing Resolution

With the fiscal year ending on Sept. 30, Congress has few days to finish negotiations and pass a continuing resolution (CR) to keep the government open until Congress returns for a lame-duck session after the election. While there is no appetite for a government shutdown this close to the election, the CR is facing obstacles. Regardless, the Senate wants to move forward with a CR this week.

To secure his vote for the Inflation Reduction Act, Democratic leadership promised Sen. Joe Manchin (D-WV) Congress would pass legislation by the end of September to overhaul the permitting process for some infrastructure projects. This legislation is still being developed and would provide fast-track approval process for domestic energy projects, including natural gas pipelines. That promise has divided the party, and Republicans are still angry with Democrats for having circumvented them on the IRA. Senate Republicans are likely to try to have the Senate take up alternative legislation on permitting reform. Manchin is to release his own proposal and has dismissed the Republican proposal.

If the Senate fails to pass the CR with permitting reforms attached, it could take up a separate, “clean” version of the bill that strips those provisions. If the Senate does manage to pass the whole package, the House could opt to remove the Manchin bill and send the spending measure back to the Senate without it.

In addition, other additions to the CR are being discussed. This includes some extension of the FDA User Fee legislation and additional COVID funding.

Senate Finance Committee Releases Discussion Draft on Mental Health Workforce Shortage

On Sept. 22, the Senate Finance Committee released a discussion draft concerning mental health workforce shortages, who can seek Medicare reimbursement and burnout across all healthcare sectors. Two more discussion drafts on crisis care and mental healthcare parity are expected soon. Earlier this year the committee created five work groups to focus on different aspects of mental healthcare and delivery. Prior to the draft released on Sept. 22, the committee released drafts on children’s mental health and telehealth.

The workforce shortage discussion draft, which was led by Sens. Debbie Stabenow (D-MI) and Steve Daines (R-MT), would add 400 additional Medicare Graduate Medical Education slots for psychiatrist residencies as well as increase Medicare’s Health Professional Shortage Area bonus payments for psychiatrists. The proposal also would permit psychologists, clinical social workers, marriage and family therapists, mental health counselors and other providers to receive bonus payments.

The proposal would also let licensed clinical social workers bill Medicare for health behavior assessment and intervention services, which the draft says are vital to ensure a patient’s consistent treatment for chronic conditions.

Senators propose requiring Medicare to cover mental health services provided by marriage and family therapists, as well as licensed professional counselors. CMS proposed similar policy in its 2023 Medicare physician fee schedule and the House Ways and Means Committee passed a similar proposal on Sept. 21.

The discussion draft would also create a new exception under the physician self-referral law, which generally prohibits providers from referring patients to an entity with which the physician has a financial relationship. The proposed exception would let hospitals and other systems provide evidence-based mental health programs for physicians to increase resiliency and prevent suicide.

Path Forward for FDA User Fee Legislation Still Difficult

Sens. Patty Murray (D-WA) and Richard Burr (R-NC) announced they have a deal for a “practically clean” reauthorization of FDA user fee programs that would be attached to a temporary government funding bill. However, Senate Minority Leader Mitch McConnell (R-KY) wants to eliminate even the few policy riders the two negotiated, according to press reports. The issue needs to be resolved soon since the Senate plans to act on a stop-gap funding bill this week.

Read more on healthcare policy in McGuireWoods Consulting’s Washington Healthcare Update.

This Week in Washington: Congress Focuses on FDA User Fee Legislation, Telehealth and Continuing Resolution; Administration Issues Executive Order on Biomanufacturing

Congress

House

House Passes Legislation to Streamline Prior Authorization in Medicare Advantage

On Sept. 14, the House unanimously passed legislation by voice vote to streamline the Medicare Advantage prior authorization system. The vote came shortly after the Energy & Commerce health subcommittee unanimously passed a version of the Improving Seniors’ Timely Access to Care Act earlier in the day. A vast majority of the House cosponsored the bill, along with 40 senators in the upper chamber. It is expected that the legislation will be part of the year-end package in the Senate.

The bill establishes an electronic prior authorization process for Medicare Advantage, as well as a real-time approvals process for routinely approved products and services, and increased data transparency surrounding MA and the prior authorization process. Prior authorization in MA has come under fire after a controversial HHS Office of the Inspector General report found inappropriate denials.

The legislation was sponsored in the House by Reps. Suzan DelBene (D-WA), Mike Kelly (R-PA), Ami Bera (D-CA) and Larry Bucshon (R-IN). It had more than 320 cosponsors.

Bipartisan Legislation Introduced to Mitigate Physician Fee Schedule Cuts

On Sept. 13, Reps. Ami Bera (D-CA) and Larry Bucshon (R-IN) introduced legislation to mitigate CMS’s proposed physician fee schedule cuts slated for 2023. Physicians have been concerned about reductions in the fee schedule since the Centers for Medicare and Medicaid Services released the fee schedule for 2023. CMS proposed a 4.4 percent decrease in the conversion factor for 2023. While the rule is not yet final, there is concern CMS may not have the ability to make changes to increase reimbursement as it has with other pay rules in the past, because some of the fee reductions CMS proposed were tied to evaluation and management changes already in place, because of prior years’ cuts mitigated by Congress and because Medicare Access and CHIP Reauthorization Act (MACRA) set up pay updates of the fee schedule, which includes a 0 percent pay update for 2023.

Bera and Bucshon also recently asked stakeholders how to change MACRA. They also introduced a Sense of Congress that the Department of Health and Human Services and the House and Senate should work to ensure Medicare’s payment system is predictable and stable.

Senate

Senate Pushed to Pass Extension of Pandemic Telehealth Waivers

On Sept. 13, a group of 375 telehealth stakeholders sent a letter to the Senate urging it to pass a two-year extension of pandemic telehealth waivers that also includes access to clinically appropriate controlled substances without in-person prescribing requirements and pre-deductible coverage for telehealth services under high-deductible health plans. Senate movement on the House-passed telehealth extensions, coupled with the controlled substances and HDHP waivers, would give stakeholders an extra couple years to lobby for permanent reforms.

The Alliance for Connected Care, American Telemedicine Association (ATA), College of Healthcare Information Management Executives (CHIME), Connected Health Initiative, Consumer Technology Association, Executives for Health Innovation, Health Innovation Alliance, HIMSS and Partnership to Advance Virtual Care organized the coordinated effort among the nearly 400 telehealth stakeholders.

The groups are asking the Senate to pass a two-year extension of pandemic telehealth flexibilities, as the House recently did when it passed HR 4040. However, the groups also want to extend a provision that lets health plans offer coverage of telehealth services pre-deductible to people enrolled in high-deductible health plans linked to health savings accounts or remove in-person requirements for prescription of controlled substances via telehealth, which is not included in the House bill.

The Joint Committee on Taxation and Congressional Budget Office scored the temporary HDHP provision included in the CARES Act at $90 million a year. Ninety-six percent of employers adopted the pre-deductible coverage for telehealth services under the CARES Act and 76 percent would like to make the provision permanent, according to the Employee Benefit Research Institute issue brief on pre-deductible coverage in HSA-eligible health plans.

HELP Committee Members Write

This week, a group of 29 Democrats led by Senate HELP Committee chair Patty Murray (D-WA) wrote to Secretary of HHS Becerra urging the administration to strengthen federal privacy protections under the Health Information Portability and Accountability Act (HIPAA) to broadly restrict providers from sharing patients’ reproductive health information without their explicit consent—particularly with law enforcement or in legal proceedings over accessing abortion care. The senators specifically said HHS should update the HIPAA Privacy Rule to prevent covered entities from sharing reproductive health information, especially for purposes of potential criminal or civil proceedings. The senators also said HHS should increase education for patients about their rights under the HIPAA Privacy Rule and should ensure all cases involving reproductive health information receive timely compliance and enforcement response.

Read more on healthcare policy in McGuireWoods Consulting’s Washington Healthcare Update.

This Week in Washington: The House and Senate return to face funding the government and other issues; the administration reverses for good the Trump-era “public charge” rule.

Congress

House

Funding the Government

Current funding for the federal government runs out on Oct. 1; Congress will need to do a short-term Continuing Resolution (CR). Currently being discussed in the House is a CR to run through Dec. 16. What is unclear is whether the CR will have anything attached to it.

The White House has asked that COVID and monkeypox funding be attached. They have requested $22.4 billion in COVID money and $4.5 billion for monkeypox funding. Republican senators state that there is already unspent money that could be used for these purposes. The administration also released a list of programs that should be included or programs they would not object to being included on the CR.

Meanwhile, Senate Budget Committee Chairman Bernie Sanders (I-VT) announced that he will vote against the CR if it includes a package of energy provisions meant to satisfy Sen. Joe Manchin (D-WVA). Sanders says that “at least” 59 House Democrats will be releasing a letter opposing the energy provisions as well.

Bipartisan Group of Members Ask for Input on How to Revamp the Medicare Access and CHIP Reauthorization Act (MACRA)

Eight House members led by Reps. Ami Bera (D-CA) and Larry Bucshon (R-IN) are asking stakeholders for feedback concerning how to fix MACRA without dramatically increasing Medicare spending.

Members Push for Audio-Only Telehealth Coverage

Reps. Ann McLane Kuster (D-NH), Lori Trahan (D-MA) and Peter Welch (D-VT) wrote CMS Administrator Chiquita Brooks-LaSure to urge Medicare coverage of audio-only telehealth continue beyond the pandemic, raising concerns that ending reimbursement would add to health disparities. However, CMS has said it cannot do so without congressional action. CMS proposed to extend audio-only coverage for mental healthcare but said legislative restrictions prevent it from doing so for other telehealth services.

The letter asks CMS to answer several questions, including how the agency is measuring the effectiveness of audio-only telehealth and what data it has about the factors that impact audio-only usage as opposed to other kinds of telehealth. It also asks what CMS believes the impact of ending audio-only telehealth coverage would be on rural beneficiaries and on other groups that are more likely to use the modality, including Black patients.

Senate

FDA User Fee Bill Drama Continues

Congress has until Sept. 29 to reauthorize the FDA User Fee program. FDA Commissioner Robert Califf has said the agency could fund the programs into early November using carryover user fees. Some believe that reauthorization should be added to the short-term CR in order to give more time for members to negotiate an agreement.

Senators Ask AHIP about HIV Prevention Medication Coverage

On Sept. 8, a letter lead by Sens. Jeff Merkley (D-OR) and Tina Smith (D-MN) asked the America’s Health Insurance Plans (AHIP) about reports that some insurers are not providing cost-free coverage of HIV prevention medication and related services as required under the Affordable Care Act.

The letter comes after a federal district judge ruled that the pre-exposure prophylaxis (PrEP) mandate violates rights of a Texas employer under the Religious Freedom Restoration Act (RFRA) and that the ACA violates the appointments clause of the Constitution by deferring decisions on coverage requirements to the U.S. Preventive Services Task Force (USPSTF).

Under the ACA, insurers must cover all preventive services rated “A” or “B” by the USPSTF without cost-sharing. In June 2019, the task force gave PrEP an “A” rating, and plans were required to cover the drug as of Jan. 1, 2021. CMS issued additional guidance to clarify that ancillary services, like testing fees and adherence consultations, must also be covered without cost-sharing.

The judge has yet to issue any remedies related to the decision, so it’s unclear whether it will apply only to the plaintiffs, or nationwide.

In their letter, the senators stressed it is an insurer’s responsibility to ensure the cost-free coverage is provided.

Read more on healthcare policy in McGuireWoods Consulting’s Washington Healthcare Update.

This Week in Washington: Administration focuses on mental health and monkeypox issues

Congress

The House and Senate are in Recess

House

Restoring Hope for Mental Health and Well-being Act

The House recently passed the Restoring Hope for Mental Health and Well-being Act, which is designed to support mental health care, prevention, education and workforce training programs.

In addition to promoting compliance with mental health parity laws, the legislation would allocate $14 million each year through 2025 and $30 million each year for 2026 and 2027 for the Pediatric Mental Health Care Access grant program. That funding would permit every state to establish a program if they want to improve the integration of pediatric primary care providers with behavioral health providers by telehealth. A bipartisan group of House members is now holding discussions with key senators to create momentum for the Senate to pass the legislation when the Senate returns.

Read more on healthcare policy in McGuireWoods Consulting’s Washington Healthcare Update.

This Week in Washington:  House Passes Inflation Reduction Act by a vote of 220-207

Congress

The Senate is in its Recess

Senate

Members Push FDA to Finalize Risk-Mitigation Strategy for Mifepristonea

On Aug. 3, Sens. Warren (D-MA), Hirano (D-HI) and Baldwin (D-WI) wrote a letter asking the FDA to quickly finalize updates to the risk-mitigation strategy for mifepristone that would make the medication abortion drug more accessible in the wake of the Supreme Court’s reversal of Roe v. Wade, and to also approve the drug for miscarriage procedures.

The FDA announced in December 2021 a series of risk mitigation strategies but has yet to officially approve them. The letter requests the FDA to expedite its review of the manufacturers’ plans to certify pharmacies and to finalize the updated REMS well before the 180-day statutory deadline.

FDA has said it is starting a certification process for pharmacies, including mail order pharmacies, to dispense mifepristone but has not finalized it yet, according to a policy professional who is involved with the Protecting Access to Medication Abortion Act.

The senators also ask FDA to review the remaining pieces of the REMS to determine whether any restrictions placed on the prescription and distribution of mifepristone, including patient consent forms, are medically unnecessary.

In addition, the senators ask FDA to work toward adding a miscarriage indication to the mifepristone with misoprostol label.

House

House Passes Inflation Reduction Act

Following the Senate passage of the Inflation Reduction Act (budget reconciliation), the House returned from its recess to pass the legislation. The rule by which the House considered the legislation did not permit any amendments. In addition to including Medicare negotiation of drug prices, and an extension of the ACA credits, the legislation would require adults enrolled in Medicare, Medicaid or CHIP to receive all vaccines by the Advisory Committee on Immunization Practices without cost sharing. This means Medicare beneficiaries would not have cost sharing for adult vaccine administration covered under Medicare Part D beginning in 2023.

Text of the legislation can be found https://rules.house.gov/bill/117/hr-5376-sa

In addition, prior to Senate consideration the Congressional Budget Office (CBO) released an estimate of the bill and answered other questions in a report that can be found at https://www.cbo.gov/publication/58366

Read more on healthcare policy in McGuireWoods Consulting’s Washington Healthcare Update.