This Week in Washington: President Biden and Speaker Pelosi Open to Moving Pieces of the Build Back Better Act

The House has a district work period this week.

House

Rep. Brady Announces Updated Ways and Means Subcommittee Assignments

On Jan. 19, the Ranking Member of the House Ways and Means Committee Kevin Brady (R-TX) released updated subcommittee assignments for the 117th Congress. Rep. Vern Buchanan (R-FL) is the new ranking member of the Health Subcommittee and Rep. Greg Murphy (R-NC) will be joining the Ways and Means Committee and will sit on the Health Subcommittee.

The announcement with the full list of subcommittee assignments can be found here.

Senate

Republican Finance Committee Members Voice Their Opposition to Build Back Better Act’s Drug Pricing Measures

On Jan. 20, a group of 14 Republican members of the Senate Finance Committee led by Ranking Member Mike Crapo (R-ID) wrote a letter to their Senate colleagues voicing their opposition to the drug pricing measures in the House-passed Build Back Better Act. In the letter, the senators state that the drug pricing measures in the bill would undermine innovation and cause workforce disruptions.

The letter can be found here.

Republican Senators Call for Interim Final Rule Requiring COVID-19 Vaccinations to be Withdrawn

On Jan. 20, a group of 17 Republican senators wrote to Health and Human Services (HHS) Secretary Xavier Becerra expressing their concern with the Nov. 30 interim final rule that established vaccine and mask mandates in Head Starts and Early Head Start programs. The letter states that other COVID-19 precautions are being taken in these facilities, some district courts have granted injunctions against the final rule and the rule was made without any feedback from Head Start programs. Given these concerns, the senators request that the interim final rule be withdrawn.

The letter can be found here.

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

This week in Washington: Supreme Court Rules on Biden Administration Vaccine Mandates

House

House Democrats Introduce Bill to Increase Access to At-Home COVID-19 Tests

On Jan. 12, Reps. Don Beyer (D-VA), Dina Titus (D-NV), Joe Morelle (D-NY) and Kaiali’i Kahele (D-HI) introduced the Free At-Home Tests for All Act. The bill would require the Department of Health and Human Services (HHS) to purchase enough rapid COVID-19 tests to give two tests a week to every U.S. resident, free of charge.

The bill text can be found here.

Senate

Senate HELP Committee Advances Nomination of Robert Califf for FDA Commissioner

On Jan. 13, the Senate Health, Education, Labor and Pensions Committee voted to advance Robert Califf’s nomination for Food and Drug Administration (FDA) Commissioner with a vote of 13-8. Two Democrats, Sens. Bernie Sanders (I-VT) and Maggie Hassan (D-NH), opposed the nomination along with six Republicans. Sen. Rand Paul (R-KY) did not vote. Califf’s nomination will now go before the full Senate for a vote.

Sen. Sanders Introduces Bill to Provide N95 Masks to Everyone in the U.S.  

On Jan. 12, Sen. Bernie Sanders (I-VT) introduced the Masks for All Act, which would provide three N95 respirator masks to every person in the U.S. The bill, which was first introduced in 2020 and developed in consultation with former COVID-19 Adviser Andy Slavitt, has 15 cosponsors. The House version of the bill is led by Reps. Ro Khanna (D-CA), Lori Trahan (D-MA) and Bonnie Watson Coleman (D-NJ), with 30 additional cosponsors.

The bill text can be found here.

Sens. Cardin and Collins Introduce Bill to Extend Shelf Life of Some Prescription Drugs

On Jan. 12, Sens. Ben Cardin (D-MD) and Susan Collins (R-ME) introduced the Drug Shortages Shelf Life Extension Act. The bill would update the Food and Drug Administration (FDA) guidance regarding the shelf life of prescription drugs that are in scarce supply. In addition, the bill would require the FDA to submit a report to the Senate Health, Education, Labor and Pensions (HELP) and Energy and Commerce Committees with information regarding requests from the Secretary of the Health and Human Services Department (HHS) to change prescription drug labels.

The bill text can be found here.

Sens. Luján, Collins and Casey Introduce Bill That Aims to Improve Behavioral Health Services Following Disasters and Emergencies

On Jan. 11, Sens. Ben Ray Luján (D-NM), Susan Collins (R-ME) and Bob Casey (D-PA) introduced the Securing Uninterrupted Pandemic Preparation of Resources and Therapies (SUPPORT) Act. The SUPPORT Act aims to improve preparedness for the behavioral health needs that follow disasters, public health emergencies and other emergency events. The bill would require the Substance Abuse and Mental Health Services Administration (SAMHSA) to provide access to mental health and substance abuse disorder treatment in response to public health emergencies and would direct the Government Accountability Office (GAO) to evaluate SAMSHA’s programming during the COVID-19 pandemic.

The bill text can be found here.

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

This week in Washington: Build Back Better Negotiations on Hold

House

Reps. DelBene and Bucshon Call for Investment in KidneyX Initiative

On Dec. 20, Reps. Suzan DelBene (D-WA) and Larry Bucshon (R-IN), co-chairs of the Congressional Kidney Caucus, led a group of 18 members of Congress in a letter requesting that the Biden administration invest $25 million in the KidneyX initiative. KidneyX is a public-private partnership between the Health and Human Services (HHS) Department and the American Society of Nephrology that aims to accelerate research into chronic kidney disease and improve kidney care.

The letter can be found linked here.

Senate

Sens. Blunt and Burr Ask How HHS Will Address the COVID-19 Test Shortage

On Jan. 3, Sens. Roy Blunt (R-MO) and Richard Burr (R-NC) wrote to Health and Human Services (HHS) Department Secretary Xavier Becerra requesting information on the Biden administration’s plan to address the shortage of COVID-19 tests. The senators note that this shortage has occurred despite federal investments of $80 billion over two years to improve testing capabilities.

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

This week in Washington: President Biden acknowledges that the Build Back Better Act might not pass Congress this year.


Congress

The House and Senate are in recess.

House

On Dec. 14, the House and Senate passed the debt ceiling increase, averting a default.

Senate

Senate Passes the Methamphetamine Response Act of 2021

On Dec. 13, the Senate voted to pass the Methamphetamine Response Act of 2021, which was introduced by Sens. Dianne Feinstein (D-CA) and Chuck Grassley (R-IA). The bill would designate methamphetamine as an emerging drug threat and require the Office of National Drug Control Policy (ONDCP) to implement a plan to address its use.

Sens. Baldwin and Cassidy Introduce Bill to Improve Medical Device Safety

On Dec. 14, Sens. Tammy Baldwin (D-WI) and Bill Cassidy (R-LA) introduced the Medical Device Integrity Act, which would increase the Food and Drug Administration’s (FDA) access to information about device manufacturers in an attempt to improve pandemic preparedness and device safety.

The bill text can be found here.

Republican Senators Introduce Bill to Limit Medicaid 1115 Waiver Denials

On Dec. 15, Sens. Marsha Blackburn (R-TN), Mike Braun (R-IN), Todd Young (R-IN), Mitt Romney (R-UT), Bill Hagerty (R-TN) and Jim Inhofe (R-OK) introduced the Let States Innovate Under Medicaid Act. The bill would prevent the Centers for Medicare and Medicaid Services (CMS) from denying a Section 1115 Medicaid demonstration waiver due to the work or community engagement requirements.

The bill can be found here.

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

This week in Washington: Congress makes agreement on pathway forward to raise the debt ceiling.

House

House Passes 15 Health Bills
On Dec. 8, the House voted to pass 15 health bills. The bills, with a brief summary, can be found below.

  • The Accelerating Access to Critical Therapies for ALS Act (R. 3537) would award grants to certain small pharmaceutical companies to cover the costs of expanding ALS clinical trial access.
  • The Stillbirth Health Improvement and Education (SHINE) for Autumn Act of 2021 (R. 5487) would authorize states to collect data related to stillbirth risk factors and carry out education efforts.
  • The Early Hearing Detection and Intervention Act of 2021 (R. 5561) would reauthorize the Early Hearing Detection and Intervention (EHDI) programs at the Health Resources and Services Administration (HRSA).
  • The Improving the Health of Children Act (R. 5551) would reauthorize the National Center on Birth Defects and Developmental Disabilities at the Centers for Disease Control and Prevention (CDC).
  • The Cardiovascular Advances in Research and Opportunities Legacy (CAROL) Act (R. 1193) would authorize a grant program to study valvular heart disease.
  • The Dr. Lorna Breen Health Care Provider Protection Act (R. 1667) would require the Department of Health and Human Services (HHS) to disseminate best practices to improve the mental health resiliency and prevent suicide among healthcare providers.
  • The Oral Health Literacy and Awareness Act of 2021 (R. 4555) would require HRSA to establish a public education campaign to increase oral health literacy.
  • The Opioid Prescription Verification Act of 2021 (R. 2355) would develop trainings to help pharmacists verify the identities of people receiving controlled substance prescriptions.
  • The Synthetic Opioid Danger Awareness Act (R. 2364) would require the CDC to carry out a public education campaign on synthetic opioids.
  • The Supporting the Foundation for the National Institutes of Health and the Regan-Udall Foundation for the Food and Drug Administration (FDA) Act (R. 3743) would increase the FDA’s and NIH’s transfer authority to fund their supporting research foundations.
  • The Collecting and Analyzing Resources Integral and Necessary for Guidance (CARING) for Social Determinants Act of 2021 (R. 3894) would require the HHS Secretary to provide assistance and guidance on how to address social determinants of health within the Medicaid and the Children’s Health Insurance Program (CHIP).
  • The Social Determinants of Health Data Analysis Act of 2021 (R. 4026) would require the Government Accountability Office (GAO) to report on social determinants of health.
  • The Immunization Infrastructure Modernization Act (R. 550) would allocate $400 million in grants to improve immunization information systems.
  • The Maternal Vaccination Act (R. 951) would require the CDC to increase their efforts on maternal vaccinations.
  • The Promoting Resources to Expand Vaccination, Education and New Treatments (PREVENT) for HPV Cancers Act of 2021 (R. 1550) would reauthorize a CDC program that works to promote awareness of HPV.

Reps. Griffith and Latta Introduce Bill to Permanently Schedule Fentanyl-related Substances

On Dec. 8, Reps. Morgan Griffith (R-VA) and Bob Latta (R-OH) introduced the Halt Lethal Trafficking (HALT) Fentanyl Act (H.R. 2366), which would permanently place fentanyl-related substances on Schedule 1 of the Controlled Substance Act.

House Oversight and Reform Committee Releases Report on Drug Pricing and Pharmaceutical Practices

On Dec. 10, the House Oversight and Reform Committee released the final staff report summarizing findings of a three-year investigation into pharmaceutical pricing and business practices. The investigation was launched in January 2019 by the late Committee Chair Elijah E. Cummings. Chair Carolyn Maloney said the committee investigation found that pharmaceutical companies raise prices to meet revenue targets, target the U.S. markets for higher prices and use the patent system to suppress competition, among other things.

The staff report can be found here.

Reps. Bucshon and Buchanan Lead 100 Republican Members in Letter Opposing Federal Vaccine Mandate

On Dec. 6, Reps. Larry Bucshon (R-IN) and Vern Buchanan (R-FL) led a group of 100 Republican House members in writing a letter to the Centers for Medicare and Medicaid Services (CMS) Administrator Chiquita Brooks-LaSure. In the letter, the members state their opposition to the Biden administration’s COVID-19 vaccine mandate for Medicare and Medicaid service providers. In the letter, members cited concerns that the mandate will contribute to a worsening healthcare workforce shortage.

The letter can be found here.

25 Congressional Tri-Caucus Members Write Speaker Pelosi to Express Concern Regarding Medicare Reimbursement Cuts in the PFS Rule

On Dec. 6, a group of 25 members of the Congressional Tri-Caucus, led by Rep. Bobby Rush (D-IL), Danny Davis (D-IL) and Tony Cárdenas (D-CA), wrote to Speaker Nancy Pelosi (D-CA) to express their concern regarding Medicare reimbursement reductions in the 2022 Physician Fee Schedule (PFS) Final Rule. The final rule was released on Nov. 2, 2022, by the Centers for Medicare and Medicaid Services (CMS) and would cut Medicare reimbursement for office-based services by 20 percent or more. The members express concern that this would negatively impact health equity.

The letter can be found here.

Rep. Devin Nunes to Retire at the End of the Year

On Dec. 8, Rep. Devin Nunes (R-CA) announced that he would leave his seat in Jan. 2022 to lead former President Trump’s new media company. He has been in Congress since 2003. Rep. Nunes had been in line to be the most senior Republican member of the House Ways and Means Committee.

Senate

Senate and House Pass Bill to Phase in Medicare Sequester Cuts

On Dec. 7, the House passed the Protecting Medicare and American Farmers from Sequester Cuts Act. On Dec. 9, the Senate passed the same legislation. Specifically, the bill would:

  • Extend the 2 percent Medicare sequester moratorium until March 31, 2022, re-implementing 1 percent cuts in the second quarter of 2022 and reinstating the 2 percent cut subsequently, funded by backend increased sequester cuts in fiscal year 2030;
  • Adjust the Medicare Physician Fee Schedule conversion factor by 3 percent in calendar year 2022;
  • Delay Protecting Access to Medicare Act (PAMA)-related cuts to clinical laboratory services and the next round of private payer data reporting by one year;
  • Delay implementation of the Medicare Radiation Oncology Model until 2023; and
  • Delay application of 4 percent cuts to Medicare and other federal programs resulting from statutory Pay-As-You-Go Act requirements until calendar year 2023.

Senate Passes Bill Opposing Biden Administration Vaccine Mandate

On Dec. 8, the Senate voted 52-48 to block the Biden administration’s COVID-19 vaccine and testing requirements for private employers. Two Democrats, Reps. Joe Manchin (D-WV) and Jon Tester (D-MT), sided with Republican senators on the vote. The resolution was brought under the Congressional Review Act, which allows Congress to void federal agency rules within a certain time frame with a majority vote in the House and Senate.

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

This week in Washington: Congress passes continuing resolution, funding the government until Feb. 18.

House

Reps. McMorris Rodgers and Comer Request Information on Biden Administration Compliance With COVID-19 Vaccine Mandates

On Nov. 23, Reps. Cathy McMorris Rodgers (D-WA-5) and James Comer (R-KY-1) wrote to the Acting Director of the Office of Management and Budget (OMB) Shalanda Young requesting an update on the Biden administration’s compliance with recent COVID-19 vaccination requirements for federal employees.

The full letter can be found here.

Senate

Congress Passes Continuing Resolution to Fund Government Until Feb. 18

On Dec. 2, the House and Senate voted to pass a continuing resolution (CR) that would fund the government until Feb. 18, averting a government shutdown in the short term. Congress will need to adopt another measure to fund the government from Feb. 18 until the end of fiscal year 2022. The CR does not include any measures to mitigate the Medicare sequester cuts that are set to return on Jan. 1.

Sens. Tuberville and Burr Request Information on Monoclonal Antibody Contracts

On Nov. 23, Sens. Tommy Tuberville (R-AL) and Richard Burr (R-NC) wrote three letters requesting additional information regarding the Department of Health and Human Services’ (HHS) and Department of Defense’s (DOD) decision to grant a $142 million contract to KPMG to promote monoclonal antibody (mAb) treatment. The letters were addressed to the DOD’s Acting Undersecretary of Defense Gregory Kausner, KPMG’s S. Lawrence Kocot and HHS Secretary Xavier Becerra and raised concerns about the administration’s cancelling existing mAb contracts and KPMG’s public outreach campaign.

The full letter can be found here.

 

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

This week in Washington: House passes reconciliation package.

House

House Passes Reconciliation Package

On Nov. 19, the House passed the $1.7 trillion reconciliation package with a vote of 220-213. Votes came the morning after the Congressional Budget Office (CBO) published a complete cost estimate of the reconciliation package, also called the Build Back Better (BBB) Act. Healthcare provisions in the reconciliation package include an extension of the Affordable Care Act (ACA) tax credits, a short-term policy to address the Medicaid coverage gap, the addition of hearing benefits to Medicare, a cap for seniors’ out-of-pocket drug costs and authority for Medicare to negotiate some drug prices. The reconciliation package now goes to the Senate, where it is expected to be modified to meet reconciliation restrictions. The bill will then return to the House for another vote.

The Congressional Budget Office (CBO) estimates extending the American Rescue Plan’s higher ACA tax credits and allowing people in states that did not expand Medicaid to access the subsidies from 2022 to 2025, as well as the BBB’s other coverage provisions, would decrease the number of uninsured Americans by an average of 3.4 million over that period. The provisions together would cost about $130 billion.

The predicted drop in the number of uninsured includes 4.9 million people with individual market coverage and 100,000 additional Medicaid enrollees, net 1.6 million people with employer-sponsored coverage. CBO attributes a third of losses in employer coverage to firms no longer offering insurance and two-thirds from workers who choose not to enroll.

The American Rescue Plan (ARP) lowered the premium contribution requirements for people earning up to 400% of the poverty level and limited the contribution to 8.5% of income for others, and the BBB would extend both policies through 2025. The BBB also would lower the contribution threshold for an employer-sponsored plan to be considered affordable from 9.5% of income to 8.5%, in alignment with the individual market. CBO assumes those policies would increase spending by $43.5 billion and would reduce revenue by $30 billion over 10 years.

Extending the subsidies would result in 1.2 million fewer uninsured people during the years they are in effect, CBO and the Joint Committee on Taxation predict.

Medicaid GAP

The BBB would fix the Medicaid gap by extending the ACA tax credits to people earning 100% of the poverty level in states that did not expand Medicaid. This measure would increase spending by about $43.8 billion and reduce revenue by $13 billion over 10 years, CBO predicts. CBO and JCT say the gap fix policy would result in 1.7 million fewer uninsured.

After 2025, the extended credits and gap fix policy would have much smaller effects on sources of coverage and no net effect on the number of people without health insurance.

The ARP also offered maximum ACA tax credits to anyone on unemployment in 2021, and the Build Back Better Act would extend that policy by one year. CBO says that provision would increase expenditures by $804 and lower revenue by about $1 billion over 10 years.

The coverage provisions are part of the House Ways & Means section of the BBB that also includes a provision capping cost-sharing for insulin products at $35 (or 25% of the negotiated price, whichever is cheaper). The policy would cost a total $5.1 billion including $529 million in expenditures and $4.6 billion in lower revenues.

PBM Oversight/Transparency

A provision requiring oversight of PBMs would raise revenue by $1.7 billion (CBO and Joint Tax estimate).

Medicaid/CHIP Provisions

Requiring one-year continuous enrollment for kids in Medicaid or CHIP will save nearly $3.7 billion over 10 years while making CHIP permanent will save about $1 billion. Meanwhile, it will cost $2.21 billion to extend coverage for postpartum women from 60 days after giving birth to one year.

And CBO estimates it will cost $954 million to provide a maternal health home for pregnant and postpartum women.

Drug Pricing

Overall, the drug pricing measures, including savings and new revenues, would reduce the deficit by $297 billion and would result in 10 fewer drug inventions out of the 1,300 drugs expected to be introduced in the next 30 years.

Medicare price negotiation would contribute to $79 billion in savings, which is far less than the other drug pricing measures. The current version eventually applies to 20 of the most expensive drugs, including insulin, does not use international reference pricing and delays the risk of negotiation until biologics have been on the market for 13 years and until drugs have been on the market for nine years

The drug cost controls would save $262 billion, and the rebates that drug companies would pay when they raise prices faster than inflation would generate $34 billion in new revenue.

Repealing the Trump-era drug rebate rule saves $143 billion. The rule would have been a bigger offset had the separate bipartisan infrastructure bill not eaten into about $50 billion of those savings by delaying the rule.

Inflation rebates would save the government $49 billion by discouraging drug companies from raising prices. That’s separate from the $34 billion that inflation rebates would generate when companies raise prices faster than inflation.

The Part D redesign would save the government $1.6 billion. The bill would cap beneficiaries’ annual out-of-pocket costs, which would cost $130 million, but it would also shift a greater share of liability onto insurers. The bill would make plans pay 65% of beneficiary’s brand drug costs, including for biosimilars, and 75% of generic drug costs during the initial stage of Part D. Once beneficiaries hit the catastrophic phase, plans would pay 60% of all drug costs. Brand and biosimilar drug makers would have 10% liability during the initial phase and 20% liability during the catastrophic phase. Medicare would cover 20% of the cost of brands and biosimilars during catastrophic and 40% of the cost of generics. Generics would pay nothing throughout the phases

The CBO cost estimate can be found here.

Energy and Commerce Committee Passes Healthcare Bills Out of Committee

On Nov. 17, the House Energy and Commerce Committee passed 12 bills out of committee, 9 of them pertaining to healthcare and the healthcare workforce. The bills, which can be found listed below, now go to the House floor.

  • R. 5561, the Early Hearing Detection and Intervention Act
  • R. 5487, the Stillbirth Health Improvement and Education (SHINE) for Autumn Act of 2021
  • R. 1193, the Cardiovascular Advances in Research and Opportunities Legacy Act
  • R. 1667, the Dr. Lorna Breen Health Care Provider Protection Act
  • R. 3320, the Allied Health Workforce Diversity Act of 2021
  • R. 4555, the Oral Health Literacy and Awareness Act of 2021
  • R. 5551, the Improving the Health of Children Act
  • R. 3537, the Accelerating Access to Critical Therapies for ALS Act
  • R. 1218, the Data Mapping to Save Moms’ Lives Act

Reps. DeGette and Upton Introduce the Cures 2.0 Act

On Nov. 16, Reps. Diana DeGette (D-CO) and Fred Upton (R-MI) introduced the Cures 2.0 Act, which is intended to be a follow-up bill to the 21st Century Cures Act. The bill would establish the Advanced Research Projects Agency for Health (ARPA-H), fund Food and Drug Administration (FDA) programs and create a Medicare coverage pathway for innovative device coverage. The bill would also direct the FDA commissioner to establish incentives to increase the use of decentralized trials.

A press release on the bill can be found here. A summary of the bill can be found here. The bill text can be found here.

Rep. DeLauro and Sen. Markey Introduce Bill to Fund Research for a Universal Flu Vaccine

On Nov. 19, Rep. Rosa DeLauro (D-CT) and Sen. Ed Markey (D-MA) reintroduced the Flu Vaccine Act, which would allocate $1 billion to the National Institutes of Health to research and develop a universal influenza vaccine or prevention that protects against multiple strains of the virus.

The bill text can be found here.

Senate

Senators Introduce Bill to Strengthen the Infectious Disease and Public Health Workforce

On Nov. 18, Sens. Tammy Baldwin (D-WI), Susan Collins (R-ME), Jacky Rosen (D-NV) and Lisa Murkowski (R-AK) introduced the Bolstering Infectious Outbreak (BIO) Preparedness Workforce Act. The bill aims to address retention and recruitment issues by establishing a student loan repayment program for professionals who focus on infectious diseases (ID) and public health preparedness and response.

The bill text can be found here.

House and Senate Members Request Investigation into Nurse Staffing Agencies Pricing

On Nov. 15, Sens. Bill Cassidy (R-LA) and Mark Kelly (D-AZ) along with Reps. David McKinley (R-WV) and Doris Matsui (D-CA) wrote to White House COVID-19 Response Team Coordinator Jeffrey Zients requesting an investigation into reports of nurse staffing agencies inflating prices during the COVID-19 pandemic.

The letter can be found here.

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

This week in Washington: CBO Scores Reconciliation Package While House Waits.

House

Reconciliation Update 

In a Nov. 9 post, Congressional Budget Committee (CBO) Director Phillip Swagel said the CBO is in the process of preparing a cost estimate for the $1.75 trillion social spending reconciliation package. Swagel stated that the CBO will release estimates for some of the bill’s titles within the week, while other titles will take longer. Moderate House Democrats previously stated they would not vote for the reconciliation package until seeing the CBO scores.

House Speaker Nancy Pelosi (D-CA) has committed to holding votes on the $1.75 trillion social spending reconciliation package before Thanksgiving.

150 Members of Congress Request the Surprise Billing Final Rule be Amended

On Nov. 5, a group of 150 members of Congress, led by Reps. Brad Wenstrup (R-OH) and Tom Suozzi (D-NY), wrote to the Secretaries of the Health and Human Services, Treasury and Labor Departments. In the letter, the members requested that the recent Interim Final Rule for Surprise Billing be amended to align with the No Surprises Act, which was passed by Congress in 2020. Specifically, the letter states that the independent dispute resolution (IDR) process in the final rule does not align with the process laid out in the No Surprises Act and represents an unbalanced approach.

The letter can be found here.

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

Stethoscope on laptop keyboard

On Nov. 2, 2021, the Centers for Medicare and Medicaid Services (CMS) released a final rule to update the Physician Fee Schedule (PFS) and address other Medicare Part B issues for Calendar Year (CY) 2022. The rule, which goes into effect Jan. 1, 2022, retains proposed changes concerning telehealth and important updates to the Medicare Diabetes Prevention Program (MDPP).

Telehealth Policies Update

Because of the COVID-19 Public Health Emergency (PHE), CMS temporarily expanded the number of Medicare telehealth services from 101 to 238. Temporary additions to the Medicare telehealth service list include cardiac rehabilitation, eye exams and speech therapy, among other things. The final rule retains this expanded list through Dec. 31, 2023. This will allow more time for CMS to evaluate whether the services should be permanently added.

The rule also updates restrictions relating to furnishing mental health telehealth service to reflect the amendments of Section 123 of the Consolidated Appropriations Act of 2021. A beneficiary’s home may now be an originating site for tele-mental health services. A patient receiving tele-mental health services must have an in-person visit with a practitioner within six months of the first telehealth appointment, with at least one in-person visit required every year. The rule allows exemptions to the in-person visit requirement based on beneficiaries’ situations.

In addition, the rule updates the definition of interactive telecommunications system to specify that telehealth services can include audio-only communications for mental health services under the following conditions: The patient is located in the patient’s home at the time of service, the provider has video telecommunications capability, and the patient is not capable of using video technology or does not consent to its use. The rule also includes a new modifier requirement for audio-only communications to verify that audio was used because of beneficiary choice or limitation and not due to a lack of provider capability.

CMS also finalized its proposal to revise the current regulatory language for Rural Health Clinic (RHC) or Federally Qualified Health Center (FQHC) mental health visits to include visits furnished using interactive, real-time telecommunications technology. This change will allow RHCs and FQHCs to report and receive payment for mental health visits furnished via real-time telecommunication technology in the same way they currently do for in-person visits, including audio-only visits when the beneficiary does not consent or cannot use video technology.

For additional details, view the CMS press release announcing the physician fee schedule or the final rule.

Medicare Diabetes Prevention Program Update

The final rule waives the provider enrollment Medicare application fee for suppliers that apply to MDPP after Jan. 1, 2022. CMS believes that waiving the application fee beyond the COVID-19 Public Health Emergency (PHE) will lead to higher MDPP supplier enrollment.

In addition, CMS is eliminating the Ongoing Maintenance Session phase which will change the MDPP service period to one year. This change will align the MDPP services time frame with the Centers for Disease Control and Prevention’s (CDC) National Diabetes Prevention Program. The Ongoing Maintenance sessions phase performance payments will then be redistributed to certain Core and Core Maintenance Session performance payments. Payment amounts for attendance-only achievement goals will also be increased beginning in 2022.

For more information, see the CMS press release on the final rule’s MDPP policies or the final rule.

Read more on

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This week in Washington: Congressional Democrats reach drug pricing agreement; bipartisan infrastructure bill goes to President Biden’s desk with budget reconciliation bill delayed.

House

House Passes Bipartisan Infrastructure Bill, Delays Social Budget Reconciliation Package Bill
On Nov. 6, the House voted 228-206 to pass the $1.2 trillion bipartisan infrastructure bill. The bill now goes to President Biden’s desk for his signature. House Speaker Nancy Pelosi (D-CA) delayed voting on the $1.75 trillion budget reconciliation package until the Congressional Budget Office (CBO) report on the bill’s spending and revenue is finished. Speaker Pelosi stated that the House will vote on the bill before Thanksgiving.

Drug Pricing Reform Agreement Reached
On Nov. 2, Democratic members in the House and Senate agreed on a prescription drug pricing framework. The plan would allow Medicare to negotiate high-cost prescription drugs, impose a tax penalty for pharmaceutical companies that increase prices faster than inflation and cap Medicare Part D drugs out-of-pocket costs for seniors and people with disabilities at $2,000 a year. The proposal would also cap insulin prices at $35 a month. The Congressional Budget Office (CBO) scores show that the Medicare drug price controls will save $100 billion and repealing the rebate rule will save $150 billion. The framework can be found here.

Speaker Pelosi Says the Build Back Better Act is Paid For
On Nov. 4, House Speaker Nancy Pelosi (D-CA) wrote a Dear Colleague letter stating that the Joint Committee on Taxation (JCT) issued a report showing that the Build Back Better Act is paid for. She said that the bill would raise $1.5 trillion over 10 years. Speaker Pelosi also stated that the Rules Committee is preparing the Manager’s Amendment to include privilege fixes received from the Senate. The JCT report can be found here. The Dear Colleague letter can be found here.

Reps. Rodgers and Guthrie Release Statement on CMS Vaccine Mandate
On Nov. 4, House Energy and Commerce Ranking Member Cathy McMorris Rodgers (R-WA) and Health Subcommittee Chair Brett Guthrie (R-KY) released a statement in opposition to the Centers for Medicare and Medicaid Services (CMS) vaccine mandate for Medicare and Medicaid providers. The representatives are considering using the Congressional Review Act as a way to negate the rule. The statement can be found here.

Senate

Sens. Baldwin and Braun Introduce Bill to Reduce Anti-Competitive Practices in Healthcare
On Nov. 3, Sens. Tammy Baldwin (D-WI) and Mike Braun (R-IN) introduced the Healthy Competition for Better Care Act, which aims to reduce anti-competitive practices in healthcare. The legislation would prohibit health systems from requiring a payer or employer to contract with an affiliated provider or hospital as a condition of entering into a contract with the healthcare system. The press release with additional information on the bill can be found here.

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