This Week in Washington: Supreme Court Rules in Favor of 340B Hospitals, FDA Approves COVID-19 Vaccines for Children Under Five
Upcoming Hearings
Congress
House
- House Veterans Affairs Committee to Hold Legislative Hearing on Healthcare Bills
- House Rules Committee to Consider Four Healthcare Bills
- Appropriations Subcommittee on Agriculture, Rural Development, FDA and Related Agencies Votes to Approve FY 2023 Funding Bill
- Reps. Pallone and Scott Call on FTC to Protect Consumers Buying Infant Formula Online
Senate
- Senate Commerce Committee to Consider Healthcare Bills
- Senate Passes Bill to Expand Veterans’ Access to Healthcare Related to Burn Pit Exposure
- Sens. Wyden, Crapo, Carper and Cassidy Release Discussion Draft on Youth Mental Health
- Sens. Murray, Cantwell and Casey Call on FTC to Investigate Retail Chains’ Infant Formula Pricing Practices
Administration
- President Biden Signs Executive Order on LGBTQ Healthcare
- HHS Issues Guidance to Ensure that Audio-Only Telehealth Services Comply with HIPAA
- CMS Announces that Four States Have Extended Medicaid Postpartum Coverage
- FDA Votes to Authorize Pfizer and Moderna COVID-19 Vaccines for Children
- HRSA Announces $115 Million Awarded to Support Ending the HIV Epidemic in the U.S.
- FTC Ramps Up Enforcement of Illegal Bribes and Rebates Between Pharmaceutical Companies and PBMs
Proposed Rules
- CMS Releases Home Health Prospective Payment Systems Rate Update Proposed Rule
- CMS Publishes Proposed Rule on Funding Methodology and Changes to Basic Health Program Regulations
- FDA Announces Request for Public Comments for Adding Maximum Daily Exposure Information to Inactive Ingredient Database
Final Rules
- HHS Issues Final Rule Withdrawing SUNSET Rule
- CMS Releases Notice of Benefit and Parameters for 2023 Final Rule
- Final Rule to Change Qualifications for Products to be Considered “Made in America” Released
Courts
- Supreme Court Rules in Favor of 340B Hospitals
Reports
- MACPAC Releases June Report to Congress
- MedPAC Releases June Report to Congress
- GAO Report on the Development of Medical Countermeasures
- GAO Report on the 2022 National Drug Control Strategy
- CBO Publishes Cost Estimate on the ARPA-H Act
- CBO Releases Cost Estimate on the Enhancing Mental Health and Suicide Prevention Through Campus Planning Act
Upcoming Hearings
June 21
House Rules Committee Rules Meeting on H.R. 7666, H.R. 5585, H.R. 4176 and the Senate Amendment to H.R. 3967
2:00 p.m. The Committee will consider the rules for considering several health bills. See below for more information.
June 22
House Committee on Veterans Affairs Subcommittee on Health Legislative Hearing
10:00 a.m. The Committee will discuss six health bills. See below for more information.
Senate Commerce Committee Executive Session
10:00 a.m. The Committee will consider two health bills. See below for more information.
June 23
House Committee on Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Markup: “2023 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies, and Military Construction, Veterans Affairs, and Related Agencies Appropriations Bills”
10:00 a.m.
House Committee on the Judiciary Subcommittee on Courts, Intellectual Property and the Internet Hearing: “The Patent Trial and Appeal Board After 10 Years: Impact on Innovation and Small Businesses”
10:00 a.m.
Senate Special Committee on Aging Hearing: “Strengthening Support for Grandfamilies During the COVID-19 Pandemic and Beyond”
10:00 a.m.
House Committee on Education and Labor Subcommittee on Civil Rights and Human Services Hearing: “Examining the Policies and Priorities of the U.S. Department of Agriculture’s Food and Nutrition Service”
10:15 a.m.
House Committee on Appropriations Subcommittee on Departments of Labor, Health and Human Services, Education and Related Agencies Markup: “FY 2023 Labor, Health and Human Services, Education and Related Agencies Bill”
5:30 p.m.
June 24
House Select Committee on the Climate Crisis Hearing: “Cutting Methane Pollution: Safeguarding Health, Creating Jobs, and Protecting our Climate”
9:00 a.m.
Congress
House
House Veterans Affairs Committee to Hold Legislative Hearing on Healthcare Bills
On June 22, the House Committee on Veterans Affairs Subcommittee on Health will hold a legislative hearing on the following bills related to healthcare:
- H.R. 291, the VA COST SAVINGS Enhancements Act,
- H.R. 345, the Reproductive Health Information for Veterans Act,
- H.R. 1216, the Modernizing Veterans’ Health Care Eligibility Act,
- H.R. 1957, the Veterans Infertility Treatment Act of 2021,
- H.R. 6273, the VA Zero Suicide Demonstration Project Act of 2021, and
- H.R. 7589, the REMOVE Copays Act.
House Rules Committee to Consider Four Healthcare Bills
On June 21, the House Rules Committee will meet to discuss the following four healthcare bills. Bills typically go to the House Rules Committee before they go to the House floor, as the Rules Committee sets rules that govern how the bills will be considered.
Appropriations Subcommittee on Agriculture, Rural Development, FDA and Related Agencies Votes to Approve FY 2023 Funding Bill
On June 15, the House Appropriations Committee Subcommittee on Agriculture, Rural Development, Food and Drug Administration (FDA) and Related Agencies approved the fiscal year 2023 funding draft bill. The bill provides $27.2 billion in funding, an increase of $2.075 billion from 2022, and includes measures to strengthen the safety of the baby formula market, add more fruits and vegetables to government nutrition assistance programs, invest in rural broadband and fund grants to promote equitable participation in USDA programs. The full Appropriations Committee will mark up the bill on June 23.
Reps. Pallone and Scott Call on FTC to Protect Consumers Buying Infant Formula Online
On June 13, Reps. Frank Pallone (D-NJ) and Bobby Scott (D-VA) wrote to the Federal Trade Commission (FTC) calling on the agency to address the failure of online marketplaces to protect consumers from fraudulent and deceptive practices in the sales of infant formula.
Senate
Senate Commerce Committee to Consider Healthcare Bills
On June 22, the Senate Commerce Committee will hold an executive session on a number of bills. The bills to be considered that are related to healthcare can be found below.
- S. 2510, Preventing HEAT Illness and Deaths Act of 2021, and
- S. 4293, Pharmacy Benefit Manager Transparency Act of 2022.
Senate Passes Bill to Expand Veterans’ Access to Healthcare Related to Burn Pit Exposure
On June 16, the Senate voted 84-14 to pass the Honoring our Promise to Address Comprehensive Toxics (PACT) Act, which would require the Department of Veterans Affairs to cover veterans’ healthcare services related to toxic exposure due to burn pits. The bill now goes to President Biden’s desk to be signed.
Sens. Wyden, Crapo, Carper and Cassidy Release Discussion Draft on Youth Mental Health
On June 15, Sens. Ron Wyden (R-OR), Mike Crapo (R-ID), Tom Carper (D-DE) and Bill Cassidy (R-LA) released a discussion draft on youth mental health policies. The discussion draft includes policies that would allow all providers to receive Medicaid reimbursement for behavioral and physical health services on the same day, update Medicaid guidance on mental health care in schools and improve oversight of Medicaid’s Early and Periodic Screening, Diagnostic and Treatment benefit.
Sens. Murray, Cantwell and Casey Call on FTC to Investigate Retail Chains’ Infant Formula Pricing Practices
On June 14, Sens. Patty Murray (D-WA), Maria Cantwell (D-WA) and Bob Casey (D-PA) wrote to the Federal Trade Commission (FTC), directing the agency to investigate whether national retail chains have engaged in unfair practices by raising specialized infant formula prices during the shortage.
Administration
President Biden Signs Executive Order on LGBTQ Healthcare
On June 15, President Biden signed an executive order that directs the Department of Health and Human Services (HHS) to issue guidance on expanding care for LGBTQ patients. The order also requires the Education Department to release a LGBTQ-inclusive sample school policy. The executive order comes as some states have attempted to limit access to LGBTQ healthcare.
HHS Issues Guidance to Ensure that Audio-Only Telehealth Services Comply with HIPAA
On June 13, the Department of Health and Human Services’ (HHS) Office for Civil Rights (OCR) issued guidance on how covered providers and plans can utilize audio-only telehealth services in a manner that complies with the Health Insurance Portability and Accountability Act (HIPAA).
CMS Announces that Four States Have Extended Medicaid Postpartum Coverage
On June 16, the Centers for Medicare and Medicaid Services (CMS) announced that Medicaid and Children’s Health Insurance Program (CHIP) extensions in four states have allowed for 253,000 parents to access 12 months of postpartum coverage. CMS recently approved extensions of Medicaid and CHIP coverage for 12 months after pregnancy in Maine, Minnesota, New Mexico and Washington, DC, bringing the total number of states with postpartum coverage extensions to 14.
FDA Votes to Authorize Pfizer and Moderna COVID-19 Vaccines for Children
On June 17, the Food and Drug Administration (FDA) granted emergency use authorization (EUA) to two COVID-19 vaccines for use in children. Moderna’s COVID-19 vaccine, which had previously been authorized for adults 18 and older, is now authorized for children aged 6 months to 17 years of age as well. Pfizer’s COVID-19 vaccine, which had been authorized for children aged 5 and older, had its authorization amended to include children aged 6 months to 4 years.
This decision comes after the FDA’s Vaccines and Related Biological Products Advisory Committee voted unanimously in favor of granting EUA to Moderna’s COVID-19 vaccine for children aged 6 months to 5 years and Pfizer’s vaccine for children aged 6 months to 4 years on June 15. The advisory committee stated that the benefit of the vaccines outweighs any potential harm.
HRSA Announces $115 Million Awarded to Support Ending the HIV Epidemic in the U.S.
On June 16, the Health Resources and Services Administration (HRSA) announced that it had awarded $115 million to 60 recipients through the Ending the HIV Epidemic in the U.S. initiative.
FTC Ramps Up Enforcement of Illegal Bribes and Rebates Between Pharmaceutical Companies and PBMs
On June 16, the Federal Trade Commission (FTC) voted unanimously to ramp up enforcement efforts against any illegal bribes or rebates that block patient access to lower-cost drugs. The FTC is concerned that rebate practices between pharmaceutical companies and pharmacy benefit managers (PBM) are stifling competition from generic and biosimilar drugs, contributing to increasing drug costs. The FTC’s policy statement raises the following legal concerns about pharmaceutical companies’ payments to PBMs:
- Exclusionary rebates could constitute unreasonable agreements in restraint of trade under Section 1 of the Sherman Act, unlawful monopolization under Section 2 of the Sherman Act, or exclusive dealing under Section 3 of the Clayton Act.
- Influencing PBMs to place more expansive drugs on formularies instead of cheaper alternatives could violate the prohibition against unfair methods of competition or unfair acts or practices under Section 5 of the FTC Act.
- Paying or accepting rebates or fees in exchange for excluding cheaper drugs may qualify as commercial bribery under Section 2(c) of the Robinson-Patman Act.
Proposed Rules
CMS Releases Home Health Prospective Payment Systems Rate Update Proposed Rule
On June 17, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule titled “Medicare Program: Calendar Year 2023 Home Health Prospective Payment System Rate Update; Home Health Quality Reporting Program Requirements; etc.” The proposed rule would update Medicare payment policies and rates for home health agencies (HHAs). A CMS fact sheet says the rule would update home health payment and home infusion therapy rates for Fiscal Year 2023. In addition, the rule would end the suspension of non-Medicare and non-Medicaid data for HHA patients and expand the baseline years in the Expanded Home Health Value-Based Purchasing (HHVBP) Model.
Public comments will be accepted until August 16, 2022.
CMS Publishes Proposed Rule on Funding Methodology and Changes to Basic Health Program Regulations
On May 25, the Centers for Medicare and Medicaid Services (CMS) published a proposed rule titled “Basic Health Program; Federal Funding Methodology for Program Year 2023 and Proposed Changes to Basic Health Program Regulations.” The proposed rule includes information on how federal payment amounts for states establishing a Basic Health Program under the Affordable Care Act will be determined in program year 2023.
Public comments will be accepted until June 24, 2022.
FDA Announces Request for Public Comments for Adding Maximum Daily Exposure Information to Inactive Ingredient Database
On March 22, the Food and Drug Administration (FDA) issued a notice titled “Prioritizing the Addition of Maximum Daily Exposure Information and Removing Dosage Form Information From the Inactive Ingredient Database” to establish a public docket and request public comment. The public comments will help the FDA determine how to best prioritize maximum daily exposure (MDE) information for inactive ingredients that are not currently included in the Centers for Drug Evaluation and Research’s Inactive Ingredient Database, as well as if the database should be restructured by removing dosage form information.
Public comments will be accepted until June 21, 2022.
Final Rules
HHS Issues Final Rule Withdrawing SUNSET Rule
On May 27, the Department of Health and Human Services (HHS) published a final rule to withdraw the “Securing Updated and Necessary Statutory Evaluations Timely (SUNSET)” Final Rule of 2021. The SUNSET rule was originally set to go into effect on March 22, 2021, but was delayed until September 22, 2022, following a lawsuit. The SUNSET rule would have required HHS to review every rule to determine if it was still applicable after 10 years, and any rules not reviewed within that time frame would be automatically eliminated. In its withdrawal of the SUNSET rule, HHS stated that the rule faced significant opposition from stakeholders and would not expedite rulemaking.
The rule is effective immediately.
CMS Releases Notice of Benefit and Parameters for 2023 Final Rule
On April 28, the Centers for Medicare and Medicaid Services (CMS) announced the 2023 Notice of Benefit and Payment Parameters Final Rule, which aims to strengthen plan coverage offered on the federal Marketplace. The final rule will require healthcare.gov plans to offer a standardized version of each product an issuer sells in each metal tier for plan year 2023. The final rule also finalizes exchange user fees, updates quality improvement standards related to health equity and reduces the number of verification requirements for special enrollment periods. The regulations will go into effect on July 1, 2022.
A CMS fact sheet on the final rule can be found here.
Final Rule to Change Qualifications for Products to be Considered “Made in America” Released
On March 4, the Department of Defense, the General Services Administration and the Aeronautics and Space Administration announced a final rule that would increase manufacturing of critical supplies in the U.S. as part of President Biden’s “Made in America” policy. The final rule would require pharmaceutical companies that want their products to qualify as being “Made in America” for federal procurement purposes to increase the percentage of drug ingredients made in the U.S. from 55 percent to 75 percent in the next seven years. Specifically, the final rule would increase the threshold to 60 percent in 2022, 65 percent in 2024 and 75 percent in 2029. In addition, the rule will allow the government to apply price preferences to select drug products and components that will support the expansion of the domestic supply chain. The final rule will go into effect on Oct. 25, 2022.
The White House Fact Sheet on the final rule can be found here.
Courts
Supreme Court Rules in Favor of 340B Hospitals
On June 15, the Supreme Court voted unanimously to strike down reductions in reimbursement to hospitals under the 340B discount program. The court ruled that the Department of Health and Human Services (HHS) did not follow the law when it changed 340B program payment rates from average sales price plus 7 percent to average sales price minus 22.5 percent in 2018. The 340B hospitals, represented by the American Hospital Association, argued that these cuts caused 340B hospitals to lose $1.6 billion annually. The Supreme Court asserted that HHS acted unlawfully because it did not survey hospitals’ acquisition costs before reducing reimbursement rates.
Reports
MACPAC Releases June Report to Congress
On June 15, the Medicaid and Children’s Health Insurance Program (CHIP) Payment and Access Commission (MACPAC) released its June 2022 report to Congress. The report includes recommendations that would improve monitoring access for Medicaid beneficiaries, strengthen oversight of managed care direct payments, increase adult Medicaid beneficiaries’ access to vaccines, encourage greater use of health information technology in behavioral health and integrate the care of people dually eligible for Medicare and Medicaid.
MedPAC Releases June Report to Congress
On June 15, the Medicare Payment Advisory Commission (MedPAC) released its June 2022 report to Congress. The report highlights research into areas that affect the Medicare program and makes recommendations. The report includes recommendations to streamline Medicare’s alternative payment models, increase access to care, support safety-net providers, lower the cost of Medicare Part B drugs and align fee-for-service payment rates in ambulatory settings.
GAO Report on the Development of Medical Countermeasures
On June 16, the Government Accountability Office (GAO) published a report titled “Public Health Preparedness: Medical Countermeasure Development for Certain Serious or Life-threatening Conditions.” The report found that the Food and Drug Administration (FDA) has provided information and feedback to medical countermeasure developers, and has approved 16 medical countermeasures under the Animal Rule, which was passed in 2002.
GAO Report on the 2022 National Drug Control Strategy
On June 15, the Government Accountability Office (GAO) published a report titled “Drug Policy: Preliminary Observations on the 2022 National Drug Control Strategy.” The report details observations on the Office of National Drug Control Policy’s (ONDCP) 2022 National Drug Control Strategy, which was created to reduce illegal drug supplies and demand and promote prevention and treatment. The GAO observed that the National Drug Control Strategy included a range of activities such as prevention, treatment, international operations and law enforcement, which cost $39 billion in 2022.
CBO Publishes Cost Estimate on the ARPA-H Act
On June 16, the Congressional Budget Office (CBO) released a cost estimate of the Advanced Research Projects Agency-Health (ARPA-H) Act (H.R. 5585), which would establish a new research agency within the Department of Health and Human Services (HHS). The bill appropriates $500 million annually from 2023-2027 to run ARPA-H. In its cost estimate, CBO estimates that the bill would increase spending by $1.7 billion from 2022-2027.
CBO Releases Cost Estimate on the Enhancing Mental Health and Suicide Prevention Through Campus Planning Act
On June 15, the Congressional Budget Office (CBO) released a cost estimate of the Enhancing Mental Health and Suicide Prevention Through Campus Planning Act (H.R. 5407). The bill would direct the Secretary of Education to encourage higher education institutions to develop mental health and suicide prevention plans, based on existing programs. The bill would require the Secretary of Education to report to Congress on the progress of these activities. CBO estimates that the bill would cost less than $500,000 to implement over the 2022-2027 time period.
