Oct 4, 2021
Washington Healthcare Update
This week in Washington: Continuing resolution passes House, government shutdown averted for now, infrastructure and reconciliation package votes delayed.
Congress
Upcoming Hearings/Markups
House
Senate
Administration
Proposed Rules
Final Rules
Courts
Reports
Upcoming Hearings/Markups
October 6
House Veterans Affairs Committee Hearing: “Hearing to Consider Pending Nominations”
3:00 p.m.
For more information, click here.
Congress
House
Continuing Resolution Passes House and Senate, Government Shutdown Averted
On Sept. 30, both the House and Senate voted to pass the continuing resolution that will extend federal funding through Dec. 3. The bill also includes $28.6 billion for disaster assistance and $6.3 billion for Afghan refugees.
An earlier version of the bill failed to pass the Senate on Sept. 27 due to its inclusion of a measure that would raise the debt ceiling. Republicans opposed raising the debt ceiling. The passage of a “clean” continuing resolution allowed the government to stay funded. Congress has yet to deal with the debt ceiling limit issue, which must be addressed by Oct. 18 when the government will run out of borrowing authority.
Reconciliation Update
Despite House Speaker Nancy Pelosi’s efforts to hold a House vote on the infrastructure package on Friday, Oct. 1, the vote was delayed. Speaker Pelosi had previously stated the vote would be held Thursday, Sept. 30 but was forced to delay it due to fractions within the Democratic party. The Senate passed the bipartisan bill in August. Progressive Democrats have stated they will not support the infrastructure bill until moderate Democrats make a deal with them on the $3.5 trillion reconciliation package of social spending. Moderate Democratic Sens. Kyrsten Sinema (D-AZ) and Joe Manchin (D-WV) have opposed the budget reconciliation package. Sen. Manchin stated that the highest amount he would support for the reconciliation package is $1.5 trillion, a substantial decrease from the current level of $3.5 trillion. All Democratic votes are needed to pass the reconciliation legislation in the Senate.
Therefore, at the current time, both the infrastructure package and the reconciliation package are held up. Speaker Pelosi wrote a Dear Colleague letter on Oct. 2 calling for the infrastructure bill to be passed before Oct. 31.
House Judiciary Committee Markup on Healthcare Bills
On Sept. 29 and 30, the House Judiciary Committee passed several healthcare-related bills that were previously passed by the Senate. The bills and a brief description can be found below.
- H.R. 2883, the Stop STALLING Act, which would penalize pharmaceutical companies for abusing citizen petitions to delay generic and biosimilar approval
- H.R. 2891, the Preserve Access to Affordable Generics and Biosimilars Act, would codify the assumption that pay-for-delay agreements are anticompetitive and illegal
- H.R. 2873, the Affordable Prescriptions for Patients Through Promoting Competition Act of 2021, would prohibit the practice of “product hopping”
- H.R. 2884, the Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act, would cap at twenty the number of patents that pharmaceutical companies can assert in an infringement action filed before biosimilar marketing
House Energy and Commerce Committee Republicans Write to CDC Regarding COVID-19 Breakthrough Tracking
On Sept. 28, three Republican members of the House Energy and Commerce Committee wrote to the Centers for Disease Control and Prevention (CDC) Director Rochelle Walensky regarding the agency’s decision not to collect data on COVID-19 breakthrough cases unless they result in hospitalization or death. The letter was sent by Reps. Cathy McMorris Rodgers (R-WA), Brett Guthrie (R-KY) and Morgan Griffith (R-VA).
On May 1, 2021, the CDC stopped monitoring all reported vaccine breakthrough COVID-19 cases and focused on cases that resulted in hospitalization or death. In the letter, the members stated that the full extent of breakthrough infections is not known, and policy decisions are being made without complete information.
The letter can be found here.
Senate
Sen. Murray and Rep. Pallone Statement in Support of HHS Rule on Surprise Billing
On Sept. 30, Sen. Patty Murray (D-WA), chair of the Senate Health, Education, Labor and Pensions Committee, and Rep. Frank Pallone (D-NJ), chair of the House Energy and Commerce Committee, issued a press statement in support of the Health and Human Services (HHS) interim final rule on surprise billing. The interim final rule contains provisions from the No Surprises Act and establishes new protections from surprise billing and excessive cost sharing for consumers receiving healthcare services.
The press release can be found here.
Administration
Lisa Pino Appointed as HHS OCR Director
On Sept. 27, the Department of Health and Human Services (HHS) announced that Lisa Pino has been appointed as director for the HHS Office of Civil Rights (OCR). Most recently, Lisa Pino was executive deputy commissioner of New York’s Department of Health. She previously served as a senior executive service official at the Department of Homeland Security (DHS).
President Biden Appoints John Nkengasong as PEPFAR Director
On Sept. 27, President Biden nominated John Nkengasong to lead the President’s Emergency Plan for AIDS Relief (PEPFAR). Nkengasong is currently the director of the Africa Centres for Disease Control and Prevention and will need to be confirmed by the Senate.
Peter Marks to Assume Role of FDA Vaccine Office Director
On Sept. 27, the Director of the Food and Drug Administration’s (FDA) biologics center Peter Marks announced he would be the next head of the agency’s Office of Vaccines Research and Review. Marks will take on the role of acting office director one month before current director Marion Gruber leaves the agency, a move aimed to ensure a smooth transition. Marion Gruber and Phil Krause, deputy vaccine office director, announced their departures in August.
FDA to Hold Public Workshop on Drug Development to Manage Acute Pain for Children Under Two Years Old
On Sept. 28, the Food and Drug Administration (FDA) announced a notice of a public workshop titled “Analgesic Clinical Trial Designs, Extrapolation, and Endpoints in Patients from Birth to Less Than Two Years of Age.” The workshop will discuss the current states and challenges in drug development to treat acute pain in patients under two years of age. The public workshop will be held on Oct. 13 and 14 from 10 a.m. to 2 p.m. EST.
The public notice with registration information can be found here.
FDA Approves Technical Improvement for CT Imaging
On Sept. 30, the Food and Drug Administration (FDA) approved the first major technical improvement for Computed Tomography (CT) imaging in nearly a decade. The FDA granted clearance of the Siemens NAEOTOM Alpha device to Siemens Medical Solutions, Inc. The new device is designed to transform information from X-ray photons into a 3-D image.
The press release can be found here.
FCC Announces Round 2 of COVID-19 Telehealth Grants
On Sept. 29, the Federal Communication Commission (FCC) announced it had approved 72 grants for Round 2 of its COVID-19 Telehealth Program. The grants for Round 2 total $41 million and follow the first round of $42 million awarded on Aug. 26. The funds will support healthcare providers by reimbursing for telecommunications services, information services and devices necessary to enable telehealth.
SAHMSA Announces Community Health Center Grants
On Sept. 28, the Substance Abuse and Mental Health Services Administration (SAMHSA) announced that 230 community mental health centers will receive $825 million in grants. The grants will allow the centers to increase the number of crisis beds, provide behavioral health training to schools and expand mobile crisis mental health services.
NIAID Announces Grants to Study Coronavirus and Variant Vaccines
On Sept. 28, the National Institutes of Health’s (NIH) National Institute of Allergy and Infectious Diseases (NIAID) announced it has awarded $36.3 million to three academic institutions to conduct research on “pan-coronavirus” vaccines with the objective of preparing for the next generation of coronaviruses. The research focuses on developing vaccines to protect against multiple types of coronaviruses and their variants, with a primary focus on coronaviruses with potential to cause a pandemic.
CMS Announces 2022 Premiums and Deductibles for MA plans and Part D Prescription Drug Plans
On Sept. 29, the Centers for Medicare and Medicaid Services (CMS) announced 2022 premiums and deductibles for Medicare Advantage (MA) and Part D prescription drug plans. The average premium for MA plans will be $19 per month in 2022, lower than the 2021 rate of $21.22. The average premium for Part D coverage will be $33 per month in 2022, an increase from $31.47 in 2021.
For the press release with additional information on the premiums and deductibles by plan and by state, click here.
Proposed Rules
FDA Issues Industry Guidance for Assessing Electronic Health Records and Medical Claims Data
On Sept. 29, the Food and Drug Administration (FDA) issued a draft guidance for industry titled “Real-World Data: Assessing Electronic Health Records and Medical Claims Data to Support Regulatory Decision-Making for Drug and Biologic Products.” The guidance is part of a series of guidance documents under the FDA’s Real-World Evidence (RWE) program. The guidance aims to provide stakeholders with considerations when planning to use electronic health records or medical claims data in clinical studies.
The guidance can be found here.
FDA Issues Final Industry Guidance for Gene Therapy
On Sept. 29, the Food and Drug Administration (FDA) released a final industry guidance titled “Interpreting Sameness of Gene Therapy Products Under the Orphan Drug Regulations.” The guidance explains how the FDA will determine the sameness of two gene therapies when deciding if it will designate a therapy as an orphan drug, thereby granting the drug exclusivity. In the guidance, the FDA says it will consider principal molecular structural features of the gene therapy product in order to determine sameness.
The final guidance document can be found here.
Agencies Propose Regulations for Air Ambulance Reporting
On Sept. 16, the Office of Personnel Management, the Internal Revenue Service, Departments of the Treasury, Labor, Health and Human Services (HHS), Employee Benefits Security Administration and Centers for Medicare and Medicaid Services issued a set of proposed rules to implement provisions of the Consolidated Appropriations Act (CAA) of 2021. The CAA provisions to be enacted include reporting requirements for group health plans, insurers and providers regarding air ambulance services as well as disclosure requirements for agents and brokers for compensation received in connection with the sale of individual health insurance.
The CAA requires air ambulance providers to report information about services, costs, locations and denied claims to HHS and the Department of Transportation. In addition, the proposed rules provide context for reporting requirements to help providers understand potential issues and reporting timelines.
The proposed rules can be found here.
CMS Issues Proposed Rule to Repeal Trump-Era Medicare Breakthrough Device Coverage Rule
On Sept. 15, the Centers for Medicare and Medicaid Services (CMS) announced a proposed rule that would repeal Medicare Coverage of Innovative Technology (MCIT) and the “Reasonable and Necessary” final rule published Jan. 14, 2021. CMS stated that the rule would be repealed due to patient safety risks posed by requiring CMS to immediately cover devices going through the FDA approval path.
The Trump administration rule automatically granted four years of Medicare coverage to breakthrough devices awarded FDA market authorization. In addition, the rule codified the Medicare definition of “reasonable and necessary.”
Public comments on the proposed rule will be accepted for 30 days.
The proposed rule can be found here.
CMS Issues Proposed Rule to Reassign Medicaid Provider Claims
On July 30, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule titled “Medicaid Program; Reassignment of Medicaid Provider Claims.” The proposed rule would explicitly authorize states to make payments to third parties to benefit individual practitioners by ensuring health and welfare benefits, training, and other benefits customary for employees, if the practitioner consents to such payments to third parties on the practitioner’s behalf.
Comments will be accepted until Sept. 28.
The proposed rule can be found here.
Final Rules
HHS Issues Final Rule to Rescind 2020 Rule on Insulin and Epinephrine
On Oct. 1, the Department of Health and Human Services (HHS) issued a final rule to rescind a December 2020 final rule titled “Implementation of Executive Order on Access to Affordable Life-Saving Medications.” The Trump-era rule required health centers to pass on 340B discounts for insulin and injectable epinephrine to patients. Health centers had opposed the rule. In its rule to rescind the Trump administration rule, HHS stated that the 2020 rule had excessive administrative costs and burdens for health centers that would have resulted in reduced resources for critical services for patients who use insulin and epinephrine. The rule states that HHS is exploring non-regulatory options to implement the executive order.
The rule is effective Nov. 1, 2021.
The final rule can be found here.
FDA Announces 2022 Fee Rates for Material Threat Medical Countermeasures
On Sept. 30, the Food and Drug Administration (FDA) issued a notice titled “Fee Rate for Using a Material Threat Medical Countermeasure Priority Review Voucher in Fiscal Year 2022.” The notice establishes the material threat medical countermeasure (MCM) for FY 2022 and provides details on the payment procedures for the fees.
The notice can be found here.
FDA Announces 2022 Fee Rates for Rare Pediatric Diseases
On Sept. 30, the Food and Drug Administration (FDA) issued a notice titled “Fee Rate for Using a Rare Pediatric Disease Priority Review Voucher in Fiscal Year 2022.” The notice establishes the rare pediatric disease priority review fee rate for FY 2022 and provides information on the payment procedures.
The notice can be found here.
FDA Announces 2022 Fee Rates for Tropical Diseases
On Sept. 30, the Food and Drug Administration (FDA) issued a notice titled “Fee Rate for Using a Tropical Disease Priority Review Voucher in Fiscal Year 2022.” The notice establishes the tropical disease priority review rate for FY 2022 and provides information on payment procedures.
The notice can be found here.
Multiple Agencies Issue Part II of Surprise Billing Proposed Interim Rule
On Sept. 30, the Departments of Health and Human Services (HHS), Labor (DOL) and Treasury released an interim final rule with the collaboration of the Office of Personnel Management (OPM). The interim final rule with comment period is titled “Requirements Related to Surprise Billing; Part II” and builds on Part I of the rule issued on July 13, 2021. The Sept. 30 rule establishes new protections for consumers receiving healthcare items and services, and outlines provisions related to the dispute resolution process, good faith estimates for uninsured individuals, the patient-provider dispute resolution process and expanded rights to external review.
Comments will be accepted for 60 days after rule publication.
The interim final rule can be found here.
CMS Issues Final Rule on Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities
On July 29, the Centers for Medicare and Medicaid Services (CMS) released a final rule titled “Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities; Updates to the Quality Reporting Program and Value-Based Purchasing Program for Federal Fiscal Year 2022; and Technical Correction to Long-Term Care Facilities Physical Environment Requirements.” The final rule updates the payment rates used under the prospective payment system (PPS) for skilled nursing facilities (SNFs) for fiscal year (FY) 2022. In addition, the final rule includes a forecast error adjustment for FY 2022, updates the diagnosis code mappings used under the Patient Driven Payment Model (PDPM), rebases and revises the SNF market basket, implements a recently enacted SNF consolidated billing exclusion along with the required proportional reduction in the SNF PPS base rates and includes a discussion of a PDPM parity adjustment. The regulations are effective Oct. 1, 2021.
The final rule can be found here.
CMS Issues Final Rule on Inpatient Rehabilitation Facility Prospective Payment System
On July 29, the Centers for Medicare and Medicaid Services (CMS) released a final rule titled “Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2022 and Updates to the IRF Quality Reporting Program; Payment for Complex Rehabilitative Wheelchairs and Related Accessories (Including Seating Systems) and Seat and Back Cushions Furnished in Connection with Such Wheelchairs.” The final rule provides updates to and finalized proposals for the fiscal year (FY) 2022 Inpatient Rehabilitation Facilities Quality Reporting Program (IRF QRP). This rule includes one new finalized measure, the COVID-19 Vaccination Coverage among Healthcare Personnel (HCP) Measure, as well as an update to the specifications for the Transfer of Health (TOH) Information to the Patient-Post-Acute Care Quality Measure. The rule will go into effect on Oct. 1, 2021.
The final rule can be found here.
CMS Issues Final Rule on Inpatient Psychiatric Facilities Prospective Payment System
On July 29, the Centers for Medicare and Medicaid Services (CMS) released a final rule titled “FY 2022 Inpatient Psychiatric Facilities Prospective Payment System and Quality Reporting Updates for Fiscal Year Beginning October 1, 2021 (FY 2022).” The rule updates the prospective payment rates, the outlier threshold and the wage index for Medicare inpatient hospital services provided by inpatient psychiatric facilities (IPF), which include psychiatric hospitals and excluded psychiatric units of an acute care hospital or critical access hospital.
The final rule can be found here.
CMS Issues Final Rule on Hospice Wage Index and Payment Rate Update
On July 29, the Centers for Medicare and Medicaid Services (CMS) released a rule titled “FY 2022 Hospice Wage Index and Payment Rate Update, Hospice Conditions of Participation Updates, Hospice and Home Health Quality Reporting Program Requirements.” The final rule updates the hospice wage index, payment rates and aggregate cap amount for fiscal year 2022. In addition, this rule makes changes to the labor shares of the hospice payment rates and finalizes clarifying regulations text changes to the election statement addendum that was implemented on Oct. 1, 2020. The regulations are effective on Oct. 1, 2021.
The final rule can be found here.
CMS Issues Final Rule for Long-Term Care Hospital Quality Reporting Program
On Aug. 2, the Centers for Medicare and Medicaid Services (CMS) issued a final rule titled “Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year (FY) 2022 Rates; Quality Programs and Medicare Promoting Interoperability Program Requirements for Eligible Hospitals and Critical Access Hospitals; Changes to Medicaid Provider Enrollment; and Changes to the Medicare Shared Savings Program.” The rule will update and finalize proposals for the FY 2022 Long Term Care Hospital Quality Reporting Program and includes the new COVID-19 Vaccination Coverage among Healthcare Personnel (HCP) measure, among other things. The rule will go into effect Oct. 1, 2021.
The final rule can be found here.
Courts
Find a comprehensive look at “The Courts and Healthcare Policy” here.
PhRMA Files Suit Over Arkansas’ 340B Law
On Sept. 30, the Pharmaceutical Research and Manufacturers of America (PhRMA) filed a lawsuit in the U.S. District Court for the Eastern District of Arkansas over an Arkansas law concerning 340B discounts. The Arkansas law was passed in May and requires pharmaceutical companies to give 340B discounts to all pharmacies contracted by hospitals and other facilities in the 340B federal discount program. The PhRMA suit is directed at the state law’s provision that prohibits pharmaceutical companies from denying discounts to Arkansas pharmacies that contract with 340B entities. The Department of Health and Human Services (HHS) has been attempting to require pharmaceutical companies to provide discounts to all 340B contract pharmacies, an effort that is also the subject of multiple lawsuits.
Neither the federal 340B law nor the implementing regulation mentions contract pharmacies. HHS’ Health Resources & Services Administration (HRSA) is attempting to use guidance and advisory opinions to require pharmaceutical companies to offer discounts to all the pharmacies that 340B hospitals contract with. PhRMA also alleges that the Arkansas state law violates the commerce clause of the U.S. Constitution, which prohibits one state from regulating prices of goods in another state.
Reports
GAO Report on Agency Preparedness for COVID-19-Related User Fee Fluctuations
On Sept. 29, the Government Accountability Office (GAO) published a report titled “COVID-19: Reviewing Existing Policies Could Help Selected Agencies Better Prepare for Dedicated User Fee Revenue Fluctuations.” In the report, the GAO states that many federal agencies rely on user fees, which declined for many agencies in 2020. The report recommends that in order to better prepare for future user fee disruptions, the Federal Aviation Administration (FAA) and the National Park Service (NPS) review their cash management plan and target carryover balance policy and make plans to review the two policies in the future.
The full report can be found here.
If you have any questions, contact the following individuals at
McGuireWoods Consulting:
Stephanie Kennan, Senior Vice President
Alexandra Gale, 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.
To sign up for the Weekly Washington Healthcare Update, use our online
subscription form.