This week in Washington: Congress passes continuing resolution, funding the government until Feb. 18.
Upcoming Hearings/Markups
December 8
House Agriculture Committee, Nutrition, Oversight, and Department Operations Subcommittee Hearing: “Review of USDA Nutrition Distribution Programs”
10:00 a.m.
For more information, click here.
House Energy and Commerce Committee, Health Subcommittee Hearing: “The Future of Biomedicine: Translating Biomedical Research into Personalized Health Care”
10:30 a.m.
For more information, click here.
Senate Veterans’ Affairs Committee Hearing: “To Consider the Nomination of Kurt D. DelBene to be Assistant Secretary of Veterans Affairs for Information and Technology”
3:00 p.m.
For more information, click here.
December 9
House Oversight and Reform Committee Hearing: “Unsustainable Drug Prices: Findings from the Committee’s Drug Pricing Investigation and the Need for Structural Reforms”
10:30 a.m.
For more information, click here.
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.
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.
President Biden Announces New Actions to Combat COVID-19 This Winter
On Dec. 2, President Biden announced new actions to combat COVID-19 with the emergence of the new Omicron variant and with the winter months approaching. President Biden’s plan includes expanding access to free and insurer-funded at-home COVID-19 tests, securing antivirals and enacting additional requirements for people traveling internationally. The White House continues to stress the importance of COVID-19 vaccination for all Americans and booster doses for those eligible.
President Biden’s announcement can be found here.
HHS Announces Second Round of Telehealth Grants for Title X Awardees
On Nov. 23, the Department of Health and Human Services (HHS) announced that Title X awardees could apply for $35 million in telehealth grants. This is the second round of Title X grants, as $256 million in grant funding was announced on Oct. 27. The grants come after the Biden administration ended a Trump-era policy on Oct. 4 that prevented Title X grantees from referring patients for abortions.
Telehealth grant applications will open on Feb. 3, 2022 and grants will start on May 1, 2022.
HHS Launches a 405(d) Aligning Health Care Industry Security Approaches Program Website
On Dec. 2, the Department of Health and Human Services (HHS) launched a website for the 405(d) Aligning Health Care Industry Security Approaches Program. The new website provides resources and products to raise awareness about cybersecurity practices in the sector in an effort to build cybersecurity resiliency.
The website can be found here.
HRSA Announces $1.5 Billion in Funding for the Healthcare Workforce in Rural and Underserved Areas
On Nov. 22, the Health and Human Services Department’s (HHS) Health Resources and Services Administration (HRSA) announced $1.5 billion in health workforce loan repayment and scholarship programs. The programs will provide loan repayment assistance and scholarships to healthcare providers in rural and underserved areas and will allow for additional financial assistance for National Health Service Corps and Nurse Corps members.
CMS Puts COVID-19 Vaccine Mandate on Hold
On Nov. 30, a Louisiana federal district court judge halted the mandate nationwide while lawsuits are considered. On Dec. 2, the Centers for Medicare and Medicaid Services (CMS) announced it would not enforce or implement its healthcare worker vaccine mandate due to court injunctions. The vaccine rule would apply to healthcare staff in Medicare- and Medicaid-certified providers and suppliers. For more information on the court injunctions, see the “Courts” section of this newsletter.
The CMS memo describing the suspension of the rule can be found here.
CMS Announces That 810,000 Enrolled During Week Three of Open Enrollment
On Nov. 24, the Centers for Medicare and Medicaid Services (CMS) announced that 810,000 people selected plans from healthcare.gov during the third week of the Affordable Care Act’s (ACA) open enrollment period. This brings the total to 2.43 million people signed up since Nov. 1.
CMS Issues RFI Seeking Public and Stakeholder Input on the Organ Transplantation System
On Dec. 1, the Centers for Medicare and Medicaid Services (CMS) issued a Request for Information (RFI) titled “Request for Information: Health and Safety Requirements for Transplant Programs, Organ Procurement Organizations, and End-Stage Renal Disease Facilities” to solicit public and stakeholder feedback on the organ transplantation system. CMS is interested in comments on how to increase organ donations, improve the quality of dialysis care and access to dialysis services, and increase equity in organ donation and transplantation. The feedback will inform future regulations and rulemaking.
Comments will be accepted until Feb. 1, 2022.
The RFI can be found here.
CMS Publishes Medicare Telemedicine Data Snapshot
On Dec. 3, the Centers for Medicare and Medicaid Services (CMS) released a Medicare Telemedicine Data Snapshot, which provides information on Medicare beneficiaries who used telemedicine services. The snapshot shows that 28 million Medicare beneficiaries used telemedicine services from March 1, 2020, to Feb. 28, 2021.
The Medicare Telemedicine Data Snapshot can be viewed here.
CMS and CDC Issue New Procedure Codes for COVID-19 Therapeutics
On Dec. 1, the Centers for Medicare and Medicaid Services (CMS) implemented seven new procedure codes to describe the introduction or infusion of therapeutics for COVID-19 treatment into the International Classification of Diseases, Tenth Revision, Procedure Coding System (ICD-10-PCS). The new codes will go into effect on April 1, 2022. The Centers for Disease Control and Prevention’s (CDC) National Center for Health Statistics (NCHS) is also implementing three new diagnosis codes into the ICD-10 Clinical Modification (CM) that will be effective on April 1, 2022, as well.
The code tables and index can be found here.
CDC Updates COVID-19 Booster Recommendations
On Nov. 29, the Centers for Disease Control and Prevention (CDC) updated its COVID-19 booster recommendation. The CDC now recommends that everyone 18 years old and above receive a COVID-19 booster dose, either six months after their Pfizer or Moderna series or two months after their Johnson & Johnson vaccine. The booster recommendation accompanies the recent emergence of the Omicron variant.
FDA Advisors Vote in Favor of Authorizing Merck’s COVID-19 Pill
On Nov. 30, the Food and Drug Administration’s (FDA) advisors voted 13-10 in favor of authorizing Merck’s COVID-19 pill molnupiravir to treat mild-to-moderate COVID-19 in adults. This puts the pill on track for FDA approval.
FDA Issues Draft Guidance on Premarket Submissions for Device Software Functions
On Nov. 3, the Food and Drug Administration (FDA) published new draft guidance titled “Content of Premarket Submissions for Device Software Functions.” The guidance provides information on documentation sponsors need to submit for FDA’s evaluation of the safety and effectiveness of device software functions. When final, the guidance will replace prior guidance issued in 2005.
Public comments will be accepted until Feb. 2, 2022.
The draft guidance can be found here.
HHS Issues Proposed Rule to Withdraw the SUNSET Rule
On Oct. 29, the Department of Health and Human Services (HHS) issued a proposed rule that would withdraw the January 2021 final rule titled “Securing Updated and Necessary Statutory Evaluations Timely (SUNSET).” The SUNSET final rule required HHS regulations with a significant economic impact to be reviewed every 10 years, with regulations automatically expiring if they were not reviewed. This would have impacted more than 17,000 HHS regulations and required a review process considerably faster than HHS ever conducted.
The rule would have gone into effect in March 2021, but HHS issued a delay following a lawsuit.
Comments will be accepted until Dec. 28, 2021.
The proposed rule can be found here.
FDA Issues Draft Industry Guidance on Real-World Data Standards
On Oct. 22, the Food and Drug Administration (FDA) announced industry draft guidance titled “Data Standards for Drug and Biological Product Submissions Containing Real-World Data.” The guidance includes recommendations to help sponsors comply with the Federal Food, Drug and Cosmetic Act when submitting study data from real-world data sources.
Public comments will be accepted until Dec. 21, 2021.
The draft guidance can be found here.
FDA Issues Proposed Rule on Over-the-Counter Hearing Aids
On Oct. 20, the Food and Drug Administration (FDA) issued a proposed rule titled “Medical Devices: Ear, Nose, and Throat Devices; Establishing Over-the-Counter Hearing Aids.” The proposed rule would establish a new category of over-the-counter (OTC) hearing aids that could be sold to consumers directly without a medical exam or audiologic hearing. The proposed rule comes after President Biden’s July Executive Order aimed at promoting competition in the economy directed the FDA to increase access to OTC hearing aids.
Public comments will be accepted until Jan. 18, 2022.
The proposed rule can be found here.
FDA Issues Guidance on Continuous Manufacturing of Drug Substances and Products
On Oct. 12, the Food and Drug Administration issued a draft guidance document titled “Q13 Continuous Manufacturing of Drug Substances and Drug Products,” which was prepared with the support of the International Council for Harmonisation (ICH). The draft guidance provides clarification on the development and operation of continuous manufacturing and builds on prior guidelines Q7-Q10.
Comments will be accepted until Dec. 13, 2021.
The guidance can be found here.
FDA Issues Guidance Updating Unique Device Identification Policy
On Oct. 14, the Food and Drug Administration (FDA) issued a draft guidance titled “Select Updates for Unique Device Identification: Policy Regarding Global Unique Device Identification Database Requirements for Certain Devices.” The guidance revises the 2020 Unique Device Identification Guidance. The updated guidance explains there are certain class I devices for which the FDA will not enforce the Global Unique Device Identification Database (GUDID) submission requirements, and also states how a class I device labeler can determine if the device is in the scope of compliance policy.
Comments will be accepted until Dec. 13, 2021.
The guidance can be found here.
FDA Issues Final Rule to Amend Laboratory Food Testing Requirements
On Dec. 1, the Food and Drug Administration (FDA) issued a final rule titled “Laboratory Accreditation for Analyses of Foods.” The rule amends FDA regulations to establish a program for accredited laboratories to test food under certain circumstances.
The final rule will go into effect on Feb. 1, 2022.
The final rule can be found here.
CMS Issues Final Rule to Delay VBP Reporting and the Inclusion of U.S. Territories
On Nov. 17, the Centers for Medicare and Medicaid Services (CMS) released a final rule titled “Medicaid Program; Delay of Effective Date for Provision Relating to Manufacturer Reporting of Multiple Best Prices Connected to a Value Based Purchasing (VBP) Arrangement; Delay of Inclusion of Territories in Definition of States and United States.” The final rule delays the best price provisions and reporting related to VBP arrangements as part of the Medicaid Drug Rebate Program (MDRP) from Jan. 1, 2022, to July 1, 2022. In addition, the rule also delays the inclusion of five U.S. territories in the MDRP’s regulatory definition of “states” from April 1, 2022, to Jan. 1, 2023.
The regulations will be effective on Dec. 20, 2021.
The final rule can be found here.
CMS Issues Final Rule Rescinding Medicare Coverage of Innovative Technology and “Reasonable and Necessary” Final Rule
On Nov. 12, the Centers for Medicare and Medicaid Services (CMS) released a final rule to rescind the Trump administration’s “Medicare Coverage of Innovative Technology (MCIT) and Definition of ‘Reasonable and Necessary’” (MCIT/R&N) Final Rule. The final rule was published on Jan. 14, 2021, and would have gone into effect on Dec. 15, 2021. The rule would have granted up to four years of expedited Medicare coverage for certain designated “breakthrough” devices that receive market authorization. CMS states that the rule did consider the differences in devices and the potential safety impact on Medicare patients.
The final rule can be found here. A CMS press release on the final rule can be found here.
CMS Issues Final Rule for End-Stage Renal Disease Prospective Payment System
On Oct. 29, the Centers for Medicare and Medicaid Services (CMS) published a final rule titled “End-Stage Renal Disease Prospective Payment System, Payment for Renal Dialysis Services Furnished to Individuals with Acute Kidney Injury, End-Stage Renal Disease Quality Incentive Program, and End-Stage Renal Disease Treatment Choices Model.” The final rule updates payment rates under the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) for renal dialysis services starting Jan. 1, 2022. The rule also updates the acute kidney injury (AKI) dialysis payment rate for renal dialysis services and the ESRD Treatment Choices (ETC) Model.
The final rule will go into effect on Jan. 1, 2022.
The final rule can be found here. The CMS fact sheet on the final rule can be found here.
CMS Issues CY 2022 Medicare Hospital Outpatient Prospective and Ambulatory Surgical Center Payment Systems Final Rule
On Nov. 2, the Centers for Medicare and Medicaid Services (CMS) released a Final Rule titled “Calendar Year (CY) Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center (ASC) Payment Systems and Quality Reporting Programs; Price Transparency of Hospital Standard Charges; Radiation Oncology Model.” CMS is required by the January 2021 Hospital Price Transparency Final Rule to update Medicare payment policies for Outpatient Prospective Payment System (OPPS) hospitals and ASCs on an annual basis. The changes in the final rule aim to strengthen enforcement of hospital price transparency requirements and will stop the phased elimination of the Inpatient Only (IPO) list for surgical procedures. CMS will increase the penalty for hospitals that do not comply with the Hospital Price Transparency Rule starting on Jan. 1, 2022. The final rule also halts the elimination of the IPO list. In addition, the rule updates the OPPS payment rates for hospitals that meet quality reporting requirements by 2.0 percent. The final rule also details the Radiation Oncology Model, which is set to begin on Jan. 1, 2022, and last for five years.
The final rule will go into effect on Jan. 1, 2022.
The final rule can be found here. The CMS fact sheet on the final rule can be found here.
CMS Issues CY 2022 Medicare Physician Fee Schedule Final Rule
On Nov. 2, the Centers for Medicare and Medicaid Services (CMS) issued a final rule titled “Calendar Year (CY) 2022 Payment Policies under the Physician Fee Schedule and Other Changes to Part B Payment Policies; Medicare Shared Savings Program Requirements; Provider Enrollment Regulation Updates; and Provider and Supplier Prepayment and Post-payment Medical Review Requirements.” The rule includes policy changes for Medicare payments under the Physician Fee Schedule (PFS) and would continue the coverage of Medicare telehealth services and finalize changes to the Medicare Diabetes Prevention Program (MDPP) expanded model, among other things. The CY 2022 PFS conversion factor is $33.59, a decrease from the CY 2021 factor of $34.89.
The final rule will go into effect on Jan. 1, 2022.
The final rule can be found here. The CMS fact sheet on the final rule can be found here.
CMS Issues 2022 Home Health Prospective Payment System Rate Final Rule
On Nov. 2, the Centers for Medicare and Medicaid Services (CMS) published a proposed rule titled “Calendar Year (CY) 2022 Home Health Prospective Payment System Rate Final Rule.” The rule will expand the Home Health Value-Based Purchasing (HHVBP) Model. In addition, the rule updates the Medicare Home Health Prospective Payment System (HH PPS) and the home infusion therapy services payment rates for CY 2022. In addition, the proposed rule makes permanent changes to the home health Conditions of Participation (CoP) implemented during the COVID-19 public health emergency.
The final rule will go into effect on Jan. 1, 2022.
The final rule can be found here. The CMS fact sheet on the final rule can be found here.
Supreme Court Hears Arguments in Becerra v. Empire Health
On Nov. 29, the U.S. Supreme Court heard arguments in the case of Becerra v. Empire Health Foundation. The case discusses whether or not the Centers for Medicare and Medicaid Services (CMS) can exclude patients who have exhausted their Medicare Part A benefits when calculating hospitals’ disproportionate share payments (DSH).
PCMA Drops Lawsuit Regarding PBM Rebate Disclosure
On. Dec. 1, the Pharmaceutical Care Management Association (PCMA) dropped its lawsuit over a Trump administration rule that would have required pharmacy benefit managers (PBMs) to disclose publicly the prices they negotiate with pharmaceutical companies. The Department of Health and Human Services (HHS) delayed enforcement of the rule indefinitely in August 2021.
Missouri District Court Blocks CMS Vaccine Mandate in Ten States
On Nov. 30, a federal district court in Missouri issued a preliminary injunction to block the implementation and enforcement of the Centers for Medicare and Medicaid Services’ (CMS) vaccine mandate for healthcare workers in ten states. The court found that CMS acted without authority and bypassed the notice and comment period. The ten states impacted by the injunction and that do not have to comply with the mandate (unless the situation changes) are: Alaska, Arkansas, Iowa, Kansas, Missouri, Nebraska, New Hampshire, North Dakota, South Dakota and Wyoming.
Kentucky District Court Blocks Federal Contractor Vaccine Mandate in Three States
On Nov. 30, the U.S. District Court for the Eastern District of Kentucky blocked President Biden’s federal contractor vaccine mandate from being enforced in Kentucky, Ohio and Tennessee. Judge Gregory Van Tatenhove stated that a president cannot use their authority to manage the federal procurement of goods and services to impose vaccine mandates on the employees of federal contractors and subcontractors. The vaccine mandate requires companies doing business with the federal government to ensure that their workers are fully vaccinated and offers no option for weekly testing.
GAO Report on the Black Lung Benefits Program
On Dec. 2, the Government Accountability Office (GAO) published a report titled “Black Lung Benefits Program: Continued Inaction on Coal Operator Self-Insurance Increases Financial Risk to Trust Fund.” The Department of Labor (DOL) oversees the Black Lung Disability Trust Fund. The report notes that the DOL took some steps to improve its oversight of self-insured coal mine operators, but these efforts were complicated by the COVID-19 pandemic. The GAO states that the DOL has not taken necessary action to prevent additional benefit liabilities from being transferred to the trust fund and recommended that the DOL act on recommendations made in 2020.
The full report can be found here.
GAO Report on VA Property Management
On Nov. 29, the Government Accountability Office (GAO) published a report titled “VA Real Property: Enhanced Communication and Performance Measurement Could Improve Capital Asset Management.” The report states that the Department of Veterans Affairs (VA) faces challenges in meeting its capital asset management framework. The GAO recommends that the VA specify how construction and field offices should communicate during project development, define the role of the information technology office and develop performance goals for the VA’s capital asset management.
The full report can be found here.
HHS ASPE Report on Surprise Billing
On Nov. 22, the Health and Human Services (HHS) Department’s Office of the Assistant Secretary for Planning and Evaluation (ASPE) published a report on surprise medical billing. The report found that surprise medical bills are relatively common for Americans with private insurance, with an average bill of $1,200 for anesthesiologist services, $2,600 for surgical assistance and $750 for care related to childbirth. The report provides a background on surprise billing and details the consumer protections in the No Surprises Act that will go into effect on Jan. 1, 2022.
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.
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