This week in Washington: The 117th Congress will be in session on Jan. 21.

Administration

CMS: 2022 Requests for Applications for the Value-Based Insurance Design (VBID) Model and its Hospice Benefit Component
On Jan. 8, the Centers for Medicare and Medicaid Services (CMS) announced that the Value-Based Insurance Design (VBID) Model team will host a webinar on Jan. 14, 2021, from 4-5 p.m. ET. During this webinar, presenters will provide a brief review of the recently released calendar year (CY) 2022 requests for applications (RFAs) for the VBID Model and the Hospice Benefit Component. This session will also offer attendees an opportunity to ask follow-up questions. Please submit questions in advance by emailing the VBID mailbox at VBID@cms.hhs.gov.

CMS: MFAR to Be Formally Withdrawn
On Jan. 7, the Centers for Medicare and Medicaid (CMS) Administrator Seema Verma announced that CMS is withdrawing the Medicaid Fiscal Accountability Regulation (MFAR). She added that the 2020 year-end legislation that included supplemental pay transparency provisions would help achieve the proposed rule’s goals. However, the withdrawal notice did not appear to be on the Federal Register website as of her announcement.

CMS Adds to ACO, ESCO Resources with Resource Transformation Toolkit, Case Studies and Tip Sheet
On Jan. 6, the Centers for Medicare and Medicaid Services (CMS) announced the release of new resources highlighting strategies used by Medicare Accountable Care Organizations (ACOs) and End-Stage Renal Disease Seamless Care Organizations (ESCOs) in an effort to improve quality of care, lower health care costs and enhance beneficiary experience. These resources, posted on the ACO General Information web page, include:

  • care transformation toolkit that describes ACO approaches to developing and implementing programs that transform the delivery of care and relate to telehealth, home visits and timely access to skilled nursing facilities. Find the toolkit here.
  • Four case studies that feature specific ACO and ESCO initiatives to:
  • tip sheet that highlights strategies for enhancing education on home dialysis and for expanding the use of home dialysis. Find the tip sheet here.

CMS: Applications for MIPS Exceptions Due to COVID-19 Now Due Feb. 1
On Dec. 17, the Centers for Medicare and Medicaid Services (CMS) pushed back the deadline to Feb. 1 for doctors to apply for extreme and uncontrollable circumstances exceptions from the Merit-based Incentive Payment System to Feb. 1. CMS is reminding providers that that process can include a request to leave out one or more performance categories from their score due to the COVID-19 pandemic. However, the hardship application for the interoperability category would still have a Dec. 31 deadline. Find more information here.

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

Coronavirus Relief Summary

On Monday, December 21, Congress passed the Consolidated Appropriations Act, 2021, which includes the highly anticipated coronavirus relief package. The $900 billion relief package includes funding for stimulus checks, unemployment benefits, small businesses, vaccine distribution, health care, education, transportation, rental assistance, and agriculture. President Trump is expected to sign the legislation.

Compared to the CARES Act, the stimulus checks in this new relief package are smaller. Taxpayers making less than $75,000 can expect to see a $600 stimulus check, compared to $1,200 per person included in the CARES Act. Similarly, the relief package will provide an extension of the CARES Act unemployment insurance of $300 through March 14, 2021. Under the CARES Act, workers receiving unemployment received $600 per week.

Notably, the package does not include funding for state and local governments nor liability protections for businesses; however, the package does extend the deadline for spending appropriated money from the CARES Act Coronavirus Relief Fund (aid to states and localities) by one year until December 31, 2021. Liability protection and funding for state and local governments were very contentious and excluded from the package in an effort to reach an agreement before the 116th Congress adjourned.

Below we have detailed the education, broadband, student loan, workforce development, and small business provisions of the relief package.

Education

The legislation provides $82 billion for the education funding streams created under the CARES Act. Of this appropriation, $4.1 billion is allocated for the Governors Emergency Education Relief (GEER) Fund, of which $2.75 billion is earmarked for private schools. The Elementary and Secondary School Emergency Relief (ESSER) Fund will receive $54.3 billion, and the Higher Education Emergency Relief (HEER) Fund will receive $22.7 billion. Funds will be allocated to these streams using the same formulas that were used under the CARES Act. Funds must be used within 1 year of receiving them.

Broadband

The coronavirus pandemic has highlighted the importance of connectivity, especially for education as the majority of schools went virtual for the 2020-2021 academic year. To that end, the relief package provides $7 billion for broadband access.

Student Loans

The bill does not extend the student loan forbearance provisions under the CARES Act. The forbearance provisions under the CARES Act are currently set to expire on January 31, 2021, after Secretary DeVos extended the provisions earlier this month.

Workforce Development

There are no workforce development provisions in the package.

Paycheck Protection Program

The package provides $325 billion to the Small Business Administration. Of this appropriation, 284.45 billion is allocated for the Paycheck Protection Program Second Draw Loans. Small businesses with 300 or fewer employees that have lost at least 25 percent of their revenue in any quarter of 2020 are eligible to receive a second draw.

Read more on major provisions included in the bill from McGuireWoods Consulting’s federal team.

Biden Transition Update

President-elect Joe Biden’s education transition team, led by Linda Darling-Hammond, is hard at work preparing to hit the ground running on Inauguration Day (January 20, 2021). The transition team is focused on ensuring a smooth roll out of the coronavirus relief funds when the Biden Administration takes office. It is also taking steps to prepare for Biden’s policy agenda, which includes increasing Title I funding to make investments in teacher pay and early childhood education, among other things, and a focus college affordability. In addition, the transition team is reviewing policies put in place by Secretary DeVos, as President-elect Biden and his cabinet pick will likely look to reverse several of these policies, including Title IX regulations on sexual misconduct.

Connecticut Education Commissioner Miguel Cardona is set to be nominated as the next Secretary of Education. Biden has said he will choose a public school teacher to be Secretary of Education, and Cardona began his career as a fourth grade teacher.

State Legislatures

As state legislatures convene for the 2021 legislative session, legislators will have to address a number of important issues affecting their states. At the top of the list is the ongoing coronavirus pandemic and its impact on state economies and budgets. According to the Center on Budget and Policy Priorities (CBPP), states will average a 20 percent budget shortfall in FY 21. Expenses related to the pandemic, including the rollout of the vaccine, will continue to rise, while revenues decrease, causing significant uncertainty as states look to address budget shortfalls and aid in economic recovery.

Other top issues we are likely to see in state legislatures across the country include police and criminal justice reform, data privacy, redistricting, and education. While many states enacted police and criminal justice reforms in 2020, either through regular session or through special session (Oregon and Virginia, for example), we expect additional measures to be enacted in 2021. Data privacy will be another big issue for states. Following on the heels of California passing the California Consumer Privacy Act in 2018, over two dozen states introduced their own privacy bills in the 2020 legislative session. Most of these bills did not pass, but we expect similar legislation to be introduced in 2021. Redistricting will be another priority in 2021 with the completion of the 2020 Census. Finally, as the coronavirus continues to impact our education system, states will look to mitigate learning loss and the digital divide. Expanding broadband access will likely be a top priority for states.

McGuireWoods Consulting has prepared analyses of what to expect in the 2021 legislative sessions, in the following states — Florida, Georgia, Illinois, North Carolina, South Carolina and Texas, plus an overview on how to work effectively with transition teams and an update from our national multistate strategies team for a look ahead to 2021.

View a full list of state legislative session dates here.

McGuireWoods Consulting’s National Education Team

With significant political change at the state and national level, it is important to think ahead about your strategy in managing this changing landscape. McGuireWoods Consulting’s national education team provides guidance to clients on issues that migrate beyond a state border. We work with groups representing the nation’s governors, attorneys general and state legislative groups, and these officials play an increasing role in shaping education policy. In addition, MWC tracks bills and regulations throughout the country and is informed about key issues across all 50 states.

Summary

On December 21, 2020, Congress released and passed its long-awaited coronavirus relief package, which was part of a nearly 5,600 page 2021 government appropriations bill. The $900 billion COVID-19 stimulus is the result of weeks of intense bipartisan negotiations. Congress voted to approve the bill on Monday night, and President Trump is expected to sign it into law shortly. There are significant changes to the CARES Act and additional funding for several industry sectors. McGuireWoods Consulting has assembled an outline of what the bill includes, and does not include, as well as how it differs from the CARES Act, especially as it relates to the Paycheck Protection Program (PPP).

The Paycheck Protection Program

  1. $284 billion has been allocated for the new batch of PPP loans. Applicants may apply for their first or second loan.
  2. Creates a second loan from the Paycheck Protection Program, called a “PPP second draw” loan, for smaller and harder-hit businesses with a maximum loan amount of $2 million.
    • Recipients of a second PPP loan will need to meet three additional criteria. First, they must have 300 or fewer employees, down from 500; second, they must have used or will use the entirety of their first PPP loan; and third, they must have seen gross receipts decline by at least 25 percent for any quarter in 2020 compared to that same quarter in 2019.
  3. Loan terms. Borrowers may receive a loan amount of up to 2.5X the average monthly payroll costs in the one year prior to the loan or the calendar year. No loan can be greater than $2 million.
    • Seasonal employers may calculate their maximum loan amount based on a 12-week period beginning February 15, 2019 through February 15, 2020.
    • New entities may receive loans of up to 2.5X the sum of their average monthly payroll costs.
    • Entities in industries assigned to NAICS code 72 (Accommodations and Food Services) may receive loans of up to 3.5X average monthly payroll costs.
    • Businesses with multiple locations that are eligible entities under the initial PPP requirements may employ not more than 300 employees per physical location.
    • Waiver of affiliation rules that applied during initial PPP loans apply to a second loan.
    • An eligible entity may only receive one PPP second draw loan.
    • Fees are waived for both borrowers and lenders to encourage participation.
    • For loans of not more than $150,000, the entity may submit a certification attesting that the entity meets the revenue loss requirements on or before the date the entity submits their loan forgiveness application and non-profit and veterans organizations may utilize gross receipts to calculate their revenue loss standard.
    • Borrowers receive full loan forgiveness if they spend at least 60 percent of their PPP second draw loan on payroll costs over a time period of their choosing between 8 weeks and 24 weeks.
    • Includes set-asides to support first-time PPP borrowers with 10 or fewer employees, second-time PPP borrowers with 10 or fewer employees, first-time PPP borrowers who have been made newly eligible, and second-time returning PPP borrowers. Additionally, provides for a set-aside for loans made by community lenders.
    • Publicly traded companies are no longer eligible for PPP loans.
  4. Loan forgiveness. Borrowers of a PPP second draw loan would be eligible for loan forgiveness equal to the sum of their payroll costs, as well as covered mortgage, rent, and utility payments, covered operations expenditures, covered property damage costs, covered supplier costs, and covered worker protection expenditures incurred during the covered period. The 60/40 cost allocation between payroll and non- payroll costs in order to receive full forgiveness will continue to apply.

Other Business Relief Appropriations

  1. $20 billion for the Economic Injury Disaster Loan (EIDL) Advance program.
  2. $3.5 billion for continuing the SBA Section 7(a) Debt Relief program.
  3. $2 billion to enhance SBA’s core programs, including 7(a), Community Advantage, 504, and the Microloan program.
  4. $12 billion in Community Development Financial Institution and Minority Depository Institution targeted emergency investments to help low-income and minority communities.
  5. Extends the period by which employers can defer payroll taxes to April 30, 2021 and paid back by January 1, 2022.
  6. Extends both the Pandemic Unemployment Assistance (PUA) program and Pandemic Emergency Unemployment Compensation (PEUC) program.

Key CARES Act Programs For Individuals

  1. $120 billion for a 16-week extension of all unemployment assistance, with a $300 supplement per week.
    • Extended to March 14, 2021.
  2. Provides economic impact payments of $600 for individuals making up to $75,000 per year and $1,200 for couples making up to $150,000 per year, as well as a $600 payment for each dependent.
  3. An extension of the eviction moratorium until January 31 and $25 billion for emergency rental assistance.
  4. Extends credits for paid sick and family leave through March 2021.
  5. An extension and expansion of the Employee Retention Tax Credit (ERTC).
    • The ERTC is extended until July 1.
    • Increases the credit rate from 50 percent to 70 percent.
    • Raises the limit on per-employee creditable wages from $10,000 for the year, to $10,000 for each quarter.
    • Expands eligibility for the credit by reducing the required year-over-year decline in gross receipts from 50 percent to 20 percent.
    • Modifies the threshold for treatment as a ‘large employer’ by increasing the 100-employee delineation for determining the relevant qualified wage base to employers with 500 or fewer employees.

Industry-Specific Provisions

Transportation: $45 billion

  1. $15 billion for the Airline Payroll Support Program.
  2. $14 billion for transit agencies.
  3. $10 billion for state highways.
  4. $1 billion for airline contractor payroll support.
  5. $2 billion for airports and airport concessionaires.
    • No less than $200 million will be available to sponsors of primary airports to provide relief from rent and minimum annual guarantees to on airport car rental, on-airport parking, and in-terminal airport concessions.
      • “The sponsor shall provide relief from rent and minimum annual guarantee obligations to each eligible airport concession in an amount that reflects each eligible airport concession’s proportional share of the total amount of the rent and minimum annual guarantees of all the eligible airport concessions at such airport.”
  6. $2 billion for the private motorcoach, school bus, and ferry industries.
  7. $1 billion for Amtrak.

Live Venues: $15 billion

  1. Grants for shuttered live venues, theaters, museums, and zoos.
    • $2 billion will be set aside for eligible entities that employ 50 full-time employees or fewer.

Agriculture: $26 billion

  1. $13 billion in direct aid to farmers who have suffered losses due to the coronavirus.
  2. Increases the monthly SNAP benefit level by 15 percent based on the June 2020 Thrifty Food Plan through June 30, 2021.
  3. $400 million for the Emergency Food Assistance Program.
  4. $100 million in additional funding for specialty crop farmers and the Specialty Crop Block Grant Program.
  5. $100 million to support local farmers, farmers markets, and value-added production for farmers and outlets.

Education/Schools: $82 billion

  1. $54.3 billion for the Elementary and Secondary School Emergency Relief Fund (Public K-12 schools).
  2. $22.7 billion for the Higher Education Emergency Relief Fund.
  3. $20 billion distributed to all public and private non-profit institutions of higher education.
  4. $4.05 billion for the Governors Emergency Education Relief Fund.
  5. $1.7 billion to Minority Serving Institutions, including:
    • $727 million to historically black colleges and universities.
    • $320 million to Hispanic Serving Institutions.
    • $242 million to the Strengthening Institutions Program.
  6. $908 million to for-profit colleges to provide financial aid grants to students.
  7. $818.8 million in relief for outlying areas and the Bureau of Indian Education.

Major Provisions Excluded From The Package

  1. $160 billion for state and local governments.
  2. Business liability protection.

For a complete look at federal and state action related to the coronavirus, visit McGuireWoods Consulting’s Coronavirus (COVID-19) Facts and Resources website.

House and Senate Reach Deal on $900B COVID-19 Relief Package and Omnibus Appropriations Bill; Vote Today

On Dec. 21, the House and Senate reached an agreement on a pandemic rescue measure of $900 billion that will be attached to a $1.4 trillion omnibus spending bill for the fiscal year, and includes a variety of health provisions. The bill is set to be voted on today.

The COVID-19 relief measure includes $286 billion for direct economic relief for workers and families. This bill provides an additional $300 to all workers receiving unemployment assistance for eleven weeks. This bill also extends the pandemic unemployment assistance program, with expanded coverage to the self-employed gig workers and others in non-tradition employment. The bill maximizes the Pandemic Emergency Compensation Program with an additional 13 weeks of benefits. The deal includes over $284 billion dollars to first forgiveness PPP loans, dedicated set asides for very small businesses and lending through community lenders. Other provisions for small businesses include expanded PPP eligibility for 501c(6) non-profits. The bill also includes $3.5 billion for continued small business administration relief payments and $2 billion for enhancements to small business administration lending. The bill also includes funding for schools, rental assistance, nutritional programs, childcare and broadband.

Healthcare Provisions: Among the healthcare provisions is the No Surprise Act, which ends surprise medical billing. In addition, important public health programs are extended for three years. Medicaid DSH payments will not face cuts for three years. Provisions for Medicaid reporting requirements concerning state Medicaid payment and financing data are similar to the proposed medicaid fiscal accountability rule. The legislation also included Medicare extenders for three years. In addition, there were changes to orphan drug requirements and a requirement for labels to be accurate after a brand drug has left the market and other changes affecting generic drugs. More information will be posted as available.

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

Trump Signs One-Week CR Spending Bill

On Dec. 11, President Trump signed a continuing resolution to give Congress an additional week to come up with full-year spending legislation and avoid a government shutdown. The CR sets a new funding deadline of Dec. 18. The House passed the bill 343-67, and Senate passed the bill by voice vote.

FDA Announces It Will Quickly Authorize Pfizer Vaccine

On Dec. 11, the Food and Drug Administration (FDA) notified the Centers for Disease Control and Prevention (CDC), Operation Warp Speed and Pfizer that it is working to quickly finalize and issue an emergency use authorization (EUA) for Pfizer and BioNTech’s COVID-19 vaccine. The announcement followed the FDA advisory panel’s endorsement of the vaccine the same week. It is unclear whether the EUA will be for people ages 16 and up, as it is in the United Kingdom and Canada, or whether FDA will heed concerns from some of its advisors and change the minimum age to 18. The vaccine has not been tested in 16-year-olds but FDA says it is biologically reasonable to assume that its effectiveness in 16- and 17-year-olds will be similar to the vaccine’s effectiveness in younger adults.

CMS Releases Information on the Best Practices for Designing and Implementing Substance Use Disorder (SUD)-Focused Health Homes

On Dec. 10, the Centers for Medicare and Medicaid Services released a new resource for states to utilize in their Medicaid programs when considering a substance use disorder (SUD)-focused health home program to care for their beneficiaries. Specifically, this resource provides a description of the best practices for designing and implementing a SUD-focused health home state plan amendment based on the experiences of states with approved SUD-focused health home programs, as required per section 1006(a)(2) of the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities (SUPPORT) Act. Find more information here.

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

This week in Washington: COVID-19 relief bill negotiations begin in earnest; Congress works on Appropriations bills hoping to have them passed before government funding ends on Dec. 11.

House

Pelosi, Schumer Support Bipartisan $908B Pandemic Relief Proposal
On Dec. 2, House Speaker Nancy Pelosi and Senate Minority Leader Chuck Schumer said they are endorsing a new compromise $908 billion pandemic relief bill as a framework for negotiations with Senate Majority Leader Mitch McConnell (R-KY) and House Minority Leader Kevin McCarthy (R-CA). The framework proposed by a bipartisan group of senators and supported by the House Problem Solvers Caucus is over 1 trillion dollars less than Democrats are seeking in the House-passed HEROES Act. It is over $400 billion more than Republicans sought in their most recent proposal. It is unclear when the proposal would be ready for a vote on the House or Senate floor, or if either leader would commit to calling it up to vote. Senate Majority Whip John Thune (R-SD) said he thinks there is a path forward with the current framework. Find the framework here.

Senate

Cardin, Portman, Thune, Menendez Introduce Legislation to Fund COVID-19 Vaccine Public Advocacy Campaign
On Dec. 3, Sens. Ben Cardin (D-MD), Rob Portman (R-OH), John Thune (R-SD) and Bob Menendez (D-NJ) introduced bipartisan legislation to fund a science-driven public advocacy campaign to ensure that when the Food & Drug Administration (FDA) has authorized an effective COVID-19 vaccine, distribution will properly occur throughout the country. This legislation would authorize necessary funding to fund a public awareness campaign on COVID-19 vaccine information through the Department of Health and Human Services (HHS) and the Centers for Disease Control and Prevention (CDC). Grants would go to entities to start developing campaigns that target all Americans, and that would begin no later than 30 days after a vaccine is authorized.

Warner: CMS Must Extend Enrollment Window over APTC Confusion
On Dec. 3, Sen. Mark Warner (D-VA) announced that he wants the Internal Revenue Service (IRS) and the Centers for Medicare and Medicaid Services (CMS) to provide more clarity to consumers, waive any enforcement penalties and create an open enrollment period to ensure enrollees do not go without coverage during the COVID-19 pandemic. CMS announced that Affordable Care Act enrollees who have reconciled their 2019 advanced premium tax credits (APTCs) as required can keep their 2021 subsidies, even if they were notified that they are at risk of losing them, by checking a box on their exchange application. Sen. Warner does not think that is enough to help enrollees, commenting that consumers remain confused about their options and are at risk of losing their health coverage during a pandemic.

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

Bernard L. McNamee, who recently completed a term as a commissioner on the Federal Energy Regulatory Commission (FERC), has joined McGuireWoods Consulting as a senior advisor in the firm’s Richmond, Virginia, and Washington, D.C. offices, and rejoined the McGuireWoods law firm as a partner in its Richmond, Virginia office.

McNamee was nominated to FERC by President Donald Trump and confirmed by the United States Senate in 2018. During his time on the commission, McNamee was recognized as a leader on a number of important energy issues and participated in more than 1,700 published orders on issues related to wholesale electricity markets, natural gas pipelines, liquefied natural gas export facilities, oil pipeline rates, hydro facilities, reliability standards, and ratemaking. He also testified before Congress and was invited to speak before energy organizations throughout the country.

McNamee will provide McGuireWoods and McGuireWoods Consulting clients legal, policy and legislative guidance on a wide range of energy and environmental issues. His practice will focus on legislation, rulemaking, strategic planning and policy development, including issues involving Congress, the Department of Energy, the Environmental Protection Agency, and FERC, as well as regional transmission organizations (RTOs) and independent system operators (ISOs).

McNamee will assist clients with high-stakes and complex issues involving the Federal Power Act (FPA), Natural Gas Act (NGA), Public Utility Regulatory Policies Act (PURPA), Interstate Commerce Act (ICA), Renewable Fuel Standard (RFS), Nuclear Waste Policy Act (NWPA), and National Environmental Policy Act (NEPA). McNamee will also develop coalitions for clients, allowing for multilevel engagement on important energy and environmental issues.

McNamee, who is actively licensed in Virginia and Texas, is not licensed to practice law in Washington D.C., and will not maintain a law office or practice law there.

“Bernie’s insight as a FERC commissioner, his involvement in major rulemaking proceedings, his relationships with policymakers and stakeholders, and his service in significant state and federal government policy positions will provide our clients with powerful advantages. He will be a major asset to our clients with energy and environmental policy issues,” said McGuireWoods Consulting President and former South Carolina Governor Jim Hodges.

Before joining FERC, McNamee served in the U.S. Department of Energy as executive director of the Office of Policy and deputy general counsel for energy policy. His distinguished career in public service includes key leadership positions under Attorneys General in Virginia and Texas and policy advisor roles for U.S. Senator Ted Cruz of Texas and former Virginia Governor George Allen.

McNamee previously was a partner in McGuireWoods’ Regulatory & Compliance Department. He assisted electric and natural gas utilities in rate cases and in obtaining approvals to build generating facilities and transmission lines, as well as the development of renewable portfolio standards (RPS) and integrated resource planning (IRP). He played an integral role advising clients during implementation of the 2007 Virginia Electric Utility Regulation Act, which returned the state’s utilities to a modified cost-of-service regulatory model.

“We are delighted that Bernie has come home to McGuireWoods,” said J. Tracy Walker IV, the law firm’s managing partner. “The depth and breadth of his experience in public service and private practice will provide immense value to the firm and our energy clients.”

McGuireWoods lawyers and consultants represent clients across the entire energy spectrum, including utilities, conventional oil and gas investors and operators, leading sponsors and developers of solar, wind and thermal generation and financial institutions. The firm has been named a finalist for best energy practice in The American Lawyer’s inaugural Corporate Departments of the Year awards.

“McGuireWoods is recognized nationally as a leader in providing comprehensive legal, policy and business guidance to companies and investors in all sectors of the energy industry,” McNamee said. “I am excited to rejoin the firm and put my experience to work to help our clients achieve their business goals.”

This week in Washington: Congress gets organized for next Congress; House passes health care bills; COVID-19 vaccine is the talk of the town.

House

House Passes 10 Health Care Bills
On Nov. 17, the House passed 10 health care-related bills that include legislation to support new research into health disparities, improvements to food and drug labeling, and a new $10 million grant program for trauma centers that intervene in cyclical violence. The legislation also provides $1.5 billion annually in grants to states and tribal organizations to support substance use disorder (SUD) treatment and prevention, as well as new tools and authorities to prevent the illegal distribution of controlled substances. All of the bills were passed by voice vote and now must be considered by the Senate.

The House passed the following bills:

  • H.R. 4499, the NIMHD Research Endowment Revitalization Act of 2020, authorizes the National Institute on Minority Health and Health Disparities to facilitate research on minority health disparities through research endowments at current or former centers of excellence.
  • H.R. 5668, the Making Objective Drug Evidence Revisions for New Labeling Act of 2020 or the MODERN Labeling Act of 2020, allows the Food and Drug Administration (FDA) to require modifications of outdated labeling for certain generic drugs to ensure labels have complete and accurate information. The bill would require FDA to report any actions taken under this new authority to update labeling for covered drugs, including the number of drugs, description of the changes and the rationale, as well as any FDA recommendations to modify the program.
  • H.R. 4712, the Fairness in Orphan Drug Exclusivity Act, closes a loophole in the Orphan Drug Act by requiring drug manufacturers seeking orphan drug designations under the rarely used cost recovery pathway to demonstrate the absence of any reasonable expectation of the costs they incur in developing and making those drugs available in the U.S. for such disease or condition. The legislation requires FDA and the manufacturer to take into account the sales of all of the manufacturer’s drugs developed under the same orphan drug designation.
  • H.R. 2466, the State Opioid Response Grant Authorization Act of 2020, authorizes the Substance Abuse and Mental Health Services Administration (SAMHSA) State Opioid Response Grants program to align with the grant authority provided through the 21st Century Cures Act. The bill also authorizes support for state actions to address stimulant use.
  • H.R. 2281, the Easy Medication Access and Treatment for Opioid Addiction Act or the Easy MAT for Opioid Addiction Act, would require the Drug Enforcement Administration (DEA) to allow a practitioner to dispense up to a three-day supply of medication-assisted treatment. This practice is intended to relieve potential acute withdrawal symptoms while the individual awaits longer-term treatment.
  • H.R. 2117, the Food Allergy Safety, Treatment, Education, and Research Act of 2020 or the FASTER Act of 2020, would require the Centers for Disease Control and Prevention (CDC) to expand the collection of information related to the prevalence of food allergies for specific allergens and to include that information in reports to Congress. The bill would also amend the Federal Food, Drug, and Cosmetic Act (FFDCA) to include sesame as a major allergen and allow FDA, through regulation, to add other food ingredients as major allergens based on the prevalence and severity of allergic reactions to the food ingredient. Additionally, the bill would require FDA to include patient experience data on treatments for patients with food allergies in its reports on patient experience data.
  • H.R. 5855, the Bipartisan Solution to Cyclical Violence Act of 2020, would create a grant program at the Department of Health and Human Services (HHS) to support trauma centers with violence intervention and violence prevention programs. Program support would be provided to conduct research to reduce the incidence of re-injury and re-incarceration caused by intentional violent trauma.
  • H.R. 3878, the Block, Report, And Suspend Suspicious Shipments Act of 2020, creates additional requirements for drug manufacturers and distributors who discover a suspicious order for controlled substances. In addition to reporting a suspicious order of controlled substances to DEA, a manufacturer or distributor must also exercise due diligence, decline to fill the order or series of orders, notify DEA of each suspicious order or series of orders and the indicators that led to the belief that filling such orders would be a violation. These requirements would become effective one year following enactment.
  • H.R. 4806, the Debarment Enforcement of Bad Actor Registrants Act of 2020 or the DEBAR Act of 2020, would amend the Controlled Substances Act to allow the Attorney General to prohibit any registrant from manufacturing, distributing or dispensing a controlled substance or a list I chemical if that registrant meets or has met any of the conditions for suspension or revocation of registration, or has a history of prior suspension or revocations.
  • H.R. 4812, the Ensuring Compliance Against Drug Diversion Act of 2019, terminates the controlled substance registration of any registrant if the registrant dies, ceases legal existence, discontinues business or professional practice or surrenders registration. A registrant who ceases legal existence or discontinues business is required to notify DEA. Registrants must receive written consent from DEA in order to assign or transfer a registration. Registrants are also required to return certain documentation if a registrant’s work is discontinued.

Senate

Wyden Presses UnitedHealth for Details on Mental Health Coverage Shortfalls
On Nov. 19, Senate Finance Committee Ranking Member Ron Wyden (D-OR) sent a letter to health insurance company UnitedHealth requesting it disclose details about its behavioral health business, which has been subject to ongoing class action litigation for improperly denying coverage for mental health and substance use disorder (SUD) care. Sen. Wyden requested more information on factors that are driving revenue and profit growth for UnitedHealth in its behavioral health business. The letter also asks for more information about allegations that UnitedHealth directed at least one customer to Medicaid rather than covering the care itself, and whether such practices are widespread at the company. Additionally, the letter seeks details about subsidiaries, affiliates and contractors that UnitedHealth may use to administer behavioral health care coverage for third-party health plans. Find the letter here.

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

This week in Washington: House Minority Leader Kevin McCarthy announced he is waiting to see who will become the next House speaker before working on another COVID-19 stimulus package; Senate Appropriations Committee releases Republican draft proposals for FY 2021.

House

Minority Leader McCarthy Will Wait for Next House Speaker to Negotiate COVID-19 Relief
On Nov. 12, House Minority Leader Kevin McCarthy (R-CA) announced he is waiting to see who will become the next House speaker before working on another COVID-19 stimulus package. Last week, Senate Majority Leader Mitch McConnell (R-KY) called for passing a fourth stimulus package during Congress’s lame-duck session.

Ways and Means Chairman Neal: CMS Needs to Reinstate Nursing Home Staff Trainings
On Oct. 30, House Ways & Means Chairman Richard Neal (D-MA) wrote a letter to the Centers for Medicare and Medicaid Services (CMS) stating that CMS should reinstate its 75-hour nursing home staff training requirements and publicly report how many current staff have not met that requirement. Neal and eight other members want CMS to reinstate the staff training and physician oversight requirements that CMS waived due to the COVID-19 pandemic, arguing facilities are better able to prevent or contain COVID-19 when they have higher staff ratios and highly trained staff.

Senate

Senate Appropriations Committee Releases Republican Draft Proposals for Fiscal Year 2021
On Nov. 10, the Senate Appropriations Committee majority (Republican) released their draft appropriations bills. These bills have not yet gone through the regular committee process. The current continuing resolution funds the government through Dec. 11. It is unclear whether Congress will fund the government for the full year or do a continuing resolution into next year and the new Congress. Find more information here.

Sen. Murray Tells Secretaries of Education, Labor and HHS to Preserve All Records
On Nov. 10, Sen. Patty Murray (D-WA) sent letters to Secretary of Education Betsy DeVos, Secretary of Labor Eugene Scalia and Secretary of Health and Human Services (HHS) Alex Azar reminding them to comply with the Federal Records Act (FRA) and preserve all records as the end of the Trump administration approaches. Sen. Murray stressed to the Secretaries that violating the FRA can disqualify them from future federal office and reminded them that they have an obligation to inform the Archivist of any actual, impending or threatened unlawful action against records at their agency. Find the letter here.

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

This week in Washington: Washington’s focus has been on the presidential and Senate races.

House

Neal, Pallone Tell CMS to Not Ease Physician-Owned Hospital Restrictions
On Oct. 21, the House Ways and Means Chair Richard Neal (D-MA) and Energy and Commerce Chair Frank Pallone (D-NJ) sent a letter to the Centers for Medicare and Medicaid Services (CMS) to voice opposition to a provision in CMS’s proposed hospital outpatient pay rule that loosens restrictions on physician-owned hospitals. Neal and Pallone added that the proposal goes against a moratorium on the expansion of physician-owned hospitals that Congress put in place to counter concerns. They also were concerned about physician-owned hospitals’ picking patients selectively, self-referring, increasing costs and utilization, and hurting the quality of care.

Administration

CMS Announces Medicare A and B Deductibles and Part B Premium
On November 6, the Centers for Medicare and Medicaid Services announced Medicare Part A and B deductibles and premiums for 2021. The Medicare Part A inpatient deductible that beneficiaries will pay when admitted to the hospital is $1,484 in 2021, an increase of $76 from $1,408 in 2020. The majority of Medicare beneficiaries pay no Part A premium. The standard monthly premium for Medicare Part B enrollees will be $148.50 in 2021, an increase of $3.90 from $144.60 in 2020. The annual deductible for Medicare Part B beneficiaries is $203 in 2021, an increase of $5 from $198 in 2020.

Exchange Rule for Plan Year 2022 Under Review by OMB
On Nov. 5, the Office of Management and Budget (OMB) reviewed the proposed annual exchange rule for the 2022 plan year that outlines key marketplace policies, including network adequacy, actuarial value, the open enrollment window and the auto-enrollment process.

CMS, Treasury Approves Waiver Letting GA Exit Healthcare.gov in 2023
On Nov. 1, the Centers for Medicare and Medicaid Services (CMS) and the Department of Treasury approved Georgia’s request to exit healthcare.gov, take over eligibility determinations and rely on its own agents, brokers and insurance carriers for enrollment services starting 2023. The waiver, the Georgia Access Model, is the first approved under the Trump administration’s 1332 revised guidance and is expected to be challenged in court.