Pardon Our Dust
We recently launched this new site and are still in the process of updating some of our archived content. Some details of this article may be incomplete, links may be broken, and other elements may not display properly yet. We appreciate your patience and understanding.
This week in Washington: President Biden issues important executive orders on healthcare.
Upcoming Hearings/Markups
Congress
Administration
- Biden Administration Issues Pause for Review on Various Trump-Era Health Rules, Withdraws 3 Rules from Review List
- President Biden Issues Multiple Executive Orders Related to Healthcare
- HHS Amends PREP Act Declaration to Increase Workforce Authorized to Administer COVID-19 Vaccines
- CMS Announces 3-Month Special Enrollment Period, as Directed by Executive Order
- CMS: Applications for MIPS Exceptions Due to COVID-19 Now Due Feb. 1
Proposed Rules
Courts
Other
Reports
Upcoming Hearings/Markups
Tuesday, February 2
House Committee on Energy and Commerce, Subcommittee on Oversight and Investigations: No Time to Lose: Solutions to Increase COVID-19 Vaccinations in the States
The House Committee on Energy and Commerce, Subcommittee on Oversight and Investigations will hold a hearing on COVID-19 vaccine distribution and administration.
Find more details here.
Wednesday, February 3
House Committee on Energy and Commerce, Subcommittee on Health: Road to Recovery – Ramping Up COVID-19 Vaccines, Testing, and Medical Supply Chain
The House Committee on Energy and Commerce, Subcommittee on Health will hold a hearing on the federal government’s handling of COVID-19 vaccine development, testing and the medical supply chain.
Find more details here.
Congress
Rep. Underwood Reintroduces Bill Enhancing ACA Credits
On Jan. 19, Rep. Lauren Underwood (D-IL) reintroduced legislation to expand and enhance the Affordable Care Act’s (ACA) tax credits, also included in President Biden’s health reform agenda. The Health Care Affordability Act of 2021 would increase the generosity of the existing tax credits for consumers earning up to 400 percent of the federal poverty level (FPL). The bill also would remove the subsidy cliff created by the poverty threshold, ensuring that anyone buying coverage on the exchange would pay no more than 8.5 percent of income toward their premiums.
Administration
Biden Administration Issues Pause for Review on Various Trump-Era Health Rules, Withdraws 3 Rules from Review List
On Jan. 20, the Biden administration paused all rules, guidance or other agency actions that did not take effect prior to noon Jan. 20, to be subject to review by the Biden administration before they could be implemented. If the Trump administration’s actions raise questions of “fact, law, or policy,” the designated officials now leading the relevant agencies can further delay effective dates. Among the regulations that are on hold is the 2021 Physician Fee Schedule, the final rule on grandfathered group health plans and coverage, the Notice of Benefit and Payment Parameters for 2022 with updates to state innovation waivers (Section 1332) and the Revisions to the Outcome Measure Requirements for Organ Procurement Organizations.
The pause may affect the new Stark Law and Anti-Kickback Statute final rules that went into effect this month, after the Government Accountability Office (GAO) reported that the statutorily required waiting period for effectiveness was not followed.
As of Jan. 29, the Centers for Medicare and Medicaid Services (CMS) withdrew three rules from this list of paused rules, including one on third-party pay for dialysis and one on accrediting organization oversight. While the Office of Management and Budget (OMB) has withdrawn these regulations from its review process that does not mean the regulations could not be placed on the list again.
Find the ongoing list here.
President Biden Issues Multiple Executive Orders Related to Healthcare
On Jan. 28, President Biden signed an executive order to have the Department of Health and Human Services (HHS) open Healthcare.gov for a “Special Enrollment Period,” from February 15, 2021 – May 15, 2021.
The executive orders also direct federal agencies to reconsider rules and other policies, including those from the Trump administration that limit access to healthcare, and consider actions that will increase that access.
Agencies are directed to re-examine:
- Policies that undermine protections for people with pre-existing conditions, including complications related to COVID-19;
- Demonstrations and waivers under Medicaid and the ACA that may reduce coverage or undermine the programs, including work requirements;
- Policies that undermine the Health Insurance Marketplace or other markets for health insurance;
- Policies that make it more difficult to enroll in Medicaid and the ACA; and
- Policies that reduce affordability of coverage or financial assistance, including for dependents.
While the executive orders do not directly address Medicaid work requirement waivers, the Biden administration is likely to review this issue.
Biden also directed HHS to review a rule from the Trump administration to cut off federal funding for domestic family planning programs involved with abortions, such as Planned Parenthood. Biden also rescinded the global gag rule, also referred to as the Mexico City Policy, which bars international non-profits that provide abortion counseling or referrals from receiving U.S. funding.
Find the executive orders here.
HHS Amends PREP Act Declaration to Increase Workforce Authorized to Administer COVID-19 Vaccines
On Jan. 28, the Department of Health and Human Services (HHS) issued a fifth amendment to the Declaration Under the Public Readiness and Emergency Preparedness Act (PREP Act) to add additional categories of qualified persons authorized to prescribe, dispense and administer COVID-19 vaccines authorized by the Food and Drug Administration (FDA).
The amendment:
- Authorizes any health care provider who is licensed or certified in a state to prescribe, dispense and/or administer COVID-19 vaccines in any other state or U.S. territory.
- Authorizes any physician, registered nurse or practical nurse whose license or certification expired within the past five years to prescribe, dispense and/or administer COVID-19 vaccines in any state or U.S. territory so long as the license or certification was active and in good standing prior to the date it went inactive.
- Requires any health care professional described above to complete Centers for Disease Control and Prevention (CDC) COVID-19 Vaccine Training and, for health care providers who are not currently practicing or whose license or certification is expired, requires an on-site observation period by a currently practicing health care professional.
Find more details here.
CMS Announces 3-Month Special Enrollment Period, as Directed by Executive Order
On Jan. 28, the Centers for Medicare and Medicaid Services (CMS) announced it will open healthcare.gov and direct enrollment portals to all eligible consumers for a three-month special enrollment period (SEP) starting Feb. 15, and will spend $50 million on outreach and education. The announcement follows President Biden’s executive order directing the Department of Health and Human Services (HHS) to consider the re-opening of the enrollment period. The SEP will last from Feb. 15 to May 15 in all 36 states that use healthcare.gov. CMS also encourages the 15 state-based exchanges to follow suit with their own SEPs. Already, Colorado, California, New Jersey, Minnesota and Washington have announced new enrollment periods.
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. 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 still had a Dec. 31 deadline.
Find more information here.
Proposed Rules
FDA Issues Draft Guide on Proprietary Naming of Non-Rx Drugs
On Dec. 11, the Food and Drug Administration (FDA) published a draft guidance that details how sponsors should select and screen proprietary names for nonprescription drugs. The new draft guidance, Best Practices in Developing Proprietary Names for Human Nonprescription Drug Products, makes naming recommendations for drugs that are switched from full-prescription and partial-prescription to nonprescription status. In the draft guide, FDA says drugs that switch from full-prescription to nonprescription status likely can keep the same name. However, drugs that are switched from partial-prescription to nonprescription status may need to have their names changed to avoid causing confusion among consumers.
Find the draft guidance here. Public comments are due by Feb. 8, 2021.
Courts
Find a comprehensive look at “The Courts and Healthcare Policy” here.
HHS Seeks Extension to Respond to PhRMA Suit against Drug Importation Rule
On Jan. 26, the Department of Health and Human Services (HHS) requested an extra 60 days to respond to a lawsuit by the Pharmaceutical Research and Manufacturers of America (PhRMA) against the Trump administration’s drug importation rule. The judge has yet to decide whether to grant HHS the extension. If approved, the new deadline for HHS’s response would be pushed to March 30, 2021.
Other
Colorado Becomes Second State to Solicit Vendors to Run Drug Import Program
On Jan. 25, Colorado became the second state to solicit vendors to run a Canadian drug import program. The Colorado Department of Health Care Policy and Financing released an Invitation to Negotiate for relevant vendors. Colorado’s plan includes a vendor for administrative functions, a Canadian wholesaler to purchase the drugs and another vendor to import the drugs directly into the state. The vendor importing the drugs would also deal with distribution.
Find more details here.
Reports
GAO: COVID-19 – Critical Vaccine Distribution, Supply Chain, Program Integrity and Other Challenges Require Focused Federal Attention
On Jan. 28, the Government Accountability Office (GAO) released its observations of the challenges COVID-19 brings to vaccine distribution, the medical supply chain, program integrity and more. Many of these concerns were published in June 2020 as well. GAO found between December 31, 2020, and January 13, 2021, new reported COVID-19 cases averaged about 225,000 per day—over 7 and 3 times higher than the surges the nation experienced during the spring and summer of 2020, respectively. In this report, GAO made 13 recommendations to federal agencies to improve the ongoing response and recovery efforts in the areas of public health and the economy, as the new Biden administration begins to address these issues.
Find GAO’s recommendations here and full report here.
If you have any questions, contact the following individuals atMcGuireWoods Consulting:
Stephanie Kennan, Senior Vice President
Mariam Eatedali, Research Associate
Founded in 1998,McGuireWoods Consulting LLC(MWC) is a full-service public affairs firm offering infrastructure andeconomic development, strategic communications & grassroots, and governmentrelations services. McGuireWoods Consulting is a subsidiary of theMcGuireWoods LLPlaw firm and has been named in The National Law Journal’s special annualreport, “The Influence 50,” for the past several years. In the most recentreport, McGuireWoods Consulting was ranked 15th of the 1,900 governmentrelations firms in Washington, D.C.
To sign up for the Weekly Washington Healthcare Update, use our onlinesubscription form.
McGuireWoods Consulting LLC
2001 K Street
Suite 400
Washington, DC 20006-1040
+1 202 857 1700