Washington Healthcare Update

October 12, 2020

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This week in Washington: Negotiations for COVID-19 stimulus package are ongoing; House and Senate are in recess.





Proposed Regulations/Guidance

Final Regulations/Guidance




Energy and Commerce Republican Leadership Requests GAO Review of Contact Tracing Apps

On Oct. 9, House Energy and Commerce Committee ranking member Greg Walden (R-OR), Health Subcommittee ranking member Michael Burgess (R-TX) and Oversight and Investigations Subcommittee ranking member Brett Guthrie (R-KY) sent a letter to the Comptroller General Gene Dodaro to request a technology assessment of COVID-19 contact tracing apps by the Government Accountability Office (GAO). In the letter, the members ask GAO to review the use of these apps in other countries as well.

Find the full letter here.

House Democrats Introduce Bill Penalizing Labs for Slow COVID-19 Test Results

On Oct. 2, Reps. Suzan DelBene (D-WA), Mike Sherrill (D-NJ) and Terri Sewell (D-AL) introduced a bill to penalize laboratories that take longer than three days to provide coronavirus test results and to reward fast turnarounds. The Strictly Pay for Efficient and Expedited Delivery of Your (SPEEDY) COVID- 19 Tests Act would pay 25 percent more for COVID-19 test results returned within 24 hours. Medicare pay rates would remain the same if results are delivered within two days, and pay rates from before the pandemic would apply to tests when results take three days.

After 72 hours, labs would receive no reimbursement for processing a COVID-19 test. The bill also threatens to pull labs’ ability to participate in Medicare if they do not process samples within 28 days. All tests must be processed within 28 days. The bill provides an additional 36-hour extension for rural communities and labs supporting medically underserved areas.

Find the bill here.


Sen. Alexander and Rep. Walden Ask for Input on Modernizing 340B Drug Pricing Program

On Oct. 9, Senate Health, Education, Labor and Pensions (HELP) Committee Chairman Lamar Alexander (R-TN) and House Energy and Commerce Committee ranking member Greg Walden (R-OR) released a statement calling for input on how to improve the 340B Drug Pricing Program. Suggestions from stakeholders must be submitted by Oct. 30, 2020, to the following email addresses: 340B@help.senate.gov and 340B@mail.house.gov.

Find the full statement here.


FDA Open to Using Foreign Data to Approve a COVID-19 Vaccine

On Oct. 7, Peter Marks, director of the Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration (FDA), announced during a webinar that FDA is open to using data from other countries to approve a COVID-19 vaccine. He added that FDA would need to make sure it adheres to its own standard for data review, which is unique among global regulators. Marks added that FDA might ask for a smaller study to be done in the U.S. to ensure the immune response in the U.S. population is similar to that of the population studied outside the United States.

FDA Will No Longer Review Labs’ EUA Requests For COVID-19 LDTs

On Oct. 7, the Food and Drug Administration (FDA) updated its COVID-19 testing FAQ webpage to show it will no longer review emergency use authorization (EUA) requests for laboratory-developed tests (LDTs) for COVID-19. In August, the Department of Health and Human Services (HHS) blocked FDA from regulating all LDTs, including COVID-19 LDTs, but said at the time that labs could still voluntarily request EUAs in order to get liability protection for COVID-19 tests. FDA announced it made this change to focus its attention on other types of COVID-19 tests in order to increase testing access. In the FAQ, FDA said it will continue to prioritize COVID-19 EUA requests for point-of-care tests, at-home collection tests, high-throughput and widely distributed tests, and tests that reduce reliance on test supplies.

Find the update here.

CMS Releases Star Ratings for 2021 Medicare Advantage and Part D Prescription Drug Plans Ahead of Medicare Open Enrollment

On Oct. 8, the Centers for Medicare and Medicaid Services (CMS) announced the star ratings for 2021 Medicare Advantage and Medicare Part D prescription drug plans. Almost half, about 49 percent, of Medicare Advantage plans that offer prescription drug coverage will have an overall rating of four stars or higher. The average Star Rating for a stand-alone prescription drug plan rose to 3.58 in 2021 from 3.50 in 2020. Medicare Open Enrollment begins Oct. 15, 2020, and ends Dec. 7, 2020.

Find the star ratings here.

CMS: Revised Medicare Loan Repayment Terms

On Oct. 8, the Centers for Medicare and Medicaid Services (CMS) released the Medicare loan repayment terms as revised by the latest continuing resolution (CR) passed by Congress, including the option for providers to request an extended repayment schedule if they are facing financial hardships. CMS also said that providers and suppliers could use COVID-19 provider relief funds to repay their Medicare loans. The recently enacted CR extends both the period before provider loan repayment begins and the period before the balance must be repaid in full, as well as reduces the recoupment percentage and lowers the interest rate under the Medicare Accelerated and Advance Payment Programs.

Find more information here.

HHS Begins Enforcing Hospital COVID-19, Flu Data Reporting

On Oct. 7, the Department of Health and Human Services (HHS) began the 14-week compliance window under its interim final rule that requires hospitals to report COVID-19 data directly to the HHS or possibly lose access to the Medicare and Medicaid programs. The guidance released for the compliance period also requires hospitals to report influenza data. Initial notices on whether a hospital is meeting the requirements will go to all facilities on Oct. 7, and three weeks later, an advisory notice will go out to facilities that are still not reporting the necessary data. If the hospital is still non-compliant, they will receive another notice three weeks later and an enforcement notice once weekly for the next month until they are compliant. Hospitals will be dropped from Medicare and Medicaid 30 days after the last of the four enforcement letters, but they can appeal the decision.

Find more information here.

President Trump Executive Order Creates Working Group on COVID-19 Impact on Mental Health

On Oct. 5, President Trump signed an executive order to create a working group to examine how COVID-19 has affected mental health. The Coronavirus Mental Health Working Group will be co-chaired by Department of Health and Human Services (HHS) Secretary Alex Azar and Acting Director of Domestic Policy Council Brooke Rollins. It will submit a report to the president within 45 days that outlines a plan to improve coordination among private and public stakeholders and agencies to improve mental and behavioral health conditions for vulnerable groups, including minorities, seniors, veterans, small business owners, people with substance use disorder and survivors of domestic violence.

Find the executive order here.

Proposed Regulations/Guidance

HHS: Stakeholder Group to Address Health Coverage for Released Inmates

On Oct. 1, the Department of Health and Human Services (HHS) solicited nominations for a group that will examine policies and strategies to help individuals who were eligible for Medicaid while incarcerated transition back into health coverage when they reenter communities.

The group will consist of 24 stakeholders, including two federal members, and will meet once to develop best practices for states to ease the health care-related transition for an individual who is incarcerated back to the community. The group will also discuss practices that ensure continuity of health insurance coverage under commercial coverage or Medicaid; and ensure that transition is done no later than 30 days after the individual is released.

The group is required to submit a report to HHS and Congress. HHS is seeking 22 non-federal members who are representatives of managed care organizations, Medicaid beneficiaries, health care providers, the National Association of Medicaid Directors, state Medicaid agencies and representatives from local and state prison systems. HHS will appoint one member to lead the group.

Find the solicitation here. Nominations are due by Oct. 23, 2020.

HHS Proposes Rule to Implement President Trump’s Insulin Executive Order

On Sept. 28, the Department of Health and Human Services (HHS), through the Health Resources and Services Administration (HRSA), released a notice of proposed rulemaking to ensure community health centers receive grants for the purchase of insulin and injectable epinephrine through the 340B Drug Pricing Program. These discounted drugs will be available to community health center patients with low incomes who also have health insurance with a high cost-sharing requirement for either insulin or injectable epinephrine, health insurance with a high unmet deductible or no health insurance.

Find the proposed rule here. Public comments are due by Oct. 28, 2020.

Final Regulations/Guidance

FDA Issues Vaccine EUA Guidance

On Oct. 6, the Food and Drug Administration (FDA) released guidance that lays out the criteria for any COVID-19 vaccine manufacturer seeking emergency use authorization (EUA). The guidance reveals the EUA-plus standards that FDA already communicated to industry and to its vaccine advisors. The recommendations in the guidance describe information and data that would support issuance of a EUA, including chemistry, manufacturing and controls information; nonclinical and clinical data; and regulatory and administrative information. The guidance provides further detail on the EUA process for investigational vaccines and provides additional context to the information provided in FDA’s June guidance regarding the development and licensure of COVID-19 vaccines.

Find the guidance here.


Find a comprehensive look at “Courts and Healthcare Policy in 2020” here.

SCOTUS Hears Arguments on Whether States Can Regulate PBMs

On Oct. 6, the Supreme Court justices heard arguments in a case that could determine whether states may regulate pharmacy benefit managers (PBMs) to lower drug prices. At issue in Rutledge v. Pharmacy Care Management is an Arkansas law requiring PBMs to reimburse pharmacies at least the price that pharmacies pay for generic drugs. The law also lets pharmacies challenge PBM reimbursement rates and lets pharmacies refuse to dispense drugs on which they would lose money due to low PBM reimbursement. More than 40 states have laws that regulate PBMs, 35 states joined Arkansas in the suit and 45 state attorneys general filed an amicus brief supporting Arkansas.

Follow the case here.


GAO: Laboratory Safety – FDA Should Strengthen Efforts to Provide Effective Oversight

On Oct. 8, the Government Accountability Office (GAO) released a report on the Food and Drug Administration’s creating a new office within the agency in 2017 to oversee its lab safety program. Now, three years later, there are still disagreements within the FDA about the office’s roles and responsibilities. FDA’s lab safety program does not include key elements of effective oversight. For example, lab safety office staff cannot inspect labs unannounced. According to GAO, unannounced inspections can help to better observe a lab’s normal operating conditions. GAO recommended that the FDA resolve disagreements over the office’s roles and responsibilities and provide it with the authority to oversee lab safety.

Find GAO’s recommendations here, and full report here.

GAO: Prescription Drug Monitoring Programs – Views on Usefulness and Challenges of Programs

On Oct. 1, the Government Accountability Office (GAO) released a report on prescription drug monitoring programs, and how prescription medications, if misused or overprescribed, can lead to dangerous drug interactions, abuse, overdose or death. Prescription drug monitoring programs are state-operated electronic databases that track patient prescriptions for opioids and other medications. According to the report, physicians said that access to these programs improved patient care and helped them prevent drug misuse and potentially dangerous drug prescribing.

However, GAO reports that drug-monitoring programs are not always accessible from within electronic health record (EHR) systems. State and federal agencies are helping to integrate the two systems, such as by offering funds or providing technical support.

Find the full report here.

OIG Questions Effectiveness of FDA’s Opioid REMS, Suggests Changes

On Sept. 29, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) released a report for the Food and Drug Administration (FDA) on how to improve Risk Evaluation and Mitigation Strategy (REMS) for transmucosal immediate-release fentanyl. According to the report, the programs for fentanyl and extended-release opioids are not suited to quickly address the opioid crisis. FDA agreed with some of the proposals, including one that says FDA should seek more enforcement authority from Congress, but pushed back against OIG’s suggestion for mandatory prescriber education, saying such education is not feasible or practical.

Find the full report here.


If you have any questions, contact the following individuals atMcGuireWoods Consulting:

Stephanie Kennan, Senior Vice President
Mariam Eatedali, Research Associate

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