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Sep 14, 2020

Washington Healthcare Update

This week in Washington: The Republican COVID-19 legislative package fails to pass in the Senate; Congress is in negotiations for a continuing resolution to fund the government until 2021.

Upcoming Hearings/Markups

Congress

Hearings/Markups

House

Senate

Administration

Proposed Regulations/Guidance

Final Regulations/Guidance

Reports


Upcoming Hearings/Markups

Sept. 23, 2020

Senate Committee on Health, Education, Labor and Pensions: COVID-19: An Update on the Federal Response

The Senate Committee on Health, Education, Labor and Pensions will hold a hearing for a COVID-19 federal response update.

Find more information on the hearing and panel here.

Hearings/Markups

House Energy and Commerce Committee: Full Committee Markup

The House Energy and Commerce Committee held a full committee markup and favorably reported all 26 health-related bills to the House floor with bipartisan support. The legislation included expanding access to mental health services, combating the opioid epidemic, reauthorizing key public health programs, improving Medicare enrollment, streamlining public health data sharing for Tribes and facilitating access to marijuana for research.

Find more information and summary of the legislation here.

Senate Committee on Health, Education, Labor and Pensions (HELP): Vaccines - Saving Lives, Ensuring Confidence, and Protecting Public Health

The Senate Committee on Health, Education, Labor and Pensions (HELP) held a full committee hearing for updates on how far along the government and its industry partners are in working to prevent, diagnose and treat COVID-19. The focus of the hearing was an upcoming vaccine for COVID-19.

Why this is important: The panel repeated to the committee that none of the safety and efficacy assessments would be skipped or abbreviated in creating a COVID-19 vaccine. According to the National Institutes of Health (NIH), efforts to shorten the timeline, but still achieve a safe and effective vaccine, are based in eliminating downtimes and assuming the costs of at-risk manufacturing.

Find more information here.

House

Congress Negotiating a Continuing Resolution to Fund Government until 2021

On Sept. 8, the Trump administration and congressional leaders tentatively agreed to work on a continuing resolution (CR) to keep the government open past Sept. 30 when current appropriations are due to expire. The CR would fund the government at 2020 levels until Congress passes a full appropriation bill for fiscal year 2021. The Trump administration included a list of items known as “anomalies” that it wants Congress to address in the CR. The Trump administration wants funding for Medicare and Medicaid extenders, most of which are set to run through Nov. 30, as well as a provision to extend funding for the Food and Drug Administration’s (FDA) rare pediatric disease priority review voucher program.

Senate

GOP Coronavirus Relief Package Fails to Pass Senate

On Sept. 10, a slimmed-down version of the Senate Republicans’ coronavirus relief bill failed to pass in the Senate after a vote to end debate on the legislation failed, 52-47. Senate Majority Leader Mitch McConnell (R-KY) introduced the package that included liability protections for health care facilities, paycheck protection program money and funding for state COVID-19 testing. The total cost of the bill was about $500 billion, about half of what Republicans initially proposed earlier this summer.

Warren, Casey Release Report on USPS Delivery of Prescription Drugs Delayed by Postmaster’s Changes

On Sept. 10, Sens. Elizabeth Warren (D-MA) and Bob Casey (D-PA) released a report that mail deliveries of prescription drugs are running on average about a day later than usual due to recent actions by U.S. Postmaster General Louis DeJoy. Some deliveries are delayed upwards of seven days, which the senators say could lead to seniors’ not receiving medicines when they need them and cause health care costs to rise.  Deliveries of prescription drugs by the Postal Service (USPS) took 18 percent to 32 percent longer after DeJoy began implementing new changes at the Postal Service, according to pharmacy benefit managers (PBMs) surveyed by the senators.

Find the report here.

Carper, Cassidy Lead Bipartisan Letter to CDC, HHS for Improvement and Modernization of COVID-19 Data Collection and Management

On Sept. 8, Sens. Tom Carper (D-DE) and Bill Cassidy (R-LA) led a bipartisan group of senators in a letter to the Department of Health and Human Services (HHS) and the Centers for Disease Control and Prevention (CDC) to improve, automate and modernize COVID-19 data collection and management. The senators asked HHS and CDC to use technologically advanced systems and build on existing data sources in order to provide public health officials and community leaders with more accurate, real-time information as they make decisions about reopening during the COVID-19 pandemic.

Find the letter here.

Administration

FDA Warns Website Operators Illegally Selling Opioids to Consumers

On Sept. 10, the Food and Drug Administration (FDA) issued warning letters to 17 website operators for illegally selling unapproved and misbranded opioids online in violation of the Federal Food, Drug, and Cosmetic Act. Misbranded opioids include those offered for sale without a prescription, as well as opioids that lack adequate directions for use. The opioids offered for sale include products such as tramadol and oxycodone.

Find the press release here.

Proposed Regulations/Guidance

FDA Seeks Input on Proposed “Right To Try” Reporting Requirements

On July 23, the Food and Drug Administration (FDA) proposed annual reporting requirements for drug manufacturers who provide investigational drugs to patients under the Right to Try pathway. The FDA proposes the reports be submitted separately from investigational new drug application reports, and it asks stakeholders for input on which entities should be responsible for submitting the annual Right to Try summary reports. The proposed rule is required under the Right to Try Act, which mandates companies that make their investigational drugs available through that pathway submit annual summaries to FDA. FDA then will make a consolidated version of those reports publicly available.

Find the proposed rule here. Public comments are due by Sept. 22, 2020.

CMS Proposes to Expand Telehealth Benefits Permanently for Medicare Beneficiaries Beyond the COVID-19 Public Health Emergency

On Aug. 4, the Centers for Medicare and Medicaid Services (CMS) proposed permanently extending the availability of certain telemedicine services after the COVID-19 public health emergency (PHE) ends, giving Medicare beneficiaries access to health care particularly in rural areas where access to health care providers may otherwise be limited. CMS is proposing to permanently allow some telehealth services, including home visits for the evaluation and management of a patient (in the case where the law allows telehealth services in the patient’s home), and certain types of visits for patients with cognitive impairments. CMS is seeking public input on other services to permanently add to the telehealth list.

The billing and coding requirements for Evaluation and Management (E/M) (or office/outpatient visits) make up 20 percent of the spending under the Physician Fee Schedule. Simplified coding and billing requirements for E/M visits will go into effect Jan. 1, 2021. In this rule, CMS is proposing to increase the value of many services that are comparable to or include office/outpatient E/M visits such as maternity care bundles, emergency department visits, end-stage renal disease capitated payment bundles, physical and occupational therapy evaluation services and others.

Find the proposed rule here. Public comments are due by Oct. 5, 2020.

Final Regulations/Guidance

HHS Allows Pharmacists to Administer COVID-19 Vaccines

On Sept. 9, the Department of Health and Human Services (HHS) released a final guidance that pharmacists will be allowed to administer COVID-19 vaccines to anyone three years or older without a prescription. The HHS authorization preempts state and local laws. Pharmacists must take a training program before administering coronavirus vaccines. Pharmacy interns may give shots too, if they are under pharmacist supervision.

Find the final guidance here.

FDA: Updated Guidance Flexible on Plasma EUA Requirements

On Sept. 2, the Food and Drug Administration (FDA) released an updated guidance document to the Emergency Use Authorization’s (EUA) requirement that plasma donations be tested for anti-SARS-CoV-2 antibodies using the Ortho VITROS SARS-CoV-2 test, and that blood centers use those test results to identify whether donated units of plasma are high titer or low titer. FDA is giving blood centers that collected investigational convalescent plasma prior to the Trump administration’s Aug. 23 emergency use authorization, 90 days to meet the EUA’s new requirements.

Find the guidance here.

FDA: Guidance on Control of Nitrosamine Impurities in Human Drugs

On Sept. 1, the Food and Drug Administration (FDA) finalized its guidance on how drug manufacturers can prevent unacceptable levels of nitrosamines in drug products. The final guidance recommends drug manufacturers conduct a comprehensive risk assessment strategy that involves collaborating with active pharmaceutical ingredient (API) manufacturers to identify conditions, including pathways that could risk the final drug product’s developing nitrosamine impurities. If any potential risks are found during the manufacturing or storage process, product batches should be tested using sensitive, validated methods.

Find the final guidance here.

Courts

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

Reports

GAO: Medicaid Information Technology - Effective CMS Oversight and States’ Sharing of Claims Processing and Information Retrieval Systems Can Reduce Costs

On Sept. 9, the Government Accountability Office (GAO) published a report on the Centers for Medicare & Medicaid Services (CMS) reimbursement to states for most Medicaid costs, including health care costs and administrative costs, such as IT. CMS reimbursed states $34.3 billion for Medicaid IT systems in FY 2008-18. GAO found that the documentation of CMS’s reviews for most IT funding requests in 2016-2018 lacked information, indicating that reviews may not have been complete. CMS is supposed to oversee states’ use of funds. GAO found that the IT systems had little oversight from either CMS or state chief information officers. In addition, CMS was no longer supporting efforts to reduce duplication by sharing state systems.

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

GAO: COVID-19 - Brief Update on Initial Federal Response to the Pandemic

On Sept. 9, the Government Accountability Office (GAO) published a report that updates GAO oversight of some aspects of the federal response to the COVID-19 pandemic. Findings include:

  • Spending - Federal obligations totaled $1.5 trillion and expenditures totaled $1.3 trillion, as of June 30.
  • Public health - Between Jan. 1 and June 30, about 125,000 more deaths occurred from all causes than would normally be expected, an indicator of the pandemic’s effect on health care outcomes.
  • Actions - Agencies have taken action on some of GAO’s June 2020 recommendations. For example, Treasury officials stated that nearly 70 percent of $1.6 billion in economic impact payments sent to the deceased has been recovered.

Find the full report here.


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

Stephanie Kennan, Senior Vice President
Mariam Eatedali, Research Associate

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