Washington Healthcare Update - June 2020 #4

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This week in Washington: Trump administration again attempts to overturn ACA in Supreme Court, House considers legislation to shore up ACA and multiple hearings related to the COVID-19 pandemic.

Upcoming Hearings/Markups

Congress

Hearings/Markups

  • Senate Committee on Health, Education, Labor and Pensions (HELP): “COVID-19: Lessons Learned to Prepare for the Next Pandemic”
  • House Committee on Energy and Commerce: “Oversight of the Trump Administration’s Response to the COVID-19 Pandemic”
  • House Committee on Ways and Means: “Examining the COVID-19 Nursing Home Crisis”

House

  • House Votes Today on Democratic ACA Bill

Senate

  • Murray and DeLauro Concerned Trump Administration’s Leadership Changes to COVID-19 Vaccine Project Could Delay Progress

Administration

  • CDC Updates List of Health Conditions at Risk for COVID Complications
  • CMS Resumes Nursing Home Staff Data Collection
  • CMS: Medicare Care Choices Model One-Year Model Extension Announcement
  • CMS Announces Membership of Independent Coronavirus Commission on Safety and Quality in Nursing Homes
  • HRSA Gets 908K Requests for COVID-19 Funds to Test and Treat Uninsured
  • HHS, Drug Manufacturers Working on Plan for Leftover Hydroxychloroquine
  • HHS Sets Aside $500M for Convalescent Plasma as FDA Considers EUA

Proposed Regulations/Guidance

  • FDA Announces Public Meeting for Stakeholder Input on GDUFA Reauthorization
  • CMS: Calendar Year 2021 Payment and Policy Changes for Home Health Agencies and Calendar Year 2021 Home Infusion Therapy Benefit
  • IRS: Payments to Health Sharing Ministries, Direct Primary Care Deductible

Courts

  • DOJ Again Asks Supreme Court to Rule ACA Unconstitutional
  • Federal Judge Rules CMS Can Move Forward with Hospital Price Disclosure Rule

Reports

  • GAO: COVID-19 - Opportunities to Improve Federal Response and Recovery Efforts
  • GAO: Public Health Preparedness - HHS Should Take Actions to Ensure It Has an Adequate Number of Effectively Trained Emergency Responders

Upcoming Hearings/Markups

Tuesday, June 30, 2020

Senate Committee on Health, Education, Labor and Pensions (HELP): “COVID-19: Update on Progress Toward Safely Getting Back to Work and Back to School”

The Senate HELP committee will hold a hearing in its continuing series on Americans returning to work and school during the COVID-19 pandemic.

Find more details on the hearing here.

House Committee on Energy and Commerce: High Anxiety and Stress: Legislation to Improve Mental Health During Crisis

The Subcommittee on Health of the Committee on Energy and Commerce will hold a hearing to discuss 22 pieces of legislation, a response to mental health concerns during the COVID-19 pandemic.

Find more details on the hearing here.

Hearings/Markups

Senate Committee on Health, Education, Labor and Pensions (HELP): “COVID-19: Lessons Learned to Prepare for the Next Pandemic”

Tuesday, June 23, 2020: The Senate HELP committee held a hearing to cover the lessons learned from shortcomings of the response to the COVID-19 pandemic, in preparation for the future.

Find more details on the hearing here.

Why is this important: According to the witness panel at the hearing, the U.S. was unprepared for the coronavirus pandemic and needs to invest more in the tools needed to monitor outbreaks and respond rapidly to the next health crisis. The panel added that health security is national security, and should be treated as such, with more being spent on public health at all levels.

House Committee on Energy and Commerce: “Oversight of the Trump Administration’s Response to the COVID-19 Pandemic”

Wednesday, June 24, 2020: The House Committee on Energy and Commerce held a full committee hearing to discuss the Trump administration’s response to the COVID-19 pandemic thus far.

Find more details on the hearing here.

Why is this important: FDA Commissioner Stephen Hahn said the COVID-19 pandemic has shed light on the need for increased use of real-world evidence (RWE) to help regulators make decisions in real time, and he asked Congress to provide more support for advancing generation of RWE. He added that the FDA has an access-to-information issue.

House Committee on Ways and Means: “Examining the COVID-19 Nursing Home Crisis”

Thursday, June 25, 2020: The House Committee on Ways and Means held a hearing to discuss the disproportionate effect COVID-19 is having on nursing home residents.

Find more details on the hearing here.

Why is this important: According to the witness panel, the only way to truly protect the health and safety of residents and staff is for all facilities to have ready access to testing and require that residents and staff are regularly tested. Testing will help control the spread of the virus among the residents, staff and the community at large, as staff and others come and go from these facilities. Analysis suggests that up to 40 percent of U.S. deaths from COVID-19 have taken place in nursing homes or long-term care facilities.

House

House Votes Today on Democratic ACA Bill

On June 29, the House of Representatives will vote on the Patient Protection and Affordable Care Enhancement Act, a bill by House Democrats to enhance the Affordable Care Act (ACA) by boosting the law’s tax credits, reversing the Trump administration rules seen as undermining the law and encourage states to take up the Medicaid expansion. The bill also includes drug-pricing provisions as an offset. According to the Congressional Budget Office (CBO) score for the legislation, if the 14 states that have yet to take up the Medicaid expansion would do so, another 4 million people could gain coverage.

Find the legislation here.

Senate

Murray and DeLauro Concerned Trump Administration’s Leadership Changes to COVID-19 Vaccine Project Could Delay Progress

On June 23, U.S. Senator Patty Murray (D-WA) and Congresswoman Rosa DeLauro (D-CT), chair, wrote to Department of Health and Human Services (HHS) Secretary Alex Azar about the Trump administration’s recent removal of Biomedical Advanced Research and Development Authority (BARDA) employees from project leadership roles on several COVID-19 vaccine contracts. The members warned these changes could delay the progress toward a COVID-19 vaccine and urged the administration to reinstall BARDA employees immediately as project leads on COVID-19 vaccine contracts.

Find the full letter here.

Administration

CDC Updates List of Health Conditions at Risk for COVID Complications

On June 25, the Centers for Disease Control and Prevention (CDC) updated its list of underlying health conditions that might increase a person’s risk of complications from COVID-19. The update increases the percentage of American adults who are in the high-risk category. Chronic kidney disease, chronic obstructive pulmonary disease, serious heart conditions, sickle cell disease, type 2 diabetes and a weakened immune system are among the conditions that might increase a person’s risk of experiencing severe complications from COVID-19.

People with asthma, high blood pressure, neurologic conditions and cerebrovascular disease, and those who have a body mass index of 30 or greater also might be at higher risk of experiencing severe complications. The CDC’s update reverses a previous stance that people 65 years or older were at higher risk, stating that there is no exact cutoff age at which people should not be concerned about the risks.

Find the press release here.

CMS Resumes Nursing Home Staff Data Collection

On June 25, the Centers for Medicare and Medicaid Services (CMS) announced nursing homes will resume submitting staffing data to CMS by Aug. 14, but quality star ratings will carry over from the last quarter of 2019. CMS is resuming the payroll-based journal reporting after it opted to waive the reporting in March due to the COVID-19 pandemic. Nursing homes now will need to submit data on staffing from April through June by mid-August. This means staffing measures and ratings will be updated in October based on the data that nursing homes submit this summer.

Find the memo here.

CMS: Medicare Care Choices Model One-Year Model Extension Announcement

On June 25, the Centers for Medicare and Medicaid Services (CMS) announced it will extend the Medicare Care Choices Model (MCCM) by one calendar year, through Dec. 31, 2021. Under the extension, participating MCCM hospices will be able to enroll eligible beneficiaries through June 30, 2021, and provide MCCM services for them through Dec. 31, 2021. The extension will not affect the model’s other existing operations or policies. The extension will apply to hospices already participating in the model and no new hospices will be enrolled. CMS will contact hospices participating in the model shortly, and invite them to apply for the voluntary extension.

Find more information here.

CMS Announces Membership of Independent Coronavirus Commission on Safety and Quality in Nursing Homes

On June 19, the Centers for Medicare and Medicaid Services (CMS) announced that the MITRE Corporation has published the membership of the independent Coronavirus Commission on Safety and Quality in Nursing Homes. CMS is seeking an independent review and comprehensive assessment of the nursing home response to the Coronavirus Disease 2019 (COVID-19) pandemic. The agency tasked the contractor, MITRE, to solicit membership applications, select the members and facilitate the commission’s work. The commission’s review will help inform current and future responses to COVID-19 and potential future infectious disease outbreaks within nursing homes.

Find more information here.

HRSA Gets 908K Requests for COVID-19 Funds to Test and Treat Uninsured

On June 23, the Health Resources and Services Administration (HRSA) announced that it has received more than 908,720 claims to cover the costs of COVID-19 testing or treatment for uninsured individuals since the reimbursement program went live in May. As of June 17, HRSA says, the 3,940 providers who have agreed to the terms and services of the reimbursement program have been reimbursed $31,569,044 for testing claims and $154, 975,155 for treatment claims. Not all of the 908,720 claims submitted so far will be paid.

Find more information here.

HHS, Drug Manufacturers Working on Plan for Leftover Hydroxychloroquine

On June 23, the Department of Health and Human Services (HHS) and drug manufacturers that donated hydroxychloroquine and chloroquine to the national stockpile are determining what to do with leftover inventory. One lawyer suggested that companies consider taking back the hydroxychloroquine and sending it to countries with high rates of malaria. There are now 63 million tablets of hydroxychloroquine and 2 million tablets of chloroquine left in the stockpile inventory. None of the donated chloroquine tablets were deployed by the Strategic National Stockpile for COVID-19.

The Food and Drug Administration (FDA) revoked the emergency use authorization (EUA) for hydroxychloroquine and chloroquine on June 15 after multiple clinical trials showed the drugs might do more harm than good. Even before the EUA was revoked, hospital pharmacies planned to return donations of hydroxychloroquine, which hospitals could only use for COVID-19 patients.

HHS Sets Aside $500M for Convalescent Plasma as FDA Considers EUA

On June 22, the Department of Health and Human Services (HHS) paid another $102 million for convalescent plasma, made out of blood donated by patients who recently recovered from COVID-19, out of $500 million that has been set aside for the blood product. Food and Drug Administration (FDA) Commissioner Stephen Hahn said the FDA is considering authorizing emergency use (EUA) of the product to treat COVID-19 patients. The Mayo Clinic this week released promising preliminary results from a study of 20,000 patients treated with the plasma, helping them to create antibodies to fight off the virus.

Proposed Regulations/Guidance

FDA Announces Public Meeting for Stakeholder Input on GDUFA Reauthorization

The Food and Drug Administration (FDA) will hold a virtual public meeting to request public input on the reauthorization of the Generic Drug User Fee Amendments of 2012 for fiscal years 2023 through 2027 (GDUFA III). FDA’s current GDUFA authorization (GDUFA II) expires at the end of fiscal year 2022 (in September 2022).

The virtual meeting will take place July 21, 2020.

Deadline for registration is July 7, 2020, at this link here.

CMS: Calendar Year 2021 Payment and Policy Changes for Home Health Agencies and Calendar Year 2021 Home Infusion Therapy Benefit

On June 25, the Centers for Medicare and Medicaid Services (CMS) proposed to permanently expand home health telehealth options, initially approved for use during the COVID-19 pandemic, as part of its proposed 2021 home health pay rule. The rule would also implement new wage index calculations while capping cuts that could be tied to those calculations. According to CMS, home health agencies would see a 2.6 percent Medicare pay bump under the rule. The proposal also updates the home health wage index, but also includes a 5 percent cap on decreases in a geographic area’s wage index value for 2021.

Find the proposed rule here, which will be published on June 30, 2020.

IRS: Payments to Health Sharing Ministries, Direct Primary Care Deductible

On June 8, the Internal Revenue Service (IRS) proposed that premiums and fees paid for direct primary care or health care sharing ministries be eligible for reimbursement by employers under health reimbursement arrangements (HRAs) and for deduction as a medical expense. The draft IRS rule stems from a June 24, 2019, executive order that required the IRS to issue regulations within six months to allow certain arrangements, including direct primary care and HCSMs, as eligible medical expenses under section (213)d of the IRS code.

Find the draft rule here.

Courts

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

DOJ Again Asks Supreme Court to Rule ACA Unconstitutional

On June 26, the Department of Justice (DOJ), in its opening Supreme Court brief, again asks that the Affordable Care Act’s (ACA) coverage mandate be ruled unconstitutional and not severable from the rest of the law. The brief said that once the law’s individual coverage mandate and two key provisions are invalidated, the remainder of the ACA should not be allowed to remain in effect. The justices will hear arguments in the case sometime next term, although it is unclear if they will occur before the November presidential election.

Find the brief here.

Federal Judge Rules CMS Can Move Forward with Hospital Price Disclosure Rule

On June 23, Judge Carl Nichols of the U.S. District Court for the District of Columbia ruled that the Centers for Medicare and Medicaid Services (CMS) could proceed with its mandate that hospitals publish negotiated rates. The American Hospital Association (AHA) will appeal the ruling and seek expedited review. In his decision, Judge Nichols rejected AHA’s argument that the final rule exceeds the Department of Health and Human Services’ (HHS) statutory authority, violates the First Amendment and is arbitrary and capricious under the Administrative Procedure Act. He added that all of the information required to be published by the final rule can allow patients to make pricing comparisons between hospitals.

Reports

GAO: COVID-19 - Opportunities to Improve Federal Response and Recovery Efforts

On June 25, the Government Accountability Office (GAO) released a report on the $2.6 trillion Congress appropriated in emergency assistance for people, businesses, the health care system, and state and local governments, during the COVID-19 pandemic. The report covers how the federal agencies are administering this spending. GAO found that the Small Business Administration processed over $512 billion in guaranteed small business loans, but is not ready to address fraud risks and has not said how it plans to oversee the loans. Also, the Internal Revenue Service (IRS) and the Treasury made 160.4 million payments worth $269.3 billion to taxpayers as of May 31, including payments to more than a million deceased individuals.

Find the full report here.

GAO: Public Health Preparedness - HHS Should Take Actions to Ensure It Has an Adequate Number of Effectively Trained Emergency Responders

On June 23, the Government Accountability Office (GAO) released a report on medical emergency responders (e.g., doctors and nurses) enrolled in a Department of Health and Human Services (HHS) program that can be called up and sent to help states and localities in a public health emergency. GAO found that HHS does not know if it has enough responders available with the critical skills and competencies needed for current or future emergencies. In 2017, for example, HHS had a responder shortage and relied on the Department of Defense (DOD) to provide medical care. Also, HHS needs to evaluate its training to ensure that it effectively prepares responders for national emergencies like the COVID-19 pandemic.

Find the GAO’s five recommendations here.

Find the full report here.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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