Washington Healthcare Update

May 4, 2020

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: Senate returns to session, Rep. Pallone lays out legislative priorities for COVID-19 response as House delays return to Washington.



House cancels plans to return to session this week.


Senate returns to session Monday, May 4.


Proposed Regulations/Guidance

Final Regulations/Guidance





Pallone Lays Out Legislative Priorities for National COVID-19 Response

On May 1, House Energy & Commerce Committee Chair Frank Pallone (D-NJ) released a memo calling for expanded testing, centralized supply chain coordination and communication, improved public health data collection, free testing and treatment coverage for everyone, including uninsured individuals, and fair reimbursement for health care providers who provide COVID-19-related services.

Find more information here.

Bill Introduced to Allow Mail-Order Medicaid Prescriptions during COVID-19 Pandemic

On April 20, Reps. Anna Eshoo (D-CA) and Lisa Blunt-Rochester (D-DE) introduced H.R. 6557, the MAIL Act, a bill to encourage states to allow Medicaid mail-order prescriptions and let beneficiaries obtain a 90-day supply of drugs without restriction during the public health emergency. The bill would increase by 1 percent federal payments for mail-order Medicaid claims during the COVID-19 outbreak. On March 20, the Centers for Medicare and Medicaid Services (CMS) sent a notice asking Medicare Part D plans to let seniors obtain prescriptions without in-person contact.

Find the bill here.


CMS Set to Announce Insulin Affordability Policy

On April 30, the Centers for Medicare and Medicaid (CMS) Administrator Seema Verma said that CMS would soon announce a plan to lower the cost of insulin for seniors. Friday, May 1 was the deadline for insurers to apply to participate in a Part D demonstration to cap beneficiaries’ monthly insulin costs at $35 and insulin manufacturers already said they would participate.

CMS: New Independent Commission to Address Safety and Quality in Nursing Homes

On April 30, the Centers for Medicare and Medicaid Services (CMS) announced a new independent commission that will conduct a comprehensive assessment of the nursing home response to the 2019 novel coronavirus (COVID-19) pandemic. The commission will provide independent recommendations to the contractor to review and report to CMS to help inform immediate and future responses to COVID-19 in nursing homes.

Find more detail here.

Final Non-Discrimination Rule under Review at OMB

As of April 24, the Office of Management and Budget (OMB) is reviewing the final version of changes to the Affordable Care Act’s (ACA) non-discrimination provision proposed by the Trump administration. The proposal would roll back protections for transgender individuals, repeal several language requirements and narrow the scope of the law.

Proposed Regulations/Guidance

DEA: Controls to Enhance the Cultivation of Marijuana for Research in the U.S.

On March 20, the Drug Enforcement Agency (DEA) released a proposed rule for adding additional research marijuana growing licenses. The only research-grade medical marijuana currently grown in the U.S. is at the University of Mississippi, while 37 prospective producers have applied for and are awaiting decisions on their applications to grow research marijuana.

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

FDA: Change in Safety Requirements for Diabetic Drugs

On March 9, the Food and Drug Administration (FDA) released a draft guidance to no longer require drug manufacturers to conduct large cardiovascular safety studies for all new type 2 diabetes therapies. The FDA is recommending new safety requirements that will focus on evaluations that are broader than heart disease. Companies will need to include at least 4,000 patients exposed to the drug in phase III clinical trials, with at least 1,500 patients exposed to the drug for at least one year and 500 patients exposed to the drug for at least two years.

Find the draft guidance here. Public comments are due by June 8, 2020.

CMS: Coordinating Care from Out-of-State Providers for Medicaid-Eligible Children with Medically Complex Conditions – Reopened Comment Period

As of today, May 4, the Centers for Medicare and Medicaid Services (CMS) reopened the comment period for the request for information (RFI), Coordinating Care from Out-of-State Providers for Medicaid-Eligible Children with Medically Complex Conditions, by 30 additional days. The RFI is to address access to care across state lines in Medicaid for children with medical complexity.

Find the proposed rule here. The new comment period deadline is June 3, 2020.

CMS Proposes 2.9 Percent Pay Increase for Inpatient Rehab Facilities

On April 16, the Centers for Medicare and Medicaid Services (CMS) released a proposal to increase pay for inpatient rehabilitation facilities in fiscal 2021, lift the requirements for postadmission evaluations and allow nonphysician practitioners to provide more services. CMS proposes to increase the inpatient rehabilitation facility payment by 2.9 percent, and proposes to maintain outlier payments at 3 percent of total payments. CMS says this would be an overall $270 million increase in fiscal 2021 relative to fiscal 2020. The proposal includes adoption of the Office of Management and Budget’s (OMB) statistical area delineations and would apply a 5 percent cap on wage index decreases from fiscal 2020 to fiscal 2021.

Find the proposed rule here. Public comments are due by June 15, 2020.

Final Regulations/Guidance

CMS Urges States to Loosen Rules on Telehealth in Medicaid

As of April 24, the Centers for Medicare and Medicaid Services (CMS) is encouraging states to loosen their laws and regulations in order to broaden the use of telehealth in Medicaid and the Children’s Health Insurance Program during the coronavirus pandemic. Noted in the new COVID-19 telehealth toolkit, CMS added that states should consider policy changes such as expanding which beneficiary groups are eligible for telehealth coverage, increasing reimbursement rates for telehealth services and revising scope-of-practice rules that determine which providers can deliver care via telehealth. States do not need to obtain federal permission to reimburse providers for telehealth services in the same manner or at the same rate that they pay for in-person services. However, a state plan amendment is necessary to revise payment methods to account for additional telehealth costs.

Find the toolkit here.

FDA: Do Not Use Hydroxychloroquine for COVID-19 in Outpatient Setting

On April 24, the Food and Drug Administration (FDA) warned that COVID-19 patients should not use hydroxychloroquine or chloroquine outside of the hospital or clinical trial setting due to serious heart-related adverse events and death that have been reported in the FDA Adverse Event Reporting System database and the American Association of Poison Control Centers’ National Poison Data System, as well as in medical literature.

Find the press release here.

OMB Approves 340B Drug Cost Survey, Hospitals Must Send Data by May 15

On April 23, the Office of Management and Budget (OMB) approved the Centers for Medicare and Medicaid’s (CMS) plan to survey hospitals on their 340B drug acquisition costs. OMB commented that CMS must show the data collected is not biased before it can be used in rulemaking. The survey must be completed by May 15, according to a CMS portal where 340B hospitals can fill out the survey. However, some hospitals say it will be hard to submit the data given the COVID-19 pandemic.


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

HHS Gives Opening Remarks in Medicare Overpayment Case

On April 24, during opening remarks, the Department of Health and Human Services (HHS) told the D.C. Circuit that back in 2018, U.S. District Judge Rosemary Collyer misunderstood key facts when they vacated a Medicare Advantage overpayment rule with multibillion-dollar implications for reimbursement and False Claims Act litigation. According to HHS, the federal judge relied on a “false premise” that the rule requiring Medicare Advantage insurers to return unwarranted payments was not legally sound because it did not account for unwarranted payments in traditional Medicare. The case is UnitedHealthcare Insurance Co. et al. v. Azar et al., case number 18-5326, in the U.S. Court of Appeals for the District of Columbia Circuit.

Court Lets FDA Extend PMTA Deadline for Tobacco Products to Sept. 9

On April 23, a federal district court granted the Food and Drug Administration’s (FDA) request to give tobacco companies until Sept. 9 to file premarket tobacco applications (PMTA) for e-cigarettes, cigars and other new tobacco products. The extension is 120 days from the original May 12 deadline in the case American Academy of Pediatrics v. FDA.


Pharmacy Groups Release Draft Compounding Guidelines for States

On April 27, the Alliance for Pharmacy Compounding and the National Alliance of State Pharmacy Associations released draft guidelines to help state boards of pharmacy ensure compounding pharmacies comply with the Food and Drug Administration’s (FDA) recent guidance. The FDA released guidance that temporarily eases restrictions on pharmacy compounders and allows pharmacists to compound drugs for hospitals without first receiving a patient-specific prescription.

Find more information here.

Indian Pharmaceutical Alliance Urges FDA to Conduct Virtual Facility Inspections

On April 20, the Indian Pharmaceutical Alliance sent a letter to the Food and Drug Administration (FDA) urging for desk reviews, including virtual inspections, of certain drug manufacturing facilities in India for the duration of the COVID-19 pandemic as a way to proceed with facility inspections and mitigate future drug shortages. The letter added concern that the indefinite postponement of FDA foreign inspections could lead to disruptions in America’s drug supply.


GAO: Priority Open Recommendations – Department of Health and Human Services

On April 30, the Government Accountability Office (GAO) released its annual 55 priority open recommendations for the Department of Health and Human Services (HHS) as of April 2020. For example, the recommendations include that HHS should work with its interagency biodefense team to document key steps for making and enforcing decisions related to biological threats, e.g., COVID-19. HHS has closed 13 priority recommendations since March 2019, and GAO urges HHS to refocus its efforts on more of these when the COVID-19 response is no longer a top priority.

Find the full report here.

GAO: Antibiotic Resistance – Additional Federal Actions Needed to Better Determine Magnitude and Reduce Impact

On April 29, the Government Accountability Office (GAO) released a report examining federal challenges to address antibiotic resistance:

Surveillance—Tracking resistant infections is tough because of reliance on sampling and voluntary reporting

Diagnostics—Lack of data on clinical outcomes impedes the development and use of antibiotic-resistance tests

New treatments—The pipeline of new antibiotics is inadequate and federal efforts haven’t fully incentivized development

Antibiotic use—Federal requirements to improve antibiotic use are mostly limited to hospitals and nursing homes

Find the full report and eight recommendations from GAO here.

GAO: Priority Open Recommendations – Department of Veterans Affairs

On April 27, the Government Accountability Office (GAO) released a report outlining its annual 33 priority open recommendations for the Department of Veterans Affairs (VA) as of April 2020. GAO includes that when the VA is able to refocus its efforts from the COVID-19 pandemic, it should address GAO’s open recommendations. Since GAO’s previous letter in March 2019, VA implemented 10 of the priority recommendations.

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

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