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This week in Washington: COVID-19 bill negotiations continue; House and Senate remain in district work periods.
Congress
House
- Energy and Commerce Democrats Ask Insurers for Details on COVID-19 Coverage, Profits
- House and Senate Democrats Against Proposed Rule Granting Flexibility for Grandfathered Plans
Senate
Administration
- HHS Will Not Use March-In Rights for Remdesivir
- CDC Outlines Data Modernization Plan After COVID-19 Info Switch to HHS
Proposed Regulations/Guidance
- FDA Seeks Input on Proposed “Right To Try” Reporting Requirements
- CMS Proposes to Expand Telehealth Benefits Permanently for Medicare Beneficiaries Beyond the COVID-19 Public Health Emergency
- CMS: Calendar Year 2021 Payment and Policy Changes for Home Health Agencies and Calendar Year 2021 Home Infusion Therapy Benefit
Final Regulations/Guidance
Courts
Other
House
Energy and Commerce Democrats Ask Insurers for Details on COVID-19 Coverage, Profits
On Aug. 13, House Energy & Commerce Democrats asked five major health insurers and four dental insurance companies to explain their profits, coverage policies and practices during the COVID-19 pandemic. Chair Frank Pallone (D-NJ), Oversight subcommittee Chair Diana DeGette (D-CO) and Health subcommittee Chair Anna Eshoo (D-CA) sent letters to Anthem, Cigna, CVS Health, Humana and UnitedHealth Group, as well as dental insurance companies. The letters asked for the companies’ net income and earnings for years 2018, 2019 and each of the first two quarters of 2020, broken down by line of business and including stand-alone dental. The letters asked for member premiums and the claims amounts paid out during each of those periods.
House and Senate Democrats Against Proposed Rule Granting Flexibility for Grandfathered Plans
On Aug. 11, House Labor & Education Chair Bobby Scott (D-VA), Energy & Commerce Chair Frank Pallone (D-NJ), Ways & Means Chair Richard Neal (D-MA), Senate Finance ranking Democrat Ron Wyden (D-OR) and Senate Health, Education, Labor and Pensions (HELP) ranking member Patty Murray (D-WA) asked the Trump administration to end its proposal for more flexibility to grandfathered plans not compliant with the Affordable Care Act (ACA). The listed concerns included an increase in cost sharing during the COVID-19 pandemic, as well as an increase of the premium adjustment percentage that could increase out-of-pocket costs.
Senate
Baldwin, Murphy Ask CBO to Revisit Assumptions on Short-Term Plans
On Aug. 13, Sens. Tammy Baldwin (D-WI) and Chris Murphy (D-CT) asked the Congressional Budget Office (CBO) to reevaluate the determination that an amount of the short-term limited-duration insurance (STLDI) plans allowed by the Trump administration should be considered as health insurance. CBO earlier projected traditional short-term plans for which those enrolled would be considered uninsured, and new STLDI plans, the enrollees of which would be considered insured. The senators said only plans without protections are being offered.
Administration
HHS Will Not Use March-In Rights for Remdesivir
On Aug. 13, the Department of Health and Human Services (HHS) announced it will only use march-in rights to lower the cost of COVID-19 drugs if all a product’s patents are owned by the federal government, which is not the case for remdesivir. The Trump administration’s stance is in opposition to that of a bipartisan group of 34 state attorneys general that asked the Trump administration to either use its march-in rights or allow states to sidestep patents to lower the cost of remdesivir, which hospitals are using to treat COVID-19.
CDC Outlines Data Modernization Plan After COVID-19 Info Switch to HHS
On Aug. 12, the Centers for Disease Control and Prevention (CDC) Director Robert Redfield announced plans to use its $500 million from the CARES Act to update and improve local data collection and contact tracing systems. In response to Rep. Lucy McBath’s (D-GA) request for more information, Redfield said the investment would specifically combine some of the CARES Act investments with funds from the Paycheck Protection Program to send $12.1 billion to states so they can modernize their systems and improve their integration with national systems. CDC will also invest in contact tracing with software that will help contact tracers manage their cases or opt-into proximity tracing and exposure notifications with people’s phones.
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.
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 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. Public comments are due by Aug. 31, 2020.
Final Regulations/Guidance
FDA: Marketing Status Notifications Under Section 506I of the Federal Food, Drug, and Cosmetic Act
On Aug. 10, the Food and Drug Administration (FDA) finalized guidance to provide clarity on when FDA will change the marketing status of a drug in the Orange Book. The guidance describes when and how brand and generic drug sponsors should notify the FDA of changes to the marketing status of their approved products. It finalizes FDA’s 2019 draft guidance of the same name. Insurers told FDA that this information was essential to companies’ efforts to bring new generics to market. FDA also responded to requests for more information about marketing status notifications for drugs that are sold under multiple national drug codes (NDCs), but FDA did not address the separate questions about drug shortage notifications.
Find the final guidance here.
Courts
Find a comprehensive look at “Courts and Healthcare Policy in 2020” here.
Appeals Court Says Silver-Loading Should Factor into 2018 CSR Pay, Not 2017
On Aug. 14, the U.S. Court of Appeals for the Federal Circuit ruled that with the Supreme Court’s recent decision on Affordable Care Act’s (ACA) risk corridor payments, the Department of Health and Human Services (HHS) owes insurers money for cost-sharing reduction payments (CSR) from 2017. How much the federal government owes for 2018 payments depends on the insurers’ practice of silver-loading, and the plans will have to make the case for damages before a lower court. The appeals court released two opinions, one in Sanford Health Plan v. U.S, which focused on CSR payments for 2017, and one in Community Choice Inc., v. U.S. and Maine Community Health Options v. U.S., which focused mainly on how to handle the amount the federal government will owe for 2018 CSR payments.
Other
NIH Director Does Not Expect October Estimate for COVID-19 Vaccine Distribution
On Aug. 13, the National Institutes of Health Director Francis Collins denied estimates that a COVID-19 vaccine could be out for distribution earlier than November or December. Collins said an Oct. 1 timeline for distribution would only happen in a miracle scenario.
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Stephanie Kennan, Senior Vice President
Mariam Eatedali, Research Associate
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