This week in Washington: Congress passes funding bill for an additional week to come up with full-year spending legislation to avoid a government shutdown.
Administration
- Trump Signs One-Week CR Spending Bill
- FDA Announces It Will Quickly Authorize Pfizer Vaccine
- CMS Releases Information on the Best Practices for Designing and Implementing Substance Use Disorder (SUD)-Focused Health Homes
Proposed Rules
- FDA Issues Draft Guide on Proprietary Naming of Non-Rx Drugs
- CMS Proposes New Rules to Address Prior Authorization
Final Regulations/Guidance
- CMS Final Rule: 340B Drug Pricing Program; Administrative Dispute Resolution
Courts
- Supreme Court Ruling Opens Door to State Regulation of PBMs
Reports
- The Commonwealth Fund: Income-Related Inequalities in Affordability and Access to Primary Care in Eleven High-Income Countries
- GAO: Medicaid - CMS Needs More Information on States’ Financing and Payment Arrangements to Improve Oversight
Administration
Trump Signs One-Week CR Spending Bill
On Dec. 11, President Trump signed a continuing resolution to give Congress an additional week to come up with full-year spending legislation and avoid a government shutdown. The CR sets a new funding deadline of Dec. 18. The House passed the bill 343-67, and Senate passed the bill by voice vote.
FDA Announces It Will Quickly Authorize Pfizer Vaccine
On Dec. 11, the Food and Drug Administration (FDA) notified the Centers for Disease Control and Prevention (CDC), Operation Warp Speed and Pfizer that it is working to quickly finalize and issue an emergency use authorization (EUA) for Pfizer and BioNTech’s COVID-19 vaccine. The announcement followed the FDA advisory panel’s endorsement of the vaccine the same week. It is unclear whether the EUA will be for people ages 16 and up, as it is in the United Kingdom and Canada, or whether FDA will heed concerns from some of its advisors and change the minimum age to 18. The vaccine has not been tested in 16-year-olds but FDA says it is biologically reasonable to assume that its effectiveness in 16- and 17-year-olds will be similar to the vaccine’s effectiveness in younger adults.
CMS Releases Information on the Best Practices for Designing and Implementing Substance Use Disorder (SUD)-Focused Health Homes
On Dec. 10, the Centers for Medicare and Medicaid Services released a new resource for states to utilize in their Medicaid programs when considering a substance use disorder (SUD)-focused health home program to care for their beneficiaries. Specifically, this resource provides a description of the best practices for designing and implementing a SUD-focused health home state plan amendment based on the experiences of states with approved SUD-focused health home programs, as required per section 1006(a)(2) of the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities (SUPPORT) Act.
Find more information here.
Proposed Rules
FDA Issues Draft Guide on Proprietary Naming of Non-Rx Drugs
On Dec. 11, the Food and Drug Administration (FDA) published a draft guidance that details how sponsors should select and screen proprietary names for nonprescription drugs. The new draft guidance, Best Practices in Developing Proprietary Names for Human Nonprescription Drug Products, makes naming recommendations for drugs that are switched from full-prescription and partial-prescription to nonprescription status. In the draft guide, FDA says drugs that switch from full-prescription to nonprescription status likely can keep the same name. However, drugs that are switched from partial-prescription to nonprescription status may need to have their names changed to avoid causing confusion among consumers.
The draft guidance can be found for comment under docket No. FDA-2020-D-0770.
CMS Proposes New Rules to Address Prior Authorization
On Dec. 10, the Centers for Medicare and Medicaid Services (CMS) issued a proposed rule that would require payers in Medicaid, CHIP and QHP programs to build application programming interfaces (APIs) to support data exchange and prior authorization. APIs allow two systems, or a payer’s system and a third-party app, to communicate and share data electronically. Payers would be required to implement and maintain these APIs using the Health Level 7 (HL7) Fast Healthcare Interoperability Resources (FHIR) standard.
Find the proposed rule here. Public comments are due by Jan. 4, 2021.
Final Regulations/Guidance
CMS Final Rule: 340B Drug Pricing Program; Administrative Dispute Resolution
On Dec. 10, the Centers for Medicare and Medicaid Services (CMS) finalized the rule that creates a new panel to help settle disputes in a federal drug discount program. The final rule comes after numerous manufacturers stopped providing discounts on a range of drugs to pharmacies that have contracted with hospitals and providers in the 340B program serving vulnerable populations. The rule calls on the Department of Health and Human Services (HHS) to assemble a panel from a range of key agencies, including the Centers for Medicare and Medicaid Services (CMS) and the Health Resources and Services Administration (HRSA), which oversees the 340B program. This panel would resolve contentious disputes in the program, such as when a hospital or clinic claims drug manufacturers have overcharged them, or if manufacturers think a provider is abusing the system to get extra discounts.
Find the final rule here.
Courts
Find a comprehensive look at “Courts and Healthcare Policy in 2020” here.
Supreme Court Ruling Opens Door to State Regulation of PBMs
On Dec. 10, the Supreme Court unanimously ruled in favor of an Arkansas law that regulates how much pharmacy benefit managers (PBMs) can pay pharmacies, clearing the way for the more than 40 states with similar laws that aim to use PBM regulation to control drug prices. At issue in Rutledge v. Pharmaceutical Care Management Association was an Arkansas law requiring PBMs to pay pharmacies no less than pharmacies pay for generic drugs. The state adopted the law in response to concerns that reimbursement rates set by PBMs are often lower than pharmacies’ costs. The law also lets pharmacies challenge PBM reimbursement rates and lets pharmacies refuse to dispense drugs for which they would lose money due to low reimbursement.
Reports
The Commonwealth Fund: Income-Related Inequalities in Affordability and Access to Primary Care in Eleven High-Income Countries
On Dec. 9, the Commonwealth Fund released a survey analysis that shows U.S. income-related inequality and relatively worse access to primary care could threaten the nation’s recovery from the pandemic. The survey compared the health experiences of adults with lower incomes and income-related disparities across 11 countries: Australia, Canada, France, Germany, the Netherlands, New Zealand, Norway, Sweden, Switzerland, the United Kingdom and the U.S.
Among the findings:
- On nearly every measure the study used, income-related disparities were greatest in the U.S.
- Half of U.S. adults with lower income do not get needed care because it is too costly. Even many with higher income skip care for cost reasons.
- Difficulty with paying medical bills is mostly a U.S. phenomenon: 36 percent of adults with lower income in the U.S. reported this problem, versus 7 percent to 16 percent in the other countries.
Find the full report here.
GAO: Medicaid - CMS Needs More Information on States’ Financing and Payment Arrangements to Improve Oversight
On Dec. 7, the Government Accountability Office (GAO) released a report on improving data collection on states’ financing and payments in financing Medicaid. States mostly use their general funds to finance the nonfederal share, but they can also use funds from care providers and local governments. From 2008 to 2018, states relied more heavily on the other funds. Since the federal government matches all nonfederal funds, responsibility for a larger portion of Medicaid payments effectively shifted to the federal government and away from states.
GAO recommends:
- CMS should collect and document complete and consistent provider-specific information about Medicaid payments to providers, including new state-directed managed care payments and states’ sources of funding for the nonfederal share of these payments.
Find the full report here.
