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Featured Analysis

E&C-Health Subcommittee Advances 10 Bills to Full Committee on Surprise Billing, Drug Pricing, Extenders

The House Energy and Commerce Subcommittee on Health convened a markup of 10 health care bills, including advancing H.R. 3630, the “No Surprises Act,” bipartisan legislation to address surprise medical bills. The Subcommittee also advanced H.R. 2296, the FAIR Drug Pricing Act, which requires pharmaceutical manufacturers to justify price increases above a certain threshold. The Subcommittee adopted an amendment in... More (McChesney, 7/11/19) #Community Health Centers, #Drug Pricing, #Disproportionate Share Hospitals (DSH), #Pediatrics, #Hospitals, #Cost-Sharing


CMS-Agency Estimates CY 2020 Home Health Agency Payments to Increase by 1.3 Percent under Proposed Rule

The Centers for Medicare and Medicaid Services (CMS) issued the calendar year (CY) 2020 home health prospective payment system and rate update proposed rule (release; fact sheet). What it is. The proposed rule affects payments to home health agencies (HHAs) beginning Jan. 1, 2020. Why it is important for you. CMS proceeds with implementation of Bipartisan Budget Act (BBA)-driven Patient-Driven... More (Zatorski, 7/11/19) #Home Health, #Quality


Recent Analysis

Congress | Regulations


Senate-Hassan, Murkowski Introduce Bipartisan Bill to Increase Access to MAT for SUD

Senators Maggie Hassan (D-NH) and Lisa Murkowski (R-AK) introduced the bipartisan Mainstreaming Addiction Treatment (MAT) Act intended to increase access to medication-assisted treatment (MAT) for substance use disorder (SUD). Highlights of the bill follow: Eliminates the requirement for health care professionals to apply for a waiver through the Drug Enforcement Agency in order to prescribe narcotic drugs in schedule III,... More (Llamas, 7/11/19) #Mental and Behavioral Health, #Physicians, #Prescription Drugs, #Telehealth


FDA-Agency Releases Two Draft Guidance Documents: Using the Inactive Ingredient Database and Updating Drug Substance Monographs

The Food and Drug Administration (FDA) recently announced two draft guidance documents for industry, the details of which follow. Using the Inactive Ingredient Database: This draft guidance describes the FDA’s thinking around how industry stakeholders can best leverage the agency’s Inactive Ingredient Database (IID) for the development of drug products and evaluating excipient safety. The agency notes that inactive ingredients... More (LaRosa, 7/11/19) #Food and Drug Administration


FDA-Agency Finalizes new REMS Guidance; Defines Changes to REMS and Outlines Submission Procedures

The Food and Drug Administration (FDA) recently released final guidance defining the types of changes to approved risk evaluation and mitigation strategies (REMS). It also outlines how “application holders should submit changes to an approved REMS, and how the FDA will process submissions from application holders for changes to REMS.” Beginning on p. 3, the guidance outlines the FDA’s distinctions... More (LaRosa, 7/11/19) #Food and Drug Administration


CMS-Agency Proposes Rule Rescinding Requirements for States to Monitor Access to Medicaid Services; Comments Due Sept. 13

The Centers for Medicare & Medicaid Services (CMS) released a proposed rule that would rescind the required monitoring process states must engage in to ensure sufficient beneficiary access to Medicaid fee-for-service (FFS) (press release). CMS describes the required process, established in 2015, as overly burdensome for states, and that many have “raised concerns about both the administrative burdens and programmatic... More (LaRosa, 7/11/19) #Administrative Simplification, #Program Integrity


Upcoming Events


FDA Meeting: LPAD Draft Guidance

Fri July 12, 2019

FDA hosts a meeting titled, “Limited Population Pathway for Antibacterial and Antifungal Drugs [LPAD].” Details. #Food and Drug Administration

FDA-ASCO Workshop

Fri July 12, 2019

FDA and the American Society of Clinical Oncology (ASCO) hosts a workshop titled, “2019 Clinical Outcome Assessments in Cancer Clinical Trials Fourth Annual Workshop.” Details. #Oncology





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