This issue brief provides an overview of key 2016 GOP Presidential candidates’ healthcare reform-related proposals. It further outlines more comprehensive Affordable Care Act (ACA) alternative policies put forward by both lawmakers and conservative think tanks. In conclusion, we assess the likelihood of ACA repeal (or fundamental reform) and strategic and political considerations in that regard... Read More
Impact Health - Issue Brief: Biosimilars
This memorandum provides background on the Food and Drug Administration’s (FDA’s) implementation of the Biologics Price Competition and Innovation Act’s (BPCIA) abbreviated licensure pathway for products that are biosimilar to – or interchangeable with – a licensed biologic reference product. After a lengthy wait for implementing guidance, key pieces of which remain pending, biosimilars implementation has begun to accelerate. The FDA and Centers... Read More
Impact Health - Issue Brief: Outline of Likely 2017 CHIP and Medicare Extenders Package
This chart outlines the provisions that will potentially be included in the CHIP and Medicare extenders package Congress is likely to address next year. These items were most recently extended in MACRA 2015 (aka the permanent SGR repeal bill) and, for the most part, expire on September 30 or December 31 of next year. We have summarized each item and... Read More
Impact Health - Issue Brief: The 340B Program
This memorandum provides background on the 340B Drug Pricing Program to assist with review of the Health Resources and Services Administration (HRSA) omnibus guidance on key program parameters, released August 27, 2015. Congress has demonstrated sustained interest in the program, raising the possibility that HRSA’s highly anticipated guidance may not be the final word on these key issues. The Medicare Payment... Read More
Impact Health - Side by Side of CMMI & IPAB Authorities
This chart compares the constitution, authorities, and other parameters for the Center for Medicare and Medicaid Innovation (CMMI) and the Independent Payment Advisory Board (IPAB)... Read More
Impact Health - Issue Brief: Medicare Hospital Quality Reporting and Payment Programs
This memorandum provides an overview of key Medicare hospital quality reporting and payment programs, including their recent developments and significant upcoming changes. We begin with a brief outline of these programs, noting for example the Centers for Medicare and Medicaid Services’ (CMS) early experience with quality reporting-focused initiatives, such as the Hospital Inpatient Quality Reporting (IQR) Program. Building on the... Read More
Impact Health - Issue Brief: MACRA's Merit-Based Incentive Payment System
This Issue Brief provides an overview of key Medicare physician payment reforms to be implemented via the upcoming Merit-based Incentive Payment System (MIPS) pursuant to the latest “doc fix,” the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) (P.L. 114-10). Although MIPS – which entails a consolidation of three Medicare physician quality reporting initiatives – is not set to... Read More
Impact Health - TRP Catalogue of Grant and Demonstration Opportunities
This is a catalogue of key select grant and demonstration opportunities in the healthcare space. The document features the open or imminent Federal offerings in this regard (as of the date of publication), with deadlines, summaries and links to additional details provided. We have labeled each opportunity based on the broad issue area(s) addressed. Please take a moment to review... Read More
Impact Health - Issue Brief: Opioid Policy Developments
Opioid abuse has assumed a prominent role in federal policymaking, with Congress and the Administration seeking to advance solutions to a mounting epidemic. According to a recent Department of Health and Human Services (HHS) report, opioid overdose deaths quadrupled between 1999 and 2013, while only 1 million of an estimated 2.5 million people who may benefit from medication-assisted treatment (MAT)... Read More
Impact Health - Issue Brief: Competitive Acquisition Program for Medicare Part B Drugs
This brief provides background information on the Centers for Medicare and Medicaid Services’ (CMS) Medicare Part B Drug and Biological Competitive Acquisition Program (CAP). Although the program is no longer in operation, the Center for Medicare and Medicaid Innovation (CMMI) renewed attention on the program by requesting comment on it as part of the Medicare Part B Drug Payment Model... Read More
Impact Health - Issue Brief: Socioeconomic Status in Medicare Quality Reporting and Payment Programs
This memorandum provides an overview of key efforts to account for socioeconomic status (SES) in Medicare quality reporting and payment programs. Passage of the Affordable Care Act (ACA) spurred widespread adoption of incentivized pay-for-performance programs, but there is growing concern that the quality measures implemented under such programs do not adequately adjust for certain patient-related social risk factors that affect health... Read More
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