Insight Entries – Page 19

WHG - EpiPen and the Pricing Debate - Congressional Oversight and Campaign Proposals

The chorus of disapproval about the cost of EpiPen prescriptions reached a crescendo last week after the maker of the drug, Mylan, was widely lambasted for drastic price increases in the product which is widely used to combat potentially life-threatening allergic reactions. Over the past decade, the list price for a package of two injectors has jumped from $94 to... Read More

WHG - Aetna and the Exchanges - What It Means for the ACA, Third-Party Payers, and the 'Public Option'

Last week, Aetna – one of the nation’s largest private insurers – announced that it would withdraw from 11 of the 15 Affordable Care Act (ACA) state exchanges where it sells health plans. Aetna, which had 838,000 exchange customers at the end of June, said its policyholders are turning out to be sicker and costlier than expected. In addition to... Read More

WHG - Quick Note re Fall Outlook & Cures/Innovations Package

Through some recent discussions with lead staff, we have gotten a clearer picture of the likely congressional activities during the September and post-election lame duck work periods that we wanted to pass along. According to Senate Republican leadership, the September work period is likely to focus on the “messes” left over from July: Puerto Rico pension issues, Zika, and the... Read More

WHG - Issue Brief: Clinton and Trump Health Policy Proposals

TRP Health Policy has prepared an issue brief outlining Hillary Clinton and Donald Trump’s stated healthcare priorities. While it emphasizes those impacting the pharmaceutical space, in light of the headline debates around drug pricing, the memo also explores other aspects of their healthcare agendas... Read More

WHG - 2016 Federal Election Outlook

TRP Health Policy has prepared a PowerPoint deck that examines the 2016 Federal elections and potential implications for healthcare. Here we walk through recent polling on the presidential and congressional races, consider the priorities of the key candidates and their parties, and look to areas of likely focus next year. In brief, no matter how you slice it, we will... Read More

WHG - Issue Brief: Child Nutrition and WIC Reauthorization

This memorandum provides an overview of the Child Nutrition and WIC Reauthorization Act (CNR), including background on the federal child nutrition programs it would address (section II) and details on the five-year reauthorization process (section III). Also provided below is background on the iteration of CNR currently in place, the Healthy, Hunger-Free Kids Act (HHFKA) (P.L. 111-296), which was signed into... Read More

WHG - Issue Brief: Part B Drug Pricing Levers - Least Costly Alternative and Inherent Reasonableness

With the increased politicization of drug pricing, the Administration is reportedly contemplating regulatory changes it might undertake to address the issue, such as deploying least costly alternative (LCA) or inherent reasonableness authority. However, both of these paths face considerable legal and political obstacles, and LCA policies likely would require legislation restoring HHS authority prior to implementation... Read More

WHG - Issue Brief: Telemedicine Coverage and Reimbursement

This memorandum explores the reimbursement and regulatory landscape for telemedicine services, particularly those relating to population health. The memo provides a brief definition of telemedicine, in contrast to broader telehealth services (sec. II), before outlining how government and private payers reimburse providers for certain telemedicine services (sec. III). Additionally, the memo identifies alternative sources of telemedicine funding via grant and... Read More

WHG - Issue Brief: Republican Alternatives to the ACA

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

WHG - 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

WHG - 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

WHG - 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

WHG - 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

WHG - 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

WHG - 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

WHG - 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

WHG - 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

WHG - 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

WHG - 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