Weekly Spotlight

If the recent Ways and Means Committee markup is any indication, the extension of telehealth flexibilities established during COVID may have a pay-for after all in the form of PBM reform, back from the dead.

Speaking of hovering on the brink, the Medicare Trustee’s pushed back by five years their estimate of when the Medicare Trust Fund will become insolvent. Although the new report claims this is largely due to greater income and lower expenditures than was projected last year, one wonders about the lasting impact of COVID fatalities on all our healthcare-related estimates.

Health systems are also reeling from yet another cyberattack, this time at Ascension hospitals, as Congress and others continue to probe what happened at Change Healthcare.

Other Regulatory News

Centers for Medicare and Medicaid Services (CMS)

Medicare Hospital Trust Fund to Stay Solvent Until 2036, Trustees’ Report Says

The Medicare Hospital Insurance Trust Fund is expected to remain solvent until 2036, 5 years longer than projected last year, the Medicare trustees said Monday in their annual report to Congress, but they also expressed concern about low payment rates to physicians. The longer hospital trust fund solvency is “largely due to greater income and lower expenditures than was projected last year,” a senior administration official said on a call with reporters. “Income was projected to be higher because the number of covered workers and average wages per worker were both projected to be higher than last year’s estimate.”

#All

CMS Publishes Resource of Health Equity-Related Data Definitions, Standards, and Stratification Practices

Standardized data collection and stratification allow for comprehensive analyses that can be combined or compared across multiple programs or initiatives; and in turn, offer an important first step towards improving population health. This document serves as a technical resource that can be used by organizations and entities, such as providers, states, community organizations, and others, that wish to harmonize with CMS when collecting, stratifying, and/or analyzing health equity-related data. It may also clarify differences in results that may arise when different data standards and definitions are used. This document includes suggested definitions, standards, and stratification practices for the following sociodemographic elements:

• Race and Ethnicity
• Sex (assigned at birth)
• Gender identity
• Sexual orientation
• Disability status
• Primary Language
• English language proficiency
• Rurality/urbanicity or residence

#All

2024 CMS Health Equity Conference

Virtual registration will remain open until May 14 for the 2024 CMS Health Equity Conference on May 29-30?

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The Pharmaceutical Firms With Drugs On Medicare’s Price Negotiation List Spent $162 Billion On Shareholder Handouts, Marketing, And Overhead In 2023

A new report calls out pharmaceutical companies with drugs on the IRA drug price negotiation list for their spending priorities in 2023. According to the report, the eight pharmaceutical companies that manufacture the ten medications on the Biden administration’s list for Medicare price negotiations have spent lavishly on a variety of expenses, including millions in executive compensation and billions in advertising and shareholder handouts, with most spending far less on research and development. Collectively, these companies spent a total of $95.9 billion on research and development expenses, compared to $162 billion on stock buybacks, dividends, and marketing and administrative costs and nearly $500 million on compensation for their boards and executives. Additionally, these companies spent at least $83.2 million on trade association dues, $10.6 million on political contributions and $57.8 million on lobbying in 2023.

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The World is Relying on the United States to Get Value-Based Drug Pricing Right

Stat news reports, the changing landscape of drug pricing policy in the U.S. has implications for the global pace and direction of innovation. Drug policy changes are being influenced by perceptions of the value of novel medicines relative to their budgetary impacts, with some believing that many medicines may not be worth their cost, creating an important role for health technology assessments (HTA). The goals of these assessments are to ensure that society does not overpay for new medications, but also does not inadvertently discourage the development of worthwhile medicines and other health technologies.

#Drug, #Patient

HHS Releases Draft Guidance for the Second Cycle of Medicare Drug Price Negotiation Program

The second cycle of negotiations will include up to 15 additional drugs selected for negotiation, increasing access to innovative, life-saving treatments for people with Medicare and lowering costs for Medicare and taxpayers. In accordance with the law, CMS will announce up to 15 additional drugs selected for potential negotiation for 2027 by February 1, 2025. This second round of negotiations will occur during 2025, and any negotiated maximum fair prices will be effective for this second set of drugs starting January 1, 2027.

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MA News

Gaps in Medicare Advantage Data Remain Despite CMS Actions to Increase Transparency
KFF reports on gaps in Medicare Advantage data. CMS has recently taken actions to increase transparency in Medicare Advantage. In particular, the agency has clarified and expanded reporting requirements for Medicare Advantage insurers pertaining to use of supplemental benefits that may be available to researchers and others upon request within a few years. In addition, CMS is requiring Medicare Advantage insurers to post summary data on the timeliness and use of prior authorization on their own websites beginning in 2026.

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Risk Adjustment and Incentives for Upcoding in Medicare
Healthcare Economist explores the incidence of upcoding in MA

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Some Medicare Advantage Organization Denials of Prior Authorization Requests Raise Concerns About Beneficiary Access to Medically Necessary Care
According to a new report from the HHS Office of the Inspector General, Medicare Advantage Organizations sometimes delayed or denied Medicare Advantage beneficiaries’ access to services, even though the requests met Medicare coverage rules.

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Food and Drug Administration (FDA)

Chemo Can be Brutal. This FDA Effort Aims to Make it Less So.

In new reporting, The Washington Post looks into FDA’s efforts to improve dosing guidelines:

“When doctors began using the drug sotorasib in 2021 with high expectations for its innovative approach to attacking lung cancer, retired medical technician Don Crosslin was an early beneficiary. Crosslin started the drug that July. His tumors shrank, then stabilized. But while the drug has helped keep him alive, its side effects have narrowed the confines of his life.”

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Risk Evaluation and Mitigation Strategy Logic Model: A Framework to Link Program Design With Assessment; Draft Guidance for Industry; Availability

FDA is announcing the availability of a draft guidance for industry entitled “REMS Logic Model: A Framework to Link Program Design With Assessment.” The guidance describes FDA’s risk evaluation and mitigation strategy (REMS) logic model. The principles in this guidance apply to designing a REMS, developing a REMS assessment, and modifying a REMS.

#Drug

Safety and Quality Concerns with Getinge Cardiovascular Devices – Letter to Health Care Providers

FDA alerted health care providers and facilities about continued safety and quality concerns with the following Getinge/Maquet cardiovascular medical devices:

• Getinge/Maquet/Datascope Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pump (IABP) devices and
• Getinge/Maquet Cardiohelp system and HLS Sets.

The FDA recommends that health care providers and facilities transition away from these devices and seek alternatives, if possible. These recommendations are based on continued concerns that Getinge/Maquet has not sufficiently addressed the problems and risks with these recalled devices.

#Device, #Hospital, #Patient, #Provider

Health and Human Services (HHS)

New Guidance Buys More Time for HHS on Surprise Billing

HHS, DOL, and Treasury issued new guidance on the No Surprises Act with significant implications for providers and payers. At issue – the calculation of the qualifying payment amount (QPA), which serves as the basis for how an enrollee’s co-payments are calculated when they inadvertently receive care from out-of-network providers. CMS set the methodology in an Interim Final Rule; last year, the federal courts declared CMS’ approach invalid. However, CMS used enforcement discretion to allow insurers to continue using the old methodology through May 1. Last week, the Departments extended that date another six months – essentially meaning plans don’t need to comply with the courts’ perspective for the foreseeable future.

#Provider, #Hospital, #Patient, #Payer

Hill Happenings

Cassidy /HELP Whitepaper: NIH in the 21st Century: Ensuring Transparency and American Biomedical Leadership

As Ranking Member of the Senate Health, Education, Labor, and Pensions (HELP) Committee, Cassidy issued a request for information (RFI) from stakeholders seeking feedback on NIH’s current activities and statutory framework. Respondents to the RFI ranged from academic institutions; relevant professional societies, think tanks, and trade associations; patient advocates; and individual researchers sharing their observations from careers working within the NIH ecosystem. Respondents identified multiple opportunities for legislative action that would build upon past congressional efforts to strengthen NIH and the U.S. biomedical research enterprise. In this white paper, Cassidy put forward a selection of proposals to invite discussion of policies that may be appropriate for legislative action.

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Notable Notes

ICER Debuts Clinical Trial Diversity Assessment Framework

New medical product sponsors should expect to have the diversity of their clinical trials scrutinized as part of the US Institute for Clinical and Economic Review’s clinical and cost-effectiveness evaluations using a new in-house tool.The new tool provides a way of quantifying the degree of diversity by race/ethnicity, sex and age in clinical trials, but the results will not factor into the US health technology assessment body’s cost effectiveness determinations for new drugs.

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50-State Survey of Telehealth Insurance Laws

Foley & Lardner’s 50-State Survey of Telehealth Insurance Laws provides a detailed report on each State’s telehealth commercial insurance coverage and payment/reimbursement laws. The report is useful to health care providers (both traditional and emerging), lawmakers, entrepreneurs, telemedicine companies, and other industry stakeholders as a guide of telehealth insurance laws and regulations across all 50 states and the District of Columbia.

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Hack Targeting Ascension Hospital Chain is Impacting Patient Care

Ascension, one of the largest health systems in the United States was struck by a cyberattack that knocked patient record systems offline and forced medical staff to log care on paper.

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New DOJ Health Care Task Force Will Tackle Competition Problems in Health Care Markets

The Justice Department announced the formation of the Antitrust Division’s Task Force on Health Care Monopolies and Collusion (HCMC). The HCMC will guide the division’s enforcement strategy and policy approach in health care, including by facilitating policy advocacy, investigations and, where warranted, civil and criminal enforcement in health care markets.

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Health Care Leaders Plot How to Expand Diversity in Clinical Trials

Even with the recent awareness that clinical trials often lack the diversity that would make them representative, women and people of color remain underrepresented in studies. The work of bringing diversity to research is complex, and several experts gathered at the Milken Institute Global Conference to discuss potential strategies to make progress, starting with ways to build trust among the communities that have a history of being mistreated or exploited by the scientific community. Here are some of their big ideas.

#Device, #Drug, #Patient