Weekly Spotlight

While there may not be a lot there yet, we’ll be keeping an eye on anything that develops from a recent request from Congressman Michael C. Burgess, M.D. (R-TX), Chairman of the Budget Committee Health Care Task Force, and House Budget Committee Chairman Jodey Arrington (R-TX) to Comptroller General Gene Dodaro of the U.S. Government Accountability Office (GAO) requesting an investigation into the Center for Medicare and Medicaid Innovation (CMMI) and its effect on the federal budget. CMMI, which seems intent on testing the theory that you have to spend money to make money, was created under the Affordable Care Act to test innovations that would promote value-based care. CMMI Director Elizabeth Fowler featured prominently in the Centers for Medicare and Medicaid Services’ quarterly call with the Administrator this week, where she touted the announcement of the new TEAM Alternative Payment Model.

Other Regulatory News

Centers for Medicare and Medicaid Services (CMS)

CMS Publishes New IRA Guidance

This draft guidance describes how CMS intends to implement the Negotiation Program for initial price applicability year 2027 (January 1, 2027 to December 31, 2027), including clarifying certain policies that CMS set forth in the 2026 document guidance. This draft guidance also sets forth additional policies regarding manufacturer effectuation of the MFP in 2026 and 2027, and specifies the requirements that will be applicable to manufacturers of drugs that are selected for negotiation and the procedures that may be applicable to drug manufacturers, Medicare Part D plan sponsors (both Prescription Drug Plans (PDPs) and Medicare Advantage Prescription Drug (MA-PD) Plans), pharmacies, mail order services, and other dispensing entities that dispense drugs covered under Medicare Part D.

#DRUG, #PATIENT

Food and Drug Administration (FDA)

FDA Plans AdCom Listening Session

FDA plans to hold a listening session in June to discuss possible changes to the role of its advisory committees, coming as senior agency officials seek to shift the advisers’ focus on product approval decisions to debates surrounding scientific policies. But that push has also faced backlash from some lower-level FDA officials. High-ranking FDA officials have expressed interest in reducing the number of votes held by advisory committees on product approvals, potentially focusing more meetings on broader scientific questions. FDA’s upcoming meeting will also include a discussion on the composition of advisory committees, how to improve the experience for committee members, and how to ensure public awareness of advisory committees’ roles.

#Device, #Drug, #Patient, #Provider

CDER’s Office of New Drugs 2023 Annual Report Now Available 

The Center for Drug Evaluation and Research (CDER) published the 2023 Office of New Drugs (OND) Annual Report, which captures the office’s major achievements of 2023 to include notable drug approvals, guidances, publications, participation in meetings, workshops, webinars, conferences, and more. 

#Drug, #Patient

Health and Human Services (HHS)

White House Indefinitely Delays Plan to Ban Menthol Cigarettes

In a surprising move, the Administration announced it will delay publishing regulations banning the use of menthol flavoring in cigarettes. Sec Becerra said, “This rule has garnered historic attention and the public comment period has yielded an immense amount of feedback, including from various elements of the civil rights and criminal justice movement. It’s clear that there are still more conversations to have, and that will take significantly more time.”

#All

Notable Notes

Is Industry Influence Driving LVAD Use by Cardiologists?

A new study presented at the Annual meeting of the  Society for Cardiovascular Angiography and Interventions shows that use of intravascular microaxial left ventricular assist devices (LVADs) grew from 4.1% to 9.8% of all PCIs for acute myocardial infarction complicated by cardiogenic shock from 2015 to 2017, despite limited evidence demonstrating safety or clinical effectiveness and higher cost. Payments from industry to physicians have been associated with greater likelihood of brand-name drug prescribing and medical device use. We examined whether payments from the LVAD manufacturer to cardiologists performing PCI were associated with any use of LVADs.

#Device, #Patient, #Payer, #Provider

Transradial PCI Finally Normalized in the U.S., Though Holdouts Remain

Radial artery access has become the dominant approach for percutaneous coronary intervention (PCI), with real-world practice supporting the safety benefits of this strategy, according to registry data from the last decade. Adoption of transradial PCI rose from approximately 20% of cases in 2013 to nearly 60% in 2022, based on 6.7 million cases from the CathPCI registry.

#Patient, #Provider

WHO reports widespread overuse of antibiotics in patients hospitalized with COVID-19

New evidence from the World Health Organization (WHO) shows the extensive overuse of antibiotics during COVID-19 pandemic worldwide, which may have exacerbated “silent” spread of antimicrobial resistance (AMR). While only 8% of hospitalized patients with COVID-19 had bacterial co-infections requiring antibiotics, three out of four or some 75% of patients have been treated with antibiotics ‘just in case’ they help.

#All

FTC Publishes Health Breach Notification Rule Over Objections

The Federal Trade Commission on Friday (April 26) finalized a controversial plan to require vendors of personal health records (and related entities that are not covered by HIPAA) to notify individuals, the FTC and, in some cases, the media of a breach of personally identifiable health information. Third-party service providers to vendors of personal health records and related entities are mandated to notify related entities following the discovery of a breach under the updated rule.

#All

Closing Gender-Based Disease Disparities Starts in the Lab

According to a new study, despite the fact men have lower life expectancy than women and are at a higher risk of developing serious health conditions like heart disease and lung cancer, women spend 25% more of their lives in poor health compared to men. This is in part because women disproportionately experience stroke-related disability, ovarian and breast cancers, dementia, and autoimmune diseases including multiple sclerosis (MS), which have long gone without a cure. At the same time, research and anecdotal accounts show that women often feel under-served and underrepresented in terms of the healthcare they receive.

#All

Pharma’s reputation with patient groups is sliding again thanks to prices and shortages

The pharmaceutical industry saw its reputation slip last year among patient advocacy groups thanks to growing concern about the rising prices for medicines and a lack of confidence prompted by increasing shortages, according to a new survey. Of more than 2,500 groups queried, 57% reported that the industry maintained an “excellent” or “good” reputation as it goes about the business of developing and providing medicines. Although the findings suggest a clear majority of patients are largely satisfied with drug companies, this represents a decline — albeit, a slight one — after several years in which the industry was seen more positively.

#Drug, #Patient

USPSTF Finalizes New Breast Cancer Screening Recommendations

The U.S. Preventive Services Task Force (USPSTF) has revised its breast cancer screening recommendations and now suggests women at average risk for breast cancer should start screening at a younger age.

#Patient, #Payer, #Provider, #Hospital