Weekly Spotlight

It may be nothing… but the Centers for Medicare and Medicaid Services, Medicare Learning Network MLN Connects newsletter is highlighting CMS’s December 2023 guidance on proper coding and billing for global surgical services. The timing of this unsolicited reminder might portend major changes coming in the Physician Fee Schedule proposed rule due out early next month.

Surgeons have been fighting back changes to the way that global surgical services are billed for years since CMS proposed to unbundle surgical payments and have surgeons bill for each individual patient visit during the post-operative period. Surgeons took exception to the notion that global surgical services were a) misvalued and b) did not reflect the actual number of patient visits accrued in the post-operative period. After Congress intervened, asking for CMS to provide evidence to back up their suspicions, CMS commissioned a series of reports from RAND. The surgical community took exception to the research methodology and CMS appeared to shelve the issue. Of course, this also meant that they failed to update global surgical reimbursement commensurate with the increased value of evaluation and management visits taking place in the primary care setting.

Could this reminder be a signal to surgeons that their time flying under the radar has come to an end?

#Provider

Other Regulatory News

Centers for Medicare and Medicaid Services (CMS)

CMS Updates Information on New Hospital Price Transparency Requirements Commencing July 1, 2024

June 5: CMS posted updated FAQs on the Hospital Price Transparency website with additional information to help hospitals understand and meet new compliance requirements taking effect on July 1, 2024. The FAQs also provide additional information for hospitals, consumers, and other stakeholders.

#Hospital

CMS Star Ratings Unreliable for Surgical Quality?

Higher CMS hospital star ratings generally were associated with better surgical outcomes, but there was wide variability within each star-rating group, suggesting its utility for assessing surgical quality may be limited, according to a cohort study.

#Hospital, #Provider

US Drug Negotiations Plan Shifts Focus for Rare Disease Programs

Bloomberg Law says some drug makers are halting or reshaping research into rare disease drugs over concerns they may not recoup their costs. The Medicare negotiation program exempts from bargaining orphan drugs with a single Food and Drug Administration indication to treat a rare disease. But drugs with designations to treat more than one rare disease or condition will not qualify for exclusion and may be subject to price negotiations.

#Patient, #Drug

KFF: How State Medicaid Programs Are Approaching Eligibility, Enrollment, and Renewals, During and After the Unwinding

On June 20, 2024, KFF hosted an hour-long web briefing focused on changes to eligibility policies, renewal processes, and other actions states took during the unwinding and the impact those changes may have on the future of the Medicaid program. With end of the pandemic-era Medicaid continuous enrollment policy on March 31, 2023, states resumed dis-enrollments that had been paused for three years. Since April 2023, nearly 23 million people have been dis-enrolled nationally, though the share of people who have been dis-enrolled varies across states. Differences in how states approached the unwinding and in the renewal policies and procedures they had in place contributed to the variation in state unwinding experiences.

#Patient, #Payer

Medicare Advantage Star Ratings proposal targets top performers

Medicare Advantage insurers that have earned high quality scores in the past stand to lose up to $19.5 billion over 10 years in bonus payments under a policy proposal on the books at the Centers for Medicare and Medicaid Services.

#Payer

Food and Drug Administration (FDA)

FDA gets pointed input on ‘optimizing’ advisory committee panels

FDA is inviting written and electronic comments on optimizing advisory committees to be submitted by Aug. 13. See also: Remarks by Dr. Califf and Dr. Bumpus at the FDA Public Meeting: Optimizing FDA’s Use of and Processes for Advisory Committees (June 13). A 2023 study in JAMA Health Forum found that between 2010 and 2021, the agency’s choices aligned with advisory committees 97% of the time when the experts voted in favor of the treatment. But when advisers voted down a treatment, regulators agreed only 67% of the time.

#Drug, #Device, #Patient

Considerations in Demonstrating Interchangeability With a Reference Product: Update

The U.S. Food and Drug Administration announced that biosimilars seeking an interchangeable status would no longer require studies showing switching between a biosimilar and its branded reference product does not present any potential safety risks or risk of diminished efficacy

#Drug, #Patient

FDA published report on public workshop to enhance clinical study diversity

The U.S. Food and Drug Administration is announcing the publication of a report on topics discussed at the 2-day virtual public workshop titled “Public Workshop to Enhance Clinical Study Diversity,” held November 29 and 30, 2023. FDA organized the workshop, in collaboration with the Clinical Trials Transformation Initiative, to discuss strategies to increase broader representation in clinical trials.

#Patient, #Device, #Drug

Health and Human Services (HHS)

Funding Instability Plagues Program That Brings Docs to Underserved Areas / Biden-Harris Administration Invests $11 Million to Expand Medical Residencies in Rural Communities

On Thursday, June 13, 2024, the U.S. Department of Health and Human Services (HHS), through the Health Resources and Services Administration (HRSA), awarded more than $11 million to 15 organizations to establish new residency programs in rural communities. Unlike funds for Medicare graduate medical education, funding must be appropriated by Congress.

#Provider

Hill Happenings

Chair Rodgers Unveils Framework for NIH Reform, Requests Stakeholder Input

House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA) unveiled a framework that lays out the current challenges facing the National Institutes of Health (NIH) and contains recommendations for reform.

#All

Uninsured rate to hit 8.9% by 2034, CBO projects

The uninsured rate is poised to climb over the coming decade, the Congressional Budget Office predicts in an article published in the journal Health Affairs Tuesday.

#All

CBO: Spending in the 340B Drug Pricing Program, 2010 to 2021

The Congressional Budget Office obtained data from the Health Resources and Service Administration to measure spending in the 340B Drug Pricing Program from 2010 to 2021 and look at factors associated with changes in spending over time. Those data measure spending in the 340B program by National Drug Code, by the type of facility where drugs were prescribed, and by whether drugs were distributed through a contract pharmacy. In the 340B Drug Pricing Program (340B), drug manufacturers sell drugs at discounted prices to participating hospitals and federal grantees. 340B facilities benefit from the program because the difference between the acquisition cost and the amount they are paid (often called the “spread”) is larger for drugs acquired through the 340B program.

#Drug, #Hospital

Notable Notes

Inside the Struggle to Improve Diversity, Equity, and Inclusion in Academic Medicine

Leaders in diversity, equity, and inclusion (DEI) at academic health centers reported several core challenges in their roles that have led to burnout and isolation, according to a qualitative study.

Key themes that emerged from interviews with 32 DEI leaders included variability in roles, responsibilities, and access to resources; a mismatch between institutional investments and directives; and a lack of evidence-based practices or standards to guide the work.

#All

National Health Expenditure Projections, 2023–32: Payer Trends Diverge As Pandemic-Related Policies Fade

Health care spending growth is expected to outpace that of the gross domestic product (GDP) during the coming decade, resulting in a health share of GDP that reaches 19.7 percent by 2032 (up from 17.3 percent in 2022).

#All

Like Doctors, More Nurse Practitioners Are Heading Into Specialty Care

Even though nearly 90 percent of nurse practitioners are certified to work in primary care, only about a third choose the field, according to a recent study.

#Provider

Trends in Private Equity Consolidation in Cardiovascular Care

Over one in 10 cardiology practices in several states — Rhode Island, Nevada, Louisiana, Arizona, Oklahoma, Texas, and Florida — have been acquired by private equity.

#Provider

Alternative Models of Nurse Staffing May Be Dangerous in High-Stakes Hospital Care

Reducing the proportion of RNs in hospitals, even when total nursing personnel hours are kept the same, is likely to result in significant avoidable patient deaths, re-admissions, longer lengths of stay, and decreased patient satisfaction, in addition to excess Medicare costs and forgone cost savings to hospitals.

#Provider, #Hospital, #Patient