Weekly Spotlight
They’re here!
The Fourth of July can be counted on for two things: fireworks, and Medicare payment rules, the defining documents that sort DC health policy folk into two camps. On one side, there are the Hill staffers and lobbyists who are trying to strategically plot a path through the appropriations quagmire to get to August recess. Then there are the regulatory staff whose year has just started.
And… since this is my soapbox, I’d like to take just one moment to speak to my friends the political fundraisers. Next month, before you hit send on that cheerful request for just one more check, you might want to re-think the “I hope you’re enjoying recess,” opener. Some of us are, in fact, up to our eyeballs in regs and have no idea what recess means other than traffic is better.
You might have had a chance to get a pleasant reply if there was something to look forward to in those pages, but if your target audience works for hospitals or providers, chances are they’re not finding a whole bunch to be happy about. In addition, this year’s hospital outpatient prospective payment system proposed rule comes in at a svelte 984 pages but the physician fee schedule is throwing haymakers and weighing in at 2248 pages.
Other Regulatory News
Centers for Medicare and Medicaid Services (CMS)
Physician Fee Schedule Proposed Rule
CMS published the annual physician fee schedule (PFS) proposed rule. The 60-day comment period ends September 9, 2024. Fact Sheet. According to the proposal, Medicare physician payments would decline 2.9% in 2025. The draft regulation provoked sharp criticism from the American Medical Association and other medical societies, which renewed their calls for Congress to take action. In addition, certain telehealth policies that existed prior to the COVID-19 public health emergency will go back into effect on January 1, 2025 unless Congress takes action.
#Provider, #Patient
Hospital Outpatient Prospective Payment System Proposed Rule
CMS published the Medicare hospital Outpatient Prospective Payment System (OPPS) proposed rule for calendar year 2025. Hospitals groups are pushing back against CMS’ proposed 2.6% pay bump for 2025, arguing that the increase is inadequate as a large portion of the nonprofit hospital sector continue to see operating margins in the red or hover above zero.
#Hospital
CMS To Codify How 340B, Drug Shortages Factor Into Medicare Inflation Rebate Policy
The Inflation Reduction Act of 2022 established new requirements under which drug companies must pay inflation rebates if they raise their prices for certain drugs faster than the rate of inflation. In this proposed rule, CMS is proposing to codify policies established in the revised guidance for the Medicare Prescription Drug Inflation Rebate Program that include, but are not limited to, the following:
- Establishing the method and potential data sources to remove 340B units from the total number of units used to calculate the total rebate amount for a Part D rebatable drug.
- Establishing the method and process for reconciliation of a rebate amount for Part B and Part D rebatable drugs, including the circumstances that may trigger such a reconciliation.
- Clarifying rebate calculations for Part B and Part D rebatable drugs in specific circumstances, including exclusion of Part B units of single-dose container or single-use package drugs subject to discarded drug refunds.
#Drug, #PATIENT
New Medicare Advantage star ratings give extra bonuses to multiple insurers but Medicare Advantage marketing ruling leaves 2025 enrollment in flux
More than two dozen Medicare Advantage insurers received higher quality marks for 2024, based on a STAT review of new data released July 2 by the federal government. Meanwhile a legal victory for Medicare Advantage insurers and marketers ironically may cause some headaches when open enrollment for 2025 rolls around. Last week, the U.S. District Court for the Northern District of Texas ordered a stay against a CMS regulation that prohibits insurers from offering volume-based bonuses to top Medicare Advantage marketers, thereby suspending the regulation’s cap on broker fees.
#PAYER, #PatienT
Food and Drug Administration (FDA)
Addressing Misinformation About Medical Devices and Prescription Drugs Questions and Answers Guidance for Industry
Draft recommendations from FDA aim to help patients and their health care providers avoid making medical decisions based on faulty information. Specifically, the agency wants companies to feel comfortable communicating online when false or inaccurate information about their products is decimated on social media.
#Drug, #Device
Health and Human Services (HHS)
HHS Releases Proposed Interoperability, Health Data Rule
HHS’ Office of the National Coordinator for Health Information Technology released a proposed rule that would advance interoperability among providers, patients and payers.
#All
Biden administration ignores calls to bolster hospital price transparency
The federal government will not modify regulations that dictate how hospitals publish their prices for consumers, ignoring pleas from patient advocates who have said hospitals still are not fully complying with the 3-year-old law.
#Hospital
Hill Happenings
Drugmakers are losing crucial friends on Capitol Hill
Six key pharma-friendly lawmakers who were in office when Democrats passed a historic drug pricing reform law will likely have left Capitol Hill by the beginning of 2025. They have 160 combined years of service in Congress, and will take that century and a half of knowledge about legislating on complex health care issues with them.
#Drug
Coalition To Senate Finance: Mark Up SITE Act To Address Rising Health Care Costs, Hospital Consolidation
A group of thought leaders, patient advocates, employers, and health care providers, sent a letter to Senate Finance Committee Chairman Ron Wyden (D-OR) and Ranking Member Mike Crapo (R-ID) urging action on the Site-based Invoicing and Transparency Enhancement (SITE) Act.
#Hospital
Can the National Institutes of Health navigate multiple storms and rebuild its bipartisan support?
The NIH faces unprecedented skepticism from the Hill, as reported by Stat news.
#All
Notable Notes
From Dr. Oz to Heart Valves: A Tiny Device Charted a Contentious Path Through the FDA
In 2013, the FDA approved an implantable device to treat leaky heart valves. Among its inventors was Mehmet Oz, the former television personality and former U.S. Senate candidate widely known as “Dr. Oz.” But since MitraClip won FDA approval, versions of the device have been the subject of thousands of reports to the agency about malfunctions or patient injuries, as well as more than 1,100 reports of patient deaths, FDA records show.
#Device
Opinion: Adaptive trial designs will increase clinical trial speed, safety, and effectiveness
Health care is undergoing an important and well-needed shift from a one-size-fits-all approach to more personalized, precise, patient-focused care. A similar approach needs to be implemented at scale for clinical trials.
#Drug, #Device
Biopharma layoffs are leaving the industry’s scientists reeling — and in search of scarce opportunities
Biopharma layoffs have been higher over the past couple of years than during the industry’s boom times during the Covid-19 pandemic. About 67% of life science employees laid off during the first half of 2024 were at biopharma companies with more than $1 billion in annual sales, according to data the Biotechnology Innovation Organization shared with STAT.
#Drug
AbbVie dramatically outspent its pharma company rivals in 2023 to promote its drugs to doctors
AbbVie paid health care providers roughly $145.7 million last year to promote its drugs, according to a STAT analysis of newly released government data.
#Drug
Report shows U.S. biotechs are wary of Chinese partnerships due to looming BIOSECURE Act
Looming anti-China biotechnology bill has spooked U.S. life sciences companies, according to a report by L.E.K. Consulting.
#Drug
Biden administration appeals jury finding in battle over patents for HIV prevention pills
The Biden administration has appealed a decision in which a federal court jury last year sided with Gilead Sciences over the rights to a pair of groundbreaking HIV pills.
#Drug, #Patient
Opinion: Private equity and neuroscience: a novel approach to developing new treatments for neurological disorders
One emerging approach that is rapidly gaining traction is a private equity model for neurotherapeutics based on a four-step process — search, evaluate, invest, develop. This strategy is being embraced by companies such as Neurvati Neurosciences, and several private equity and venture capital firms.
#Drug, #Patient
Expand community-based research to make clinical trials more diverse
Innovations in clinical trial designs and tools have the potential to unlock a new era of research that is more convenient for patients, more reflective of real-world treatment conditions, and more likely to enable participation of a diverse set of individuals. But a recent study reveals how far the U.S. is from realizing this potential: regions of the country with the worst social drivers of health are the least likely to host clinical trials.
#Patient, #Drug, #Device
FTC plans to sue PBMs over the high cost of insulin and other medicines
After publishing a scathing report, the Federal Trade Commission announced plans to sue the three largest pharmacy benefit managers over their negotiating tactics for various medicines, including insulin, that pushed patients toward higher-priced treatments, according to a source familiar with the matter.
This development has placed renewed focus smaller PBMs. Companies such as AffirmedRx, Liviniti, MedOne Pharmacy Benefit Solutions, Navitus Health Solutions, RxPreferred Benefits and SmithRx are employing a twofold strategy. Part one pitches potential customers on a more transparent business model. Part two is lobbying Congress to pass legislation that would rein in CVS Health subsidiary CVS Caremark, UnitedHealth Group subsidiary OptumRx and Cigna subsidiary Express Scripts and open the PBM business to more competition.
For more, watch, “Behind the Counter,” an in-depth video series demystifying the complex world of patents and drug pricing.
#Patient, #Payer, #Drug
Sex, Age, and Patient Experience in Cardiologist Reviews: A Large-Scale Artificial Intelligence-Enabled Analysis
Female cardiologists and older cardiologists tended to get lower average online ratings relative to their peers.
#Provider, #Patient
Procedural Volume and Outcomes with Atrial Fibrillation Ablation: A Report from the NCDR AFib Ablation Registry
The success and outcomes of atrial fibrillation (Afib) ablation were linked to hospital and operator procedure volumes.
#Provider, #Patient
In Constant Battle With Insurers, Doctors Reach A.I.
As health plans increasingly rely on technology to deny treatment, physicians are fighting back with chatbots that synthesize research and make the case.
#Provider, #Payer, #PATIENT
The Department of Commerce’s Bureau of Industry and Security (BIS) to Investigate U.S. Pharmaceutical Supply Chain
The Commerce Department’s Bureau of Industry and Security will conduct a “comprehensive assessment” of the active pharmaceutical ingredient (API) industrial base to “inform a strategy aimed at securing the API supply chain,
#Drug
