Weekly Spotlight
PHEW! After this week, you’ll forgive us for taking a pause next week to collect ourselves. The next Digest will be published on July 12 for the week of July 8th (and anything pressing from the previous week). Meanwhile, we’ll be keeping an eye out for the annual CMS surprise PFS and/or IPPS mic drop on July 3.
Have a safe and Happy 4th!
Other Regulatory News
Centers for Medicare and Medicaid Services (CMS)
Medicare Advantage – 2023 Loss Ratio Analysis
There was a lot of hand-wringing from Medicare Advantage insurers that their customers were getting loads of care in 2023. But their medical loss ratios (a percentage showing how much of their government-funded premiums insurers paid to hospitals, doctors, and other providers) show that last year was actually pretty comparable to 2021.
#All
Health Groups Have High Hopes for the Latest Prior Authorization Bill
Medical groups are optimistic that a recently reintroduced bill to rein in prior authorization has a better chance of passage now than it did last time around. “We believe the bill is poised for adoption this year,” Katie Orrico, JD, CEO of the American Association of Neurological Surgeons, said in an email to MedPage Today.
#All
The IRA could lead to higher out-of-pocket costs for 3.5 million Medicare patients in 2026
A new analysis from Milliman (and funded by PhRMA) finds the IRA’s drug pricing provisions could undermine the benefits of the new out-of-pocket limit for millions of seniors and people with disabilities. As a direct result of these provisions, 3.5 million Part D patients taking a medicine subject to an MFP could see higher out-of-pocket costs in 2026.
#Drug, #Patient
The Biden administration will impose inflation penalties on 64 prescription drugs for the third quarter of this yea
A provision of the Inflation Reduction Act requires drugmakers to pay rebates to Medicare if they hike the price of a medication faster than the rate of inflation. Some patients will pay a lower coinsurance rate for the 64 drugs covered under Wednesday’s announcement, which fall under Medicare Part B, for the period from July 1 to Sept. 30. Some Medicare Part B patients may save as much as $4,593 per day if they use those drugs during the quarter.
#Drug
Telemedicine has become a lifeline for rural America—will it last?
Providers in rural and under-served areas that have come to rely on telehealth are lobbying hard to keep what they see as a must-have for their organizations.
#Hospital, #Provider, #Patient
PrEP for HIV National Coverage Determination Technical Frequently Asked Questions for Pharmacies
The Centers for Medicare & Medicaid Services (CMS) released a Technical Frequently Asked Questions for Pharmacies regarding the Preexposure Prophylaxis (PrEP) Using Antiretroviral Drugs to Prevent HIV National Coverage Determination (NCD) expected to be made public and effective in late September 2024.
#Patient, #Provider, #Payer, #Drug
Food and Drug Administration (FDA)
How Kaiser is tracking risky medical devices
Tracking how well medical devices work when they are inside of people is notoriously tricky because the government and health insurance companies do not require providers to put a device’s identification number on insurance claims. But Kaiser Permanente has run its own device registry for years, and it has learned important lessons, my colleague Lizzy Lawrence reports
#Device
FDA issues draft guidance on clinical trial diversity plans
The FDA has put out long-awaited draft guidance aimed at getting drug companies and device makers to enroll more people of color and women in clinical trials. It’s the first step in carrying out a law that requires companies to submit plans to the FDA on how they will enroll participants who are representative of the relevant patient population. The public now has three months to provide feedback on the draft before the agency finalizes the guidance
#Drug, #Device, #Patient
Health and Human Services (HHS)
Mounting state lawsuits oppose gender nondiscrimination rule
Lawsuits in 18 states could upend a federal nondiscrimination rule scheduled to take effect early next month and designed to protect healthcare services for LGBTQ+ patients.
#All
Appeals court does not block US mandate to cover cancer screenings, HIV drugs
A U.S. appeals court on Friday refused to block a federal mandate requiring health insurers to cover preventive care services like cancer screenings and HIV-preventing medication at no extra cost to patients, but ruled against the government on a key legal issue that leaves the mandate’s future in doubt.
#All
States build momentum to protect 340B drug discounts – for now
Drug manufacturers are rolling back their limitations on 340B drug discounts as more states pass laws aimed at making the program’s benefits more accessible.
#Drug, #Hospital
Federal budget constraints may hurt older Americans with HIV
Researchers say that by the end of the decade, 70 percent of people in the United States living with HIV will be older than 50. Thanks to advances in medicine, the diagnosis is no longer a death sentence. But there’s a catch: People living with HIV are at increased risk for other health problems, such as diabetes, depression and heart disease. As their health needs increase, more is required of the Ryan White HIV/AIDS Program, the comprehensive federal system that provides HIV primary medical care, medications and essential support services for low-income people living with the virus.
#Patient
HHS finalizes ban on EHR ‘information blocking’
Providers found to have knowingly blocked other parties from accessing electronic health records data will suffer Medicare pay penalties under a new regulation.
#Provider
Hill Happenings
Reps. Nadler, Chu & Sen. Warren Lead Bicameral Letter to CMS Urging Oversight of Artificial Intelligence and Algorithms Used in Medicare Advantage Coverage Decisions
Reps. Jerrold Nadler (NY-12), Judy Chu (CA-28), and Sen. Elizabeth Warren (MA) led 45 House Members and 4 Senators in a bicameral, bipartisan letter this week urging the Centers for Medicare and Medicaid Services (CMS) to increase oversight of artificial intelligence (AI) and algorithmic software tools used to guide coverage decisions in Medicare Advantage (MA) plans.
Meanwhile, Humata, a private authorization startup reported $25M in funding. Humata primarily serves providers with a tool that aims to expedite prior authorization approvals. The company said in a release it plans to use the funding to broaden the scope of its generative artificial intelligence technologies and expand its customer base to include more payers.
#All
CMS Needs to Do a Better Job With Value-Based Care, Experts Tell House Panel
Value-based care — in which medical practices are paid based on the value of their care, not on volume — is a good idea but the Centers for Medicare & Medicaid Services (CMS) need to improve its implementation, doctors and a healthcare executive told members of the House Ways & Means Health Subcommittee.
#Provider, #Patient, #Hospital, #Payer
House panel passes bills to expand breakthrough device and Medicare obesity drug coverage, cancer screening
A House committee overwhelmingly passed four bills on Thursday that would expand Medicare coverage of obesity drugs and cancer screening blood tests and place guardrails around Medicare’s discretion in covering drugs and devices approved by the Food and Drug Administration.The committee also voted on a bill concerning Medicare coverage of innovative medical devices. Device makers have complained for years about the gap between approval from the Food and Drug Administration and securing coverage from CMS, which typically leads the way for private insurers.
Meanwhile, shares of Grail, the liquid biopsy company that hopes that its test, Galleri, will be widely used to screen for cancer, became a publicly traded stock (with the ticker GRAL) that any investor can buy or sell on the Nasdaq.
#DEVICE, #DRUG, #PATIENT, #PROVIDER, #PAYER
AMA offers MACRA reforms in response to Senate Finance Committee white paper
AMA has published its response to the May 17 white paper from Chairman Wyden and Ranking Member Crapo of the Senate Finance Committee on the Medicare Physician Fee Schedule and its impact on chronic care management.
#PROVIDER
Notable Notes
The ACA preventive care 5th Circuit ruling, explained
The legal mandate for no-cost health insurance coverage of preventive medicine took a bruising in federal court last week but is still alive — for now. The U.S. Court of Appeals for the 5th Circuit issued a narrow ruling last week weakening the provisions of the Affordable Care Act of 2010 that eliminated cost-sharing for screenings, vaccinations, contraception and other services. For now, it applies only to the employers that brought the case in 2021. Everyone else will carry on as before. But further legal activity is coming, and it could lead to sweeping results that diminish health insurance coverage of services such as birth control, cancer testing and pre-exposure prophylaxis against HIV, known as PrEP.
#PATIENT, #PAYER
Supreme Court undercuts regulators’ authority across government
Federal agencies’ longtime authority to regulate industries was significantly weakened by a Supreme Court decision on Friday. The 6-3 decision, though it stems from cases on fishing regulations, will ripple across government agencies that have broadly interpreted the powers handed to them by Congress since a 1984 decision known as Chevron. The ruling could open the door to lawsuits challenging regulations across the government, including from pharma companies, hospitals, and insurers.
#All
When Hospital Prices Go Up, Local Economies Take a Hit
Companies lay off workers to make up for health-insurance costs after hospitals raise prices, research finds.
#All
Progress on health disparities is slow after 20 years: report
The National Academies of Sciences Engineering and Medicine on Wednesday said law and policy changes aimed at eliminating health disparities have made slow and uneven progress improving racial inequities over the past 20 years. The Ending Unequal Treatment report found that people of color in 2024 are still disproportionately uninsured, under-utilizing care services and underrepresented in the healthcare workforce.
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Biden and Trump spar over Medicare and abortion in a presidential debate filled with mistakes and falsehoods
For the most part, substantive debates on health policy between President Biden and former President Trump were overshadowed by mistakes, errors, and blatant falsehoods in Thursday night’s presidential debate.
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The Opaque Industry Secretly Inflating Prices for Prescription Drugs
Pharmacy benefit managers are driving up drug costs for millions of people, employers and the government.
#All
More Than 1 in 4 Seniors Have Asymptomatic Valve Disease in UK Sample
Undiagnosed heart valve disease was highly prevalent in a large community study of otherwise healthy people recruited from primary care in the U.K., researchers found. There was a 28.2% prevalence of mild, moderate, or severe asymptomatic valvular heart disease in older people with no previously known heart disease and no prior indication for echocardiography.
#Patient, #Provider, #Device, #Hospital, #Payer
Insurers bet on new type of job-based health benefits
Health insurance companies hungry for a piece of the large and lucrative employer health plan market see a recently created exchanges-based product as their way in.
#Payer
Travel nursing demand declines, staffing agencies pivot
Employment firms, which quickly pivoted to create a marketplace for temporary clinical help amid pandemic-related staffing shortages, benefited from the lucrative hourly rates commanded by travel nurses — wages begrudgingly accepted by hospitals. Now, however, employers are reducing their budgets for travel staff and spending more to recruit and retain permanent employees, which in turn is lowering demand and pay rates for contract workers.
#Provider, #Hospital, #Patient
Baylor St. Luke’s to pay $15M to settle concurrent heart surgery allegations
Houston-based Baylor St. Luke’s Medical Center, Baylor College of Medicine and Surgical Associates of Texas have jointly agreed to pay $15 million to resolve claims they billed for concurrent heart surgeries that violated CMS teaching physician and informed consent regulations.
#Provider, #Patient
A key tool that businesses have counted on to keep a lid on employee drug spending — filling prescriptions by mail — is now driving up their costs
Drugs delivered by mail are costing multiples more than those picked up at a store counter. Markups were as much as 35 times higher than what other pharmacies charged, according to a recent analysis of millions of prescriptions in Washington state.
#Patient, #Payer, #Provider, #Drug
Ateev Mehrotra, the researcher the telehealth lobby loves to hate, isn’t backing down
As telehealth lobbyists seize on this moment years after pandemic lockdowns to win new protections and incentives from Capitol Hill, Ateev Mehrotra, the industry’s chief critic, is determined to warn congressional committees that the booming virtual care business comes with tradeoffs.
#All
Duke-Margolis to Host 2024 State of Real-World Evidence Policy
The event on Thursday, July 25 will feature a full discussion on the latest developments in real-world data and real-world evidence (RWD/E) policy. A draft agenda is now available on the event webpage and contains more details about key discussion topics
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