Regulatory Update – Week of July 15, 2024

Introduction
This week, Congress is out but everyone else seems to be in!

Weekly Spotlight

Stay tuned for more detailed analysis of the physician payment rules. Today we’re taking a moment to return volley on original reporting from John Wilkerson at STAT on how “The effort to reform physician pay is set to pit primary care docs against highly paid specialists.” In the article, Wilkerson quotes intrepid startup blogger “Courtney Savage, founder of Savage Health Policy.” For more information and less self promotion, head on over to STAT!

#Provider

Other Regulatory News

Centers for Medicare and Medicaid Services (CMS)

MedPAC releases 2024 Data Book

MedPAC Data Book on health care spending and the Medicare program

#All

Here come Medicare’s first negotiated drug prices

CMS is due to publish the negotiated price list on September 1 but rumors suggest the timing may run a bit closer to the democratic convention.

#Drug, #Patient

AHA urges CMS to reconsider proposed organ transplant access model

The American Hospital Association is urging CMS not to implement a proposed mandatory payment model meant to increase access to organ transplants, saying it is constructed in a way that may exacerbate inequalities and add “unnecessary disruption” to the transplant ecosystem.

#Hospital

CMS Releases Final Part Two Guidance to Help People with Medicare Prescription Drug Coverage Manage Prescription Drug Costs

CMS is releasing the final part two guidance regarding plan outreach and education for the Medicare Prescription Payment Plan, which aims to ensure that people with Medicare prescription drug coverage are aware of the payment option. Starting in 2025, the Medicare Prescription Payment Plan provides the option to people with Medicare prescription drug coverage to spread the costs of their prescription drugs over the calendar year rather than paying in full at the pharmacy counter each time they fill a prescription

#Patient, #Drug

Maternal health providers are wary of CMS’ obstetric proposals

Maternal health advocates say CMS’ standards could lay out a starting point for improvement, but providers are worried the agency’s focus on quality collaboratives could lead to a set of standards that are far from uniform.

#Patient, Provider

CMS DINGS AETNA FOR SURPRISE BILLING MISTAKES

CMS released an audit Aetna’s compliance with the No Surprises Act.

#Payer, Provider, Patient

CMS floats proposals to boost Medicare ACOs

The Medicare pay cut looming for doctors next year comes with a sweetener for providers that participate in Medicare Shared Savings Program accountable care organizations.

#Provider

Opinion: Why Has Medicare’s Innovation Center Failed?

Opinion from Chris Pope, a senior fellow at the Manhattan Institute

#Provider

Food and Drug Administration (FDA)

CDRH Announces Reorganization of Several Offices to Increase Organizational Agility and Advance Public Health Mission

CDRH announced new organizational changes to “help strengthen and better position the Center to protect and promote the public health.”

#Device

Health and Human Services (HHS)

New Report: Is Everything Health Care? Evaluating Social Determinants of Health (SDOH)

According to a new report from the Manhattan Institute, the Biden administration’s recently published The U.S. Playbook to Address Social Determinants of Health cites extensive research to argue that increasing public spending on housing, education, food, and neighborhood environments will often pay for itself by reducing health care costs. These non-medical factors are called social determinants of health (SDOH), but the bulk of SDOH research is substandard and does not appropriately disentangle causation from correlation.

#All

Hospitals eye graduate medical education in post-Chevron lawsuit

Hospitals belonging to the UNC Health, UChicago Medicine and Yale New Haven Health systems sued Health and Human Services Secretary Xavier Becerra, alleging the federal government underpaid hospitals for graduate medical education under an allegedly flawed reimbursement calculation.

#Provider

Hill Happenings

A Senate bill was touted as a cure for ‘patent thickets.’ Some say the drug industry watered it down

A bill to restrict two pharmaceutical manufacturer market tactics is drawing attention. The goal of the legislation was to make it more difficult for brand-name companies to assert rights to countless patents on a medicine in order to delay competition from lower-cost generic versions of their medicines.

#Drug

Notable Notes

Chevron Healthcare Roundup

Republicans who support the PBM bills and cheered the Supreme Court rulings see the FTC’s recent actions as another reason for Congress to step in — especially since the Supreme Court just made it harder for agencies like the FTC to follow their own paths.

#All

Modern Healthcare explores Chevron healthcare implications.

#All

McDermott+ analysis tackles what comes next post-Chevron

#All

Cardiology News

Taking a page from the physics of bird flight, researchers are trying to develop a passive flow-controlled, self-cleaning TAVR valve to inhibit valve thrombosis and improve valve performance

#Device, #Patient

Researchers made a case for failure to rescue (FTR) as a potential quality metric in percutaneous coronary intervention (PCI), using records from a large nationwide registry.

#Provider

After getting a transvenous implantable cardioverter-defibrillator, patients were several times more likely to develop tricuspid regurgitation than those who got a subcutaneous device, according to post hoc analysis of a randomized trial.

#Patient

Most early-career cardiologists received some industry payments — those in procedural subspecialties got a median $1,801 in their last year of fellowship and $1,112 annually after a few years out of training.

#Provider

Cancer News

Donald Trump promised cures for cancer and other diseases when he accepted his party’s presidential nomination Thursday night at the Republican National Convention in Milwaukee.

#Patient, #Drug, #Device

A cancer care navigation startup has raised $95 million from prominent tech investors to help payers and providers spend less on cancer patients while improving their health — including by doling out incentive payments to providers and keeping a cut of insurers’ savings.

#Patient, #Payer, #Provider

Healthcare Workforce

Increased salary stipends and/or housing stipends were the most concretely identified benefits of unionization of residency programs. However, unintended consequences of unionization were the irrelevance of certain negotiated benefits, paradoxical losses of surgery department-provided benefits, and framing of resident-faculty relationships as adversarial.

#Provider

Since the Federal Trade Commission proposed the noncompete ban, some physicians have refused to sign employment contracts that include those clauses.

#Provider

Microsoft global outage forces health systems to cancel appointments, delay procedures

On Thursday, a widespread outage to Microsoft systems took down computers in health systems around the globe, leading many to cancel non-urgent medical appointments and surgeries as they encouraged patients to make plans for disrupted travel and delays in care.

#All

Why Covid is surging this summer — and what health experts say has changed

Even as SARS-CoV-2 has joined the ranks of the respiratory viruses that will continue circulating and causing infections, a spike in cases like this summer’s still causes disruptions in people’s lives — as well as some confusion over issues like tracking down tests, the best time to get vaccine boosters, and the latest advice on managing the infection.

#All

IRBs fail to assess trials’ scientific merit, putting participants at risk

IRBs are supposed to protect trial participants’ interests by assessing a trial’s scientific merit, as described in the trial’s protocol. However, according to a recent study, many IRBs routinely ignore the legal requirement to assess scientific merit, giving clinical trials a stamp of ethical approval without this essential assessment.

#All

Novel Program Helps People With HIV Manage Chronic Pain

A novel behavioral pain management program reduced pain severity and pain-related functional interference in people living with HIV, according to a randomized clinical trial. The Skills to Manage Pain (STOMP) program was associated with a mean difference of -1.25 in the Brief Pain Inventory (BPI) total score (scale of 0-10) when compared with enhanced usual care (P<0.001),

#Patient

Urban Institute Tool Shows Impact of New Rules on Medical Debt

Starting in 2022, the three nationwide credit reporting companies made significant changes to medical debt reporting. These changes helped cut the number of Americans with medical debt in collections in half and improve credit scores. But, 15 million Americans still have medical debt in collections, and most debt balances remain on credit reports.

#Patient

Commonwealth Fund 2024 State Scorecard on Women’s Health and Reproductive Care

Deaths from preventable causes are on the rise and deep inequities persist, leading to stark racial differences in maternal mortality and deaths from breast and cervical cancers. Despite a small rebound in women’s life expectancy in 2022, it remains at its lowest since 2006.1

#Patient

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