From Washington, DC

• STAT News tells us,
  • “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.
  • “[By a 36-4 bipartisan vote],the House Ways & Means Committee passed obesity drug coverage legislation that would offer a limited pathway for adults 65 and older to get their weight loss drugs paid for by Medicare. Right now, Medicare is prohibited from covering medications used for weight loss, like Wegovy and Zepbound. 
  • “However, the new plan is significantly more restrictive than prior proposals. It’s primarily targeted at making sure that people currently taking weight loss drugs don’t get kicked off when they enter the Medicare program, such as by turning 65.” * * *
  • “Another bill that gained even more support would expand Medicare coverage of cancer screening. The legislation passed on a 38-0 vote. 
  • “Medicare is allowed to pay for FDA-approved tests that diagnose diseases, but it doesn’t cover tests that simply screen healthy people for cancer. The bill would open the door for Medicare to pay for cancer screening tests, including Grail’s Galleri.” 

• MedPage Today informs us,
  • “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.
  • “I am a proponent of the need to move to value-based care, improving quality while decreasing wasteful spending and ensuring access,” Robert Berenson, MD, an institute fellow at the Urban Institute in Washington, D.C., said at Wednesday’s subcommittee hearing on improving value-based care for patients and providers. “However, I believe that value-based payment as a mechanism to promote better care delivery has gotten off track and needs a thorough reevaluation and reformulation.”

• Fierce Pharma relates,
  • “Leading health legislators say they are focused on reducing prescription drug prices while minimizing unintended consequences of the Inflation Reduction Act (IRA).
  • “House Rep. Scott Peters, D-California, and Rep. Mariannette Miller-Meeks, R-Iowa, shared their priorities during a program put on by The Hill and the Alliance for Aging Research.
  • “Peters stressed that the drug manufacturing industry needs to stay in the U.S., unlike how the country let chip manufacturing business slip away and go offshore. He also wants lawmakers to budget healthcare expenditures differently.
  • “Innovation might cost more money upfront, even if it saves money down the line,” he said. “In the Budget Committee, which I also serve on, we’re talking about how to think about balancing the budget over time. If we don’t think about the future costs of all these diseases, as part of that calculation, I think we’re going to miss the mark.”

• Per CMS fact sheets,
  • On June 26, 2024, the Centers for Medicare & Medicaid Services (CMS) issued the Calendar Year (CY) 2025 Home Health Prospective Payment System (HH PPS) proposed rule, which would update Medicare payment policies and rates for Home Health Agencies (HHAs). These changes can support timely admission to home health services, which has demonstrated improvements for patient outcomes and reducing risk of hospital readmissions. 
• and
  • “On June 27, 2024, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule to update payment rates and policies and includes requests for information under the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) for renal dialysis services furnished to Medicare beneficiaries on or after January 1, 2025.
  • “For CY 2025, CMS is proposing to increase the ESRD PPS base rate to $273.20, which would increase total payments to all ESRD facilities, both freestanding and hospital-based, by approximately 2.2%.”

• HHS’s Office for Civil Rights announced,
  • “At the HHS Office for Civil Rights, we believe patient privacy is essential to ensuring high quality reproductive health care. HHS OCR is encouraging HIPAA covered entities and business associates to begin implementing the new HIPAA Privacy Rule to Support Reproductive Health Care Privacy to help protect patient privacy and ensure compliance later this year. To aid in this, we have compiled resources for both community members and HIPAA Covered Entities or Business Associates. 
    • “For resources to help communicate with stakeholders and community members click here.
    • “For a fact sheet summary of the rule click here (en español).
    • “To hear directly about the rule from Director Melanie Fontes Rainer click here (en español).
    • “To view a recorded briefing by Deputy Director for Health Information Privacy, Data and Cybersecurity Timothy Noonan click here.
    • “For a model attestation for a requested use or disclosure of protected health information potentially related to reproductive health care click here.
  • “The effective date of the Final Rule was June 25, 2024. This is the date that HIPAA covered entities and their business associates may begin implementing the new requirements. Covered entities and business associates are not required to comply with the new requirements until December 23, 2024, except for the new changes to the HIPAA Notice of Privacy Practices which has a compliance date of by February 16, 2026.”

• Healthcare Dive lets us know,
  • “The U.S. Supreme Court ruled 6-3 on Thursday to allow Idaho doctors to perform abortions to stabilize a patient’s life and health. 
  • “However, the court declined to take up the fundamental legal question underlying the case: whether a federal law mandating hospitals provide medical services during emergencies [known as EMTALA] supersedes near-total state abortion bans.
  • “It is the court’s first ruling on statewide abortion restrictions since Roe v. Wade was overturned in 2022, ending the constitutional right to abortion in the United States.”

• CMS observed,
  • “CMS’ first responsibility is to the people we serve, including anyone who steps into the emergency department of a Medicare-participating hospital. If any individual believes their EMTALA rights have been violated, they should continue to report the circumstances to CMS or their state survey agency. To the maximum extent permitted by law, we will continue to investigate complaints and hold hospitals accountable to provide the emergency stabilizing treatment that EMTALA has required for decades.”

• The Wall Street Journal reports,
  • “The Supreme Court rejected a bankruptcy plan for OxyContin-maker Purdue Pharma that would have allocated billions of dollars from members of the wealthy Sackler family to combat opioid addiction in exchange for shielding them from civil lawsuits over their alleged role in fueling the drug epidemic.
  • “The 5-4 decision marks a victory for the minority of opioid victims who voted to reject the settlement plan because they want to continue pressing lawsuits against the Sackler family members who own Purdue, and a loss for the majority of opioid victims and state and local governments who voted to accept it.”
  • “The high court said U.S. bankruptcy law doesn’t allow for a release of the Sacklers’ legal liabilities stemming from their ownership of Purdue when not all opioid-related plaintiffs have accepted the terms offered by the company’s family owners, whose wealth has been estimated at $11 billion.” * * *
  • “Thursday’s ruling—among the highest-profile bankruptcy decisions ever from the high court—weakens the ability of corporations and their insiders to use bankruptcy to resolve mass litigation alleging they harmed consumers. 
  • “The Sacklers didn’t file for bankruptcy themselves and didn’t agree to place “anything approaching their full assets on the table” for distribution to opioid victims, [Justice Gorsuch] wrote [for the Court’s majority]. “Yet they seek a judicial order that would extinguish virtually all claims against them for fraud, willful injury, and even wrongful death, all without the consent of those who have brought and seek to bring such claims,” he wrote. 
  • “Nothing in U.S. bankruptcy law authorizes that outcome, [Justice] Gorsuch said.

• Fierce Pharma adds,
  • “The Supreme Court decision sends the case back to bankruptcy court for future deliberations, according to a statement from Connecticut Attorney General William Tong.”

From the public health and medical research front,

• The New York Times reports,
  • “All Americans ages 6 months and older should receive one of the new Covid-19 vaccines when they become available this fall, the Centers for Disease Control and Prevention said on Thursday.
  • “The recommendation comes as the nation faces a summer wave of Covid, with the number of infections rising in at least 39 states and territories.
  • “Most Americans have acquired immunity against the coronavirus from repeat infections or vaccine doses, or both. The vaccines now offer an incremental boost, remaining effective for only a few months as immunity wanes and the virus continues to evolve.
  • “Still, across every age group, a vast majority of Americans who were hospitalized for Covid did not receive one of the shots offered last fall, according to data presented at a meeting on Thursday of the C.D.C.’s Advisory Committee on Immunization Practices.
  • “Dr. Mandy Cohen, the agency’s director, accepted the unanimous advice of the panel on Thursday to recommend another round of immunizations.”

• The NIH Director writes in her blog,
  • “Cancer arises when changes in genes that normally control cell division lead to unchecked growth at the expense of healthy tissues. One of the most common genetic alterations across human cancers—occurring in 95% of pancreatic cancers but also many non-small cell lung cancers, colorectal cancers, and others—is in a gene known as KRAS. While promising new treatments targeting KRAS to shrink cancerous tumors have recently gained approval, less than 40% of pancreatic cancers respond to treatment with KRAS inhibitors for reasons that aren’t well understood.
  • “There’s much more to learn about how KRAS spurs cancer growth—and how KRAS-mutant cancers resist treatment with existing KRAS inhibitors. To address this need, researchers behind two studies in Science have established the most comprehensive molecular portrait yet of the workings of KRAS and how its many downstream impacts may influence outcomes for people with pancreatic cancer. The findings could lead to new treatment approaches, including ways to potentially guide treatment for individuals with pancreatic cancer, the third leading cause of cancer-related death in the U.S.
  • “These studies, supported in part by NIH, come from a team led by Channing Der  and Adrienne Cox, together with Jeffrey Klomp, Clint Stalnecker, and Jennifer Klomp, at the Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill. The researchers were inspired in part by the Food and Drug Administration’s recent approval of treatments that block a mutated version of KRAS that drives many pancreatic cancers. The team was also motivated by the realization that many patients whose cancers initially respond to the new treatments relapse rather quickly as the cancers find ways to reactivate underlying growth pathways.” * * *
  • “Importantly, the researchers found that the molecular signatures they’ve uncovered may predict tumor responses in patients treated with KRAS inhibitors or ERK inhibitors. Based on their findings, they suspect that the reason so many pancreatic cancers don’t respond to KRAS inhibitors may be because the drugs simply don’t block KRAS well enough—and not because the cancers no longer depend on KRAS signals for their growth. The researchers suggest it may be beneficial to monitor these underlying molecular pathways in patients to better understand treatment outcomes and guide treatment decisions.
  • “The team plans to continue exploring the role of these and other important drivers of cancer growth and treatment resistance. Ultimately, their goal is to help advance the development of the next generation of KRAS inhibitors that will work even better for many more people with pancreatic or other KRAS-driven cancers.”

• Health Day notes,
  • “A full third of American adults take multivitamins, despite prior studies suggesting they do little to boost health.
  • “Now, a study involving almost 400,000 people finds zero benefit from multivitamin use in helping folks live longer.
  • “Among people “without a history of major chronic diseases, we did not find evidence to support improved longevity among healthy adults who regularly take multivitamins,” concluded a team led by Erikka Loftfield. She’s with the Division of Cancer Epidemiology and Genetics at the U.S. National Cancer Institute (NCI).
  • “Her team published its findings June 26 in the journal JAMA Network Open.

• Healio calls to our attention a study finding
  • “Alcohol intake of more than 12 g per day was associated with increased risk for hypertension.
  • “Hypertension risk plateaued at higher levels of alcohol intake for men, but risk continued to rise for women.”

• STAT News offers a detailed article titled “By the numbers: America’s alcohol-related health problems are rising fast.”

From the U.S. healthcare business front,

• Per Healthcare Dive,
  • “Walgreens is pulling back its focus on healthcare services after the strategic shift failed to bolster the struggling retailer’s financial health.
  • “Walgreens plans to reduce its stake in value-based medical chain VillageMD, and will no longer be the company’s majority owner, CEO Tim Wentworth told investors on a Thursday morning call after announcing third quarter earnings below analyst expectations.
  • “Walgreens also plans to close a “significant portion” of its roughly 8,700 stores in the U.S., Wentworth said. The company didn’t share a specific figure, but said it is reviewing one-quarter of its stores that are underperforming financially. Walgreens has already closed hundreds of stores over the past few years.” * * *
  • “Walgreens plans to launch a retail pharmacy action plan to improve customer experience in its stores, better align its pharmacy and healthcare businesses and focus on reliable products in areas like women’s health, Wentworth said.
  • “The company is also in discussions with health insurers and pharmacy benefit managers to change how its pharmacies are paid, to create more stability in a challenging reimbursement environment.”

• Modern Healthcare reports,
  • “At-home emergency care is gaining momentum — and could cost millions less — but reimbursement challenges create an access barrier for some patients.
  • “Deploying healthcare in patients’ homes gained traction during the COVID-19 pandemic as a way to ease overcrowding at hospitals and prevent the virus from spreading. Emergency department care at home lets patients bypass the waiting room through referrals from hospitals or primary care providers if they determine patients do not have life-threatening illnesses or injuries. While many private insurers reimburse for such care, traditional fee-for-service Medicare and Medicaid do not pay for it as a stand-alone service.
  • “Emergency department-at-home programs deploy paramedics or nurses to check vital signs, draw blood and take x-rays with portable imaging devices. Physicians supervise the visits via telehealth, then refer patients to primary care providers for further treatment or to hospital emergency departments if more complex care is needed.
  • “Healthcare technology company Medically Home and primary care provider Atrius Health, a division of UnitedHealth Group’s Optum Health, offer emergency department-care-at-home through a partnership in the Boston area. A study they published last week in the New England Journal of Medicine found more than 83% of 3,668 patients who received emergency care at home over two years did not require a trip to the hospital, saving Atrius approximately $4.5 million.
  • “Medically Home launched its service in 2020 and has served approximately 7,000 patients through contracts with three provider groups, including Atrius. The primary care provider has value-based care contracts with most of its patients and takes on the full risk for their care.”
• FEHBlog observation: Intriguing!

• Per Fierce Healthcare,
  • “Nineteen rural Minnesota hospitals and their 50-plus clinics have banded together to form a clinically integrated network (CIN) serving more than 750,000 people.
  • “The so-called Headwaters High-Value Network, announced Thursday, stitches the independent hospitals’ services together so that Minnesotans can coordinate their care across care sites. Together, the member groups employ about 9,000 people and bring in $1.3 billion of annual net revenue.
  • “Members of the network also said the approach will help their hospitals control rising care costs through reduced administrative burden and shared services. The CIN said it is “in discussions” with other interested rural Minnesota hospitals and “expects to grow.”

• Beckers Hospital Review identifies the ten best states for hospital experience. Nevada leads the pack.

• Beckers Hospital Review adds,
  • “Mark Cuban Cost Plus Drug Co. will serve as a wholesale drug distributor for all 71 hospitals affiliated with Community Health Systems, the organizations announced June 27. 
  • ‘Cost Plus Drugs launched the wholesale services in early 2024, but for the first time, the company is rolling out the offering to a large health system.
  • “The pharmaceutical company has direct relationships with 38 of the 40 largest generic manufacturers and multiple secondary distributors, according to Cost Plus Drugs’ CEO and co-founder, Alex Oshmyansky, MD, PhD.