Medicare drug price talks take shape

Presented by The American Hospital Association

With help from Robert King, Alice Miranda Ollstein and Megan R. Wilson

Driving the day

PATIENTS TO GUIDE MEDICARE DRUG PRICE NEGOTIATIONS — The Biden administration wants Medicare patients and their caregivers to play a key role in drug price negotiations slated to begin this fall, Medicare Director Meena Seshamani told Robert.

Efforts to identify and negotiate lower prices for 10 drugs in Medicare Part D — a major part of the Inflation Reduction Act — are just beginning. But Seshamani said the contours of the negotiating process are already starting to take shape, and real-world evidence on how a drug has been used since its approval will play a big role.

The agency plans to incorporate the “on-the-ground” perspective of patients and their caregivers to understand how the high costs of drugs impact families, she said.

“Does this drug meet an unmet need?” Seshamani asked. “How does it address the needs of specific populations so we can get at this issue of gaps in care and disparities among the population?”

CMS released initial guidance in March detailing how it will select the drugs, and Seshamani said final guidance will be released later this summer after considering public comments. The agency will select the 10 drugs by September, with the negotiation process running through 2024 and the new prices taking effect in 2026.

The top drug industry group PhRMA told POLITICO that it has no problems with the approach but is concerned about the lack of clarity in the guidance on the quality of data standards. Drugmakers also remain concerned about transparency in the process, which CMS has said will be confidential.

The agency continues to hire new staff to conduct the talks, which Seshamani said will include people with industry and clinical expertise, as well as economists.

WELCOME TO TUESDAY PULSE. I’m Megan Messerly, your trusty states reporter, filling in today and tomorrow. Are you anxiously awaiting the next batch of Medicaid unwinding data on Thursday like I am? Have your patients (or you!) recently lost their Medicaid coverage? Other Medicaid unwinding drama to share? Drop me a line at [email protected].

And don’t forget to send tips to Daniel Payne, your regular Pulse host, at [email protected].

TODAY ON OUR PULSE CHECK PODCAST, host Ben Leonard talks with Robert King about his interview with Medicare Director Meena Seshamani and her approach to charting her path in drug price negotiations. Robert also discusses Seshama’s professional background and how it could be bringing both a clinical and economic perspective to her role.

Around the Nation

ACA PREVENTIVE CARE MANDATE AT STAKE — The fate of the Affordable Care Act mandate requiring health insurance companies to cover preventive care hangs in the balance today.

A 5th U.S. Circuit Court of Appeals panel will hear oral arguments this afternoon on a challenge filed by conservative employers in Texas to the Affordable Care Act’s mandate that health insurance cover preventive care services, including the HIV prevention drug PrEP, with no out-of-pocket costs, Alice reports.

At stake is access to a wide range of no-cost services — like annual physicals, cancer screenings and Pap tests — for tens of millions of people on employer-sponsored insurance and Obamacare’s individual market.

The panel hearing arguments this afternoon skews conservative. Two of the three judges on the panel were appointed by former President George W. Bush and the other by former President Barack Obama.

How we got here: Texas District Judge Reed O’Connor — the author of several previous rulings against pieces of Obamacare — ruled in March for the challengers, striking down all of the U.S. Preventive Services Task Force’s decisions since 2010 that stipulated what insurers must cover without cost-sharing.

In May, the 5th U.S. Circuit Court of Appeals issued an administrative stay of that lower court ruling — keeping the current coverage rules in place while the case proceeds.

Covid

COVID RULES BOOSTED KIDS’ COVERAGE — Pandemic-era Medicaid rules resulted in hundreds of thousands of kids gaining coverage, a new study found.

The continuous coverage rules, put in place during the public health emergency, resulted in a 4.6 percent increase in kids enrolled in Medicaid in 26 states that previously had no such rules compared with those that did, according to the study, published in Health Affairs’ June edition.

The study, conducted by researchers at the University of Pennsylvania and Children’s Hospital of Philadelphia, found that the policy resulted in more than 655,000 additional children being covered.

Before the pandemic, 24 states had voluntarily adopted 12-month continuous-coverage requirements for children — a policy that will kick in nationwide in 2024 as a result of the year-end spending bill that Congress passed in December. The researchers said the findings suggest the new policy “may lead to modest improvements in the stability of children’s health insurance coverage in the future.”

VACCINES FUEL EEOC COMPLAINTS — New federal data shows that workplace vaccine requirements caused a nearly 20 percent uptick in charges filed with the EEOC, POLITICO’s Nick Niedzwiadek reports. The agency saw a more than 550 percent increase in charges alleging religious discrimination, as well as more modest increases in charges of disability and sex discrimination, while charges of race-based discrimination remained about flat.

SCHOOLS FRET OVER COVID RELIEF DOLLARS — The Education Department is reassuring states that federal Covid-19 relief dollars won’t be taken away from schools as part of the debt ceiling deal, POLITICO’s Mackenzie Wilkes reports. While the legislation does rescind some unobligated K-12 funds, the department said all that money has already been committed.

IN THE STATES

OBAMACARE, MEDICARE CALL CENTER WORKERS STRIKE — Workers at federal contractor Maximus, which operates call centers to answer Medicare and Obamacare questions for CMS, went on strike in five states Monday. The action, in Florida, Kentucky, Louisiana, Mississippi and Virginia, comes as the call center workers play a key role in helping people transition into exchange plans amid a massive Medicaid redetermination effort. Employees are protesting the layoff of 700 workers last month and calling for a $25-an-hour starting wage.

A ROADMAP AS GOVERNMENTS TAKE ON SUD — The O’Neill Institute for National and Global Health Law at Georgetown University Law Center on Tuesday released a new report suggesting how state and local governments can use recent opioid settlement dollars and other funds to address substance use disorder. Their recommendations include taking a science- and evidence-based approach, standardizing data reporting and outcome metrics across government agencies and aligning funding streams.

N.J. UNIONS SLAM HEALTH PLAN REPORT — New Jersey’s public sector unions are slamming a new report from the state Treasury department suggesting that the state employees’ and teachers’ health plans are too generous, POLITICO’s Daniel Han reports. According to the report, the average annual cost for participating employees is about $22,000, compared to about a $14,000 average cost per employee nationally.

Lobby Watch

TO THE HILL — More than 500 long-term care professionals are headed to the Capitol this week to lobby for more measures to boost their workforce and to oppose staffing minimums proposed by the Biden administration, Daniel reports.

The American Health Care Association and the National Center for Assisted Living will meet with lawmakers to discuss workforce policy, including the Building America’s Health Care Workforce and the Ensuring Seniors’ Access to Quality Care Act.

The group will also discuss the transition out of the pandemic and the resumption of pre-Covid-19 protocols, as well as the impacts of Medicaid redetermination on long-term care patients.

HOSPITALS FLY IN TO KEEP SITE NEUTRAL OUT — The American Hospital Association is shepherding more than 200 hospital and health system executives around Capitol Hill today, aiming to keep a number of policies off lawmakers’ agenda, Megan R. Wilson reports.

The advocates are meeting with members on key committees — including the House Energy and Commerce Committee and the Senate Finance Committee — on a number of legislative priorities, including pushing back on proposals involving the so-called site-neutral payment policy, which would ensure Medicare and patients pay the same amount for a service regardless of where it’s performed.

Hospitals say that the cuts imposed by the changes would harm their ability to provide care, but lawmakers — including House Energy and Commerce Chair Cathy McMorris Rodgers (R-Wash.) — are pushing back on the inflated prices.

While the committee recently took action on site-neutral payments involving medications and treatments, McMorris Rodgers has said she wants to pursue broader reform.

Names in the News

Ted Love, the former CEO of Global Blood Therapeutics, was elected chair of the Biotechnology Innovation Organization’s board of directors. Love, who will serve a two-year term, succeeds Nkarta CEO Paul Hastings.

What We're Reading

Low profit margins on generics, foreign manufacturing and supply-chain issues have left chemotherapy drugs in short supply, alarming patients and doctors alike, The Washington Post reports.

Patient advocates want to create a National Transportation Safety Board for health care accidents, but hospitals could hamstring their efforts, KFF Health News reports.