Tuesday’s Tidbits

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From Capitol Hill Fierce Healthcare reports

Senate leadership said they reached a deal with centrist Sen. Joe Manchin, D-W.Va., to give Medicare narrow authority to negotiate lower drug prices and extend key Affordable Care Act subsides for another two years.

“We are excited about doing something on prescription drugs,” Schumer said during a press conference Tuesday. “This is something we have waited for.”

Centrist Sen. Joe Manchin, D-W.Va., had reached a narrow deal to give Medicare the power to negotiate for lower prices on up to 10 drugs in 2026 and up to 20 drugs starting in 2029. The package includes a host of other reforms that include a $2,000 cap on out-of-pocket drug costs.

The deal released earlier this month would also repeal a controversial Trump-era rule that stripped Part D rebates of their safe harbor from prosecution under federal anti-kickback laws. 

It now includes a two-year extension of a boost to ACA subsidies that has helped fuel record-breaking enrollment of more than 14 million people.

The Senate majority leader plans to move this legislation via the reconciliation process which means the Senate Parliamentarian must confirm that the bill meets the standards for the reconciliation approach.

STAT News adds that the Senate majority leadership has encountered problems from across the aisle in obtaining passage of the must-pass Food and Drug Administration users fee bill which helps fund the thousands of FDA experts who process drug review requests. Absent the necessary user fee funding, these folks will be furloughed.

From the Omicron and siblings front

AHIP tells us

Today the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) unanimously voted to recommended the use of the Novavax two-dose COVID-19 vaccine as a primary vaccine series for adults 18 years and older.  The two dose series is recommended to be administered by intramuscular injection with 3-8 weeks between doses depending on the patient risk and immunocompetency status.

The Committee reviewed data showing the vaccine is approximately 90.4% effective in preventing mild, moderate or severe COVID-19 and 79% effective in a subset of people aged 65 years or older. Additionally, the vaccine had favorable safety data that showed mild side effects. Committee members noted the hope that Novavax’s traditional protein-based vaccine will help to convince the 10-13% of adults who remain unvaccinated to receive a COVID-19 vaccine.

Members also expressed concerns about vial size, potential discard waste, and lack of an expiration date on the vial or carton, with clinicians needing to go to NovavaxCovidVaccine.com to get expiration date. The committee clearly stated that the vaccine is not recommended to be used in combination with other COVID-19 vaccines for primary or booster series completion at this time.

The FDA granted the Novavax vaccine an emergency use authorization on July 14. CDC Director Walensky is expected to make an official recommendation statement on Novavax in the coming day.

The Wall Street Journal reports that natural immunity from contracting Covid, typically has lasts 90 days. However, the highly contagious and current king of Covid infections, Omicron BA.5, can bear natural immunity based on an earlier strain of Omicron. Rest assured that your natural immunity can be expected to last 90 days when you contracted Omicron BA.5.

Also from the public health front,

The New York Times reports on the difficulties that New Yorkers infected with monkeypox have encountered when they seek treatment for that disease.

“What many of us learned in medical schools is that monkeypox is a mild, self-limiting illness,” said Dr. Mary Foote, medical director of the office of emergency preparedness and response at the city’s Department of Health, speaking at a Thursday briefing hosted by the Infectious Diseases Society of America. “But the reality on the ground is that a lot of people with this infection are really suffering.”

What’s also striking, she said, about this outbreak, is “how many of these patients have had difficulty getting the care they need to treat these symptoms.”

STAT News adds

[E]ven as global health officials race to curb spread of the virus, most experts polled by STAT said they don’t believe it will be possible to contain it.

Not everyone is categorical — or pessimistic.

Rochelle Walensky, director of the Centers for Disease Control and Prevention, and Rosamund Lewis, the World Health Organization’s technical lead on monkeypox, expressed the belief that with a lot of effort, transmission in the population of men who have sex with men can be stopped.

Walensky’s optimism in this case derives from the fact that, to date, the virus appears to be spreading mainly within a defined community — one that has mobilized to get out the word of the risk its members face.

“Within this community there was a lot of high-risk [exposures] before we were able to test enough, educate enough, both on the provider side and the patient side. And there’s a lot of that happening right now,” Walensky said.

Healio notes

In June, HHS began shipping orthopoxvirus tests to five commercial laboratory companies — Aegis Science, Labcorp, Mayo Clinic Laboratories, Quest Diagnostics and Sonic Healthcare — to increase monkeypox testing capacity and access. As of Monday, they all have begun testing, the most recent being Sonic Healthcare. * * *

In addition to increased testing, the CDC has issued travel alerts and expanded access to vaccines in response to the outbreak. HHS also ordered an additional 2.5 million doses of Bavarian Nordic’s Jynneos vaccine to strengthen preparedness. This followed an earlier order made for 2.5 million doses that will begin arriving over the next year and will bring the federal stockpile of vaccine to treat monkeypox to nearly 7 million doses by mid-2023.

Medscape reports

Overdose deaths continued increasing in 2019-2020, especially among Black and American Indian/Alaskan Native (AI/AN) individuals, the CDC reported Tuesday.

Overdose deaths in the U.S. increased by about 30% during that period, said Mbabazi Kariisa, PhD, MPH, a health scientist in the CDC’s Division of Overdose Prevention, during a phone briefing with reporters. “We know that health disparities play a key role in overdose death rates among people in certain racial and ethnic minority groups. In just 1 year, overdose death rates increased 44% for Black people and 39% for American Indian and Alaskan Native people.”

STAT News tells us “The deaths were broadly driven by illicit fentanyl, CDC officials said, though deaths attributed to other drug types, including stimulants like methamphetamine, have also been rising in recent years.”

In advocacy news, MedPage Today discusses the American Medical Association President Jack Resneck’s campaign to tie physician burnout to prior authorization and other health insurer hassles. It’s unfortunate that the various health care professional and trade associations can’t work together to reduce healthcare spending while improving quality.

In that regard, Kaiser Health News reports

Fresh off the Federal Trade Commission’s successful challenges to four hospital mergers, the Biden administration’s new majority on the commission is primed to more aggressively combat consolidation in the health care industry than it has in past years.

Although hospital mergers were supposed to improve cost efficiency, experts agree that the creation of huge conglomerates and hospital networks has driven up U.S. medical costs, which are by far the highest in the world. Many enjoy near-monopoly pricing power. * * *

Extensive research has found that prices rise when hospital systems acquire or merge with their competitors or when they buy a significant percentage of physician practices in their market. Highly consolidated markets, such as Northern California (dominated by Sutter Health) and western Pennsylvania (dominated by UPMC) tend to have higher prices.

The FTC has a long history, under both Democratic and Republican administrations, of antitrust enforcement actions to block so-called horizontal mergers between hospitals that could stifle competition in a market.