Trump administration 

• The Trump administration released 800 pages of revised regulations for the existing anti-kickback statute and Stark law, setting off what is expected to be a months-long rule-making process. The changes are meant to encourage care coordination among providers, and promote value-based arrangements to improve patient care.

• A U.S. District Judge issued a preliminary injunction against the Trump administration’s “public charge” rule, which would block legal immigrants seeking public welfare such as Medicaid from obtaining legal residency, preventing the policy from taking effect nationwide next week. A few days earlier, President Donald Trump took action to require that immigrants applying for visas prove they either already have health insurance or can afford to buy private coverage, effective 30 days from the date the presidential proclamation was issued, Oct. 4.
  

• Though the Justice Department is arguing in court that the Affordable Care Act is unconstitutional, if the federal appeals court issues a decision to invalidate the health law, the Trump administration plans to request a stay of the ruling, according to current and former administration officials. 

• The Health and Human Services Department published new guidance for physicians treating patients that have prescriptions for opioids, recommending that they do not abruptly reduce dosages for people dependent on the drugs to manage chronic pain. 

Opioid litigation

• A bankruptcy judge will delay by six months the upcoming trial in the massive opioid case brought by 24 states against Purdue Pharma LP, giving the drugmaker time to settle more than 2,600 lawsuits from across the country. The OxyContin-maker’s plan to strike a deal with dozens of states and localities is contingent on the drugmaker first resolving all Justice Department probes, according to a court filing.

• Arizona is weighing whether to back out of the settlement with Purdue, as the state attorney general argued in a court filing that the drugmaker sought to undermine “material terms” of the deal by requesting current lawsuits be halted while the company completes bankruptcy proceedings. 

Electronic cigarettes

• In the coming weeks, life insurance company Prudential Financial Inc. will begin classifying electronic cigarette users as smokers, making those customers subject to the same elevated insurance rates for individual coverage as people who smoke traditional cigarettes. 

• In light of new federal data showing that the number of confirmed and probable cases of vaping-related illnesses has grown to 1,299, the Centers for Disease Control and Prevention is working on new guidance for providers, emphasizing that all patients presenting symptoms of respiratory infection are asked if they have used vapes. 

• A team of researchers at New York University studying mice found long-term exposure to vapor from electronic cigarettes increased the risk of cancerous tumors in the lungs and potentially cancerous growth in the bladder. 

• School systems in St. Charles, Mo., Olathe, Kan., and on Long Island in New York filed suit against Juul Labs Inc., alleging that the electronic cigarette manufacturer’s marketing practices put the health of students at risk and required school officials to shift time and resources toward preventing and combating the effects of vaping and nicotine addiction. Walgreens Boots Alliance Inc. and Kroger Co. are the latest national retail stores to commit to stop selling electronic cigarettes.

Drug pricing

• Jim Greenwood, the top executive at BIO, a trade group representing pharmaceutical companies, announced his plans to leave the drug lobby at the end of 2020. 

• Democratic presidential candidate and South Bend Mayor Pete Buttigieg of Indiana has a drug pricing plan that would authorize the federal government to negotiate the cost of prescription medications in Medicare, and apply those prices to private insurance plans and Medicaid. 

Medicaid work requirements

• The U.S. Court of Appeals for the District of Columbia heard oral arguments Friday in a lawsuit targeting Medicaid work requirements in Kentucky and Arkansas, which were previously struck down by a federal judge. 

Insurance 

• A new report from the Georgetown University Center on Health Insurance Reforms and the Urban Institute finds an increasing number of states are exercising flexibility in their health insurance marketplaces, either weighing or preparing to depart from the federal marketplace established under the Affordable Care Act. Maine, Nevada, New Jersey, New Mexico, Pennsylvania and Oregon are among those states.

STIs

• The CDC reported that the prevalence of sexually transmitted diseases in 2018 rose to 2.46 million cases, a record high, attributable in part to low funding for state and local health departments. 

• California Gov. Gavin Newsom (D) signed legislation enabling pharmacists in the state to distribute HIV prevention pills to patients without requiring a prescription.

• The House and Senate return to session Tuesday.

• On Wednesday morning, the House Committee on Appropriations hosts a hearing on the threat of e-cigarettes to public health. CDC Principal Deputy Director Anne Schuchat will testify.

• The House Committee on Energy and Commerce subcommittee will also host a hearing on e-cigarettes Wednesday morning, focused on legislation to reduce youth vaping.

• Jury selection for the bellwether federal opioid case begins Wednesday. The trial is set for Oct. 21.

• On Thursday, The Atlantic will convene a discussion with policymakers and experts on how to balance innovation and access.

1) Overhaul is proposed for decades-old Medicare fraud rules
Ricardo Alonso-Zaldivar, The Associated Press

2) Trump Moves to Ease Anti-Fraud Rules in Bid to Improve Care
Shira Stein, Bloomberg Law

3) Trump administration plans to delay any changes if the ACA loses in court
Paige Winfield Cunningham and Yasmeen Abutaleb, The Washington Post

4) CDC says STD cases in U.S. rose to record high in 2018 as funding lags
Gabriella Borter, Reuters

5) Mice that vaped nicotine for a year had a dramatic increase in tumor growth, study finds
Emily Baumgaertner, Los Angeles Times

6) Johnson & Johnson, Risperdal maker hit with $8B verdict
The Associated Press

7) Scientists Designed a Drug for Just One Patient. Her Name Is Mila.
Gina Kolata, The New York Times

8) They Enrolled In Medical School To Practice Rural Medicine. What Happened?
Lauren Weber, Kaiser Health News

9) California OKs pharmacists to dispense HIV prevention meds
The Associated Press

10) Exclusive: Top drug lobbyist to depart next year
Sarah Karlin-Smith, Politico