Cancer doctors and dozens of lawmakers in Congress are questioning whether the federal health department overreached when it blocked medical practices from mailing specialty drugs like oral cancer treatments directly to patients at the end of the COVID public health emergency.

Why it matters: At issue is the Biden administration's interpretation of a federal anti-fraud law that bars doctors from steering Medicare and Medicaid patients to facilities and services in which they have a financial interest.

• The Centers for Medicare and Medicaid Services waived sanctions during the pandemic but now considers the shipments a violation of the law that could get providers fined or even kicked out of Medicare and Medicaid.

Yes, but: Some providers say requiring people to instead pick up the drugs in person or refer them to mail-order pharmacies could disrupt care and impose unnecessary burdens, especially on patients in rural or underserved areas.

What's happening: 54 House lawmakers are pressing Health and Human Services Secretary Xavier Becerra to retract guidance issued in 2021 that they say blocks drugs that have been dispensed to a patient from being delivered as a convenience or necessity.

• The Community Oncology Alliance is weighing a lawsuit, saying the CMS circumvented the federal rulemaking process that gives industry groups a chance to comment on policy changes.

The other side: CMS says it's returning to the policy that was in place before the pandemic and that its 2021 guidance aimed to "reiterate" the status quo. The agency noted beneficiaries are still able to get outpatient prescription drugs through Part D plan networks mail orders and pharmacy networks.

• "CMS will closely monitor patient complaints to watch for any issues affecting patient access," a CMS official said via email.

Yes, but: "We have story after story of delays and denials at the hands of PBM mail-order pharmacies," Ted Okon, executive director of the Community Oncology Alliance, told Axios.

Between the lines: Certain cancer drugs have been in shortage, making this issue more urgent, Stephanie Parker, retail pharmacy manager of Illinois CancerCare.

• "I know my inventory level. I know how many weeks on hand I've got and I can work with the providers proactively before I run out," she said. "When you go to a mail-order facility, you're just sending a prescription out. You don't know."

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Editor's note: This story has been corrected to note Ted Okon is the executive director of the Community Oncology Alliance, not the Cancer Oncology Alliance.

Another policy change that coincided the end of the public health emergency has left some hospital outpatient clinics potentially shut out of the government's discount drug program, Axios' Arielle Dreher writes.

Why it matters: The change is rattling health systems with a lot of poorer patients that are accustomed to buying medicines at cheaper prices and keeping the savings, and comes as many are trying to push more care to offsite clinics.

Driving the news: The Health Resources and Services Administration, part of HHS, rescinded guidance in May that outlines how hospitals had the flexibility to tap into the program to treat some patients at offsite clinics, the trade publication 340B Report first reported.

• The guidance was issued at the start of the pandemic, but wasn't explicitly connected to the COVID-19 public health emergency. It disappeared around the time the PHE lapsed on May 11, when numerous other pandemic-era health payments and regulatory flexibilities expired.
• That caught the industry flat-footed because hospitals assumed they would continue operating on the existing interpretation of 340B rules.
• Hospitals say they're now at risk of being audited and running afoul of federal rules if discounted drugs are used at clinics that haven't yet appeared on their most recent Medicare cost reports.
• Hospitals that improperly use 340B drugs could be forced to make up the discount to drug manufacturers.

What they're saying: "I can't tell whether they changed their policy," Maureen Testoni, CEO of 340B Health, told Axios.

• HRSA referred Axios to the agency's website, which notes that the agency's COVID-19 webpage has been removed and that 340B covered entities need to comply with "all applicable regulations, guidance and policies." HRSA directs hospitals to send queries to HRSA's main 340B program contractor Apexus.

The FDA will allow the importation of the chemotherapy drug cisplatin from China to ease serious shortages that are squeezing U.S. health providers, Arielle and I write.

Why it matters: Cancer doctors have been sounding alarms about shortages of lifesaving drugs, including cisplatin, which is used to treat testicular, ovarian, bladder, head and neck, lung, and cervical cancers.

• They've showed the fragillity of the U.S. drug supply chain.

What they're saying: "We may be in one of the worst chemotherapy drug shortages in history," Amanda Fader, director of the Center for Rare Gynecologic Cancers at the Johns Hopkins Hospital told reporters in a briefing on Friday.

Details: China-based Qilu Pharmaceutical, with its distributor Apotex, is coordinating with the FDA to boost supply in the U.S.

• The imported drugs, which carry vial and carton labels in Chinese, are not FDA-approved but will temporarily be allowed to address the critical shortage, officials said.
• "In these situations, we very carefully assess product quality and require companies to take certain measures to ensure the products are safe for patients," FDA commissioner Robert Califf said in a tweet.

"His experiments were not working because he was eating a lot of Italian food with a lot of garlic."

Thanks to the warmer, wetter weather, mosquito season could be especially itchy and long this year, Axios' Carly Mallenbaum writes.

• And everything from body odor to what you drink can affect how miserable you get.

TL;DR: While you may want to grab more garlic, beer is not your friend here.

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