From Washington DC —

• The Food and Drug Administration announced
  • approve[ing] Opill (norgestrel) tablet for nonprescription use to prevent pregnancy— the first daily oral contraceptive approved for use in the U.S. without a prescription. Approval of this progestin-only oral contraceptive pill provides an option for consumers to purchase oral contraceptive medicine without a prescription at drug stores, convenience stores and grocery stores, as well as online.
• The New York Times adds,
  • The pill’s manufacturer, Perrigo Company, based in Dublin, said Opill would most likely become available from stores and online retailers in the United States in early 2024.
• The OTC contraceptive will be available with no member cost sharing from FEHB plan network pharmacies due to the Affordable Care Act’s contraceptive mandate. Per the New York Times,
  • The company did not say how much the medication would cost — a key question that will help determine how many people will use the pill — but Frédérique Welgryn, Perrigo’s global vice president for women’s health, said in a statement that the company was committed to making the pill “accessible and affordable to women and people of all ages.”

• The American Hospital Association informs us
  • “The Centers for Medicare & Medicaid Services July 13 issued a proposed rule that would increase Medicare hospital outpatient prospective payment system rates by a net 2.8% in calendar year 2024 compared to 2023. This includes a proposed 3.0% market basket update, offset by a 0.2% cut for productivity.”
• and
  • “The Centers for Medicare & Medicaid Services July 13 released its calendar year 2024 proposed rule for the physician fee schedule. The rule proposes a decrease to the conversion factor by 3.34%, to $32.75 in calendar year 2024, as compared to $33.89 in CY 2023. This reflects the expiration of the 2.5% statutory payment increase for CY 2023; a 1.25% statutory payment increase for 2024; a 0.00% conversion factor update under the Medicare Access and CHIP Reauthorization Act; and a -2.17% budget-neutrality adjustment.  * * * 
    “CMS also proposes several provisions to advance access to behavioral health services. For example, it would create a new benefit category for marriage and family therapists and mental health counselors under Part B. In addition, CMS would establish new payment codes for mobile psychotherapy for crisis services.”\
• The public comment deadline for both proposed rules is September 11, 2023.

• STAT News reports
  • “A key Senate health care panel has developed a plan to tackle reforms to middlemen in the pharmacy drug payment system, according to bill text obtained by STAT.
  • “The draft legislation, authored by Senate Finance Chair Ron Wyden (D-Ore.) and ranking member Mike Crapo (R-Idaho), includes several measures to regulate how pharmacy benefit managers are paid by health plans to negotiate with drugmakers.
  • “The most significant measure is a bill from Sens. Bob Menendez (D-N.J.) and Marsha Blackburn (R-Tenn.) that would prohibit PBMs from getting any income outside of service fees, and prohibits those service fees from being related to drugs’ list prices.
  • “Other provisions include a bill from Sens. Catherine Cortez Masto (D-Nev.) and Thom Tillis (R-N.C.) to require PBMs to send annual reports to Medicare insurance plans about their rebate and price negotiations, a policy that would ban PBMs from charging Medicaid more than they pay for drugs (a practice called spread pricing), and a mandate for the Department of Health and Human Services to outline acceptable performance measures for pharmacies.”

From the public health front

• The Wall Street Journal reports
  • Two different arms of the World Health Organization released separate findings on the widely used sweetener aspartame—one calling it safe and the other identifying it as a possible cancer hazard.
  • Here’s what you need to know:
  • Is it safe to drink Diet Coke?
    • Yes, in moderate amounts. Food regulators around the world agree that aspartame is safe. Aspartame has been studied for decades. The WHO reaffirmed its recommendation that people consume no more than 40 milligrams of aspartame a day for each kilogram they weigh—which would be a lot of soda.
    • With around 200 mg of aspartame per 12-ounce can of Diet Coke, that is roughly 16 cans a day for a 175-pound person. People get aspartame from some other food sources, though, and often the presence or amounts of aspartame in them aren’t disclosed. The WHO and other health experts also caution against consuming large amounts of sweetened products, including soda. They recommend drinking water instead.
    • “This is particularly important for young children” whose tastes are developing, said Dr. Francesco Branca, director of the WHO’s department of nutrition and food safety.
  • Obviously, the article continues on with other FAQs, but this is the one that caught the FEHBlog’s attention.

• The U.S. Preventive Services Task Force finalized its research plan for chronic kidney disease screening.

• STAT News tells us
  • “Amid ongoing controversy over the cost of medicines, a key Biden administration official told Covid-19 vaccine manufacturers that their next round of shots should be priced reasonably, a move that comes after two key suppliers were accused of price gouging.”

• The CMS Administration informed insurers and others
  • “As we look toward efforts to provide updated COVID-19 vaccines this fall, we know you may have questions about the shift away from U.S. Government purchasing of vaccines to a more traditional commercial market. To be clear, that shift has not yet occurred, and the currently authorized and approved COVID-19 vaccines continue to be free and widely available nationwide. We also wanted to send these reminders from the Centers for Medicare & Medicaid Services (CMS) about COVID-19 vaccine coverage and encourage you to start planning now for the fall vaccination campaign.
  • “[M]ost private health insurance, like employer-sponsored plans, Marketplace plans, and other individual market coverage that is subject to the Affordable Care Act (ACA) market reforms are required to cover vaccines for COVID-19 authorized for emergency use or approved by the FDA and recommended by the ACIP and their administration, without patient cost-sharing.”

• Fierce Healthcare relates
  • The Centers for Medicare & Medicaid Services (CMS) is recommending preexposure prophylaxis (PrEP) with oral or injectable antiretroviral therapy to people at risk of HIV without patient cost sharing. * * *
  • Currently, Medicare beneficiaries are only guaranteed access to daily oral PrEP through Part D, facing out-of-pocket costs, said Carl Schmid, executive director of the HIV+Hepatitis Policy Institute. Injectable PrEP has not been covered traditionally.

• Roll Call points out
  • “One year after the creation of the three-digit crisis hotline known as 988, officials say the next step is expanding awareness and local crisis care.
  • “More than 4 million people have called, texted or chatted the suicide prevention hotline in the year since its creation, according to Laurel Stine, executive vice president and chief policy officer for the American Foundation for Suicide Prevention.
  • “She estimates that number will grow in the next fiscal year to 9 million contacts.
  • “We have to be mindful that Rome was not built in a day,” she said. “We’ve had a fragmented mental health behavioral health crisis system for a number of years.”

• Forbes reports on the “worsening” cancer drug shortage which it describes as a resolvable public health emergency.

From the generative AI front —

• Healthcare Dive notes
  • Generative artificial intelligence could capitalize on the healthcare industry’s wealth of unstructured data, alleviating provider documentation burden and improving relationships between patients and their health plans, according to a new report by consulting firm McKinsey.
  • The report argues generative AI could help payers quickly pull benefits material for members or help call center workers aggregate information during conversations about claims denials. Providers could use AI to take conversations with patients and turn them into clinical notes, create discharge summaries or handle administrative questions from workers at health systems.
  • But healthcare leaders should start planning now if they want to use generative AI, as the risks can be high, the report said. Data fidelity and accuracy is key, so executives should begin assessing the quality of their AI tech stacks and considering potential problems like bias and privacy concerns, according to McKinsey.

• Econtalk host Russ Roberts held an informative interview with Marc Andreessen about generative AI.