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FDA approves first over-the-counter oral contraceptive
On July 13, the Food and Drug Administration (FDA) approved the first daily oral contraceptive pill for non-prescription use. OPill, a progestin-only oral contraceptive, will be available as an over-the-counter contraceptive option in 2024 after a unanimous vote in support of its application from two FDA advisory committees that spurred the agency to quickly approve the switch to non-prescription status.
The AMA earlier this year wrote (PDF) U.S. Department of Health and Human Services (HHS) Secretary Becerra urging support for OTC oral contraceptive options. The AMA also submitted comments (PDF) in support of the Opill application.
Perrigo Company, the manufacturer of OPill, expects the product to be available in-store and online from leading retailers during the first quarter of 2024. Pricing information for this product is not available yet. AMA continues to advocate for affordability of OTC contraceptive options and has urged HHS to consider financial assistance or coverage mandates to help ensure broad access to these important contraceptive options.
AMA calls for removal of problematic cost measures in MIPS
CMS reevaluates cost measures in the Merit-based Incentive Payment System (MIPS) on a 3-year cycle. In response to a request for comment about 12 cost measures that are being reevaluated, the AMA strongly urged CMS to remove both the Total Per Capita Cost (TPCC) and Medicare Spending Per Beneficiary (MSPB) clinician measures from MIPS. These measures hold physicians accountable for costs they cannot influence, such as drug prices.
The AMA raised concerns with the methodology of both measures, including attribution, double counting of the same costs, exclusions, and lack of alignment with other measures. In addition, the AMA's comments cited a recent study finding that oncologists scored poorly on both measures, arguing that these measures do not account for the variation in costs in the standard-of-care medicine by specialty. The AMA also pointed out that both the TPCC and MSPB clinician measure specifications rely on the CPT code set from 2020, which would fail to account for major coding updates to Evaluation and Management (E/M) services in 2021 and 2023. Finally, the AMA urged CMS to provide an additional opportunity for comment when actual performance data about these measures becomes available.
New cybersecurity resources available
The AMA has curated resources for physicians and practice staff to protect patient health records and other data from cyberattacks. Two useful cybersecurity-related updates are available on the AMA physician cybersecurity web page:
- The HHS Office for Civil Rights (OCR) and the Federal Trade Commission (FTC) recently sent a joint letter (PDF) to hospital systems and telehealth providers cautioning them about the privacy and security risks related to the use of online tracking technologies that may be integrated into their websites or mobile apps and how these tools may be impermissibly disclosing consumers’ sensitive personal health data to third parties. OCR highlighted these concerns in a bulletin it issued late last year that reminded entities covered by HIPAA of their responsibilities to protect health data from unauthorized disclosure under the law. Those entities not covered by HIPAA still have a responsibility to protect against the unauthorized disclosure of personal health information—even when a third party developed their website or mobile app.
- The Healthcare and Public Health Sector Coordinating Council (HSCC) released a new eight-part cybersecurity video series to help clinicians better understand the ins and outs of cyber hygiene. In under one hour, this “Cybersecurity for the Clinician” video training series explains in non-technical language what physicians and medical students need to understand about how to help keep health care data, systems and patients safe from cyber threats. The HSCC is a national public-private partnership dedicated to strengthening the nation’s health care critical infrastructure.
How physician practice ownership and organization has changed
A new report (PDF) from the AMA describes the changes in the ownership and organization of physician practices between 2012 and 2022. Over that period, the share of physicians who work in private practices dropped by 13 percentage points from 60.1% to 46.7%. The report shows that “by far, the most cited reason for hospital and health system acquisition had to do with payment.” Eight in 10 physicians surveyed said the need to negotiate higher payment rates was a very important or important “reason as to why their practice was sold to or acquired by a hospital or health system.” Read the press release for additional details.
