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What We’re Reading: Contraceptive Coverage Mandate; Change Healthcare Hacked; Clinical Trial Transparency

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The House Democratic Women’s Caucus wrote a letter urging insurers to comply with both contraceptive coverage requirements and recent Biden administration guidance; several pharmacy chains are experiencing disruptions following a hack at Change Healthcare, UnitedHealth’s technology unit; the FDA said it is not planning to take a tougher stance against clinical trial reporting requirement noncompliance.

Democrats Ask Insurers to Meet Contraceptive Coverage Mandate

The House Democratic Women’s Caucus wrote a letter to the biggest insurance association, urging insurers to comply with contraceptive coverage requirements and recent Biden administration guidance, according to Roll Call. The 2010 law mandates most health plans to cover FDA-approved contraception without a copay for patients going to an in-network health provider. However, there has been pushback and litigation over exceptions and enforcement of the law. In response, the Biden administration issued guidance in January, suggesting ways insurers can comply with the law. Consequently, the letter written to America’s Health Insurance Plans (AHIP) president and CEO Mike Tuffin seeks a response from insurers by March 1 on whether they will adopt the suggested standards and how they plan to comply with coverage requirements. It also asks for clarity on exception processes and is part of a broader effort by Democrats to ensure affordable and accessible contraception for women.

Pharmacies Nationwide Disrupted Following Hack of Change Healthcare Network

Several pharmacy chains are experiencing disruptions following a hack at Change Healthcare, UnitedHealth’s technology unit, according to Reuters. UnitedHealth said that the problems began Wednesday after a “suspected nation-state associated cybersecurity threat actor” gained access to Change Healthcare’s systems. In response, Change Healthcare immediately disconnected its systems to protect its partners and patients and to prevent further impact, saying at this time that it cannot estimate the duration or extent of the disruption. The outage affected a variety of pharmacy chains, including CVS Health, which was unable to process insurance claims in certain cases. Also, Walgreens said a small percentage of prescriptions may be affected, but they have procedures in place to process and fill them with minimal delay or interruption. Other companies affected include GoodRX and Publix Super Markets.

FDA Gives Mixed Response to Petition Seeking Greater Clinical Trial Transparency

The FDA has responded to a citizen petition filed last year by Universities Allied for Essential Medicines (UAEM), saying it is not planning to take a tougher stance against clinical trial reporting requirement noncompliance, according to Stat. In the petition, UAEM urged the FDA to increase enforcement by issuing more notices and penalties for noncompliance. In response, the FDA denied an overall increase in enforcement but partially granted the request, agreeing to consider UAEM’s proposed enforcement framework when revisiting existing guidance. The agency also granted the request to establish a public dashboard of prenotices, acknowledging the value of transparency in compliance actions and the potential to increase voluntary compliance. In response, UAEM’s Executive Director Justin Mendoza, MPH, said, “It is promising to see the FDA focus on ensuring better accountability through its pre-notice dashboard, but it is concerning to see the FDA continue to rely on voluntary compliance despite the evidence presented in our petition.”

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