Tag: Rule

Florida sues Biden administration over new transgender health care rule

Florida’s top prosecutor and a Catholic medical group on Tuesday sued the Biden administration in an effort to block a rule that they say will force doctors to provide gender transition care against their judgment or face heavy penalties.

The lawsuit by Florida Attorney General Ashley Moody and the Catholic Medical Association (CMA), filed in federal court in Tampa, takes aim at a new rule, published by the U.S. Department of Health and Services (HHS) on Monday that would ban discrimination in health care on the basis of gender identity.

The rule is based on an anti-discrimination provision within the Affordable Care Act, the national health insurance law better known as Obamacare, which forbids sex discrimination.

In their complaint, Moody and CMA say the new rule goes beyond the anti-discrimination law. They say it would force doctors to provide, and insurance to pay for, treatments including puberty blockers, hormones and surgeries for transgender minors and adults against their medical or ethical judgment.

They also said the rule conflicted with a Florida law banning such treatments, which are known as gender-affirming care, for minors.

“These rules trample states’ power to protect their own citizens and we will not stand by as Biden tries, yet again, to use the force of the federal government to unlawfully stifle Florida’s effort to protect children,” Moody said in a statement.

The plaintiffs claim that the rule is “arbitrary and capricious” under a federal law governing agency rulemaking, and violates doctors’ right to free speech and freedom of religion under the First Amendment of the U.S. Constitution. They are asking the court for an order blocking its enforcement.

HHS said not immediately respond to a request for comment.

The agency and major medical organizations such as the American Academy of Pediatrics have said that gender-affirming

New California rule aims to limit health care cost increases to 3% annually

SACRAMENTO, Calif. (AP) — Doctors, hospitals and health insurance companies in California will be limited to annual price increases of 3% starting in 2029 under a new rule state regulators approved Wednesday in the latest attempt to corral the ever-increasing costs of medical care in the United States.

The money Californians spent on health care went up about 5.4% each year for the past two decades. Democrats who control California’s government say that’s too much, especially since most people’s income increased just 3% each year over that same time period.

The 3% cap, approved Wednesday by the Health Care Affordability Board, would be phased in over five years, starting with 3.5% in 2025. Board members said the cap likely won’t be enforced until the end of the decade.

A new state agency, the Office of Health Care Affordability, will gather data to enforce the rule. Providers who don’t comply could face fines.

“We want to be aggressive,” board chair Dr. Mark Ghaly said, while acknowledging that the cap “really translates into a major challenge” for the health care industry.

The vote is just the start of the process. Regulators will later decide how the cost target will be applied across the state’s various health care sectors. And enforcement will be progressive, with several chances for providers to avoid fines.

California’s health care industry has supported the idea of a statewide cost target but argued a 3% cap is too low and will be nearly impossible to meet. In December, the Center for Medicare and Medicaid Services said the cost to practice medicine in the United States would increase 4.6% this year alone.

The board based the target on the average annual change in median household income in California between 2002 and 2022, which was 3%. Dr. Tanya W. Spirtos, president

HHS Finalizes Rule to Advance Health IT Interoperability and Algorithm Transparency

The U.S. Department of Health and Human Services (HHS) through the Office of the National Coordinator for Health Information Technology (ONC) today finalized its Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing (HTI-1) rule. This follows the release of the HTI-1 proposed rule in April 2023. The HTI-1 final rule advances patient access, interoperability, and standards, including the following:

  • Algorithm Transparency: Establishes first of its kind transparency requirements for the artificial intelligence (AI) and other predictive algorithms that are part of certified health IT. ONC-certified health IT supports the care delivered by more than 96% of hospitals and 78% of office-based physicians around the country. HHS’ leading-edge regulatory approach will promote responsible AI and make it possible for clinical users to access a consistent, baseline set of information about the algorithms they use to support their decision making and to assess such algorithms for fairness, appropriateness, validity, effectiveness, and safety.
  • USCDI Version 3: Adopts the United States Core Data for Interoperability (USCDI) Version 3 (v3) as the new baseline standard within the ONC Health IT Certification Program (Certification Program) as of January 1, 2026. Developers of certified health IT will also have the ability to move to USCDI v3 sooner. USCDI v3 includes updates to prior USCDI versions focused on advancing more accurate and complete patient characteristics data that could help promote equity, reduce disparities, and support public health data interoperability.
  • Enhanced Information Blocking Requirements: Revises certain information blocking definitions and exceptions to support information sharing, and adds a new exception to encourage secure, efficient, standards-based exchange of electronic health information under the Trusted Exchange Framework and Common AgreementSM (TEFCASM).
  • New Interoperability-Focused Reporting Metrics for Certified Health IT: Implements the 21st Century Cures Act’s requirement to adopt

21st Century Cures Act information-blocking rule has no impact on patient complaints in radiology

The information-blocking rule under the 21st Century Cures Act—requiring providers to grant patients immediate access to their radiology reports—appears to have no impact on patient complaints.

That’s according to a new single-center analysis from Vanderbilt University Medical Center published Friday in JAMA Health Forum [1]. The Cures Act first went into effect in December 2016 and entered its first compliance phase in April 2021. It aims to help increase patient access to health information, also including consultation notes, physical exams, lab and pathology work, and discharge summaries.

To better understand the law’s impact, researchers at VUMC analyzed nearly 8,500 unsolicited patient complaints logged at their institution between 2020 and 2022. They found that such grievances increased from over 3,000 in the year leading up to the information-blocking rule’s implementation to nearly 5,500 in the year after.

“In this cohort study with interrupted time-series analysis, the Cures Act [information-blocking rule] was not associated with a change in the monthly rate of [unsolicited patient complaints] at a large academic medical center,” lead author Robert J. Dambrino IV, MD, with Vanderbilt’s Department of Health Policy, and colleagues wrote Sept. 29. “A qualitative review of the complaints suggests that there are unintended consequences of complex medical information being immediately available to patients. Further study of the effects of this legislative mandate with multi-institutional data and a longer time horizon may be helpful for further understanding of this law’s effect on [unsolicited patient complaints].”

Prior to Jan. 1, 2021, Vanderbilt’s policy was to release radiology reports three business days after results were available, pathology reports 15 calendar days later, and to never electronically share clinical notes. After the law change went into effect, the Tennessee institution began providing immediate access to all three via its patient portal.

After the rule went into effect, topics

Consumer Health Information and Increased Scrutiny: FTC Brings First Action Under Health Breach Notification Rule

The Federal Trade Commission (“FTC”) has brought its first enforcement action for violations of the Health Breach Notification Rule (“HBNR”), signaling heightened federal agency scrutiny of digital health platforms, advertising relationships, and uses and disclosures of health information.

On February 1, 2023, the FTC brought an enforcement action against GoodRx, a digital health company, for alleged violations of the FTC Act and the HBNR, resulting in a reported $1.5 million civil penalty and injunctive relief. As the FTC’s first enforcement action under the HBNR, this illustrates an increased willingness of the FTC to penalize certain disclosures of health information outside of the HIPAA context.

The FTC claimed in its complaint that, although GoodRx is not subject to HIPAA, the company is a “vendor of personal health records” subject to the HBNR. The FTC alleged that GoodRx:

  • Improperly shared consumer health information with advertisers without consumer notice and consent and failed to notify consumers, the FTC, and media of such unauthorized disclosures;
  • Inappropriately utilized tracking technologies for targeted advertising;
  • Failed to limit third-parties’ use of consumers’ health information; and
  • Failed to implement formal policies protecting consumer health information.

The FTC and GoodRx stipulated to a joint proposed order requiring GoodRx to pay $1.5 million to the FTC and implement remedies regarding its data privacy practices, including:

  • Complying with HBNR notification requirements;
  • Permanently banning the disclosure of health information for most advertising purposes or requiring express consumer consent; and
  • Directing its third-party advertisers to delete all health information received.

Federal agencies increasingly are scrutinizing HIPAA and non-HIPAA covered entities for violations relating to health information. This action follows the FTC’s recent statement emphasizing that developers of digital health apps, connected devices, and other health products have obligations under the HBNR and signaling upcoming enforcement. It also follows the Office of Civil

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