HHS recently released a final rule that allows practitioners in Opioid Treatment Programs to start patients on methadone or buprenorphine via telehealth. However, the final rule does not apply to the broader range of providers, leading telehealth advocates to call for additional changes from the DEA.
HHS recently published guidance outlining voluntary cybersecurity performance goals for the healthcare sector. Taylor Lehmann, a cybersecurity executive at Google Cloud, noted that "what is on HHS paper will most likely become what is in the actual final rulemaking or new regulatory requirements that become law."
A bipartisan group of senators sent a letter to HHS asking it to rethink its appeal of a recent federal district court decision that limits the use of “copay accumulators" — which are programs insurers use to prevent medication copay assistance from counting toward patients’ deductibles or out-of-pocket maximums.
Last week, HHS finalized a new rule that requires healthcare AI developers to provide more data about their products to customers, which could aid providers in determining AI tools’ risks and effectiveness. Some AI leaders believe the new guardrails are a step in the right direction, and others are skeptical about whether the new rules are necessary or will be effective.
HHS announced a new care model that aims to provide mothers with Medicaid coverage with more personalized maternal health care. This includes access to doulas and midwives and screening for health-related social needs.
Thirty states have been conducting Medicaid and CHIP automatic renewals incorrectly, leading to many individuals being wrongly removed from coverage. Because of this, nearly 500,000 children and other individuals will have their coverage reinstated.
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
HHS released a new proposed rule to update nearly 50-year old regulations protecting people with disabilities from discrimination while seeking healthcare. With its new proposal, HHS is amending the regulations to be clearer in their language, as well as more aligned with the Americans with Disabilities Act, the Americans with Disabilities Amendments Act and amendments to the Rehabilitation Act.
Novartis became the seventh drugmaker to legally challenge the White House’s Medicare drug pricing negotiation program. The company filed its lawsuit three days after HHS announced the first 10 drugs that were selected for the program — its heart failure medication Entresto was one on the list. HHS can expect to face more lawsuits from the manufacturers of the 10 drugs it named last week, experts have warned.
Vanderbilt University Medical Center is under federal investigation after it turned transgender patients’ medical records over to Tennessee’s attorney general. HHS launched the investigation a couple weeks after two VUMC patients filed a class-action lawsuit against the hospital for releasing their records to the attorney general.
HHS issued an alert warning providers about Rhysida, a ransomware gang that recently begun launching attacks on healthcare organizations. The group deploys its ransomware primarily through phishing attacks or the exploitation of legitimate cybersecurity tools.
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
CMS recently proposed a $9 billion lump sum payment to remedy illegal payment cuts for 340B drugs from 2018 to 2022. In general, hospital groups have reacted positively to the fact that 340B providers will receive lump sum payments but have expressed concern about CMS’ methods for maintaining budget neutrality with this plan.
Forty-two safety net hospitals recently sued HHS, alleging that the Medicare program “unlawfully withheld and unreasonably denied” DSH payments for decades. The plaintiff hospitals said that HHS' failure to recalculate DSH payments have cost them "tens of millions of dollars in funds that should have been paid to them many years ago."
Hospitals, clinics, nursing homes and other providers collected billions in government aid during the pandemic. Federal auditors may soon come knocking to ensure the money was spent correctly.
The FBI, CISA and HHS have all recently issued warnings about the dangers associated with the Royal Ransomware gang. Since approximately September of last year, cybercriminals have been using a Royal ransomware variant to compromise organizations across the U.S., many of which have been healthcare providers.
David Finn, CHIME Association Executive Healthcare and Information Sector, lead of the cybersecurity pavilion initiatives at ViVE 2023, does not mince words. With ransomware attacks surging to an all time high this month, Finn said in an interview that security is no longer a defensive posture; we are engaged in a war.
