CMS Releases Proposed Rule to Advance ACA Coverage in 2024
CMS hopes the changes will increase healthcare access for underserved populations, streamline the plan selection process and simplify enrolling in Marketplace coverage.
Patient Files Class-action Suit Against Advocate Aurora Health Following Data Breach
The patient is alleging that the patient portal he used to communicate with his doctors at Advocate Aurora and to schedule appointments used a pixelated code that also enabled logging in via Facebook and then shared data with Facebook.
Government issues final rules to prevent surprise medical bills
Following litigation battles and multiple iterations of the Act, the final rules address the arbitration process for insurers and provide more transparency for patients.
Texas sues HHS, claims the agency is trying to turn ERs into abortion clinics
The attorney general of Texas says the recent federal mandates and guidance issued to healthcare providers to protect abortion access are unconstitutional and conflict with state law.
The “biggest thorn in President Trump’s side” is now HHS Secretary. What’s next?
California Attorney General Xavier Becerra may have won a narrow confirmation to be the Department of Health and Human Services Secretary, but if his past is any indication, his agenda will be bold when it comes to reining in pharma companies, boosting the Affordable Care Act and scrutinizing hospital consolidation.
In Becerra, an HHS nominee with political skill but no front-line health experience
Xavier Becerra, President-elect Joe Biden’s choice to head the Department of Health and Human Services, is set to be a pandemic-era secretary with no public health experience. Whether that matters depends on whom you ask. Becerra built his career in the U.S. House of Representatives before becoming California’s attorney general, and some wonder whether […]
A Deep-dive Into Specialty Pharma
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.
La FDA, c’est moi: In memo, HHS’ Azar asserts power to sign new rules, traditionally purview of agencies’ lawyers
The New York Times reported that in a memo, Alex Azar stated that the power to sign new rules is "reserved" for him, a move that one expert called a "power grab." It is unclear how it will affect authorizations of vaccines against the coronavirus.
Pfizer, BioNTech get $1.95B from HHS to supply Covid-19 vaccine
The companies will supply 100 million doses of the vaccine by the end of the year, and the government will have the option to acquire 500 million more. However, the FDA must grant an authorization based on its safety and efficacy, for which there are only preliminary data so far.
US gobbles up nearly all of Gilead Covid-19 drug remdesivir for next 3 months, leaving other nations without
HHS said it had acquired all the supplies of the drug for July and 90% of supplies for August and September. Many developing countries have access to generic versions, but WTO rules could complicate the ability of wealthy nations to import them.
HHS gives rural clinics $225M to ramp up Covid-19 testing
The announcement comes as researchers have noted that the pandemic has begun shifting from urban centers like New York to rural areas of the country. The U.S. continues to lead the world in SARS-CoV-2 infections, with more than 1.5 million cases as of Thursday.
With the Rise of AI, What IP Disputes in Healthcare Are Likely to Emerge?
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.
‘Reasonable grounds’ to believe Bright’s removal from BARDA retaliatory, whistleblower agency says
Rick Bright's attorneys said in an emailed statement Friday that the Office of the Special Counsel would request a 45-day stay on Bright's removal as director of BARDA. Bright was removed over his objections to broad use of two malaria drugs in Covid-19.
The eye-popping allegations in ousted BARDA Director Rick Bright’s whistleblower complaint
Bright alleges that his removal from BARDA was the culmination of tensions that had arisen starting three years ago over contracts worth millions of dollars he says were awarded on the basis of political connections and "cronyism" rather than scientific merit.
Here are the top companies leading the fight against coronavirus
More than 80,000 people worldwide have been infected with the SARS-CoV-2 virus. In response, the U.S. government has partnered with several companies to develop drugs to treat the infection and vaccines to prevent it.
HHS creates plan to make EHRs less painful for docs
The Department of Health and Human Services put out a series of strategies to reduce the amount of time physicians spend on documentation on Monday. The report includes suggestions to standardize certain elements of EHRs, and bring federal reporting requirements up to date.
HHS taps Regeneron Pharmaceuticals in coronavirus drug effort
The department and the drugmaker said they would leverage an existing partnership to develop monoclonal antibodies for 2019-nCoV. A drug made by Gilead Sciences for Ebola is also being tested as a treatment for the rapidly spreading virus.