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Daily News

December 31, 2020

Specialty drugs spending is on the rise, but the use of biosimilars could help lower overall costs, according to the Pharmaceuticals Strategy Group’s year-end report on drug costs.

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December 30, 2020

The HHS Office of General Counsel on Wednesday (Dec. 30) said drug manufacturers are required to provide 340B discounts to providers in the program via contract pharmacies, stating in an advisory opinion that the method by which 340B providers dispense drugs doesn’t affect the drug makers’ obligation to provide discounts.

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The federal government will wait until late January, after the new administration takes office, to begin a national campaign to combat skepticism of the COVID-19 vaccine, HHS officials told reporters Tuesday (Dec. 29).

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As other countries start planning human challenge trials to study and speed development of COVID-19 vaccines, debate continues in the United States over whether the controversial trial approach, in which participants are infected with the live virus, is ethical or necessary.

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The National Coalition on Health Care is urging the Biden transition team to make controlling drug prices a priority and suggests the incoming administration let insurers band together as one to negotiate drug prices and use inflationary rebates to curb price inflation.

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December 29, 2020

The U.S. Court of Appeals for the District of Columbia Circuit on Tuesday (Dec. 29) ruled that HHS can move forward with its controversial hospital price transparency rule on Jan. 1, agreeing with a lower court just days before the rule was set to go into effect.

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FDA wants developers of at-home and over-the-counter COVID-19 tests to ensure their testing platforms are set up to report users’ results to public health officials, but one cybersecurity consultant warns that allowing software to share user information raises the potential for cybersecurity and data integrity issues.

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The Biden administration should immediately work to lower health care costs by quickly implementing the surprise billing compromise in the year-end legislation, extending financial assistance to struggling providers and working with Congress to incentivize states to expand Medicaid, the National Coalition on Healthcare says in a letter to the Biden transition team outlining its priorities.

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Medicare seems to have figured out how to make coronavirus antibody therapies free for everyone in Medicare after initially struggling to determine how to make the administration of antibody therapies free for Part B beneficiaries who lack supplemental coverage.

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December 28, 2020

The surprise billing battle may be over in the halls of Congress, but provider groups, hospitals and insurers are just beginning their battle at HHS, as the agency gears up to begin its rulemaking process now that the president has signed the year-end legislative package.

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Kidney patient advocates are thrilled that the year-end spending bill includes a long-sought policy change that requires Medicare to cover immunosuppressive drugs for kidney transplant patients for as long as the treatment is needed.

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The Center for Medicare Advocacy and the National Association of Accountable Care Organizations are pushing the incoming Biden administration to halt a last-minute effort by the Trump administration to put in place a Medicare geographic direct contracting option -- which the Commonwealth Fund has called one of the biggest changes to Medicare since managed care.

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December 24, 2020

Operation Warp Speed chief Moncef Slaoui said he thinks vaccine makers should unblind their trials once they get emergency use authorization and let participants who received placebo move over to the active vaccine arm, no matter their risk group, a view that conflicts with FDA’s stance that vaccine makers should keep their trials blinded for as long as possible to obtain more robust safety and efficacy data.

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The year-end bill’s $3 billion provider relief fund is far less than the $35 billion spending pot expected by providers, as lawmakers decided at the last minute it would be adequate to direct HHS to reuse an estimated $20 billion in reclaimed or unused provider relief in future distributions.

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The year-end spending package Congress passed Monday night (Dec. 21) includes reforms aimed at increasing Medicare beneficiaries’ access to post-acute care.

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The 2020 year-end package that passed the House and Senate Monday (Dec. 21) includes a number of policies aimed at improving hospice care, and the National Hospice and Palliative Care Organization says the bill will help provide uninterrupted access to hospice providers during the pandemic -- though the group will closely watch how the program integrity provisions are implemented.

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December 23, 2020

By granting a 14-day restraining order to delay the start of the most-favored-nation demonstration on Wednesday (Dec. 23), a federal judge signaled the drug industry will likely succeed in killing the demo.

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States have up to six months after the COVID-19 public health emergency ends to begin kicking ineligible enrollees off Medicaid and Children’s Health Insurance Program rolls, according to a CMS guidance released Tuesday (Dec. 22) that dictates how states should return to the normal redetermination process after the pandemic.

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The Trump administration managed to buy another 100 million doses of Pfizer’s coronavirus vaccine for about $2 billion after turning down the extra 100 million doses this summer, and as recently as this November, and finding itself in a bind because other countries bought those doses in the interim.

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Twenty-five days is not long enough to comment on the prior authorization rule CMS proposed in early December, the Association for Community Affiliated Plans said Tuesday (Dec. 22) in a letter asking the agency to extend the comment period by at least 90 to 120 days.

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