Reconciliation Bill Update

From the Partnership for Medicaid Home-Based Care

The bill that could carry additional HCBS funding – is moving along.  The closed-door reconciliation negotiations between Senate Majority Leader Chuck Schumer (D-NY) and Sen. Joe Manchin (D-WV) took a turn subsequent to the Department of Labor releasing data showing inflation at a 40-year high of 9.1 percent.  As a result, it looks like the Senate is considering a smaller reconciliation bill that would include drug pricing provisions and a short extension of ACA subsidies.   

Sen. Manchin told Majority Leader Schumer that until the August reports on interest and inflation rates are released, the two should not pursue a reconciliation package that includes climate change spending and tax increases.  He reiterated his opposition to the House-passed Build Back Better Act and stressed that the reconciliation package should focus on financial and energy security. 

Sen. Manchin’s spokesperson declined to comment on whether the Senator supports the inclusion of $150 billion for home- and community-based services but reiterated his concerns about inflation and his commitment to “lower healthcare costs for seniors and working families.”

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CMS Administrator Chiquita Brooks-LaSure Reemphasizes Home- and Community-Based Services Focus

Home Health Care News | By Joyce Famakinwa
 
On Tuesday, the U.S. Centers for Medicare & Medicaid Services (CMS) took the time to map out the federal agency’s strategic plans and key initiatives moving forward.
 
During the national stakeholder call, CMS Administrator Chiquita Brooks-LaSure, CMS Chief Operating Officer Jon Blum and Deputy Administrator and Director of Center for Medicaid and CHIP Services Dan Tsai, among others, discussed Medicare program compliance, payment innovation and protecting the Medicare program for years to come.
 
“We really have tried, over the Biden-Harris Administration, to be really clear in saying what our objectives are,” Brooks-LaSure said. “It’s been a little over a year since we unveiled the six pillars, which really were meant to help guide our work.”

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FDA Authorizes Novavax Covid Vaccine, in Hopes the Traditional Shot Will Convince Holdouts

StatNews | By Matthew Herper

The Food and Drug Administration on Wednesday authorized the Covid-19 vaccine developed by Novavax, a small Maryland biotech firm, for people 18 and over, voicing hope that the availability of a more traditional vaccine might help convince those skeptical of the Covid shots using new mRNA technology to get inoculated.

As with other Covid vaccines, the Novavax shot will be free to consumers, because the U.S. government will purchase the doses. But before the vaccine will be widely available, it must also be recommended by the director of the Centers for Disease Control and Prevention. That recommendation will likely follow a July 19 meeting of an expert committee convened by the CDC.

“Authorizing an additional Covid-19 vaccine expands the available vaccine options for the prevention of Covid-19, including the most severe outcomes that can occur such as hospitalization and death,” said FDA Commissioner Robert M. Califf in a prepared statement. “Today’s authorization offers adults in the United States who have not yet received a COVID-19 vaccine another option that meets the FDA’s rigorous standards for safety, effectiveness and manufacturing quality needed to support emergency use authorization.”

The U.S. has received 3.2 million doses of the vaccine that are ready to be shipped to states once the vaccine is authorized and recommended by the CDC.

“Today’s FDA emergency use authorization of our COVID-19 vaccine provides the U.S. with access to the first protein-based COVID-19 vaccine,” said Stanley C. Erck, Novavax’s CEO. “This authorization reflects the strength of our COVID-19 vaccine’s efficacy and safety data, and it underscores the critical need to offer another vaccine option for the U.S. population while the pandemic continues.”

Unlike the vaccines from Pfizer/BioNTech and Moderna, the Novavax vaccine has had a bumpy path to the market. Novavax received $1.6 billion in support from the U.S. government’s Operation Warp Speed project in July 2020. At the time, the hope was that the company might begin making a vaccine by the beginning of 2021. But while the Moderna and Pfizer/BioNTech shots released data in November of 2020, results were not available for the Novavax vaccine until June of 2021.

There were also questions about the ability to produce the vaccine in large amounts. The original deal between Novavax and Operation Warp Speed would entitle the U.S. to 100 million doses of the vaccine. In the press release announcing the vaccine’s emergency use authorization, FDA officials emphasized that the vaccine had not only met the FDA’s bar for safety and efficacy but also “assessment of the manufacturing processes and information.”

In June, a panel of FDA advisers voted 21 to 0, with one abstention, that the Novavax vaccine’s benefits outweigh its risks.

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