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Thursday, March 3, 2022

Civica aims to launch low-cost insulin in U.S. by 2024

 Non-profit drugmaker Civica said on Thursday it expects to launch lower-cost versions of insulin in the United States by 2024, to help diabetic patients struggling with high prices for the life-sustaining medicine.

Civica, launched in 2018 to make generic drugs, said it would produce three copycat versions of insulin, and make them available at roughly the same price for all customers, once approved by U.S. health regulators.

The company's products, which would be available as both vials and pre-filled pens, are biosmilars to Sanofi SA's SASY.PA Lantus, Eli Lilly and Co's LLY.N Humalog and Novo Nordisk's NOVOb.CO Novolog.

The maximum price for all three of Civica's products would be no more than $30 per vial and no more than $55 for a box of five pen cartridges, the company said.

That compares with $300 per vial and $500 for five pens, which are the average wholesale prices, according to Civica.

More than 34 million people in the United States have diabetes, according to the U.S. Centers for Disease Control and Prevention (CDC).

https://www.userwalls.com/n/civica-aims-launch-low-cost-insulin-2024-2903652/

U.S. Healthcare Agencies Request Data on COVID Misinformation

 The U.S. Department of Health & Human Services and the Office of the Surgeon General will request input on COVID-19 misinformation online as they seek to understand the role it played during the pandemic and its impact on health decisions made by individuals.

The agencies will put out a Request For Information (RFI) on Thursday to collect public comments and data within 60 days from stakeholders such as academic institutions, advocacy groups, government entities and community-based organizations.

"This RFI seeks to understand both the impact of health misinformation during the COVID-19 pandemic and the unique role that technology and social media platforms play in the dissemination of critical health information during a public health emergency," the agencies said.

The RFI will look for details on how rampant COVID misinformation is on tech platforms, their policies to fight suh content and sources who spread such lies online. It will also look for data on how such content impacted trust in the healthcare system, morale of healthcare workers and the implications for future public health emergencies.

Reuters reported in February the White House has eased up in its fight against vaccine misinformation after Biden accused Facebook last year of "killing people" by spreading vaccine lies.

https://www.usnews.com/news/us/articles/2022-03-03/u-s-healthcare-agencies-request-data-on-covid-misinformation

Novo Nordisk more than doubles sales target for obesity drugs

 Danish drugmaker Novo Nordisk has more than doubled its target for sales of obesity drugs by 2025 after overwhelming demand for its new Wegovy drug.

Novo Nordisk now aims to generate annual obesity drug sales of more than 25 billion Danish crowns ($3.72 billion) by 2025, the company said at its capital markets day on Thursday.

Its previous goal was to double its 2019 obesity drug sales totalling 5.7 billion crowns.

The company had a breakthrough with Wegovy, which was released in the United States in June last year and helps to achieve weight loss of 17% on average over almost two years.

Novo Nordisk was overwhelmed by initial demand for Wegovy, leading to supply shortages.

The company took a further hit in December, when a contract manufacturer filling syringes for pens to inject the drug temporarily halted deliveries and manufacturing after issues relating to good manufacturing practice.

https://www.marketscreener.com/quote/stock/NOVO-NORDISK-A-S-1412980/news/Novo-Nordisk-more-than-doubles-sales-target-for-obesity-drugs-39650205/

I-Mab Gets Orphan Drug Designation for Gastric-Cancer Treatment

 I-Mab said on Thursday that it has been granted an orphan drug designation by the U.S. Food and Drug Administration for its gastric-cancer treatment.

The drug, TJ-CD4B, is a novel Claudin bispecific antibody that treats gastric cancer, gastroesophageal junction cancer and related cancers.

The clinical-stage biopharmaceutical company said the designation would help it expedite its global clinical development and bring to market a novel treatment for the group of cancers.

I-Mab said it is undergoing Phase 1 trials in the U.S. and China in patients with advanced solid tumors stemming from gastric and related cancers.

https://www.marketscreener.com/quote/stock/I-MAB-95388118/news/I-Mab-Gets-Orphan-Drug-Designation-for-Gastric-Cancer-Treatment-39651621/

Roche teams up with research institutions for new Alzheimer's trial

 Roche Holding is launching with three research institutions a new late-stage clinical trial of its gantenerumab treatment in Alzheimer's disease, the Swiss drugmaker said on Thursday.

The trial aims to evaluate the potential of gantenerumab to slow disease progression in people with the earliest biological signs of Alzheimer's disease, before too much permanent neurological damage is done, it said in a statement.

https://www.reuters.com/business/healthcare-pharmaceuticals/roche-teams-up-with-research-institutions-new-alzheimers-trial-2022-03-03/

Wednesday, March 2, 2022

CMS wallops nursing homes with planned staffing requirements and increased penalties

The Centers for Medicare & Medicaid Services will establish minimum staffing requirements as part of a broad plan to “crack down on unsafe nursing homes,” the White House announced on Monday. 

The agency said it plans to conduct a new study to determine the level and type of staffing needed to ensure safe and quality care and will issue proposed rules within one year.

The reform measure is part of four new initiatives to ensure that residents get the quality care they need, according to the White House. President Joe Biden plans to raise the initiatives, which are sure to chafe nursing home operators, during his State of the Union address Tuesday evening. 

Biden also will call on Congress to supply almost $500 million to increase CMS’s survey budget by nearly 25%, an administration statement said.

The new initiatives also include plans to reduce resident room crowding, with CMS planning to explore ways to accelerate phasing out rooms with three or more residents and to promote single-occupancy rooms.

The agency also intends to update the Skilled Nursing Facility Value-Based Purchasing Program by proposing new payment changes based on staffing adequacy and the resident experience, as well as how well facilities retain staff.

Lastly, the agency will launch a new effort to identify what it calls problematic diagnoses and refocus efforts to continue to bring down the inappropriate use of antipsychotic medications.

The Biden administration also pledged to ramp up its accountability and oversight of nursing homes and called on Congress to raise the dollar limit on per-instance financial penalties levied on poor-performing facilities from $21,000 to $1,000,000. 

Failure ‘widespread’

The administration delivered a general broadside to nursing home operators while announcing the new plans.

“In the past two years, more than 200,000 residents and staff in nursing homes have died from COVID-19 — nearly a quarter of all COVID-19 deaths in the United States,” the White House statement stated. “Despite the tens of billions of federal taxpayer dollars flowing to nursing homes each year, too many continue to provide poor, sub-standard care that leads to avoidable resident harm. In fact, failure to comply with Federal guidelines at nursing homes is widespread.”

It cited a Government Accountability Office report that found that, from 2013 to 2017, 82% of all inspected nursing homes had an infection prevention and control deficiency, “including a lack of regular handwashing,” that was identified through Medicare and Medicaid surveys. 

“Without decisive action now, these unacceptable conditions may get worse,” the administration said. 

Officials said that establishing minimum staffing levels will ensure that residents will be provided “safe, quality care, and that workers have the support they need.”

“Nursing homes will be held accountable if they fail to meet this standard,” they noted.

The consumer-facing Care Compare website will “prominently” display whether a facility is meeting future minimum staffing requirements. The agency also will “ensure that ratings more closely reflect data that is verifiable, rather than self-reported, and will hold nursing homes accountable for providing inaccurate information. “

In addition, President Biden will ask Congress to expand CMS’ powers so it can validate data and take enforcement action against facilities that submit incorrect information.

“CMS intends to propose new payment changes based on staffing adequacy, the resident experience, as well as how well facilities retain staff,” officials added in the White House statement.

Private equity slammed

The administration announcement took especially harsh aim at private equity’s ownership of nursing homes.

“Private equity firms have been buying up struggling nursing homes, and research shows that private equity-owned nursing homes tend to have significantly worse outcomes for residents,” a fact sheet provided by the White House said. 

It noted that private equity firms’ investment in nursing homes “has ballooned” from $5 billion in 2000 to more than $100 billion in 2018, with about 5% of all nursing homes now owned by private equity firms. 

It explained a recent study found that residents in nursing homes bought by private equity were 11.1% more likely to have a preventable emergency department visit and 8.7% more likely to experience a preventable hospitalization, when compared to residents of for-profit nursing homes not associated with private equity.

Another examination over 17 years , a working paper, examined 18,000 nursing facilities and found that private equity ownership increased “excess” resident mortality by 10%, increased prescription of antipsychotic drugs for residents by 50%, decreased hours of frontline nursing staffing by 3%, and increased taxpayer spending per resident by 11%.

“That suggests an additional 20,150 lives lost as a result of private equity ownership,” the administration said. Another study found that private equity-backed nursing homes’ COVID-19 infection and death rates were 30% and 40% above statewide averages, respectively.

“Too often, the private equity model has put profits before people — a particularly dangerous model when it comes to the health and safety of vulnerable seniors and people with disabilities,” the White House statement said. “Recent research has found that resident outcomes are significantly worse at private equity-owned nursing homes.”

CMS targets SFF facilities, corporate owners

The administration also intends to come down harder on consistently poor performing facilities. 

The Special Focus Facility program will be “overhauled to more quickly improve care … including changes that will make its requirements tougher and more impactful.”

“Facilities that fail to improve will face increasingly larger enforcement actions, including termination from participation in Medicare and Medicaid, when appropriate,” the administration said.

CMS also will expand how often it will penalize poor-performing facilities based on desk reviews of data submissions, which will be performed in addition to on-site inspections.

It said that beyond previously reversing President Trump’s move to levy one-time fines on “bad actor nursing homes,” CMS will now explore making such per-day penalties the default penalty for non-compliance.

The administration also wants Congress to give CMS added authority  to “require minimum corporate competency” so that individuals or entities can be barred from obtaining a Medicare or Medicaid provider agreement for a nursing home if they have had compliance problems, past or present.

President Biden also will ask Congress to allow CMS to levy penalties and enforcement actions on owners or operators, even after a poor-performing building is closed.

In addition, CMS will increase pressure on corporate owners and operators by creating a new database that will track and identify owners and operators across states “to highlight previous problems with promoting resident health and safety.”

The agency also plans to collect and publicly report “more robust” corporate ownership and operating data, according to the White House briefing statement.

Senior administration officials earlier Monday said the reform measures are part of new actions that the Biden-Harris administration is taking this year to tackle some of the most pressing competition and consumer protection problems across our economy. Included would be “new steps to protect seniors and other nursing home residents by cracking down on unsafe nursing homes.” 

https://www.mcknights.com/news/cms-wallops-nursing-homes-with-planned-staffing-requirements-and-increased-penalties/

Manchin proposes dramatically scaled down version of Build Back Better

 Sen. Joe Manchin (D-W.Va.), who torpedoed President Biden’s Build Back Better agenda at the end of last year, on Wednesday laid out a dramatically scaled down version that he says he could vote for under the special budget reconciliation process.  

Manchin said he could support a reconciliation package that reforms the tax code and lowers the cost of prescription drugs if the money raised is split between spending on new climate change proposals and deficit reduction and fighting inflation.  

The West Virginia senator clarified he hasn’t made any formal counterproposal to the White House but is sketching the outlines of a proposal that he could support along with the rest of the Senate Democratic Caucus.

Whatever Manchin ultimately agrees to would have a different name than the Build Back Better Act, which he said in December he couldn't support. 

“There’s not a proposal, there’s just a conversation,” he said of informal talks with White House officials.  

“It just makes all the sense in the world. The one thing that we as Democrats all agreed on was the 2017 tax cuts were weighted unfairly. So if you want to fix the tax cuts and make everyone pay their fair share, whether it’s the very wealthiest or the corporations that pay nothing — I think the president identified that last night — then you have to fix the tax code,” he said.  

“Then you find out what revenues you have from that if you fix it,” he added.

Manchin also said there is broad agreement among Democrats on passing legislation to reduce the cost of prescription drugs and suggested that modeling a program on what the Department of Veterans Affairs does to negotiate lower prices for military veterans would be a good idea.  

“The other thing that we should all agree on is the high pharmaceutical prices, so you allow the negotiations. And I just said the organization that does the best job is the VA, the veterans administration gets some of the lowest prices. Maybe we should look at them and let them basically do [that] for our Medicaid and Medicare [recipients],” he said.

Manchin says half of the revenue raised from tax reform and prescription drug reform should be used to lower the deficit and fight inflation and the other half should be spent on whatever 10-year program has the most support in the Democratic caucus. 

He suggested spending on an array of initiatives to fight climate change would likely unify his Democratic colleagues.  

“Half of that money should be dedicated to fighting inflation and reducing the deficit,” he said. “The other half you can pick for a 10-year program, whatever you think is the highest priority and right now it seems to be the environment — and that’s a pretty costly one — would take care of it.” 

White House negotiators last year hammered out the outlines of a scaled-down agreement with centrist Sen. Kyrsten Sinema (D-Ariz.) and other Democratic senators to lower the cost of prescription drugs, but it didn’t go as far as some liberals, such as Sen. Bernie Sanders (I-Vt.), initially wanted.  

Asked to clarify whether he wants the prescription drug proposal deal with Sinema and other lawmakers renegotiated, Manchin said he wasn’t intimately familiar with the details of that proposal.  

“I’m just throwing it out,” he said of his idea for prescription drug reform. 

Asked about what he thought of the work already done on the issue with Sinema, Manchin responded: “I haven’t seen it.” 

Manchin also declined to comment on the details of the tax reform he would like to see enacted.

“I’m just saying reconciliation is for getting your financial house in order,” he said, adding that whatever tax reform comes to the floor may be different than what White House officials and senators negotiated last year. 

“I’m talking about a fair tax system,” he said, declining to take a position on the wealth surtax that the White House unveiled as part of its framework in the fall.

But he insisted that he’s not engaged in any formal talks with the White House. 

“Everybody knows pretty much where I am,” he said. “This is nothing new. What I just told you all ... is nothing new. I’ve been saying it for a year.”  

https://thehill.com/homenews/senate/596580-manchin-proposes-dramatically-scaled-down-version-of-build-back-better