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Thursday, December 12, 2024

Lawmaker group wants to force health insurers, PBMs to sell off pharmacies

 A bipartisan group of lawmakers introduced legislation that would force the breakup of pharmacy benefit managers (PBMs), the drug industry middlemen that have come under increasing scrutiny by lawmakers and regulators. 

A Senate bill led by Sens. Elizabeth Warren (D-Mass.) and Josh Hawley (R-Mo.) would prohibit a parent company of an insurer or PBM from also owning pharmacies, forcing companies to divest their pharmacy businesses within three years. 

It’s a practice the lawmakers called “a gross conflict of interest that enables these companies to enrich themselves at the expense of patients and independent pharmacies.” 

A companion bill in the House is led by Reps. Diana Harshbarger (R-Tenn.) and Jake Auchincloss (D-Mass.) 

PBMs are on the hot seat, as lawmakers and regulators dig into what they say are the perverse incentives within the industry that drive up drug prices.  

“PBMs have manipulated the market to enrich themselves — hiking up drug costs, cheating employers, and driving small pharmacies out of business,” Warren said in a statement.  

PBMs negotiate the terms and conditions for access to prescription drugs for hundreds of millions of Americans. They are responsible for negotiating prices with drug companies, paying pharmacies and creating formularies that determine which drugs patients can access and how much they cost. 

As the industry has grown more consolidated, critics say PBMs have exerted greater control over patients’ access to medicine. PBMs are vertically integrated, serving as health plans and pharmacists.  

The three biggest PBMs—CVS Health’s Caremark, Cigna’s Express Scripts and UnitedHealthGroup’s OptumRx—are owned by insurance companies, which in turn also own specialty, mail order or retail pharmacies.  

PBMs and brand drug manufacturers negotiate rebates — volume-based discounts for plans and pharmacies — which the PBM then passes on to employers. The industry argues they help keep costs contained and insurance premiums low. 

But a Federal Trade Commission investigation found PBMs also impose restrictions that limit access to less expensive drugs and inflate the cost of cancer drugs. A report by House Republicans had similar findings, and also explored how PBMs charge patients more to use their local pharmacy as a way to steer patients to the PBM-affiliated ones.  

“The insurance monopolies are ruining American health care. Patients and independent pharmacies are paying the price. This legislation will stop the insurance companies and PBMs from gobbling up even more of American health care and charging American families more and more for less,” Hawley said in a statement. 

It’s likely too late in the year for the bill to advance, but the bipartisan effort shows lawmakers are trying to lay the groundwork for reform next year. President-elect Trump has also indicated he backs efforts to crack down on PBM business practices. 

There are efforts to include a provision in the year-end spending bill that would change how PBMs are paid in order to eliminate an incentive to drive patients to the highest-cost drugs. 

Last summer, Harshbarger and Auchincloss teamed up for a bill targeting PBMs attempts to steer patients to their preferred pharmacies.  

But Wednesday’s legislation, if passed, would represent the most significant attempt yet to regulate the industry.  

https://thehill.com/policy/healthcare/5035450-bipartisan-lawmakers-want-to-force-health-insurers-pbms-to-sell-off-pharmacies/

Trump, GOP expected to undo Biden’s divisive nursing home rule

 Republicans are expected to rescind the Biden administration’s contentious nursing home staffing rule before it is set to take effect. 

The move would come as a relief for the nursing home industry, which has argued the mandate doesn’t appropriately address current workforce challenges. But consumer advocates and public health experts who have fought to protect the rule fear repealing it will harm residents and long-term care facility workers alike.   

More than 200,000 nursing home and long-term care residents died during the first two years of the COVID-19 pandemic, with the spread of the virus and resulting deaths linked to staffing shortages.   

In response, the Biden administration proposed three reforms to nursing homes, including setting a national minimum staffing requirement.   

As part of the rule establishing that requirement, which was finalized earlier this year, nursing homes would be required to provide every resident with at least 3.48 hours of nursing care a day, including at least 0.55 hours of care from a registered nurse and 2.45 hours of care from a nurse aide.   

It also would require nursing homes to have a registered nurse on site 24 hours a day, seven days a week to ensure that critical care can be given to residents at any time.   

The rule has faced bipartisan opposition, with Republicans pushing particularly hard against the staffing mandate.   

Lawmakers in both the House and Senate introduced joint resolutions under the Congressional Review Act (CRA) to overturn the rule in the months after it was finalized.

“Severe workforce and nursing shortages have already hampered access to care. The Biden administration’s rule would only make it worse,” Sen. Bill Cassidy (R-La.), ranking member of the Senate Committee on Health, Education, Labor and Pensions, said in statement after co-sponsoring the Senate measure introduced by Sens. James Lankford (R-Okla.) and Joe Manchin (I-W.Va.). “We are pushing to ensure seniors can rest easy knowing they can access quality care when they need it.”  

Neither of the resolutions has passed, and the rule is currently set to take full effect for urban facilities in 2027 and for rural nursing homes in 2029.  

GOP lawmakers proposed fully repealing the rule as part of a preliminary offer for health care policies to be added to the continuing resolution Congress is working to pass by Dec. 20 to avert a government shutdown.  

And there are multiple ways it could be blocked from being implemented or undone entirely under the incoming Trump administration.  

Lawmakers in the House and Senate, both of which will soon be controlled by narrow GOP majorities, could pass legislation like the Midnight Rules Relief Act, which would amend the CRA to allow Congress to overturn federal regulations enacted during the final year of the current administration instead of the current 60-day look-back period, according to Leading Age, a nursing home industry group.   

Congressional lawmakers could also use the budget and appropriation process to stop the implementation of the rule.   

On top of this, the Trump administration could issue a new rule to roll the current one back or eliminate it, according to health policy nonprofit KFF.   

“This would have to go through the rulemaking process but could ultimately undo the provisions in the rule,” said Priya Chidambaram, senior policy manager on Medicaid and the uninsured at KFF.   

Beyond the incoming Republican trifecta, the court battles currently playing out over the rule also provide a potential avenue for it to be overturned. 

Its defeat would mark a victory for the nursing home industry, which has urged Republican lawmakers — along with some Democrats — to scrap the rule, arguing that it sets an impossible, and pricey, standard for facilities to meet that will ultimately worsen care for residents and cause closures.

Instead, nursing home industry groups like the American Health Care Association and National Center for Assisted Living (ACHA/NCAL) have called for “targeted investments” to increase the long-term care workforce.  

One proposed strategy to help attract more caregivers to the profession is to offer financial assistance for current or future caregivers as well as training and educational opportunities, according to the group’s website.  

“Nursing homes will struggle to find qualified caregivers and be forced to limit admissions, downsize, or close altogether,” a spokesperson for the AHCA/NCAL wrote in an email to The Hill.   

The organization was one of two industry groups that filed a lawsuit earlier this year in an attempt to block the rule.   

Less than 20 percent of nursing facilities in the country currently meet all three of the minimum staffing requirements in the rule, according to an analysis from KFF. And most of the facilities that are not meeting those requirements are for-profit nursing homes or long-term care facilities.   

According to the analysis, 11 percent of for-profit facilities can meet the staffing minimums, while 41 percent of nonprofits and 39 percent of government facilities can.  

The AHCA/NCAL estimates that the nursing home industry would need to hire roughly 100,000 more nurses and nursing aides to ensure that every facility meets all three of the rule’s requirements. That bump in staffing would cost $6.5 billion a year, the organization said.  

The federal government, meanwhile, estimates the cost of implementing the final rule would be $43 billion over 10 years.   

But however costly or “illogical” opponents of the rule believe it to be, labor unions, consumer advocates and public health experts have contended it would ultimately help improve the health and safety of nursing home residents and staff.   

“We have minimum staffing standards for doggy day cares, we have minimum staffing standards for child care centers,” said Sam Brooks, director of public policy at the National Consumer Voice for Quality Long-Term Care. “It’s absurd to think that this is some burden that is going to undo the industry.”  

Brooks told The Hill that the rule is designed to raise the standard of care at the worst-performing nursing facilities in the country and that it is not a “one-size-fits-all” mandate.   

One 2024 study found that fewer nursing home residents are hospitalized or visit emergency rooms at facilities with more registered nurses. Another 2024 study from the University of California, San Francisco shows that nursing homes with higher numbers of certified nursing assistants improve the quality of care residents receive.   

Sherry Culp, the long-term care ombudsman at Kentucky’s Cabinet for Health and Family Services, recalls how the importance of staffing at nursing and long-term care facilities was repeatedly underlined at 20 nursing home resident forums she and her colleagues hosted across the state.  

“Staffing was the thing that came up at every forum, and the negative impacts of being short-staffed,” said Culp. She added that she recently received a report of how a rapidly declining nursing home resident was left grossly unattended to due to understaffing.   

The resident’s decline was discovered after a family member visited them and found them unable to speak with multiple trays of untouched food around their bed and their shoes filled with urine, she said. 

“If there were sufficient staff, would someone not be coming in to check and see if this person was able to eat … or to come in to see if that resident needed assistance to go to the toilet or needed to be changed?”   

Experts, advocates and unions are fighting to keep the rule from being overturned. In a joint letter to congressional leadership last week, they urged lawmakers to oppose any legislation or end-of-year deal that “derails or postpones” it.   

“Industry opposition makes little sense when many facilities already meet or exceed specific components of the staffing rule and when the rule’s total ratios are less than current national averages,” the letter reads.  

“There is virtually universal agreement that facilities should employ registered nurses around the clock. Fundamentally, it is a rule designed to address the poorest-performing homes in the country.” 

https://thehill.com/policy/healthcare/5033563-nursing-home-staffing-rule-repeal-expected/

ActBlue update: Subpoenaed for likely foreign ‘gift card’ donations to Dem Party, candidates

 ActBlue, which is a funding application that all Democrats in Alaska use, is under investigation by Congress for its probable use of foreign donations to Democrat candidates, such as Rep. Mary Peltola, the Alaska Democratic Party, and Democrats in the Alaska Legislature.

On Tuesday, the Committee on House Administration’s Chairman Bryan Steil announced findings of his subpoena of ActBlue that reveal that only in September of 2024 did ActBlue create policies to “automatically reject donations that use foreign prepaid/gift cards, domestic gift cards, are from high-risk/sanctioned countries, and have the highest level of risk as determined,” by its solution provider, a company called Sift, an artificial intelligence-powered fraud detection service.

“While this is a positive step forward, there is still more work to be done to ensure our campaign finance system is fully protected from fraud and unlawful foreign interference,” Congressman Steil said. “The documents provided to the Committee also confirm that ActBlue still accepted these concerning payment methods in July, a period when Democrats raised a record number of campaign money before implementing these safeguards.”

Steil is still working to create transparency in campaign funding to prevent foreign funds from being illegally funneled into U..S. political campaigns.

Background of the committee’s work

On Oct. 31, 2023, following reports that ActBlue was accepting political contributions without a three-digit card verification value (CVV), Chairman Steil sent a letter demanding answers on ActBlue’s practices, questioning if they are complying with federal campaign finance laws and preventing foreign and illegal contributions.

On Nov. 27, 2023, ActBlue responded to Chairman Steil’s letter saying it did not require a CVV in order to contribute on their website.

On Sept. 6, 2024, Chairman Steil introduced H.R. 9488, the Secure Handling of Internet Electronic Donations (SHIELD) Act. The legislation prohibits political committees from accepting an online contribution unless the contributor provides the CVV and billing address associated with the card and from accepting online contributions from prepaid cards. It also adopts a top legislative recommendation from the FEC to prohibit individuals from knowingly aiding or abetting a person making a contribution in the name of another person.

On September 11, 2024, the SHIELD Act passed the Committee on House Administration by a voice-vote.

On Sept. 18, 2024, Chairman Steil sent letters to the Attorneys General from Texas, Virginia, Arkansas, Florida, and Missouri, updating them on the Committee’s investigation into ActBlue, a major democratic fundraising platform. Along with the letter, the Attorneys General received the data and evidence that the Committee has collected over the course of almost a year. 

On Oct. 28, 2024, Chairman Steil sent a letter to ActBlue demanding documents and information related to the platform’s donor verification policies and potential vulnerabilities that foreign actors may exploit to illegally participate in the U.S. political process.

On Oct. 30, 2024, Chairman Steil issued a subpoena to ActBlue for documents related to ActBlue’s donor verification policies and the potential for foreign actors to use the platform to launder illicit money into U.S. political campaigns.

The investigation is ongoing.

Investigative journalist James O’Keefe, founder of Project Veritas, blew open the ActBlue business model, when he interviewed people across the country whose names were being used as funding “mules” to candidates, unbeknownst to the supposed donors. The practice of using “straw donors” is a form of identity theft sometimes called “smurfing.”

In October, House Speaker Mike Johnson announced a website where people can check to see if they have been victimized by ActBlue or other funding application that funnels funds to political campaigns.

https://mustreadalaska.com/actblue-update-subpoenaed-for-likely-foreign-gift-card-donations-to-democratic-party-candidates/

Russia in contact with Syrian rebels, hopes to keep military bases, Interfax reports

 Russia has established direct contacts with the political committee of Syria's Islamist rebel group, Hayat Tahrir al-Sham, the Interfax news agency quoted Russian Deputy Foreign Minister Mikhail Bogdanov as saying on Thursday.

Interfax reported that Bogdanov, speaking to journalists, also said that Moscow aimed to maintain its military bases in Syria to continue "fighting international terrorism".

Bogdanov said contacts with HTS, the most powerful force in the country after the overthrow of President Bashar al-Assad, were "proceeding in constructive fashion".

Russia, he said, hoped the group would fulfil its pledges to "guard against all excesses", maintain order and ensure the safety of diplomats and other foreigners.

Bogdanov said Russia hoped to maintain its two bases in Syria - a naval base in Tartous and the Khmeimim Air Base near the port city of Latakia - to keep up efforts against international terrorism.

"The bases are still there, where they were on Syrian territory. No other decisions have been made for the moment," he was quoted as saying.

"They were there at the Syrians' request with the aim of fighting terrorists from the Islamic State. I am proceeding on the basis of the notion that everyone agrees that the fight against terrorism, and what remains of IS, is not over."

Maintaining that fight, he said, "requires collective efforts and in this connection, our presence and the Khmeimim base played an important role in the context of the overall fight against international terrorism."

https://uk.news.yahoo.com/russia-contact-syrian-rebels-hopes-183422527.html

Canada government sells its Air Canada stake

 The Canadian government has sold its roughly 6% stake in Air Canada in the past few days, the Globe and Mail reported on Thursday, citing a source.

The government sold its Air Canada shares at an average selling price of about C$25 a share, the newspaper reported. Ottawa had bought Air Canada shares for about C$23.18 apiece in April 2021.

https://www.msn.com/en-ca/news/canada/canada-government-sells-its-air-canada-stake-globe-and-mail-reports/ar-AA1vKKvk

Private Medicare plans must cover Biogen's ALS drug, US agency says

 The Centers for Medicare & Medicaid Services has directed private insurers providing Medicare Advantage plans to cover Biogen's amyotrophic lateral sclerosis drug Qalsody after finding instances of coverage denial.

Qalsody received the U.S. Food and Drug Administration's accelerated approval last year, but CMS said it found many Medicare Advantage plans, which cover adults 65 years and older or those with disabilities, were denying coverage by calling the drug "experimental and investigational".

FDA's accelerated approval pathway allows for earlier approval of drugs that treat serious conditions. Companies still require to conduct confirmatory trials to confirm that the drug actually provides a clinical benefit, following which the FDA grants a traditional approval for the drug.

CMS does not make a distinction between drugs that are marketed under an accelerated FDA approval versus a traditional approval, the agency said in a memo dated Dec. 9, and directed insurers to immediately discontinue the policy that denied coverage for the drug.

The agency said it expects insurers to contact patients who were inappropriately denied coverage of the drug to inform that policies have changed.

The ALS Association, a patient advocacy group, late on Wednesday said it began working with CMS to investigate "unjust denials" of coverage for the drug by insurance companies, who labeled the drug as "experimental".

The association urged people previously denied Qalsody by their Medicare Advantage plan to contact their ALS specialist to secure access to the treatment.

https://www.marketscreener.com/quote/stock/BIOGEN-INC-4853/news/Private-Medicare-plans-must-cover-Biogen-s-ALS-drug-US-agency-says-48582440/

Acadia Sells Rare Pediatric Disease Priority Review Voucher for $150 Million

 Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced the closing of the sale of its Rare Pediatric Disease Priority Review Voucher (PRV) for $150 million before fees and expenses. As described at the time the agreement to sell was announced on November 5, 2024, Acadia is required to pay Neuren Pharmaceuticals Limited one-third of the net proceeds, pursuant to a license agreement between the companies.

Acadia plans to invest proceeds from the sale of the PRV to support its commercial operations, R&D programs in central nervous system and rare disease, and future business development.

https://www.businesswire.com/news/home/20241211326451/en