CMS to crack down on Medicare Advantage audits, poised to claw back billions from insurers

 Federal regulators likely will claw back billions of dollars in overpayments made to Medicare Advantage plans beginning in 2018, backtracking from an earlier proposal that sought to collect on overpayments made to insurers more than a decade ago.  

Regulators had proposed to go back further, reaching back as far as 2011 to claw back overpayments. The CMS released the final rule on Monday for health insurers that operate Medicare Advantage plans, which cover about 29 million Americans. 

One key change is that regulators will extrapolate from a small subset of audits and apply the error rate to the insurer’s Medicare Advantage business. 

Before, insurers didn’t have to worry about these audits financially, Ted Doolittle, former deputy director for CMS’ Center for Program Integrity, which oversees Medicare fraud, said in an interview. 

“A little bit of a free pass has gone away,” Doolittle said, adding that the financial penalty wasn’t steep enough before because it was only applied to an audit of a small subset of claims. 

The CMS said the common-sense policies will strengthen oversight of the program to help ensure Medicare’s fiscal sustainability. 

Federal regulators have raised concerns about alleged payment abuses in the MA program for years, specifically for those tied to risk adjustments. 

“Today we are taking long overdue steps to conduct audits and recoup funds,” HHS Secretary Xavier Becerra said in a statement on Monday. 

Medicare Advantage plans, run by private insurers, are paid capitated rates to provide health coverage to millions of Americans.

The plans also receive what are called risk-adjusted payments designed to raise payments to plans for sicker members. 

Sicker members generate higher risk scores, which results in higher payments to plans.

Federal regulators have said the arrangement creates a financial incentive for health plans to inflate risk scores and “game the system.” The HHS Office of Inspector General (OIG) has flagged the use of health risk assessments that plans use to collect information on members in an effort to boost risk scores. 

A previous OIG report said that by CMS’ own estimates, Medicare made $50 billion in overpayments from 2013 through 2017 from “from plan-submitted diagnoses that were not supported by beneficiaries’ medical records.”

The final rule that seeks to bolster audits on overpayments comes as enrollment in Medicare Advantage is expected to reach a milestone this year, more seniors will be enrolled in an MA plans than traditional fee-for-service Medicare. 

https://www.healthcaredive.com/news/federal-regulators-crack-down-on-medicare-advantage-audits-poised-to-clawb/641562/

Biden administration plans to end COVID public health emergency in May

 The Biden administration on Monday announced that the COVID-19 public health emergency, which has been in place since January 2020, is set to end on May 11.

“The COVID-19 national emergency and public health emergency (PHE) were declared by the Trump Administration in 2020.  They are currently set to expire on March 1 and April 11, respectively.  At present, the Administration’s plan is to extend the emergency declarations to May 11, and then end both emergencies on that date,” the Office of Management and Budget said in a statement.

Since it was first declared on Jan. 31, 2020 by former Health and Human Services (HHS) Secretary Alex Azar, the national PHE has been renewed 12 times under two different administrations. The most recent renewal was declared on Jan. 11.

The Biden administration has repeatedly said it would provide a notice of at least 60 days if it decided to end the PHE so that health care providers and stakeholders could have time to prepare. Monday’s announcement provides gives 101 days until the emergency officially ends.

“To be clear, continuation of these emergency declarations until May 11 does not impose any restriction at all on individual conduct with regard to COVID-19,” OMB said in its statement. “They do not impose mask mandates or vaccine mandates.  They do not restrict school or business operations.  They do not require the use of any medicines or tests in response to cases of COVID-19.”

As OMB noted, an abrupt end to the PHE would cause “wide-ranging chaos and uncertainty throughout the health care system.” Since the declaration, programs such as Medicaid have operated under special rules, allowing beneficiaries to retain their coverage during the pandemic.

Under the flexibilities that were enacted under the PHE, traditional Medicare and Medicare Advantage beneficiaries were able to receive free at-home COVID-19 testing and treatments and pay no cost-sharing.

Private insurance providers were also required to cover coronavirus testing and services with no cost-sharing and without prior authorization.

Last year, Medicaid released guidance on a 12-month period of “unwinding” after the PHE ended in which operations would return to pre-pandemic norms. The guidance dictated that state Medicaid and CHIP agencies will be allowed to begin their “unwinding” period either one month before the PHE ends, the same month that it ends or the month after it ends.

The end of the PHE will also mean the end of Title 42 border policy, which allows border officials to expel foreign nationals and ignore asylum claims for the sake of public health protections.

“The number of migrants crossing the border has been cut in half, approximately, since the Administration put in place a plan in early January to deter irregular migration from Venezuela, Cuba, Nicaragua, and Haiti. The Administration supports an orderly, predictable wind-down of Title 42, with sufficient time to put alternative policies in place,” OMB stated.

GOP lawmakers have already unveiled legislation to end the PHE, including the ‘‘Pandemic is Over Act.” That bill, introduced by Rep. Brett Guthrie (R-Ky.) earlier this month, would end the PHE the same day it is enacted. With a Democratic majority in the Senate and a veto by President Biden almost certain to occur if it were to be passed by Congress, this bill appeared to mostly symbolic in nature, designed to put on the record Republican lawmakers’ discontent with the ongoing PHE.

The Biden administration criticized the methods by which the legislation aimed to end the emergency, saying it would impose “highly significant impacts” on the U.S. health care system and government operations as well as allow “thousands of migrants per day into the country immediately without the necessary policies in place.”

Senate Republicans said the move is overdue.

“It makes sense. Everybody’s either got immunity through taking the vaccine, had [COVID-19] or probably both. It’s time to move on,” Sen. Lindsey Graham (R-S.C.) said shortly after the White House’s announcement. 

“That’ll have some impacts. … Most people would argue it’s long overdue. I think we’ve said goodbye —- not entirely, but for all intents and purposes —- to the pandemic a long time ago and I think it’s probably high time our policies reflect that,” Sen. John Thune (R-S.D.) said.

https://thehill.com/policy/healthcare/3836604-biden-administration-plans-to-end-covid-public-health-emergency-in-may/

UnitedHealth $750K Grant to Community Health Care Association of NYS 'To Improve Health Equity'

 UnitedHealthcare Community Plan of New York has announced a $750,000 investment to support a grant program in collaboration with the Community Health Care Association of New York State (CHCANYS). Grants will be awarded to federally qualified health centers (FQHCs) throughout New York to increase access to care coordinators and care navigators, commonly known as community health care workers or "CHWs" at FQHCs.

The application-based program will invite any FQHC in New York state to apply for the grant funding, with awards ranging from $25,000 to $33,000 for up to 15 health centers. Funding recipients will establish a learning collaborative among community health centers utilizing CHWs to share best practices for staffing, training, engagement and scope of work.

https://finance.yahoo.com/news/unitedhealthcare-provides-750-000-grant-130000529.html

U.S. House Republican to pursue safeguards on classified documents

 

The Republican head of a key U.S. House of Representatives committee said on Monday that he will pursue bipartisan legislation to better ensure the proper handling of classified documents at the White House when administrations leave office.

House Oversight Committee Chairman James Comer said it is essential to have legislation ensuring classified material is not transferred from the offices of the president and vice president to unsecured locations at the end of an administration.

The discovery of classified documents at former President Donald Trump's Mar-a-Lago resort and at other sites including President Joe Biden's Delaware home have led to the appointment of two different special counsels and raised national security fears.

Classified documents have also turned up at the Indiana home of former Vice President Mike Pence.

"We have to reform the way that documents are boxed up when they leave the president's and vice president's office and follow them into the private sector," Comer told a National Press Club forum.

"Somebody needs to oversee all of the documents that are going into boxes to make sure they're not classified."

Comer said that he and Representative Jamie Raskin, the oversight panel's top Democrat, hope to have a bill in place before Biden leaves office. A Raskin spokesperson was not immediately available for comment.

"We're going to work together in a bipartisan way to come up with a legislative fix prior to this administration leaving and the next information coming into office," the Kentucky Republican added.

Comer's committee is scheduled to have a transcribed interview with National Archives General Counsel Gary Stern on Tuesday. The sessions follows a Comer demand for information from the National Archives concerning documents found in Biden's possession.

The Republican, who has also sought material on the misplaced documents from the White House and Justice Department, said he wants to know if any of the documents found at Biden's home were handled by the president's son Hunter Biden, who has long been a target for Republican accusations of influence peddling.

Comer said his panel will hold the first public hearing of its investigation of Biden family business dealings on Feb. 8.

The House Oversight probe is a distraction for Biden and could cast a shadow over the Democratic president as he gears up for a possible 2024 re-election bid.

The committee will hear testimony from three former Twitter employees and the social platform's handling of information about Hunter Biden.

https://www.marketscreener.com/quote/stock/BOXED-INC-130552221/news/U-S-House-Republican-to-pursue-safeguards-on-classified-documents-42850374/

U.S. says FTX founder Bankman-Fried needs limits on communications, asset access

 

The U.S. government on Monday urged a judge to reject Sam Bankman-Fried's claim it went too far by insisting that the indicted founder of the now-bankrupt FTX cryptocurrency exchange be banned from contacting his former colleagues.

In a letter to U.S. District Judge Lewis Kaplan in Manhattan, prosecutors also asked that a bail condition that prevents Bankman-Fried from accessing or transferring assets at FTX and his Alameda Research hedge fund be left in place.

They argued those assets were "vulnerable to exploitation and in need of protection from the defendant."

The requests came two days after Bankman-Fried's lawyers proposed letting their client access crypto assets and continue communicating with most of FTX's and Alameda's estimated 350 employees, some of whom they said could help his defense.

Mark Cohen and Christian Everdell, who represent Bankman-Fried, did not immediately respond to requests for comment. They have until Feb. 1 to address prosecutors' view on accessing assets.

Bankman-Fried, 30, has been free on $250 million bond and confined at his parents' home in California, after pleading not guilty to fraud for allegedly looting billions of customer dollars from FTX.

Prosecutors previously raised concerns about witness tampering after Bankman-Fried on Jan. 15 sent an encrypted message over the Signal app to an FTX affiliate's general counsel, who could testify against him at a trial set to begin in October.

"I would really love to reconnect and see if there's a way for us to have a constructive relationship, use each other as resources when possible, or at least vet things with each other," Bankman-Fried had written.

In Monday's letter, prosecutors called the message an effort to "improperly influence" the general counsel, no matter how benign it might seem.

"The defendant's position of authority with respect to his former employees, combined with his recent outreach to a former employee about the case, raises a sufficient specter of witness tampering," prosecutors said.

Prosecutors also want to ban Bankman-Fried from using apps such as Signal that let users auto-delete messages, and instead have him communicate in text messages, emails and phone calls.

Bankman-Fried's lawyers have said their client was trying simply to provide assistance to the general counsel, and has not been not using the auto-delete feature.

They also proposed that Bankman-Fried not be allowed to talk with select colleagues, including former Alameda chief Caroline Ellison, former FTX technology chief Zixiao "Gary" Wang and former FTX engineering chief Nishad Singh.

Ellison and Wang have pleaded guilty and are cooperating with prosecutors.

https://www.marketscreener.com/news/latest/U-S-says-FTX-founder-Bankman-Fried-needs-limits-on-communications-asset-access--42849844/

Quince Pipeline Update and Business Outlook for 2023

 Quince Therapeutics, Inc. (Nasdaq: QNCX), a biotechnology company focused on acquiring, developing, and commercializing innovative therapeutics that transform patients’ lives, today provided an update on the company’s development pipeline and business outlook for 2023. The company intends to prioritize capital resources toward the expansion of its development pipeline through opportunistic in-licensing and acquisition of clinical-stage assets targeting debilitating and rare diseases. Quince plans to out-license its bone-targeting drug platform and precision bone growth molecule NOV004 designed for accelerated fracture repair in patients with bone fractures and osteogenesis imperfecta.

Key highlights of the company’s strategic growth plan include:

Prioritizing pipeline expansion through in-licensing and acquisition

Out-licensing of bone-targeting drug platform and precision bone growth molecule NOV004

Competitively positioned with strong balance sheet

• Strong cash position of approximately $94 million in cash, equivalents, and marketable securities as of December 31, 2022.

• Significant cash runway to support pipeline expansion through in-licensing and acquisition, as well as fund capital and operating expenditures into at least 2028.

• Expect annual capital and operating expenditures to approximate $11 million in 2023, excluding the impact of corporate restructuring and potential business development activities.

The company has not completed preparation of its financial statements for the fourth quarter or full year of 2022.

https://finance.yahoo.com/news/quince-therapeutics-provides-pipeline-business-210500178.html

Does Evidence Support Pharmacologic Treatment for Dementia?

 The enormous impact of cognitive impairments across the most diverse aspects of individual and public health emphasizes why the search for effective treatments to prevent the occurrence and slow the progression of these disorders is essential.

Recently, the US Food and Drug Administration (FDA) granted accelerated approval (ie, with no formal advisory committee meeting) for the use of lecanemab, an experimental monoclonal antibody capable of clearing the amyloid protein buildup from the brains of people living with early-stage Alzheimer's disease. As with aducanumab, the benefits associated with lecanemab were modest, and the medication caused concerning adverse events. But the outcry for treatment is so intense that the Alzheimer's Association referred to the FDA approval as a "historic moment."

This clearly highlights the lack of high‑quality evidence to support existing treatments for cognitive impairment, as we will see below.

No Robust Evidence

In 2018, the only Level A (strong) recommendation included in the American Academy of Neurology guidelines was to discuss the lack of evidence supporting the use of cholinesterase inhibitors (ChEIs) with patients and caregivers.

In 2020, "Dementia prevention, intervention, and care: 2020 report of The Lancet Commission" concluded that ChEIs have a useful, modest role in improving cognition and activities of daily living in patients with mild to moderate Alzheimer's disease. The authors wrote that memantine can be prescribed in combination, or each drug can be used separately, for moderate and severe Alzheimer's disease. However, it was felt that they offer only a small benefit.

In 2021, a thorough Cochrane review emphasized that ChEIs (donepezil, galantamine, and rivastigmine), as well as memantine, are prescribed to alleviate symptoms and delay disease progression in dementia. Given uncertainties about the benefits and adverse effects of these drugs in the long term and in severe dementia, the review sought to evaluate the effects of withdrawal or continuation of ChEIs or memantine, or both, in people with dementia — up to October 2020.

Seven trials were included in the review. All the participants had dementia due to Alzheimer's disease, but in some trials, the disease was mild to moderate, and in others it was moderate to severe or very severe. Six trials investigated the effects of stopping a ChEI, and one trial investigated stopping either a ChEI (specifically, donepezil) or memantine. The authors decided not to pool its results with the other six trials. Effects were measured over different periods of time in different trials. The authors looked separately at effects in the first 2 months (short term), between 3 and 11 months (medium term), and after a year or more (long term).

In summary, the results suggest the following conclusions about maintaining treatment with a cholinesterase inhibitor, compared with withdrawal:

• may be beneficial in the short and medium term, and probably in the long term, on memory and reasoning

• may confer little to no short-term effect, uncertain medium-term effect, and probable long-term benefit on the ability to perform activities of daily living

• may confer short- and medium-term benefits, but not long-term ones, on behavioral and mood symptoms

• showed no clear evidence in regard to physical health or risk of dying

• showed insufficient evidence in regard to quality of life or probability of nursing home placement.

The authors found no trials that only investigated stopping memantine. There was no evidence about types of dementia other than Alzheimer's disease, and the authors were unable to draw specific conclusions about continuing or stopping treatment at different stages of the illness.

The authors concluded that although there was uncertainty about the results, in light of the methodologic limitations and sources of bias inherent in the studies reporting these findings, most of the evidence pointed to benefits of continuing treatment with ChEIs.

In 2022, a systematic review of 24 studies on patients with dementia with a mean follow-up of 6-120 months indicated moderate-quality to high-quality evidence of a consistent association between long-term treatment with ChEIs and a reduction in all-cause mortality in patients with dementia. However, this study does not rule out the possibility of bias related to the absence of published trials with negative results. Moreover, the primary concern of patients and their families is quality of life and not mortality.

Practical Implications

Much like the Alzheimer's Association, patients and family members long for dementia treatments, which is only fair from an emotional point of view. Rationally, however, there is a lack of high-quality evidence on the benefits of the drugs already available.

As clinicians, in practice, we must do the following:

• Prioritize the prevention of cardiovascular risk factors

• Promote social activities, memory exercises, and treatment for depression and deafness

• Identify the causes of dementias that may be reversible

• Restrict the use of medications with anticholinergic effects

• Periodically assess basic cognition and functional capacity

• Refer patients to specialized services when needed.

If we decide to prescribe ChEIs or memantine, it is imperative that we be aware of possible adverse effects and recommended care. In addition, as has been stated, we must discuss this lack of evidence with patients and their family members and share the treatment decision.

Treatment may be discontinued due to a lack of adherence, persistent increase in the speed of cognitive decline, low life expectancy, drug intolerance, and patient or family preference.

The impact of dementias may be underestimated. A new disease, limbic-predominant age-related TDP-43 encephalopathy (LATE), a TDP-43 protein disease, has been identified in autopsies. It usually affects those over age 80 years and is a type of dementia that affects memory, thinking, and social skills, imitating Alzheimer's-type dementia. In community-based autopsy cohorts, 25% of brains presented LATE-NC burden associated with cognitive impairment. This condition may be having a growing impact among the aging population that is still relatively unknown in public health.

We need effective treatment options now more than ever!

Mauricio Wajngarten, MD, PhD

Cardiologist, Lecturer in Cardiology, Faculty of Medicine, University of São Paulo, São Paulo, Brazil

Disclosure: Mauricio Wajngarten, MD, PhD, has disclosed no relevant financial relationships.

https://www.medscape.com/viewarticle/987375