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Monday, January 3, 2022

CMS wants insurers to offer standardized plan options on the ACA exchanges

 The Biden administration is aiming to require insurers to offer standardized plan designs on the Affordable Care Act's (ACA's) exchanges.

As part of the Centers for Medicare & Medicaid Services' (CMS') 2022 Notice of Benefit and Payment Parameters rule, which was released late Tuesday, payers would have to offer standardized plan options for every product network type, plan tier type and plan classification.

CMS said the goal is to allow consumers to have an easier shopping experience. As standardized plans share a uniform cost-sharing structure, it's simpler to compare across plans.

“We are building a more competitive, transparent and affordable health care market," said Department of Health and Human Services Secretary Xavier Becerra. "At the end of the day, health care should be a right for everyone, not a privilege for some.”

In addition, CMS wants to reestablish mandated network adequacy reviews for plans on the federal exchange. 

"The standards used for these reviews would highlight key characteristics like time and distance to care, as well as appointment wait times," CMS said in a release.

The rule also aims to address health equity through several provisions. For one, insurers would be required to include 35% of essential community providers in each plan's service area. Ensuring access to those facilities would improve access to coverage for people in underserved and low-income areas, CMS said.

The rule would also bar insurers explicitly from discriminating against patients based on sexual orientation or gender identity. Protections for these covered services were removed in 2020 under the Trump administration.

The rule also proposes streamlining the essential health benefits non-discrimination policy by requiring insurers to rely on clinical evidence in their plan designs. For example, a plan could not force inordinately high prescription costs on people with chronic conditions without a clinical backing.

https://www.fiercehealthcare.com/payer/cms-wants-insurers-to-offer-standardized-plan-options-aca-exchanges

Theranos founder Elizabeth Holmes guilty on four counts

 A federal jury on Monday found Theranos founder Elizabeth Holmes guilty on four counts of wire fraud, more than two years after she was charged with misleading investors with fraudulent claims about the efficacy of her blood-testing technology.

The jury made up of eight men and four women found Holmes, 37, guilty after a four-month trial on three counts of wire fraud against Theranos investors and one count of conspiracy to commit wire fraud, as The Wall Street Journal reported.

The jury found Holmes not guilty on three counts of committing wire fraud against patients who had paid Theranos for blood test results. The jury was unable to reach a verdict on two other counts of wire fraud and one count of conspiracy to commit wire fraud.

CNBC reported that U.S. District Court Judge Edward Davila will sentence Holmes at a later date. Holmes potentially faces decades in prison, with the penalty for wire fraud being up to 20 years.

Her conviction is a bleak result for the Stanford University dropout, who was once hailed as the next Steve Jobs, after whom she modeled herself.

With her lofty claim of being able to conduct a multitude of diagnostic tests with only one drop of blood, Holmes was able to attract a bevy of eager investors, including the family of former Education Secretary Betsy DeVos, media mogul Rupert Murdoch and the pharmacy chain Walgreens.

Apart from investors, Holmes also had a slew of cultural and political luminaries who publicly supported her ambitions. Former Secretaries of State Henry Kissinger and George Schultz sat on Theranos's board of directors.

Holmes once participated in a panel with former President Clinton, who said he was "impressed" by her "dogged determination" to improve the quality of laboratory tests.

During the trial, prosecutors said that Holmes "chose fraud over business failure," having recognized that her company's flagship product had numerous defects, but still decided against informing her many investors.

“She chose to be dishonest. This choice was not only callous; it was criminal," assistant U.S. Attorney Jeff Schenk said in his closing arguments.

Holmes's defense sought to paint her as an entrepreneur who wished to improve health care. During her testimony, Holmes stated that any information she disseminated came from experts within her company.

“I wanted to convey the impact,” she said. "I wanted to talk about what this company could do a year from now, five years from now, 10 years from now. They weren’t interested in today or tomorrow or next month, they were interested in what kind of change we could make."

Holmes also claimed that Theranos COO Ramesh “Sunny” Balwani, with whom she was in an undisclosed relationship for 10 years, was physically and emotionally abusive towards her and controlled her daily life.

She has accused Balwani of rape, saying he would "force me to have sex with him when I didn’t want to because he would say that he wanted me to know he still loved me.”

Balwani's own trial is scheduled to begin later this year. He also faces charges of wire fraud and conspiracy to commit wire fraud.

https://thehill.com/regulation/court-battles/588094-jury-finds-theranos-founder-elizabeth-holmes-guilty-on-four-counts

Neurodegenerative disease biotech Vigil Neuroscience sets terms for $112 million IPO

 Vigil Neuroscience, a Phase 1 biotech developing antibody therapies for neurodegenerative diseases, announced terms for its IPO on Monday.


The Cambridge, MA-based company plans to raise $112 million by offering 7 million shares at a price range of $15 to $17. At the midpoint of the proposed range, Vigil Neuroscience would command a fully diluted market value of $491 million.

The company is utilizing a precision medicine approach to develop a pipeline of therapies, initially addressing genetically defined patient subpopulations, that it believes will activate and restore immune cell function within the brain. Its lead candidate, VGL101, is a fully human monoclonal antibody (mAb) that is initially being developed for adult-onset leukoencephalopathy with axonal spheroids and pigmented glia (ALSP). In November 2021, the FDA cleared Vigil's IND for VGL101 in ALSP. The company initiated its first-in-human Phase 1 trial in December, and topline data is expected in the 2H22.

Vigil Neuroscience was founded in 2020 and plans to list on the Nasdaq under the symbol VIGL. Morgan Stanley, Jefferies, Stifel, and Guggenheim Securities are the joint bookrunners on the deal. It is expected to price during the week of January 3, 2022.

Hypertension biotech CinCor Pharma sets terms for $176 million IPO

 CinCor Pharma, a Phase 2 biotech developing oral treatments for hypertension and cardio-renal diseases, announced terms for its IPO on Monday.


The Boston, MA-based company plans to raise $176 million by offering 11 million shares at a price range of $15 to $17. At the midpoint of the proposed range, CinCor Pharma would command a fully diluted market value of $594 million.

The company's lead candidate, CIN-107, has been designed to use a differentiated mechanism of action, direct inhibition of aldosterone synthase production, with the goal of providing an improved treatment for patients suffering from hypertension, or high blood pressure. In 2021, CinCor Pharma initiated several different trials for patients suffering from hypertension as well as primary aldosteronism, or PA. The company is also exploring its utility in ameliorating complications of chronic kidney disease, or CKD, with plans to initiate trials in the first half of 2022. 

CinCor Pharma was founded in 2018 and plans to list on the Nasdaq under the symbol CINC. Morgan Stanley, Jefferies, and Evercore ISI are the joint bookrunners on the deal. It is expected to price during the week of January 3, 2022.

ALS biotech Amylyx Pharmaceuticals sets terms for $166 million IPO

 Amylyx Pharmaceuticals, a Phase 3 biotech developing therapies to treat ALS, announced terms for its IPO on Monday.


The Cambridge, MA-based company plans to raise $166 million by offering 8.8 million shares at a price range of $18 to $20. At the midpoint of the proposed range, Amylyx Pharmaceuticals would command a fully diluted market value of $1.1 billion.

Amylyx is developing therapies for amyotrophic lateral sclerosis (ALS) and a broad range of neurodegenerative diseases. The company believes its lead candidate, AMX0035, is the first drug candidate to show both a functional and survival benefit in a large-scale clinical trial of patients with ALS. Amylyx recently initiated a 48-week Phase 3 trial of AMX0035 for the treatment of ALS in the US and Europe. It submitted an NDS in Canada in the 2Q21, an NDA to the FDA in the 4Q21, and plans to submit an MAA in Europe in the 1Q22.

Amylyx Pharmaceuticals was founded in 2014 and booked $1 million in revenue for the 12 months ended September 30, 2021. It plans to list on the Nasdaq under the symbol AMLX. Goldman Sachs, SVB Leerink, and Evercore ISI are the joint bookrunners on the deal.

GOP senators press for answers on testing shortages despite 'ample' funding

 Two top Republican senators are calling on the Biden administration to provide answers about how it has spent billions of dollars in testing funds for COVID-19 amid shortages in such tests across the country. 

Pharmacies sold out of rapid tests, and long lines at testing sites have sprung up in the last month amid holiday travel and a massive surge in cases fueled by the omicron variant. 

Sen. Richard Burr (N.C.), the top Republican on the Senate’s health committee, and Sen. Roy Blunt (Mo.), the top Republican on the Appropriations health subcommittee, wrote to Secretary of Health and Human Services Xavier Becerra to ask why there are shortages despite the billions approved by Congress since 2020 that were specified for increased testing.

The senators pointed to $34.8 billion for testing across five bipartisan packages in 2020, and another $47.8 billion from Democrats’ American Rescue Plan in 2021. 

“With over $82.6 billion specifically appropriated for testing, and flexibility within the Department to allocate additional funds from COVID-19 supplemental bills or annual appropriations if necessary, it is unclear to us why we are facing such dire circumstances now,” the senators write. “It does not appear to be because of lack of funding, but a more fundamental lack of strategy and a failure to anticipate future testing needs by the administration.”

Health experts have also been pushing the administration for months to do more to make rapid tests free and widely available. 

Late last month, the administration took action on that front, announcing the purchase of 500 million rapid tests to be made available for free to Americans who order them online. The tests are set to become available this month. Experts have pushed for further action given the U.S. population of 330 million, saying that 500 million tests are far from enough. 

The senators are seeking information from Becerra about how much funding for testing remains unused, as well as a breakdown of how congressional funding for tests has been spent so far.

https://thehill.com/policy/healthcare/588037-gop-senators-press-for-answers-on-testing-shortages-despite-ample-funding

No charges for Cuomo in nursing home investigation: attorney

 The Manhattan district attorney's office is closing its probe into former New York Gov. Andrew Cuomo's (D) handling of nursing home deaths during the early days of the coronavirus pandemic, an attorney for Cuomo said Monday.

Elkan Abramowitz, a former high-ranking federal prosecutor who was hired by Cuomo while he was still in office, said there will be no charges.

“I was contacted today by the head of the Elder Care Unit from the Manhattan District Attorney’s Office who informed me they have closed its investigation involving the Executive Chamber and nursing homes. I was told that after a thorough investigation – as we have said all along – there was no evidence to suggest that any laws were broken,” Abramowitz said in a statement.

A spokesperson for the Manhattan district attorney did not immediately respond to a request for comment.

An investigation by the New York attorney general found that Cuomo’s administration undercounted coronavirus-related deaths at nursing homes by as much as 50 percent.

A separate investigation by the New York Assembly also recently concluded that Cuomo's administration misrepresented data on COVID-19 nursing home deaths.

New York counted only residents who died on nursing home property and did not include those who were transferred to hospitals. But according to the report, most of the deaths occurred in hospitals.

Cuomo announced his resignation in August after the New York state attorney general's office released a report detailing numerous allegations of sexual harassment from multiple women. Cuomo has denied the allegations. 

https://thehill.com/homenews/state-watch/588047-no-charges-for-cuomo-in-nursing-home-investigation-attorney