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Monday, February 7, 2022

Delaware lifting indoor mask mandate Friday; school mask requirement expires end of March

 Delaware Governor John Carney will lift the state's indoor mask mandate at the end of the week while a mask requirement for schools will expire at the end of March.


"We're in a much better place than we were several weeks ago in the middle of the Omicron surge of COVID-19 cases and hospitalizations," Governor Carney said in a statement.

Carney signed a revision to the State of Emergency order on Monday which will end Delaware's universal indoor mask mandate at 8 a.m. on Friday, February 11.

At the same time, the governor temporarily extended the mask requirement in public and private K-12 schools and child care facilities.

This requirement, which applies to children kindergarten-age and older, will expire at 11:59 p.m. on Thursday, March 31.



Carney says this temporary extension will give parents time to get their school-age children vaccinated before the expiration of the statewide requirement.

According to the governor, the March 31 date also allows districts and schools time to consider local mask requirements and gives the Division of Public Health (DPH) and the Department of Education (DOE) time to work with schools on updates to quarantine and contact tracing guidance.

"I want to be clear about this point - COVID is still circulating in our communities. And the virus still poses a risk of serious illness, particularly among those who are not up to date on their vaccinations," Carney said. "But we have the tools to keep ourselves and each other safe. Get vaccinated. Get your booster. That's especially important for children, where we continue to see low rates of vaccination. For all the parents out there - the best way to keep your child in school learning, and to prevent them from getting sick, is to get them vaccinated. It's that simple. I want to thank all Delawareans for taking this threat seriously."

Enough is enough: The VA must stop the manipulation and follow the law

 Secretary of Veterans Affairs Denis McDonough told the Senate Veterans Affairs Committee in December: “What I believe is that we are giving the best available care to our veterans, including historically high levels of care in the community.”

Well, Mr. McDonough, if the VA’s current offerings are the best this country has to offer our veterans, we have a lot of work to do.  

Since the VA MISSION Act was signed into law more than three years ago, we’ve been paying close attention to the VA as it implements this landmark legislation that affords more veterans the flexibility to take their VA benefits and seek care in their communities.

But we are concerned about the progress that has been made … or, more appropriately, lack thereof.  

When the pandemic hit in 2020, the VA should have worked overtime to increase that flexibility in accordance with the law. Instead, it did almost the opposite. Millions of appointments were canceled or delayed, many without the courtesy of a follow up.  

Fortunately, the pandemic opened the door to deeper investigations into how the VA is mishandling its community care program. The problems are systemic, and deeply rooted in the VA’s dysfunctional administration.

A recent in-depth report found that VA administrators are overruling doctors’ decisions for the sake of cost control and keeping veteran patients in the VA health care system.

Documents obtained through a Freedom of Information Act request (and subsequent lawsuit after the VA didn’t comply with the request on time) reveal the infuriating realities veterans face in their attempts to get care. 

The VA is using outdated scheduling guidance to determine who is eligible for community care, manipulating wait times so veterans are not offered alternative non-VA care, and actively dissuading veterans from using non-VA providers. Official guidance documents and phone scripts encourage VA employees to unload their coordination responsibilities onto veterans, misleading vets into thinking community care is a hassle and difficult to manage.  

This all points to the VA putting bureaucracy ahead of the men and women it exists to serve. And while the VA secretary has called suggestions that the VA is breaking the law an “overstatement,” the evidence proves otherwise. 

The VA’s own documentation shows it is not following the law, either in letter or in spirit. And that is unacceptable. 

Veterans didn’t put on the uniform and risk their lives only to come home to a health care system that is more interested in preserving its own interests than providing so much as the bare minimum of attention and care.

This year, we reaffirm our commitment to ensure the VA follows the VA MISSION Act and gives veterans access to the care they deserve. We’re prepared to do whatever it takes to accomplish that goal, including calling for hearings on the Hill and investigations from the Office of Inspector General and Government Accountability Office.

Further, we will fight to get permanent community care access standards passed by Congress so there is transparency and stability in the Community Care Program. 

Let 2022 be the year we all say “enough is enough” with the VA’s dysfunction and instead use the full force of government to demand better. Veterans deserve nothing less. 

Russ Duerstine is deputy director of Concerned Veterans for America and an Air Force veteran. Marsha Blackburn is the senior senator from Tennessee and serves on the United States Senate Committee on Veterans Affairs. 

https://thehill.com/blogs/congress-blog/politics/593166-enough-is-enough-the-va-must-stop-the-manipulation-and-follow

Zimmer Biomet Investor Day: Transcript

 https://www.marketscreener.com/quote/stock/ZIMMER-BIOMET-HOLDINGS-I-14996/news/Transcript-Zimmer-Biomet-Holdings-Inc-Analyst-Investor-Day-37806273/

Amgen Stock Remains In Limbo As Its Biggest Product Flounders

Amgen (AMGN) reported soaring fourth-quarter earnings Monday, but sales didn't inch up enough to top Wall Street's expectations — leaving Amgen stock in limbo.

During the fourth quarter, Amgen earned $4.36 per share, minus some items, on $6.85 billion in sales. Earnings rocketed 26% and easily beat expectations for $4.04 per share. But sales rose just 3%, not enough to beat projections for $6.87 billion.

The best growth came from Amgen's Evenity, an osteoporosis treatment. Sales surged 59% year over year to $143 million.

But sales from Amgen's biggest moneymaker, Enbrel, declined 13% to $1.11 billion. Enbrel treats autoimmune conditions. Amgen blamed lower net selling price and lower inventory for the dip. It also noted another of its own drugs, Otezla, gained Food and Drug Administration approval for plaque psoriasis, chipping away at Enbrel sales.

At the close, Amgen stock rose a fraction to finish at 223.53, where they remained unchanged after the post-session earnings release. Amgen stock is sitting on a floor at its 50-day moving average, according to MarketSmith.com.

Amgen Stock: Prolia, Repatha Climb

Among Amgen's bigger products, sales of osteoporosis treatment Prolia rose 17% to $873 million and revenue from cholesterol treatment Repatha inched 8% ahead to $273 million. But Aimovig, its migraine prevention drug, brought in just $90 million, falling 13% year over year.

Meanwhile, sales of bone marrow-stimulating drugs Neulasta and Neupogen tumbled 35% and 33%, respectively. Both are facing off against biosimilar competition.

Amgen didn't provide guidance for 2022, instead saying it will do so at its business review early Tuesday. For the year, Amgen stock analysts expect $17.67 earnings per share and $26.92 billion in sales.

https://www.investors.com/news/technology/amgen-stock-amgen-earnings-q4-2021/

Mental health therapists seek exemption from part of law to ban surprise billing

 Groups representing a range of mental health therapists say a new law that protects people from surprise medical bills puts providers in an ethical bind and could discourage some patients from care.

The therapists take no issue with the main aim of the legislation, which is to prevent patients from being blindsided by bills, usually for treatment received from out-of-network medical providers who work at in-network facilities. Instead, they are concerned about another part of the law—a price transparency provision—that requires most licensed medical practitioners to give patients detailed upfront cost estimates, including a diagnosis, and information about the length and costs involved in a typical course of treatment. That’s unfitting for mental health care, they say, because diagnoses can take time and sometimes change over the course of treatment.

Finally, if they blow the estimate by at least $400, the law says uninsured or self-pay patients can challenge the bills in arbitration.

Arguing that the rule is burdensome and unnecessary, mental health providers wrote a Jan. 25 letter to the Department of Health and Human Services, seeking an exemption from the “good faith” estimates for routine mental and behavioral health services. The letter was signed by 11 groups, including the American Psychological Association, the National Association of Social Workers, the American Psychiatric Association, and the Psychotherapy Action Network.

Some also worry that the law will allow insurance companies to play a larger role in dictating what even non-network mental health therapists can charge, although policy experts say it isn’t clear how that could happen. Although exact figures are not available, it’s estimated that one-third to one-half of psychologists are not in-network with insurers, the psychologists’ association said. And those numbers do not include other practitioners, such as psychiatrists and licensed clinical social workers, who are also out of network.

“We got thrown into this bill, but the intention [of the law] was not mental health but high-cost medical care,” said Jared Skillings, chief of professional practice with the American Psychological Association. “We’re deeply concerned that this [law] inadvertently would allow private insurance companies to set regional rates across the country that, for independent practitioners, would be a race to the bottom.”

Therapy costs vary widely around the U.S. and by specialty, but generally range from $65 an hour to $250 or more, according to the website GoodTherapy.

The good faith estimates must be given this year to uninsured or self-pay patients for medical or mental health care services. They were included in the No Surprises Act as part of a broader effort to give patients a good idea of cost, both per visit and for a course of treatment, in advance.

Therapists say their professional codes of ethics already require disclosure to patients of per-visit costs. Requiring diagnostic billing codes in the estimate before even seeing a patient—as they interpret the rule—is unethical, they argue, and tallying up what might be weeks or even months of treatment costs could keep some patients from undergoing care.

“If people see a large dollar amount, they might be intimidated or scared into not getting help at all,” said Linda Michaels, a private practice therapist in Chicago and co-chair of the Psychotherapy Action Network.

The counterargument, though, is that one of the law’s aims was to provide patients with pricing information—for mental health services or medical care—that is less opaque and more similar to what they’re used to when shopping for other types of goods or services.

Benedic Ippolito, an economist at the American Enterprise Institute, said he is sympathetic to medical providers’ concerns about the extra administrative burden. But “giving consumers a better sense of financial obligation they are exposed to and imposing some cost pressure on providers are both reasonable goals,” he said.

Even among providers, there is no universal agreement on how burdensome the estimates will be.

“It’s not an unreasonable thing, frankly, for psychiatrists, not just plastic surgeons or podiatrists, to say, ‘If you want me to do this and you’re not covered by insurance or whatever, it will cost you X amount for the whole episode of care and this is what you get in return,’” said Dr. Robert Trestman, chair of psychiatry and behavioral medicine at the Virginia Tech Carilion School of Medicine. Although he serves on an American Psychiatric Association committee, he was voicing his own opinion.

The Centers for Medicare & Medicaid Services said mental health providers are not exempt from the rules about good faith estimates, in a written statement to KHN. It added, however, that the agency is working on “technical assistance geared toward mental health providers and facilities.” Federal agencies often issue additional clarification of rules, sometimes in the form of FAQs.

The No Surprises Act took effect on Jan. 1. Its thrust was to bar medical providers from sending what are called surprise or “balance” bills to insured patients for out-of-network care provided in emergencies or for non-emergency situations at in-network facilities. Common before the law passed, such bills often amounted to hundreds or thousands of dollars, representing the difference between the amount insurers paid toward out-of-network care and the often much higher amounts charged.

Now, insured patients in most cases will pay only what they would have been billed for in-network care. Any additional amount must be worked out between their insurer and the provider. Groups representing emergency doctors, anesthesiologists, air ambulance providers, and hospitals have filed lawsuits over a Biden administration rule that outlines the factors independent arbitrators should consider when deciding how much an insurer must pay the medical provider toward disputed bills.

Most mental health services, however, aren’t directly touched by this part of the directive because treatment is not typically performed in emergency situations or in-network facilities.

Instead, the complaint from mental health providers focuses on the good faith estimates.

Additional rules are expected soon that will spell out how upfront estimates will be handled for people with health coverage. In their letter to HHS, the behavioral health groups say they fear the estimates will then be used by insurers to limit treatment for insured patients or influence pay negotiations with therapists.

Several policy experts say they do not think the law will affect mental health reimbursement in most cases.

“Mental health professionals will have the exact same ability to bill out-of-network, to have patients agree to whatever market price is for their services,” said Loren Adler, associate director of the USC-Brookings Schaeffer Initiative for Health Policy, who has long studied balance billing issues. “Nothing about the No Surprises Act restricts that.”

Some of the therapy groups’ concerns may stem from misreading the law or rules implementing it, say policy experts, but they still reflect the confusion providers share surrounding the rollout of the law.

As for how to handle pre-treatment diagnoses that are needed to deliver good faith estimates, CMS said in its email to KHN that providers could estimate costs for an initial screening, then follow up with an additional estimate after a diagnosis.

“No one is going to be forced to make a diagnosis of a patient they have not met,” Adler said.

https://www.fiercehealthcare.com/providers/mental-health-therapists-seek-exemption-part-law-ban-surprise-billing

Citing 'milder' omicron, 16 states reignite legal battle against CMS' vaccine mandate

 The attorneys general of 16 states resumed their legal battle against the Biden administration’s COVID-19 vaccine mandate for healthcare workers, writing Friday in a second amended lawsuit that “the situation has changed” with the rise of the highly infectious, but more vaccine-resistant, omicron variant.

In the time since their first challenge was filed and eventually rejected by a split Supreme Court, the states said that the delta variant specifically cited by the federal government in its interim final rule was supplanted by the “milder” omicron variant.

The Centers for Disease Control and Prevention (CDC) has reported that the three currently authorized COVID-19 vaccines are less effective in preventing COVID-19 infection with the omicron variant, the attorneys general wrote in the filing, while public health leaders including Anthony Fauci, M.D., have publicly suggested that the variant “will ultimately find just about everybody” regardless of vaccination and subsequent booster status.

Additionally, surveillance data show that individuals who are infected with the omicron variant are less likely to experience severe illness and hospitalization than those infected with the delta variant, they wrote.

“Simply put, the situation has changed. And that reveals a fundamental, structural defect in the rule—its one-size-fits-all approach doesn’t account for developing data and circumstances,” the states wrote in the second amended filing.

The CDC and other health authorities have continued to urge the public to seek out vaccines and boosters throughout the omicron wave, pointing to data indicating that vaccines and boosters still offer some protection against infection and substantially reduce an individual’s risk of hospitalization. These characteristics of the omicron variant and the authorized COVID-19 vaccines were not described in Friday's amended filing.

Rather, the states bolstered their argument by reiterating prior warnings that implementation of the vaccine requirement would further jeopardize a strained healthcare labor market. Hospitals and other settings are so understaffed that Health and Human Services (HHS) published guidance in January permitting asymptomatic staff with positive COVID-19 test results to return to work, the attorneys general wrote.

Additionally, they said that recently published Centers for Medicare and Medicaid Services (CMS) guidance on vaccination expectations places “the burden to implement this labyrinth of irrational rules” on state surveyors, who they wrote would also need to be vaccinated to conduct their assessments.

“The federal government has now made clear that it expects the states to implement this flawed policy with state employees,” Louisiana Attorney General Jeff Landry said in a Friday press release. “So I will continue fighting this ill-advised invasion of individual autonomy and my state’s rights.”

The amended lawsuit was filed in the same Louisiana district court that had granted the states a preliminary injunction against CMS’ interim final rule late last year. The Biden administration challenged that injunction and another shortly after, kicking off a legal battle that eventually made its way to a divided Supreme Court.

Signing onto the new amended lawsuit were the attorneys general of Louisiana, Montana, Arizona, Alabama, Georgia, Idaho, Indiana, Kentucky, Mississippi, Ohio, Oklahoma, South Carolina, Tennessee, Utah, Virginia and West Virginia.

Most of those states face a Feb. 14 deadline for healthcare workers to receive their first dose of a COVID-19 vaccine. Two states, Tennessee and Virginia, have already passed their Jan. 27 first-dose deadline.

CMS’ COVID-19 vaccine requirement applies to roughly 10.4 million healthcare workers at 76,000 medical facilities, according to the Biden administration.

The mandate is broadly supported by national healthcare industry groups and professional organizations as a “common-sense” measure to limit COVID-19 transmission, although some individual facilities and the nursing home/assisted living industry groups worried the requirement would worsen an ongoing labor shortage.

Those staffing challenges were cited last week by the governors of West Virginia and Virginia, both of whom pleaded with the Biden administration to relax or postpone the mandate “to protect our most vulnerable healthcare systems and facilities from a staffing breakdown.” Both states are signed on to Friday’s amended filing.

https://www.fiercehealthcare.com/providers/covid-19-vaccine-mandate-16-states-cms-hhs-biden

House punts sequester relief, telehealth reform in short-term spending bill

 House appropriators bypassed addressing major health priorities on telehealth and sequester relief in a short-term spending bill introduced Monday that funds the federal government through March 11.

The House Appropriations Committee released legislation Monday for the short-term continuing resolution to avert a government shutdown by Feb. 18. Health groups have been pressing for additional relief from a 2% cut to Medicare payments expected to go back into effect this summer.

But the short-term spending bill will give congressional negotiators more time to work on a larger omnibus package.

“We are close to reaching a framework government funding agreement, but we will need additional time to complete the legislation in full,” said House Appropriations Committee Chairwoman Rep. Rosa DeLauro, D-Connecticut, in a statement Monday.

The legislation does extend the enhanced federal matching rate for Medicaid funding for certain territories through March 11.

However, it does not include any policies that provider groups have been lobbying for, as groups have another month to make their case to lawmakers.

Several hospital groups are hoping to get relief from a 2% cut to Medicare payments made under sequestration. The payment cuts were suspended by Congress in 2020 at the onset of the pandemic to help providers facing massive revenue shortfalls.

Congress reached a deal late last year to keep the 2% moratorium through April, when it then declines to 1% through June and then resumes the full cut after that month.

But hospital groups say that the landscape has dramatically changed since that deal was made in early December, as the omicron-fueled surge of the virus and crippling labor shortages has caused massive strain on facility finances. Groups are hoping to use the must-pass spending bill as a vehicle for policy changes.

Some groups, such as the American Hospital Association, want the 2% moratorium to be extended through the duration of the COVID-19 public health emergency, which was extended into April by the Biden administration and could be extended again.

Other groups have wanted key flexibilities for telehealth use to be made permanent for another year or two to give the federal government more time to study the use of telehealth. The Centers for Medicare & Medicaid Services removed many barriers to Medicare reimbursement for telehealth, but those flexibilities go away after the public health emergency ends.

https://www.fiercehealthcare.com/providers/house-punts-sequester-relief-telehealth-reform-short-term-spending-bill