Employee References And Health Insurance Compliance Considerations For 2022

Nevada Carrier Partner Updates | Word & Brown

Source: Word & Brown, by Paul Roberts

The start of a new year brings recurring compliance items for employers, employees, and individual taxpayers to consider. Here is what you need to know.

California Individual Mandate Continues

California’s state individual mandate, which began 1/1/2020, continues into 2022 and the foreseeable future. Under California’s Individual Health Care Mandate, Californians are required to have qualifying health insurance for all months of the year, obtain an exemption to have insurance, or pay a fine to the California Franchise Tax Board. Individuals must have at least Minimum Essential Coverage (MEC) – which is employer-sponsored coverage, Individual and Family Plan (IFP) coverage, Medicare, Medicaid (Medi-Cal in California), etc.

The California Franchise Tax Board released an Individual Shared Responsibility Penalty Estimator to help Californians understand their non-compliance penalty exposure. The penalty is roughly 2.5% of a person’s household income or a flat dollar amount of $750 per adult and $375 per child – though the penalty can vary based on several factors, including annual inflation and a person’s tax situation.
Currently, five states and the District of Columbia have state individual health insurance mandates: California, Massachusetts, New Jersey, Rhode Island, Vermont, and Washington, D.C.

Important Considerations for Employees When Deciding to Waive Coverage

Employers should advise their employees of the ramifications created when waiving employer-sponsored health coverage in 2022, before making an enrollment decision for the year.

If an employee has been made an offer of affordable Affordable Care Act (ACA) compliant health insurance coverage by his/her/their employer of any size, that employee is ineligible for premium assistance/Premium Tax Credits (PTCs) to help pay for coverage attained on a state exchange (Covered California, Nevada Health Link, etc.). Affordability for individuals on the exchange is based on Modified Adjusted Gross Income (MAGI), which is sometimes simply referred to as household income. Employees could be required to pay back a significant portion of monies advanced for payment of their premium on the individual exchange if they claim/receive (claimed/received) an advanced PTC for which they are/were not truly eligible.

Of course, employees in California should also be made aware of the aforementioned California Individual Mandate.

Word & Brown has developed resources to help explain such details to employees in 2022, so they can make informed benefit decisions. Check out the Important Considerations for Employees Before Deciding to Waive Coverage:

Annual ACA IRS Reporting

January marks the beginning of the prime reporting season for employers considered Applicable Large Employers (ALEs) under the ACA in 2021. ALEs are required to comply with the ACA’s employer mandate, and, per the law, must offer all eligible Full Time (FT) employees at least Minimum Essential Coverage (MEC) that is affordable and meets a Minimum Value standard (a Bronze or better metal-tiered health plan). At a minimum, MEC must also be offered to those FT employees’ dependents.

ALEs in 2021 must now demonstrate their offers of coverage, in accordance with the mandate, to the Internal Revenue Service (IRS) using IRS Forms 1094-C and 1095-C in 2022. Health insurance carriers are also required to file similar IRS Forms 1095-B with the IRS, which demonstrate the coverage held by a person for the year.

Most employees who worked for an ALE in 2021 will be receiving at least two IRS Forms 1095 – one from their employer and another from their insurance carrier. Others who worked for multiple ALEs in 2021 will likely receive more forms. Employees who worked for a small, non-ALE in 2021 will receive at least one IRS Form 1095 from their health insurance carrier.

Employees should be advised that these forthcoming IRS Forms 1095 are for informational purposes; they do not need to be filed with the employees’ tax returns. The carriers’ Form 1095-B informs the recipient whether a person and his or her family members held MEC for the year, to help them complete their tax returns. The ALE’s Form 1095-C helps an employee who enrolled in individual coverage on the federal or state Exchanges (e.g., Covered California, Nevada Health Link, etc.) to determine eligibility for a Premium Tax Credit (PTC).

Word & Brown has created a reference that explains what the varying IRS Forms 1095 are and what to do with them, in languages employees can easily understand. Employees will find information on the forms, who they are sent to, who they are sent by, when they are sent, and what to do with the forms. Check out the references in: EnglishSpanishVietnameseKorean, and Chinese.

Employers considered ALEs in 2021 have until March 2, 2022, to release completed copies of IRS Forms 1095 to employees. They must also submit copies of the forms to the IRS by February 28, 2022, if submitting by paper, or March 31, 2022, if submitting electronically. Check out this reference to get a clearer look at these deadlines and responsibilities for ALEs, and more information on employer reporting penalties. Please also revisit our previous column for more details on employers’ additional ACA responsibilities in January 2022: Annual New Year Compliance Responsibilities for Employers.

CDC Is Criticized For Failing To Communicate, Promises To Do Better

CDC criticized for failing to communicate, promises to do better : Shots -  Health News : NPR

Source: NPR, by Selena Simmons-Duffin

On Friday, the Centers for Disease Control and Prevention held a telebriefing.

Director Rochelle Walensky presided, along with two career scientists. The substance was notable — updated COVID-19 guidance for K-12 schools.

But even more notable was the fact that the briefing was happening at all.

It was the first such briefing in months, despite the ongoing pandemic crisis.

That lack of regular communication has spurred criticism of the agency. In recent days, public health experts have called out CDC for confusing isolation and quarantine guidance, and asked the agency to communicate more often and more clearly.

An unmet promise

In fact, the Biden administration has repeatedly promised to put career scientists front and center in its COVID communications. But such experts have generally not appeared outside of White House COVID-19 Response Team briefings, usually held several times each week but typically only featuring political appointees, Walensky among them.

That’s not the same as a briefing by subject matter experts, sharing what they know with the press and the public.

“The fact is, there are dedicated scientists at CDC who are the world’s experts in a lot of these issues, and they need to be speaking directly to the public along with Dr. Walensky,” says Dr. Tom Frieden, CDC director during the Obama administration, who now runs Resolve to Save Lives, an initiative to help governments and outside groups prevent epidemics.

CDC is responding to these charges of inadequate communication. The agency decided to hold Friday’s briefing, Walensky told reporters on the call, because “we had heard clearly over the last week that there was interest in hearing from us independently.”

“This is hard and I am committed to continue to improve,” she said. “I anticipate that this will be the first of many briefings, and I very much look forward to them.”

Frieden is on board: “I hope this will be an inflection point in rebuilding confidence in CDC,” he says. “The more CDC can speak directly to the public following its own principles of communication in a health emergency, the better off we’ll all be.”

For CDC, COVID-19 briefings have been unusually sparse

The idea of speaking out during a public health crisis is hardly new. “CDC literally wrote the book on how to communicate in a health emergency,” says Frieden. It has clear principles to uphold, he says: “Be first, be right, be credible, be empathetic and give people practical, proven things to do to protect themselves, their families and their communities.”

Glen Nowak, who used to run media relations for the agency, says press briefings are an important part of its mission. “Typically, if there is some health development where it makes sense to notify the American public and give them recommendations and guidance as to what they should do about it, then press briefings are really helpful,” he says.

When the H1N1 outbreak began in 2009, “we did a press conference every single day for eight weeks, including weekends,” Nowak says. “We did press conferences as long as we had something that was new, something that was different, there was a need to do it.”

The idea wasn’t just to inform the public. At media briefings, says Frieden, “oftentimes, smart journalists ask tough questions, and we’d realize, ‘Oh, we didn’t say that as clearly as we intended,’ or, ‘We didn’t think of that, we’d better address that issue.’ ”

When SARS-CoV-2 was identified in China, CDC seemed to follow that playbook.

In mid-January 2020, Dr. Nancy Messonnier, then director of CDC’s National Center for Immunization and Respiratory Diseases, led the first CDC telebriefing on the subject. She was joined by another career scientist, Dr. Marty Cetron, director of CDC’s Division of Global Migration and Quarantine.

“Since the outbreaks of MERS and SARS, we have made improvements in our capacity in the United States and around the world,” Messonnier told reporters. “We’re now better poised to respond to this new threat quickly and collaboratively.”

These briefings continued every few days, until one of them jolted America to attention. On Feb. 25, 2020, Messonnier warned “this could be bad.”

“I had a conversation with my family over breakfast this morning, and I told my children that while I didn’t think that they were at risk right now, we as a family need to be preparing for significant disruption of our lives,” she said.

After her comments, financial markets crashed. President Donald Trump, whose message was that the pandemic was of little concern and under control, was so angry at Messonnier that he reportedly wanted her fired. The next day, he put Vice President Mike Pence in charge of the White House coronavirus task force. Televised COVID-19 briefings became a White House affair. The CDC director was not usually present.

The CDC telebriefings did continue for a while — although only occasionally.

Under Biden, CDC still seems sidelined

President Biden came into office promising to beat the pandemic by restoring public trust.

“Scientists and public health experts will speak directly to you — that’s why you’re going to be hearing a lot more from Dr. Fauci again — not from the president but from the real genuine experts and scientists,” Biden pledged the day after his inauguration.

Certainly, Americans have heard a lot from Dr. Anthony Fauci of NIH — the president’s chief medical adviser — and CDC’s Walensky. Both are frequent guests on TV news shows and in White House COVID-19 Response briefings, which are usually held several times a week.

But, under Biden, CDC and its career scientists seem to still be sidelined. CDC has actually done fewer telebriefings on the pandemic under Biden.

In 2020, under Trump, there were around two dozen CDC telebriefings.

In 2021, under Biden, there were two.

Dr. Celine Gounder, an infectious disease specialist and epidemiologist at NYU who considers Dr. Walensky a mentor, says she has been hoping to hear more from CDC’s career scientists in the new administration.

“I would love to hear more from them just about — what is the science that they’re doing? How do they go about it? What is their process?” she says. “I think there is something to be said for also just putting a human face on some of this,” she adds, which the public does not get when guidance changes happen via the CDC website.

She calls Walensky’s promise to bring back regular briefings “good news.”

Politics and a pandemic aren’t necessarily good bedfellows

The administration seems to be treating the pandemic as a political problem that has to be managed in a political way, says Gregg Gonsalves, an epidemiologist at Yale.

“There needs to be a lot more openness and transparency from the White House, and they need to let their scientists off the leash,” he says.

One overriding issue may be a clash between politics and public health.

Political messages need to be simple. But that doesn’t work for infectious disease messaging, says Nowak. “The situation is much more dynamic — viruses change a lot and can change in ways that render your recommendations not so effective,” he says. “With infectious disease communications, you really have to acknowledge uncertainty.”

Yet over the 14 years he worked at CDC, across Democratic and Republican administrations, he says the trend seemed to be for the White House to exert more and more strict control over messaging.

“You have to be willing to trust that the scientists and the experts who are doing those briefings are going to do what needs to be done,” he says. “And this administration is not unique, not by any stretch of imagination in terms of their willingness to trust career scientists.” Which is to say, they don’t seem to trust them very much, he adds.

Walensky’s pledge to hold more briefings “is a helpful development,” he says. “The question is going to be the frequency that they commit to holding regular press briefings, what the topics are, what the messages are.”

CDC didn’t respond to NPR’s question about how often the agency plans to hold agency-led briefings.

Frieden hopes that CDC will live up to its promise and speak directly to the public more often.

“It’s better for everyone,” he says. “It’s better for CDC because they can explain themselves. It’s better for the administration because you’re better off if you have a CDC that people trust. And it’s better for the public because you can understand the guidance.”

Insurers Must Cover At-Home COVID-19 Tests Starting Jan. 15 Under New CMS Directive

Insurers must cover at-home COVID-19 tests starting Jan. 15 under new CMS  directive | FierceHealthcare

Source: Fierce Healthcare, by Robert King

Insurers must cover at least eight at-home COVID-19 tests per covered individual starting on Saturday, per a new directive from the Biden Administration.

The frequently-asked questions document released by the Centers for Medicare & Medicaid Services (CMS) is an effort to improve access to at-home tests, which have been in short supply in recent weeks amid a surge of the virus fueled by the omicron variant. The administration, which announced it would install the requirement last month, also wants insurers to take steps to ensure consumers can get the tests at the pharmacy counter with no out-of-pocket costs.

“Testing is critically important to help reduce the spread of COVID-19, as well as to quickly diagnose COVID-19 so that it can be effectively treated,” said CMS Director Chiquita Brooks-LaSure in a statement. “Today’s action further removes financial barriers and expands access to COVID-19 tests for millions of people.”

CMS’ guidance applies to insurers and group health plans, requiring them to cover 8 free over-the-counter at-home tests per covered individual a month.

“That means a family of four, all on the same plan, would be able to get up to 32 of these tests covered by their health plan per month,” a release on the guidance said. “There is no limit on the number of tests, including at-home tests, that are covered if ordered or administered by a healthcare provider following an individualized clinical assessment, including for those who may need them due to underlying medical conditions.”

Over-the-counter test purchases also will be covered without any cost-sharing requirements such as deductibles or co-pays.

CMS is also hoping to incentivize insurers and group health plans to set up programs that would enable consumers to get tests at the pharmacy or point-of-sale without any out-of-pocket costs.

“Insurers and plans would cover the costs upfront, eliminating the need for consumers to submit a claim for reimbursement,” the agency said in the release.

If a plan or insurer makes the tests available via a preferred pharmacy or retailer, they still must reimburse the tests purchased by consumers outside of that network at up to $12 per individual or the cost of the test if it is below $12.

“If an individual has a plan that offers direct coverage through their preferred pharmacy but that individual instead purchases tests through an online retailer, the plan is still required to reimburse them up to $12 per individual test,” the agency added.

State Medicaid programs and the Children’s Health Insurance Program are already required to cover at-home tests.

However, some stakeholders are worried that the guidance doesn’t address major problems facing testing access, which can include shortages.

“The guidance issued today fails to address the enormous barriers: significant shipping delays, sold-out pharmacies and retailers and the early signs of price-gouging,” said Ceci Connolly, president and CEO of the Alliance of Community Health Plans, in a statement.

Blue Cross Blue Shield Association also was concerned about the lack of action in alleviating shortages.

“We are concerned that the policy does not solve for the limited supply of tests in the country and could cause additional consumer friction as insurers stand up a program in just four days’ time,” said President and CEO Kim Keck in a statement.

The administration is also working to send 500 million rapid tests in the coming weeks to every American.

At the onset of the pandemic, many major insurers agreed to cover the cost of COVID-19 tests. However, several of those coverage decisions were eventually reversed as the pandemic wore on.

Gavin Newsom Proposes Health Care For All In Plan To Cover Undocumented Californians

Governor Gavin Newsom proposes universal health care coverage in California  | cbs8.comSource: The Sacramento Bee, by Nadia Lopez

Gov. Gavin Newsom is proposing to extend Medi-Cal coverage to all low-income, undocumented adults, a historic expansion that would make California the first state in the nation to provide universal health care access for all residents regardless of legal status.

The plan is included in Newsom’s $286 billion state budget proposal, which is flush with a projected $45.7 billion surplus.

Coverage would begin on Jan. 1, 2024 and would cost the state an ongoing $2.7 billion annually. The program’s launch in the 2023-24 fiscal year is expected to cost $819.3 million.

“Here’s the big one: California is poised to be — if this proposal is supported — the first state in the country to achieve universal access to health coverage,” he said during Monday’s announcement. “That mean means full-scope Medi-Cal, including long-term care, (In-Home Supportive Services), and behavioral health to all low-income Californians, regardless of immigration status.”

The governor’s proposal would fill a gap in health care coverage for undocumented Californians.

Currently, undocumented people are eligible for Medi-Cal through age 26. Undocumented adults ages 50 and older will become eligible for Medi-Cal after May 1.

Newsom in June 2021 proposed an ongoing $1.3 billion spending plan to expand Medi-Cal coverage to adults and seniors age 50 and over. Undocumented children were given extended coverage in 2016 and young adults up to the age of 26 also qualify for healthcare access under a plan passed in 2020.

The state already offers some Medi-Cal coverage to undocumented individuals of all ages for emergency medical services and prenatal and maternity care.

Assemblyman Joaquin Arambula, D-Fresno, who has long advocated for the proposal, said it was “exciting” and “transformative.”

“Here in California, we don’t follow, we lead,” he said in a Monday interview with The Bee. “Providing healthcare access to our most vulnerable after this pandemic of the century is the absolutely appropriate response for us to take as a state.”

A former physician, Arambula said he regularly served undocumented patients who delayed receiving medical attention due to their lack of healthcare coverage.

“What I oftentimes would find is that our undocumented community would seek care delayed or not at all, and oftentimes forgo much of the preventative health care we know to be so beneficial,” he said. “When you don’t have health care access, you get sicker and you die sooner — that’s what I saw firsthand.”

Sarah Dar, the director of health and public benefits policy at the California Immigrant Policy Center, an immigrant rights organization, said the proposed plan would allow people to get regular checkups and access to medication. She said undocumented people are “taxpayers” and “just as much a part of California as anybody else.”

“We’ve really gotten to that place where everybody understands that equity matters and why it makes no sense to exclude people from our health care system,” she said. “People will have the peace of mind in knowing that they’re taken care of.”

But Sen. Jim Nielsen, R-Red Bluff, opposed the proposal, arguing that it would allocate public dollars to “illegal” residents.

“He’s opening the door to a blank check providing for illegal individuals who have come to California,” Nielsen said.

Still, Assemblymember Devon Mathis, R-Visalia, said the proposal could help cut costs on the healthcare system.

“Healthcare access is vital, especially in underserved areas like our San Joaquin Valley,” he said in a statement. “When it comes to healthcare, we must stop dividing our people and realize we are one large community made of friends and neighbors. To my friends who may disagree, I would encourage you to look at your fiscally conservative roots to the fact that this will reduce the overall cost on our healthcare system.”

There are an estimated 2 million undocumented immigrants in California, according to the nonpartisan Public Policy Institute of California. The state contains the largest number of undocumented people in the U.S. State officials last year projected about 200,000 undocumented immigrants would be enrolled in Medi-Cal by the end of the 2026 fiscal year.

Newsom’s spending plan for the fiscal year beginning in July 2022 focuses on five pressing challenges facing California residents, including COVID-19, climate change, homelessness, inequality and public safety, according to the blueprint.

Democrats Propose California Universal Healthcare, Funded By New Income, Business Taxes

California universal healthcare would be funded by new taxes - Los Angeles  Times

Source: Los Angeles Times, by John Myers

California would enact a sweeping, first-in-the-nation universal healthcare plan under a proposal unveiled Thursday by a group of state Democratic lawmakers, providing health services to every resident and financed by a broad array of new taxes on individuals and businesses.

Though some of the policy details of the ambitious plan were laid out last year, the way to fund it had not been determined. The proposal, now laid out in separate pieces of legislation, faces significant hurdles in the coming months — first at the state Capitol, with opposition from groups representing doctors and insurance companies, and then possibly at the ballot box, as voters would have to approve the taxes in an amendment to the California Constitution.

“There are countless studies that tell us a single-payer healthcare system is the fiscally sound thing to do, the smarter healthcare policy to follow, and a moral imperative if we care about human life,” Assemblyman Ash Kalra (D-San Jose), the proposal’s author, said Thursday.

Efforts to create a single-payer healthcare system, in which medical expenses for all residents are covered by a government-run fund, have been widely discussed in California for years. Supporters say the cost of providing care to the state’s residents would go down without the administrative expenses of private insurance plans.

They also point out the costs incurred by Californians under slimmed-down healthcare plans with high deductibles and co-pays — costs they argue will disappear if California creates a state-run program that blends state and federal dollars.

“What we’re trying to do is get rid of these dozens of buckets of funding — whether it’s private insurance, whether it’s employer, whether it’s Medi-Cal — put it into one bucket,” Kalra said.

Legislative efforts to push the idea forward have fizzled over recent decades, lacking the broad-based political support needed for a historic overhaul of the healthcare system. Kalra’s newest effort was quickly criticized by a coalition of powerful political players, including the California Medical Assn. and the California Hospital Assn. They will square off against one of the single-payer plan’s most vocal advocates, the California Nurses Assn.

Assembly Bill 1400 would create “CalCare,” a system governed by an independent board of directors that promises access to any doctor, regardless of network, and a wide variety of medical services. The new entity would push to bring payments to providers more in line with the costs of care and would seek to negotiate lower prices for prescription drugs. The plan includes long-term care coverage and services for senior citizens and disabled people, and would remove barriers based on a patient’s immigration status.

Thursday’s announcement will undoubtedly set in motion a contentious process, possibly complicated by the politics of it being an election year. Gov. Gavin Newsom, who faces reelection in the fall, campaigned for office four years ago in part on support for a single-payer healthcare system.

“It’s about access,” Newsom said in a speech at the California Democratic Party convention in 2018. “It’s about affordability. And it’s about time. If these can’t-do Democrats were in charge, we wouldn’t have had Social Security or Medicare.”

A spokesperson for the governor didn’t immediately respond to a request for comment on the new effort. But Kalra, a Bay Area Democrat who has lined up support from a group of Democratic lawmakers, reminded those in attendance at a state Capitol event on Thursday of the governor’s campaign platform.

“Doing nothing is not inaction,” Kalra said of political promises that have not produced a plan. “It is, in fact, the cruelest of actions while millions suffer under our watch.”

The plan’s proposed tax increase might present the most difficult political hurdle: As a constitutional amendment, it would require a supermajority vote in both the state Senate and Assembly and then ratification by voters in either the June or November statewide election. While Democrats have held a supermajority of seats in both houses for the better part of a decade, they have rarely found enough support within their ranks for a broad-based tax increase.

The constitutional amendment would impose a new excise tax on businesses equal to 2.3% of any annual gross receipts in excess of $2 million. A new payroll tax would also be created, equal to 1.25% of total annual wages and collected from businesses employing 50 or more people. An additional payroll tax would be required for employers with workers earning more than $49,900 a year.

All but the lowest-earning Californians would also be required to pay more in taxes. The proposed constitutional amendment would raise personal income taxes on salaries above $149,509 a year — less for those at that level, more to be paid as income goes up. All Californians reporting an annual taxable income of more than $2.5 million would see a new 2.5% surcharge. And personal income tax increases to pay for the healthcare plan could rise with inflation in future years.

The size and impact of the tax increase will be at the center of the debate. Kalra and other supporters insist the taxes will total less than what employers and Californians now pay for private insurance.

Rob Lapsley, president of the California Business Roundtable, said the proposal would impose a financial burden on those struggling with the economic impacts of the COVID-19 pandemic, and most Californians can currently receive medical treatment when needed.

“California already has near-universal healthcare coverage,” Lapsley said in a statement. “AB 1400 would eliminate healthcare options and force everyone into an untested government-run program.”

The constitutional tax increase was introduced this week, while AB 1400 was introduced last year. As a holdover proposal from 2021, it must clear the Assembly by Jan. 31. Republicans were quick to pounce on the procedural changes approved by Democrats on Thursday to fast-track the bill, which has sat for months in the Assembly without any public hearings.

“The Legislature’s majority party just voted to move a radical single-payer bill forward without an independent cost analysis,” said Assemblyman Jordan Cunningham (R-Paso Robles), vice chairman of the Assembly Rules Committee.

The bill will be considered next week by the Assembly Health Committee. The panel’s chairman, Assemblyman Jim Wood (D-Santa Rosa) said Thursday that he would vote in favor of the single-payer plan, a strong indication the measure will receive a vote by the Assembly where it needs only a simple majority to be sent to the Senate.

Supreme Court Sets Jan. 7 Special Hearing On Vaccine Mandate For Healthcare Workers

GOP-majority court chosen to consider Biden vaccine mandate - ABC News

Source: Fierce Healthcare, by Heather Landi

The Supreme Court is fast-tracking two legal cases challenging President Joe Biden’s COVID-19 vaccine mandates, including a requirement for certain healthcare workers.

The high court announced Wednesday it will hold a special hearing Jan. 7 to hear oral arguments over federal vaccine mandates that are at the heart of the Biden administration’s efforts to address COVID in the workplace.

The Supreme Court’s decision comes as the omicron variant is causing COVID-19 cases to surge nationwide.

In an unusual move, the court said it would move with exceptional speed on the two measures, a vaccine-or-testing mandate aimed at large employers and a vaccination requirement for certain healthcare workers, The New York Times reported Wednesday. The justices had not been scheduled to return to the bench until the following Monday.

The high court will hear arguments over a rule issued by the Occupational Safety and Health Administration (OSHA) that applies to employers with 100 or more workers and requires they have all staff vaccinated or tested for the virus weekly. The rule could affect more than 84 million workers.

The second is a rule released by the Centers for Medicare & Medicaid Services (CMS) in November that requires hospitals, ambulatory surgery centers, nursing homes and other healthcare facilities to ensure staff are fully vaccinated by Jan. 4 or risk losing Medicare and Medicaid funding.

The CMS rule has been challenged by a number of states. A lower court struck down the mandate for 10 states, and a divided panel in the Eighth Circuit Court of Appeals denied the government’s motion to hold off enforcing the ruling until an appeal can be heard.

Last week, a federal appeals court reinstated in 26 states the administration’s vaccination mandate for health workers at hospitals that receive federal funding. As it stands, the vaccine requirement for Medicare and Medicaid providers is blocked by courts in about half of U.S. states but not in the other half, creating the potential for patchwork enforcement across the country.

The Department of Justice (DOJ) also released a legal filing last week that seeks to overturn a ruling from a federal court late last month that blocked the mandate in 10 states.

Now, the Supreme Court will have the ultimate say on the emergency applications to stay the Missouri and Louisiana district court injunctions judicially enjoining the CMS mandate in 25 states and the emergency applications to re-stay the OSHA mandate.

In a blog post, the American Hospital Association (AHA) said, “it is unheard of for the full court to hear oral argument directly on an emergency application like this.”

“The court’s order shows the legal and practical importance of the federal government’s vaccine mandates and whether they should be stayed pending appellate review,” the AHA wrote.

In a statement issued Wednesday night, the Biden administration vowed to “vigorously defend” the vaccine mandate initiatives.

“Especially as the U.S. faces the highly transmissible omicron variant, it is critical to protect workers with vaccination requirements and testing protocols that are urgently needed. At a critical moment for the nation’s health, the OSHA vaccination or testing rule ensures that employers are protecting their employees and the CMS health care vaccination requirement ensures that providers are protecting their patients,” Jen Psaki, the White House press secretary, said in a statement.

Pence Group Files SCOTUS Brief Opposing Biden Vaccine Mandate

Pence group files SCOTUS brief opposing Biden vaccine mandate | TheHill

Source: The Hill, by Brett Samuels

Former Vice President Mike Pence on Monday announced his advocacy group has filed an amicus brief urging the Supreme Court to reject the Biden administration’s attempt to require large businesses to mandate the COVID-19 vaccine for its workers or require frequent testing.

Pence filed the brief, which was shared with The Hill, through his political advocacy group Advancing American Freedom. In the document, Pence’s organization argues the Biden White House’s mandate is unconstitutional and would exceed previous examples of the Occupational Safety and Health Administration’s (OSHA) use of emergency authority.

“America is about freedom and the ability to make the best decision for your family or business, and Joe Biden’s vaccine mandate must be stopped in its tracks in order to preserve freedom, protect American livelihoods and businesses, and to safeguard our constitution,” Pence said in a statement.

The brief outlines nine previous cases where OSHA used an emergency temporary standard to expedite the standard rule-making process. Pence’s brief argued there is a distinction in that the previous instances sought to regulate workplace dangers like asbestos or other chemicals that threatened workers’ safety, not require employees to get vaccinated or get some other medical treatment.

The brief from Pence’s group argues that the OSHA rule requiring vaccinations suggests “the Biden Administration is not truly seeking to mitigate workplace hazards through the [emergency temporary standard], but rather is attempting to use OSHA to accomplish an end that it has been unable to persuade Congress to support: the mandatory vaccination of the American public.”

The Biden White House has said it does not support making the COVID-19 vaccine mandatory for the public.

Pence’s group has previously filed amicus briefs with the Supreme Court outlining positions on prominent cases on abortion and school choice. The former vice president is the latest conservative politician to weigh in against the Biden administration’s push for large businesses to require vaccinations or regular testing for employees as part of an aggressive strategy to end the pandemic.

The workplace mandate is scheduled to take effect this month and could affect an estimated 84 million employees. It generally requires larger businesses with more than 100 employees to adopt written policies requiring workers to be vaccinated against COVID-19 or wear masks and undergo regular testing.

The Biden administration on Thursday urged the Supreme Court to leave intact a workplace vaccine-or-test mandate as public health officials contend with the surging COVID-19 pandemic.

DOJ lawyers argued that the 1970 law that established the Occupational Safety and Health Administration (OSHA) makes plain that the policy “falls squarely within OSHA’s statutory authority.”

But conservatives, including several interest groups and governors, have argued in court that the OSHA rule is an example of government overreach and that the White House should not have the power to require certain groups to get vaccinated against COVID-19, which has spread rapidly in recent weeks thanks to the highly contagious omicron variant.

FDA Authorizes First Covid-19 Booster Shot For Teens Aged 12 To 15

FDA authorizes Covid boosters for teens 12-15 - POLITICO

Source: STAT, by Helen Branswell

The Food and Drug Administration on Monday extended the emergency use authorization for the Pfizer and BioNTech Covid-19 booster shot to include teens aged 12 to 15, paving the way for them to be eligible for the jabs later this week.

It is the first booster shot to be authorized for this age group.

A panel of independent experts that advises the Centers for Disease Control and Prevention on vaccination policy will meet Wednesday to discuss the policy change. It’s possible the ACIP will issue what’s known as a permissive recommendation — saying youths aged 12 to 15 may get a booster if they wish, but stopping short of urging them to do so.

If the committee goes this route, it will likely be because of still outstanding questions about the risk of myocarditis and pericarditis — inflammation of the heart and tissue surrounding the heart, respectively — that may be associated with getting a booster shot for this age group. The ACIP’s recommendation must be approved by CDC Director Rochelle Walensky before it can come into effect.

Janet Woodcock, the acting FDA commissioner, said in a call with reporters that the FDA expects that myocarditis would be “extremely rare” in a third dose given to 12- to 15-year-olds, and that data collected from the use of the vaccine in Israel seems to back up that idea.

Peter Marks, the director of the FDA’s Center for Drug Evaluation and Research, told reporters that the myocarditis risk seems to peak in 16- to 17-year-old males. Ninety-eight percent of cases have been mild, and among males between 16 and 30, the rate of myocarditis is about one in 1,000 vaccine recipients. The risk appears to be lower, he said, with a third booster shot than with a second dose. Marks said the FDA would continue to monitor the condition.

The Biden administration is pushing to get booster shots into as many Americans as possible as the highly transmissible Omicron variant sweeps across the country. Though infections associated with this latest variant of concern appear to be mild to moderate for many people, the transmissibility of the virus is pushing case counts to new heights. Even if most cases are mild, having hordes of people sick at once is already wreaking havoc on many sectors, including air travel and health care.

As 12- to 15-year-olds became eligible to be vaccinated in May of last year, many will be ready for a booster when Walensky approves the expanded EUA.

The extension will only apply to the Pfizer vaccine, which is the sole Covid vaccine in this country authorized for use in anyone under the age of 18.

The FDA also announced that it is shortening the interval after which people are eligible for a booster shot, moving it to five months post-completion of a primary vaccination series from six months. This relates to adults, teens, and preteens eligible for a booster who have received the two-dose series of the messenger RNA vaccines made by Pfizer or Moderna. People who received the one-dose Johnson & Johnson vaccine are urged to get a second shot two months after the first jab.

The FDA also announced that children aged 5 to 11 who are moderately or severely immunocompromised will be able to get a third dose of the Pfizer vaccine 28 days after they receive their second dose. Third doses for moderately or severely immunocompromised people 12 and older were previously approved by the FDA and the CDC.

CMS Wants Insurers To Offer Standardized Plan Options On The ACA Exchanges

Affordable Care Act highlighted

Source: Fierce Healthcare, by Paige Minemyer

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.

The Big-Ticket Drugs That Have Higher Prices In 2022

Source: Axios, by Bob Herman

Drug companies raised the prices on hundreds of medications on Jan. 1, with most prices up 5% to 6% on average.

Why it matters: The start of the new year is the most popular time for drug companies to hike prices, and even though high drug prices remain one of the biggest political health care issues, increases in 2022 are tracking in line with other recent years.

By the numbers: Pharmaceutical companies increased prices on 460 drugs on Jan. 1, according to drug prices monitored by research firm 46brooklyn.

  • * The number of drugs that had price increases on Jan. 1 of prior years according to 46brooklyn: 629 (2021), 385 (2020), 359 (2019), 538 (2018) and 494 (2017).
  • * Many drugmakers implement price hikes on other days throughout January, so expect more increases in the coming days.

Between the lines: Several blockbuster drugs were included in this initial batch of 2022 price hikes.

  • * Gilead: ⬆️ 5.6% on HIV drugs Biktarvy and Descovy.
  • * Pfizer: ⬆️ 6.9% on breast cancer drug Ibrance, ⬆️ 6.9% on its Prevnar vaccine and ⬆️ 4.4% on the costly heart drugs Vyndamax and Vyndaqel.
  • * Purdue: ⬆️ 5% on opioid poster child OxyContin.
  • * Vertex: ⬆️ 4.9% on Trikafta, a blockbuster cystic fibrosis medication that has no competitors and already has a list price of more than $311,000 per year.

Yes, but: These actions affect the drugs’ list prices. Pharmacy benefit managers negotiate lower drug prices in the form of rebates, so drugmakers often collect lower net prices.

  • * However, list prices still matter because they are what the uninsured pay, and deductibles and coinsurance rates are often based on a drug’s list price.
  • * Drug companies also capture most or all of a list price increase for patented drugs that have little competition, like those mentioned above.

What they’re saying: “We expect net prices to continue to decline due to increased rebates and discounts,” a Gilead spokesperson said in response to the company’s price hikes. The spokesperson did not answer specific questions about the rebates for those drugs.

  • * “The modest increase is necessary to support investments that allow us to continue to discover new medicines and deliver those breakthroughs to the patients who need them,” a Pfizer spokesperson said. When posed specific questions about Ibrance’s rebates, the spokesperson said: “We do not disclose detail at the product-level.”
  • * Vertex’s price increases on Trikafta and its other cystic fibrosis drugs “are the first price increases for a Vertex medicine since 2017, and the first ever for … Trikafta, and they “reflect the significant value these medicines bring to patients.” Vertex similarly did not respond to questions about rebates.

Our thought bubble: List price increases don’t tell the entire story about U.S. drug pricing, but drug company claims about how net prices are falling right now distort how much prices have increased over time.

Last Updated 01/19/2022

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