Employers may still foot Covid-19 testing bills if mandate stands

From: POLITICO's Prescription Pulse - Tuesday Nov 09,2021 03:01 pm
Presented by the Pharmaceutical Care Management Association: Delivered every Tuesday and Friday by 12 p.m., Prescription Pulse examines the latest pharmaceutical news and policy.
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By Lauren Gardner and David Lim

Presented by the Pharmaceutical Care Management Association

On Tap

— Businesses may still get stuck with the bill for unvaccinated employees’ Covid-19 tests if the mandate survives legal challenges.

— One of FDA’s independent vaccine advisers is urging the public to learn some pandemic lessons from the flu, as eradicating the coronavirus appears all but impossible.

— A House Democrat has launched an investigation into companies making and selling synthetic nicotine products, apparently to evade FDA regulation.

It’s TUESDAY. Welcome back to Prescription Pulse. When you’re living through a pandemic and want to be a journalist, you might as well start young.

Send tips to David Lim (dlim@politico.com or @davidalim), Lauren Gardner (lgardner@politico.com or @Gardner_LM) or Katherine Ellen Foley (kfoley@politico.com or @katherineefoley).

 

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Pharmacy benefit managers (PBMs) are the only entity in the prescription drug supply and payment chain working to reduce Rx costs on behalf of patients. PBMs support policies that increase competition and lower costs. Learn how PBMs advocate for patients at OnYourRxSide.org.

 
Coronavirus

BUSINESS COULD STILL FOOT COVID TESTING BILL FOR UNVACCINATED WORKERSPresident Joe Biden wants unvaccinated workers to pay for office Covid-19 testing come early January — but business groups and labor-law experts argue companies will likely end up covering those costs for workers claiming religious or disability exemptions to Covid-19 vaccines. And on Friday, a federal appeals court temporarily suspended the policy, which was set to take effect in January, in response to a suit spearheaded by Texas’ Republican attorney general.

“I think employers will be hard-pressed to push the cost on to employees who fall properly within those exemptions,” Carleton Schaefer, chair of Loeb and Loeb’s employment and labor practice, said of the Covid-19 testing costs.

The Biden policy will require businesses with more than 100 employees to verify their staff is vaccinated against Covid-19 or submit to weekly tests. The Occupational Safety and Health Administration estimates that more than 75 million workers — nearly 90 percent of those covered by the regulation — will be vaccinated by the time the requirement is set to take effect. That would leave roughly 9 million holdouts, most of whom the government predicts will work in person rather than remotely.

The vaccine mandate “is a federal overstep that will only create more confusion and legal challenges,” Sen. Richard Burr (R-N.C.), the ranking member of the Senate health committee, said in a statement to POLITICO. “The move proves the administration continues to be out of touch with working Americans and risks exacerbating labor and testing shortages. Heavy-handed mandates will not solve this problem. Instead, the administration should foster cooperation with businesses and workers, with clear communication, transparency, and trust.”

In the meantime, there are also questions about whether the plan will squeeze the nation’s testing system.

The federal government has scrambled in recent months to shore up the U.S. supply of rapid tests, including at-home tests. But the vaccine mandate does not allow at-home tests to be used to satisfy the weekly testing requirement for unvaccinated workers unless employers or authorized telehealth proctors observe workers taking the tests. Trade associations for the laboratory and diagnostics industries say they are ready to meet any new demand for testing driven by the Biden mandate.

That requirement appears to be an attempt to ensure that unvaccinated workers submit results from Covid-19 tests they themselves took, said Harvard University epidemiologist Michael Mina. But it is unclear if the OSHA regulation will be effective at preventing bad actors from mailing in fraudulent samples for lab-based testing.

“It's going to be a burden on the testing system; we're going to run into test shortages,” said Georges Benjamin, executive director of the American Public Health Association. “It's going to be an administrative burden that will foster more people getting vaccinated just because of the hassle.”

The Department of Justice says it will “vigorously defend” the rule in court: At least a dozen legal challenges have been filed in the 5th, 6th, 7th, 11th and D.C. Circuits, triggering a lottery over which circuit will ultimately hear the challenge. According to a DOJ court filing, the lottery to decide which court will hear the case is scheduled for Nov. 16. But experts predict the Supreme Court will eventually have to decide whether the policy is upheld and implemented.

ICYMI: HOW TRUMP’S MODERNA VAX DEAL SHORTED THE WORLD The messenger RNA vaccine manufacturer benefited handsomely from the U.S. government’s largesse in both money and research in its quest to quickly deliver a coronavirus vaccine. But Moderna, armed with a federal contract giving it full control over its technology, has largely rebuffed the Biden administration’s efforts to help vaccinate the rest of the world while it rakes in billions from wealthy countries eager for the shots, POLITICO’s Sarah Owermohle, Adam Cancryn and Erin Banco report.

The company’s lack of cooperation despite soaring profits “has turned what began as a government success story into a prime target of lawmakers and global health advocates,” they write. And as disparities in vaccine access continue, the likelihood grows for more variants developing that could prolong the pandemic.

MONTO: LIKE FLU, ‘LEARN TO LIVE’ WITH COVID — The chair of FDA’s vaccine advisory committee argues in a recent New England Journal of Medicine piece that the world should look to pandemic and seasonal flu infection patterns to understand our likely future with Covid-19. Waves of cases of both viruses can overwhelm health systems, Arnold Monto says, and readministration of vaccines is necessary for both as immunity wanes and, at least in the case of influenza, different strains evade protection offered by shots.

“Given the parade of variants, their varying transmissibility and continuing concern about antigenic changes affecting vaccine protection, I believe it should now be clear that it is not possible to eliminate this virus from the population and that we should develop long-term plans for dealing with it after the unsupportable surges are fully controlled,” Monto writes.

FDA CLEARS MORE J&J DOSES FOR USE — FDA green-lit the use Friday of two more Johnson & Johnson Covid vaccine batches made by Emergent BioSolutions at its troubled Baltimore facility. That brings the total number of batches cleared for use to 11, though the agency noted it’s not ready to designate the plant an authorized manufacturing facility under J&J’s EUA.

 

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Drug Pricing

GENERIC DRUGMAKERS PUSH FOR CHANGES TO PRICING DEALGeneric and biosimilar manufacturers are lobbying House Democrats to tweak portions of the drug pricing deal reached late last week, POLITICO’s Megan Wilson reports. The industries argue the deal as written encourages brand-name drugmakers to crowd lower-cost competitors out of the market by negotiating generic-level prices with the government.

Eye on FDA

BLUMENTHAL: ‘I WOULD HAVE VERY GRAVE RESERVATIONS’ ABOUT A CALIFF NOMINATION — Count Sen. Richard Blumenthal (D-Conn.) among Democrats who would likely vote against confirming former FDA Commissioner Robert Califf if Biden nominates him to return to the job. The senator — one of four votes against Califf in 2016 — previously raised concern about the agency’s track record on opioid approvals.

“I would have very grave reservations about this nomination – many of the same reservations I expressed when I voted against Dr. Califf’s confirmation in 2016,” Blumenthal told POLITICO’s Adam Cancryn Monday.

 

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Tobacco

HOUSE DEM INVESTIGATES SYNTHETIC NICOTINE PURVEYORS — Rep. Raja Krishnamoorthi (D-Ill.), chairman of the House Oversight Subcommittee on Economic and Consumer Policy, requested documents and interviews Monday from two companies that make or sell synthetic nicotine products, which are not FDA-regulated. One of the companies, Puff Bar, stopped online sales after a July 2020 FDA warning letter ordered it to cease selling its flavored e-cigarettes, which hadn’t been granted premarket authorization by the agency.

But the company reformulated the products, which are geared toward children, with synthetic nicotine, a move Krishnamoorthi said was intended to avoid FDA tobacco regulations. “You have apparently made the vile decision to continue enriching yourselves by poisoning children,” he wrote. “Puff Bar should not be allowed to continue harming children due to FDA’s failure to regulate synthetic nicotine, and I intend to put an end to your predatory practices.”

 

BECOME A GLOBAL INSIDER: The world is more connected than ever. It has never been more essential to identify, unpack and analyze important news, trends and decisions shaping our future — and we’ve got you covered! Every Monday, Wednesday and Friday, Global Insider author Ryan Heath navigates the global news maze and connects you to power players and events changing our world. Don’t miss out on this influential global community. Subscribe now.

 
 


MEDICAL DEVICES

BIPARTISAN GROUP OF SENATORS PRESS CMS ON MCIT — A group of senators, including Bill Cassidy (R-La.), Michael Bennet (D-Colo.) and Kyrsten Sinema (D-Ariz.), wrote to CMS Administrator Chiquita Brooks-LaSure Friday, requesting the agency “move quickly” to release a new Medicare Coverage for Innovative Technologies rule.

“We understand that CMS proposed repealing the existing rule after experts raised concerns about operationalization and patient benefit during the comment process,” the lawmakers wrote. “CMS should address these concerns and move forward with a pathway for coverage that allows for collection of appropriate evidence for Breakthrough Devices.”

FDA AUTHORIZES ANOTHER OTC COVID TEST — iHealth garnered emergency use authorization for its Covid-19 antigen test from FDA Friday. The company says it anticipates manufacturing 100 million of the tests per month — a number it says can grow to 200 million by early 2022.

Abbott’s BinaxNOW also got an expanded indication Monday: The company’s Covid-19 test can now be used as a single test instead of in a serial manner by people who have Covid-19 symptoms.

ARTHREX SETTLES KICKBACK ALLEGATIONS FOR $16M — The Department of Justice announced Monday that Arthrex agreed to settle allegations it violated the False Claims Act by paying kickbacks to induce surgeons’ use of its products.

Coming Up in Pharma

MONDAY: The Alliance for a Stronger FDA holds a webinar with FDA Oncology Center of Excellence Deputy Director Paul Kluetz at 3:30 p.m.

Pharma Moves

Madeleine Russak is the new communications director for Sen. Mazie Hirono (D-Hawaii). She was previously the deputy communications director for the Senate HELP Committee.

Bobby Patrick will join the Advanced Medical Technology Association as vice president of state government and regional affairs, and Roxy Kozyckyj will join as director of state government and regional affairs. Patrick previously served as the vice president of strategic growth and policy at the Medical Alley Association, and Kozyckyj was the director of state government affairs at the Healthcare Distribution Alliance.

Steven Romano has been elected chair of the National Pharmaceutical Council’s board of directors. He’s executive vice president and chief scientific officer for Mallinckrodt Pharmaceuticals.

Pharma in the States

NJ SENATE HEALTH COMMITTEE OK’S PRESCRIPTION DRUG AFFORDABILITY BOARD — Members of the New Jersey Senate Health, Human Services and Senior Citizens Committee advanced legislation Monday that would create an independent board to analyze and recommend ways to lower drug prices, POLITICO’s Daniel Han reports.

Document Drawer

FDA on Monday published 48 product-specific guidances for developing generic drugs.

 

A message from the Pharmaceutical Care Management Association:

PBMs advocate for patients in the fight to keep prescription drugs accessible and affordable. Here are five ways PBMs improve patient outcomes:

· Keeping patients safe by working with their health care team and reviewing their prescriptions to prevent potentially dangerous interactions.
· Negotiating rebates from drug manufacturers and discounts from pharmacies to make drugs more affordable.
· Supporting proposals to update Medicare Part D to improve affordability, increase choice and competition, and align stakeholder incentives, including rewarding pharmacies that promote quality care and improve clinical outcomes.
· Offering home delivery of chronic medications through mail-service pharmacies.
· Providing real-time benefit tools so physicians and patients know, at the point of prescribing, what drugs are on formulary — covered by insurance — and what patients’ cost-sharing will be.

Learn more at OnYourRxSide.org.

 
 

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