Payer

Radar On Market Access: Manufacturers, Payers Wait on Federal COVID-19 Vaccine Distribution Plan

July 28, 2020

As the many COVID-19 vaccines under development barrel toward clinical trials for safety and efficacy, questions remain about how they will be distributed when they become available, AIS Health reported.

In a hearing held by a subcommittee of the House Energy & Commerce committee, pharmaceutical executives said they would rely on guidance from the Trump administration and the Centers for Disease Control and Prevention (CDC) to distribute vaccine doses.

As the many COVID-19 vaccines under development barrel toward clinical trials for safety and efficacy, questions remain about how they will be distributed when they become available, AIS Health reported.

In a hearing held by a subcommittee of the House Energy & Commerce committee, pharmaceutical executives said they would rely on guidance from the Trump administration and the Centers for Disease Control and Prevention (CDC) to distribute vaccine doses.

Those guidelines will be important to insurers, as vaccine doses aren’t likely to be available to everyone immediately, according to Mike Schneider, a principal at Avalere Health. Though some firms have already begun manufacturing doses of their vaccine in parallel to testing, the immediate availability of hundreds of millions of doses at the time of FDA approval would be unprecedented.

Schneider notes that multiple vaccines may be available at the same time, and one may offer greater protection from COVID-19 than others. Protocols will need to be developed to determine which patients will be first in line for the most effective vaccine. Schneider says that plans need to start thinking about their internal guidelines now.

He adds that PBMs, which often have the most robust data about a patient’s drug regimen and immunization status, will be essential to tracking who has been vaccinated and screened.

Schneider says that plans are unlikely to favor one vaccine over another in their formularies. For example, Prime Therapeutics, a PBM owned by Blue Cross and Blue Shield affiliates, says it is committed to obtaining a supply of COVID-19 vaccine as soon as possible, seemingly regardless of who manufactures it.

A July 20 analysis prepared by health care investment bank SVB Leerink LLC takes a different view of the shape of the initial vaccine market than Schneider’s prediction of scarcity, arguing that the sheer volume of development efforts makes more than one breakout product likely.

In any case, Schneider predicts that the initial rollout will be unusual when compared with other vaccine distribution.

“This won’t just be going to your pharmacy and your pharmacist gives you a vaccine, like the flu vaccine,” Schneider says. He suspects that rollout will involve specialized facilities that combine rapid screening with inoculations at the same site.

MMIT Reality Check on Bipolar Disorder (July 2020)

July 24, 2020

According to our recent payer coverage analysis for bipolar disorder treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

According to our recent payer coverage analysis for bipolar disorder treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

To help make sense of this new research, MMIT’s team of experts analyzes the data and summarizes the key findings for you. The following are brief highlights. To read the full piece, including payer coverage, drug competition and prescriber trends, click here.

Payer Coverage: A review of market access for bipolar disorder treatments shows that under the pharmacy benefit, about 23% of the lives under commercial formularies are covered with utilization management restrictions.

Trends: A new brand drug, Allergan plc’s Vraylar (cariprazine), for bipolar disorder will have little impact on how health plans cover these medications, experts say. Health plans will continue to encourage the use of less expensive generic bipolar drugs.

Perspectives on Trump Admin’s COVID-19 Testing Payment Guidance

July 23, 2020

As more employers turn to COVID-19 testing to see if employees are safe to return to the workplace, the Trump administration has clarified that insurers must cover only physician-ordered “medically necessary” diagnostic and antibody tests, AIS Health reported.

The guidance, released jointly on June 23 by HHS, the Dept. of Labor and the Dept. of the Treasury, also says self-funded employer plans must pay for COVID-19 testing that’s medically appropriate.

As more employers turn to COVID-19 testing to see if employees are safe to return to the workplace, the Trump administration has clarified that insurers must cover only physician-ordered “medically necessary” diagnostic and antibody tests, AIS Health reported.

The guidance, released jointly on June 23 by HHS, the Dept. of Labor and the Dept. of the Treasury, also says self-funded employer plans must pay for COVID-19 testing that’s medically appropriate.

“Testing conducted to screen for general workplace health and safety (such as employee ‘return to work’ programs), for public health surveillance for SARS-CoV-2, or for any other purpose not primarily intended for individualized diagnosis or treatment of COVID-19 or another health condition is beyond the scope” of the requirements embedded in the legislation approved by Congress earlier this year that requires insurers to pay for COVID-19 testing, the FAQ document said.

“I think now that [the insurers] have had this clarification, they’re going to use that as part of their determination of coverage,” Ashraf Shehata, KPMG national sector leader for health care and life sciences, tells AIS Health.

Richard Hughes IV, managing director at Avalere Health, says that it’s possible to argue that Congress intended insurers to cover all tests for their members, regardless of whether a physician ordered them, whether the person was symptomatic, or whether the test was needed to return to work.

However, Hughes says it’s also possible to argue that Congress gave CMS the authority to implement these testing requirements with some restrictions. “There could be tremendous variability across payers’ approaches to coverage policy and how they process claims,” he says.

In fact, many insurers already have moved to limit testing coverage in some ways, although their policies are fluid and have been updated frequently, says Danielle Showalter, principal at Avalere.

Individuals whose plans will not cover a test can turn to what Shehata calls the “retail model,” which is direct-to-consumer COVID-19 testing sites that don’t require a health care provider’s permission. Costs vary for this type of testing, which generally wouldn’t be covered by insurance unless the person is symptomatic.

Radar On Market Access: Despite Coronavirus Surge, UnitedHealth Expects Care Utilization to Rebound This Year

July 23, 2020

With COVID-19 cases and deaths surging in some U.S. states, it has become clear that the nation won’t be back to normal anytime soon. Still, the country’s largest health insurer is betting that health care utilization, and the costs associated with it, will return to something close to typical levels in the second half of the year, AIS Health reported.

With COVID-19 cases and deaths surging in some U.S. states, it has become clear that the nation won’t be back to normal anytime soon. Still, the country’s largest health insurer is betting that health care utilization, and the costs associated with it, will return to something close to typical levels in the second half of the year, AIS Health reported.

At its lowest point in April, inpatient care volume — including care for COVID-19 patients — was about three quarters less than normal, UnitedHealth Group Chief Financial Officer John Rex said during a July 15 conference call to discuss the company’s second-quarter earnings. At that same low point, utilization of outpatient and physician services fell to roughly 60% of normal levels. But in June, UnitedHealth saw inpatient volume recover to nearly 95% of baseline, and as June turned to July, outpatient and physician services were “tracking above 90%,” Rex said. “These national trends have continued thus far in July, even as certain states are seeing short-term deferral of services where there are elevated levels of infection and hospitalization,” he added.

Indeed, the company predicts that overall, “utilization’s going to come back during the second half of the year,” UnitedHealthcare CEO Dirk McMahon said.

In a note to investors, Citi analyst Ralph Giacobbe observed that the executives’ comments about health care utilization returning to normal were “surprising to us.”

“Ultimately we believe healthcare cost trends will remain muted, and as we look out over the next 12+ months we see those trends driving upside, and lower headline risk post-election driving multiples higher,” Giacobbe added.

In the second quarter, UnitedHealth’s adjusted earnings per share of $7.12 easily beat the consensus estimate of $5.28, and the firm nearly doubled its adjusted EPS compared with the second quarter of 2019. UnitedHealth also maintained its 2020 EPS outlook of $15.45 to $15.75 ($16.25 to $16.55 on an adjusted basis).

Meanwhile, job losses tied to the COVID-19 pandemic and ensuing recession led to a decline in revenue and enrollment for UnitedHealth’s commercial insurance business. But revenue rose on the government business side as Medicare and Medicaid enrollment grew “by nearly 600,000 additional people served year to date,” per the company’s earnings release.

Radar On Market Access: Trump Admin’s COVID-19 Testing Payment Guidance Stirs Debate

July 21, 2020

Weeks after the Trump administration released guidance saying private health insurers don’t have to pay for COVID-19 testing conducted for the purposes of workplace safety or public health surveillance, questions and controversy are still simmering about the implications of that edict, AIS Health reported.

“With COVID-19 cases skyrocketing and our testing capacity nowhere near where it needs to be, it is unacceptable that this Administration’s priority seems to be giving insurance companies loopholes instead of getting people the free testing they need,” wrote Frank Pallone Jr. (D-N.Y.), Bobby Scott (D-Va.), Richard Neal (D-Mass.), Patty Murray (D-Wash.) and Ron Wyden (D-Ore.) in a recent letter to HHS, the Dept. of Labor and the Treasury Dept.

Weeks after the Trump administration released guidance saying private health insurers don’t have to pay for COVID-19 testing conducted for the purposes of workplace safety or public health surveillance, questions and controversy are still simmering about the implications of that edict, AIS Health reported.

“With COVID-19 cases skyrocketing and our testing capacity nowhere near where it needs to be, it is unacceptable that this Administration’s priority seems to be giving insurance companies loopholes instead of getting people the free testing they need,” wrote Frank Pallone Jr. (D-N.Y.), Bobby Scott (D-Va.), Richard Neal (D-Mass.), Patty Murray (D-Wash.) and Ron Wyden (D-Ore.) in a recent letter to HHS, the Dept. of Labor and the Treasury Dept.

James Gelfand, senior vice president of health policy at the ERISA Industry Committee (ERIC), tells AIS Health that he’s fielded concerns that since insurers aren’t paying for back-to-work testing, workers might have to. But in reality, many of the large, self-insured businesses that ERIC represents “are starting to reopen and relaunch back up to full capacity, but most of them are not using a robust testing regime to do so.” The reason, he says, is that diagnostic tests “are essentially taking a snapshot of a moment in time with sometimes a 10-day lag time,” so they’re not very helpful to employees who need to know right away if they’re safe to go back to work.

Steve Wojcik, vice president of public policy at the Business Group on Health, says he sees the logic behind not forcing health insurers to pay for back-to-work testing.

“If there is a medical reason…to get tested, and a doctor is recommending it, then the health plan would cover it, but if testing is part of return to work, some employers may be incorporating testing [costs] into their return-to-work plans,” he points out.

According to Christen Linke Young, a fellow at the USC-Brookings Schaeffer Initiative for Health Policy, a separate problem is the fact that private insurers are required to pay for out-of-network COVID-19 testing at whatever cash price that a lab or provider lists on a public website. Because those prices aren’t necessarily constrained by prevailing market rates, that can “put a lot of upward pressure on insurance reimbursement for tests,” she says.

MMIT Reality Check on Psoriatic Arthritis (July 2020)

July 17, 2020

According to our recent payer coverage analysis for psoriatic arthritis treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

According to our recent payer coverage analysis for psoriatic arthritis treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

To help make sense of this new research, MMIT’s team of experts analyzes the data and summarizes the key findings for you. The following are brief highlights. To read the full piece, including payer coverage, drug competition and prescriber trends, click here.

Payer Coverage: A review of market access for psoriatic arthritis treatments shows that under the pharmacy benefit, about 77% of the lives under commercial formularies are covered with utilization management restrictions.

Trends: In December 2019, the FDA approved Amgen Inc.’s Avsola (infliximabaxxq) for the treatment of psoriatic arthritis, moderate-to-severe rheumatoid arthritis, moderate-to-severe Crohn’s disease in adult and pediatric populations, moderate-to-severe ulcerative colitis in adult and pediatric populations, chronic severe plaque psoriasis and ankylosing spondylitis. It is the fourth biosimilar of Remicade (infliximab) from Janssen Biotech, Inc., a Johnson & Johnson company, that the agency has approved.