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MMIT Reality Check on Acute Lymphoblastic Leukemia (July 2020)

July 10, 2020

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

According to our recent payer coverage analysis for acute lymphoblastic leukemia 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 acute lymphoblastic leukemia treatments shows that under the pharmacy benefit, about 49% of the lives under commercial formularies are covered with utilization management restrictions.

Trends: In April 2020, the FDA cleared an investigational new drug (IND) application for Autolus Therapeutics plc’s AUTO1, a CD19-targeting chimeric antigen receptor T-cell therapy for the treatment of adults with acute lymphoblastic leukemia.

Radar On Market Access: Upheld Transparency Rule Is Slated to Reshape Payer-Provider Negotiations

July 9, 2020

In another blow to an industry already beleaguered by the COVID-19 pandemic, a federal judge recently upheld a federal rule that requires hospitals to engage in unprecedented price transparency measures, AIS Health reported.

The rule would require hospitals to disclose the rates they negotiate with payers for all items and services they offer. It is slated to go into effect on Jan. 1, 2021, but the American Hospital Association (AHA) and other trade groups and health systems sued to block it.

In another blow to an industry already beleaguered by the COVID-19 pandemic, a federal judge recently upheld a federal rule that requires hospitals to engage in unprecedented price transparency measures, AIS Health reported.

The rule would require hospitals to disclose the rates they negotiate with payers for all items and services they offer. It is slated to go into effect on Jan. 1, 2021, but the American Hospital Association (AHA) and other trade groups and health systems sued to block it.

The crux of the plaintiffs’ argument in American Hospital Association v. Azar is that CMS exceeded its authority by redefining the “standard charges” that hospitals must disclose under the Affordable Care Act to include negotiated rates. But in a decision issued June 23, U.S. District Court Judge Carl Nichols determined that CMS’s interpretation of the statute was reasonable.

The AHA has already appealed the decision, and depending on how the D.C. Circuit Court rules on that appeal, the case could make it to the Supreme Court, says David Kaufman, a partner at Laurus Law Group LLC.

“Insurers today actually do have a pretty good sense of how hospitals are charging, but this is going to be a quantum leap forward for them in understanding the strategy that hospitals take in negotiating across insurance markets,” Dan Mendelson, founder of Avalere Health says regarding what will happen if the rule does take effect.

However, “the insurer will have more information, but I question whether they will have more leverage,” Mendelson says. “I think over time what this [rule] is likely to do is to drive more consistency in pricing — not necessarily lower prices across the board.”

Kaufman observes that the disclosure of hospitals’ negotiated rates may not have a uniform impact across different types of insurers.

“In certain ways, it’s a procompetitive kind of rule by providing more transparency,” he says. “However, large established insurers that have the advantage of broad networks with lower prices based on their large membership benefit by keeping their prices confidential. It helps them with providing better prices to large employers, etc. So by making those prices more transparent, it might ease barriers to entry [for] other insurers.”

Perspectives on MedImpact’s New Program to Accelerate Pharmacogenomics

July 9, 2020

With precision medicine an increasingly hot topic in health care, MedImpact is betting that a newly launched program — which reviews every drug prescribed to patients against their genetic profile — will simultaneously give the PBM a competitive edge and improve care, AIS Health reported.

In a Feb. 26 press release, MedImpact describes its new program as the industry’s first “any drug, any time, any prescriber” approach to pharmacogenomics (PGx).

With precision medicine an increasingly hot topic in health care, MedImpact is betting that a newly launched program — which reviews every drug prescribed to patients against their genetic profile — will simultaneously give the PBM a competitive edge and improve care, AIS Health reported.

In a Feb. 26 press release, MedImpact describes its new program as the industry’s first “any drug, any time, any prescriber” approach to pharmacogenomics (PGx).

“Pharmacogenetics, in the most basic sense, is looking at someone’s genes to determine their drug-metabolizing enzymes,” explains Emily Cicali, a clinical assistant professor at the University of Florida’s College of Pharmacy. For people who have lower levels of drug-metabolizing enzymes, certain medications may be less effective or ineffective, and for those have too much of those enzymes, that could overactivate drugs and “put people at risk for toxicity,” Cicali adds.

The concept of a PBM having a PGx program isn’t new, MedImpact acknowledges in its release. But up until now, most PGx programs generally operated along the lines of “one gene being tested for one drug at one point in time” to determine if there’s a potential conflict, says Karen Geary, the company’s vice president of strategy and innovation. MedImpact’s program, however, screens for genetic interactions with more than 240 commonly prescribed medications and then reviews all future prescriptions for potential drug-gene issues.

Michael Schneider, a principal at Avalere Health, says that if a program like MedImpact’s is able to significantly avert problems like adverse drug events, “then I think this type of analysis could have a big impact on the PBM industry and potentially become the standard of care.”

However, if genetic testing becomes more commonplace across wider swaths of the population, there could be downsides, he suggests. For example, the expense of large-scale genetic testing might trickle down from plan sponsors to consumers in the form of higher premiums.

Radar On Market Access: Reports Show Medicaid MCOs Are ‘Dominant,’ Increase Affordability

July 7, 2020

Two recent reports found that Medicaid managed care plans now enroll most Medicaid members, help keep costs and premiums low in the markets where they participate, and are competitive with commercial plans at the low end of the individual market in areas including network quality and benefit design, AIS Health reported.

One white paper was prepared by consultancy The Menges Group for America’s Health Insurance Plans (AHIP), and the other was authored by researchers at the Robert Wood Johnson Foundation (RWJF) and Urban Institute.

Two recent reports found that Medicaid managed care plans now enroll most Medicaid members, help keep costs and premiums low in the markets where they participate, and are competitive with commercial plans at the low end of the individual market in areas including network quality and benefit design, AIS Health reported.

One white paper was prepared by consultancy The Menges Group for America’s Health Insurance Plans (AHIP), and the other was authored by researchers at the Robert Wood Johnson Foundation (RWJF) and Urban Institute.

The Menges Group-AHIP white paper, which had a national scope, found that Medicaid MCO enrollment increased by 121% between fiscal years 2010 and 2018, from 26 million to over 56 million members, and that as of 2018, more than 75% of all Medicaid enrollees are members of an MCO, up from 50% in 2010. The report also found that, since 2017, capitated payments to MCOs have exceeded fee-for-service expenditures.

The RWJF-Urban Institute paper, which relied on case study surveys in Arkansas, California, Florida, New York, Ohio, and Washington state, concluded that MCOs offer coverage that is at least as good as commercial plans in the low end of the Affordable Care Act individual market.

“Many [stakeholders] feel there are no longer major distinctions between Medicaid and commercial insurers in the marketplaces. Most interviewees have positive perceptions of Medicaid insurers, crediting their ability to increase choice and affordability in the individual health insurance market,” wrote the paper’s authors.

Most of the surveyed stakeholders, which the paper says “included representatives from state departments of insurance, hospital associations, medical or primary care provider associations, insurance brokers, and consumer advocates,” believe that Medicaid MCOs have improved the level of competition in their state marketplace, and offer their members similar network quality to commercial plans.

MMIT Reality Check on Hemophilia A or B With Inhibitors (July 2020)

July 3, 2020

According to our recent payer coverage analysis for hemophilia A or B with inhibitors treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

According to our recent payer coverage analysis for hemophilia A or B with inhibitors 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 hemophilia A or B with inhibitors treatments shows that under the pharmacy benefit, about 48% of the lives under commercial formularies are covered with utilization management restrictions.

Trends: In April 2020, the FDA approved Laboratoire Francais du Fractionnement et des Biotechnologies S.A.’s Sevenfact [coagulation factor VIIa (recombinant)-jncw] for the treatment and control of bleeding episodes in people at least 12 years old with hemophilia A or B with inhibitors.

Radar On Market Access: Insurers Are Required to Cover Only ‘Medically Necessary’ COVID-19 Tests

July 2, 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.