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Trends That Matter for COVID Vaccine Distribution

December 31, 2020

As details continue to emerge about the availability of COVID-19 vaccines and how they will be administered, the role that payers will play in the process is becoming clearer, AIS Health reported.

It’s imperative for health plans to do two key things at the same time, according to Katherine Dallow, M.D., the vice president of clinical programs and strategy at Blue Cross Blue Shield of Massachusetts. Payers need to help the entities that will be distributing the vaccine to identify the individuals who should be first in line to be vaccinated, and they need to use their resources to help educate the community.

As details continue to emerge about the availability of COVID-19 vaccines and how they will be administered, the role that payers will play in the process is becoming clearer, AIS Health reported.

It’s imperative for health plans to do two key things at the same time, according to Katherine Dallow, M.D., the vice president of clinical programs and strategy at Blue Cross Blue Shield of Massachusetts. Payers need to help the entities that will be distributing the vaccine to identify the individuals who should be first in line to be vaccinated, and they need to use their resources to help educate the community.

“We might be able to put a puzzle together that an individual provider or group may not have,” she said during a Nov. 18 National Institute for Health Care Management (NICHM) Foundation webinar. “Data from many sources should be used to ensure those who are most vulnerable are ID’d per federal and state guidelines. We can see where folks have seen three different doctors, used telehealth and gone to urgent care.”

In addition, health plans are more likely than providers to have better data about whether individuals have received each of their vaccine doses. That’s because states may expand the scope of the type of providers that can administer vaccines in an effort to broaden access.

While multiple vaccines appear ready to come to market, health plans do have some concerns. According to a recent Avalere Health survey of 39 U.S. health plans and one PBM, collectively representing about 48 million covered lives, the effectiveness of vaccines and therapeutics is the top COVID-19 concern for more than 47% of health plans.

Radar On Market Access: Surprise Medical Billing Comes to An End, Insurers Oppose Arbitration Mechanism

December 31, 2020

After years of failed attempts, Congress has finally come to an agreement on a measure to end the practice of surprise medical billing, AIS Health reported.

Surprise billing, also known as balance billing, is the practice of charging patients for out-of-network procedures that insurers refuse to pay for in whole or in part. Often, patients incur these balance bills without their knowledge. The new legislation would ban providers from sending such a bill to patients, and would instead require providers to negotiate reimbursement with the patient’s insurer or submit the dispute to a binding arbitration process.

Providers will have 30 days from the day of the procedure to negotiate a compromise reimbursement amount with payers. If the parties can’t agree, they must submit their preferred reimbursement amounts to an HHS-approved arbitrator, who will pick one of the two amounts.

After years of failed attempts, Congress has finally come to an agreement on a measure to end the practice of surprise medical billing, AIS Health reported.

Surprise billing, also known as balance billing, is the practice of charging patients for out-of-network procedures that insurers refuse to pay for in whole or in part. Often, patients incur these balance bills without their knowledge. The new legislation would ban providers from sending such a bill to patients, and would instead require providers to negotiate reimbursement with the patient’s insurer or submit the dispute to a binding arbitration process.

Providers will have 30 days from the day of the procedure to negotiate a compromise reimbursement amount with payers. If the parties can’t agree, they must submit their preferred reimbursement amounts to an HHS-approved arbitrator, who will pick one of the two amounts.

Loren Adler, associate director of the USC-Brookings Schaeffer Initiative for Health Policy, praised the legislation as “closer to the ideal, consumer-friendly solution” than previous attempts to address the issue.

“It’s very likely that this bill reduces premiums,” says Adler, who has contributed to research that found surprise billing increases health care costs.

Insurance stakeholders are displeased that surprise bills will be resolved through arbitration. Instead of arbitration, America’s Health Insurance Plans had lobbied for out-of-network reimbursement to be tied to a benchmark rate.

Adler thinks that insurers’ objections to arbitration are overblown, and he argues carriers will gain leverage in balance billing negotiations because of the legislation.

“It seems pretty easy for an insurer or a [plan sponsor] company to call a provider’s bluff,” Adler says, citing rules in the bill that he thinks will prevent providers from abusing the arbitration system.

Dan Mendelson, founder of Avalere Health, is more skeptical about the bill’s potential to reduce costs and slow premium inflation, since it will require new administrative costs.

“There is no question that whenever you force more cost into the system, it’s going to be reflected in consumer cost,” Mendelson explains. “So there will be a premium effect. Will people actually be able to differentiate it from the typical rise in costs? No….I do expect that it will have an effect, just from an economics standpoint.”

Radar On Market Access: PBMs Continue Integration, Face More Regulatory Challenges in 2020

December 29, 2020

In 2020, the PBM industry continued to deepen its integration with other industry players, a trend that experts say is likely to continue in coming years. The PBM space has consolidated to the point that five firms — UnitedHealth Group’s OptumRx, CVS Health Corp.’s Caremark, Cigna Corp.’s Express Scripts, Anthem Inc.’s IngenioRx, Humana Inc.’s Humana Pharmacy Solutions, and the Blue Cross and Blue Shield affiliate-owned Prime Therapeutics LLC — manage the lion’s share of the pharmacy benefits offered to U.S. health plan members.

Beyond their deepening integration with the payers that own them, these firms are working to expand their data and direct-to-consumer operations, AIS Health reported.

In 2020, the PBM industry continued to deepen its integration with other industry players, a trend that experts say is likely to continue in coming years. The PBM space has consolidated to the point that five firms — UnitedHealth Group’s OptumRx, CVS Health Corp.’s Caremark, Cigna Corp.’s Express Scripts, Anthem Inc.’s IngenioRx, Humana Inc.’s Humana Pharmacy Solutions, and the Blue Cross and Blue Shield affiliate-owned Prime Therapeutics LLC — manage the lion’s share of the pharmacy benefits offered to U.S. health plan members.

Beyond their deepening integration with the payers that own them, these firms are working to expand their data and direct-to-consumer operations, AIS Health reported.

Ashraf Shehata, national sector leader for health care and life sciences at KPMG, says that a “back to basics” approach for 2021 will be essential for PBMs, especially as their health plan owners navigate the uncertainty generated by the COVID-19 pandemic. However, he notes that the space is still managing the aftereffects of transactions and is looking for more deal-making opportunities.

In that realm, the long-term integration of Express Scripts into Cigna has generated the most noise. Under Cigna, Express Scripts has deepened a horizontal relationship with Prime Therapeutics.

Meanwhile, in November, Amazon.com Inc. made a big splash by unveiling new pharmacy services, including a prescription-discount service for uninsured individuals that taps into Express Scripts’ price-negotiation powers with manufacturers.

Midwestern supermarket chain Hy-Vee, Inc. also launched a PBM in December, while in March, Costco Wholesale Corp. purchased a minority stake in Navitus Health Solutions, a subsidiary of integrated health system SSM Health.

Shehata says that PBMs’ data expertise will be a key line of business going forward, especially as regulators and the new Democratic administration increase scrutiny on the industry.

He suggests that PBMs could expand beyond the traditional role into something more like a data and analytics clearinghouse for the entire health care industry and PBMs need to be aggressive in delivering value directly to consumers as regulatory scrutiny on the industry increases.

“Big data and [artificial intelligence is] going to sit in kind of the combination of the traditional PBM, …the more traditional health claim, and… detailed EHR data,” Shehata explains. “You’ll start to see a whole generation of organizations also bring in EHR data, because it’s much more accessible now.”

MMIT Reality Check on Migraine Prevention (Dec 2020)

December 26, 2020

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

According to our recent payer coverage analysis for migraine prevention 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 migraine prevention treatments shows that under the pharmacy benefit, almost 58% of the lives under commercial formularies are covered with utilization management restrictions.

Trends: In February 2020, the FDA approved H. Lundbeck A/S’s Vyepti (eptinezumab-jjmr) for the preventive treatment of migraine in adults. The recommended dose is 100 mg every three months. Vyepti is the first FDA-approved intravenous treatment for migraine prevention, according to the company’s news release.

Perspectives on Amazon Pharmacy

December 24, 2020

Amazon.com, Inc. made a splash in the health care world on Nov. 17 when the online retail powerhouse unveiled new pharmacy offerings that aim to disrupt the prescription drug market with increased convenience and savings, AIS Health reported.

In addition to setting up its own online pharmacy, Amazon is partnering with one of the three largest PBMs — Cigna Corp.’s Express Scripts — to offer a prescription-savings benefit that will be available to Amazon Prime members. “It can be used for discounts up to 80% off generic and 40% off brand name medications at over 50,000 participating pharmacies nationwide,” according to a press release.

Amazon.com, Inc. made a splash in the health care world on Nov. 17 when the online retail powerhouse unveiled new pharmacy offerings that aim to disrupt the prescription drug market with increased convenience and savings, AIS Health reported.

In addition to setting up its own online pharmacy, Amazon is partnering with one of the three largest PBMs — Cigna Corp.’s Express Scripts — to offer a prescription-savings benefit that will be available to Amazon Prime members. “It can be used for discounts up to 80% off generic and 40% off brand name medications at over 50,000 participating pharmacies nationwide,” according to a press release.

Notably, Amazon’s new service offers similar functionalities that health insurers, PBMs and major retail pharmacies have included in their prescription-drug shopping tools — but with the twist of making it clear to consumers when it might be cheaper to purchase their drugs without insurance.

To SVB Leerink analyst Stephen Tanal, that constitutes the only notable — and likely minimal — threat to PBMs’ business models.

“The way in which it could be potentially somewhat bad for PBMs is pretty indirect,” says Tanal. “It’s the idea that to the extent that Amazon is now going to be showing every Prime customer two prices for every pharmacy transaction they do with Amazon, it’s really going to highlight the disparities of the cost to you of any given drug if you use insurance or if you choose not to use insurance.”

“What I worry about a little on the margin is, if a lot of people, a lot of the time, for a lot of different drugs start to see that cash pay’s better than insurance, boy, that’s not going to help sentiment and people’s perceptions of insurers and PBMs,” he adds. If that happens, it could increase policymakers’ appetite to regulate PBMs, Tanal points out.

Still, Ashraf Shehata, KPMG’s national sector leader for health care and life sciences, says that payer-owned PBMs have an advantage that Amazon would be hard-pressed to replicate. “The broader value proposition is the drug spend in combination with the total medical spend,” he says, noting that employers, in particular, want to look at the whole picture when trying to keep down costs.

Radar On Market Access: MCO Messaging Plays Key Role in COVID Vaccine Rollout

December 24, 2020

States and the federal government recently began rolling out the COVID-19 vaccine to health care workers across the country. Health plans, particularly those that serve high-risk individuals, may be ideally situated to coordinate care and update members on vaccination opportunities, experts tell AIS Health.

The FDA on Dec. 11 authorized emergency use of the COVID-19 vaccine made by Pfizer Inc. and BioNTech in individuals age 16 and older. Then the agency on Dec. 18 authorized Moderna’s vaccine for emergency use in people 18 years or older.

States and the federal government recently began rolling out the COVID-19 vaccine to health care workers across the country. Health plans, particularly those that serve high-risk individuals, may be ideally situated to coordinate care and update members on vaccination opportunities, experts tell AIS Health.

The FDA on Dec. 11 authorized emergency use of the COVID-19 vaccine made by Pfizer Inc. and BioNTech in individuals age 16 and older. Then the agency on Dec. 18 authorized Moderna’s vaccine for emergency use in people 18 years or older.

Health care workers and nursing home residents have been designated by the Centers for Disease Control and Prevention as the first group (phase 1a) to receive the vaccine.

“I think the paradigm of changing tires on a moving bus applies to this venture,” remarks Margaret Murray, CEO of the Association for Community Affiliated Plans (ACAP). “We certainly support the idea of getting the vaccine to front-line health care workers and the very most vulnerable populations, such as nursing home residents, first. So CDC is off to a good start.”

But ACAP, which is composed of 77 not-for-profit safety net health plans covering Medicaid, marketplace and MA enrollees, is concerned about other vulnerable seniors — such as those who are very frail or homebound and likely dual eligible — who are not part of that first round. “We need to think about them in the next wave,” Murray tells AIS Health via email. “We also need to consider how most equitably to distribute the vaccine.”

“Hopefully, this will start to evolve quickly, but there’s yet a lot to be figured out,” concurs Cheryl Phillips, M.D., president and CEO of the SNP Alliance, pointing out that there is no mechanism for tracking who has and who hasn’t received the vaccine. The plans that are most likely to serve some of the high-risk older adults that will soon qualify for the vaccine are MA Special Needs Plans, she says, “and they can be a wonderful partner for data sharing and working with providers,” as well as communicating with members to help them get the vaccine.

Murray adds messaging from plans will be crucial, especially if members are skeptical of the vaccine or behind on their vaccines in general.

Radar On Market Access: Biden Probably Won’t Roll Back New Prior Authorization Proposal

December 22, 2020

Building on previously finalized regulations aimed at advancing data interoperability in health care, CMS on Dec. 10 proposed a new rule that would require certain health plans to make their prior authorization processes more efficient and share even more data with providers and patients, AIS Health reported.

If finalized, the rule would apply only to managed care Medicaid and CHIP plans, fee-for-service Medicaid and CHIP plans, and Qualified Health Plans (QHPs) on the federally facilitated exchanges.

Building on previously finalized regulations aimed at advancing data interoperability in health care, CMS on Dec. 10 proposed a new rule that would require certain health plans to make their prior authorization processes more efficient and share even more data with providers and patients, AIS Health reported.

If finalized, the rule would apply only to managed care Medicaid and CHIP plans, fee-for-service Medicaid and CHIP plans, and Qualified Health Plans (QHPs) on the federally facilitated exchanges.

“The proposed rule is a welcome step toward helping clinicians spend their limited time on patient care,” the American Hospital Association said in a statement, adding that “we are deeply disappointed, however, that CMS chose not to include Medicare Advantage plans.”

The new proposal builds on an interoperability rule that CMS finalized in May. That rule requires Medicaid, CHIP, QHP and MA plans to share claims and other health information with patients through a Patient Access API, which will allow them to obtain their data through any third-party application they choose.

Under the new rule, starting Jan. 1, 2023, affected payers would have to include information in their already established Patient Access APIs about patients’ pending and active prior authorization decisions.

The rule would also make several changes to streamline the prior authorization process itself. As a press release from CMS explained, Medicaid, CHIP and QHP payers would be required to build and implement APIs that “allow providers to know in advance what documentation would be needed for each different health insurance payer, streamline the documentation process, and enable providers to send prior authorization requests and receive responses electronically.”

Although the incoming Biden administration could opt to reverse some of the more controversial regulations issued by the Trump administration in recent weeks, Andrew Van Ostrand, a principal in Avalere Health’s policy practice, says he doesn’t expect this latest rule will be among them.

The official comment period for the rule closes on Jan. 4, so CMS is likely to be able to finalize it before President-elect Joe Biden’s inauguration on Jan. 20, he says. “I also think that this larger issue of data interoperability…that’s been a bright spot from a bipartisan perspective.”

Therefore, “I do expect a Biden administration to carry these initiatives forward and build on them,” Van Ostrand says. However, he says there could be “tweaks to deadlines and tweaks to specific requirements.”

MMIT Reality Check on Breast Cancer HR+/HER2+ (Dec 2020)

December 18, 2020

According to our recent payer coverage analysis for hormone receptor-positive, human epidermal growth factor receptor 2-positive (HR+/HER2+) breast cancer treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

According to our recent payer coverage analysis for hormone receptor-positive, human epidermal growth factor receptor 2-positive (HR+/HER2+) breast cancer 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 breast cancer (HR+/HER2+) treatments shows that under the pharmacy benefit, about 41% of the lives under commercial formularies are covered with utilization management restrictions.

Trends: In March 2020, the FDA expanded the label of Ontruzant (trastuzumab-dttb) to include the availability of a 420 mg multidose vial. The agency initially approved the Herceptin (trastuzumab) biosimilar from Samsung Bioepis Co. Ltd. in January 2019 as a 150 mg single-dose vial for the adjuvant treatment of human epidermal growth factor receptor 2 (HER2)-overexpressing breast cancer and for metastatic breast cancer, gastric cancer or gastroesophageal junction adenocarcinoma in patients who have not received prior treatment.

Trends That Matter: Centene’s ACA Expansion

December 17, 2020

Centene Corp., which has come to dominate the Affordable Care Act exchange market by continuing to expand even when other carriers pulled back, is facing more competition now that the market has stabilized and insurer participation has increased, AIS Health reported.

Given that dynamic, Citi analyst Ralph Giacobbe advised investors recently that he was placing a “negative catalyst watch” on Centene due to the new competitive pressures it’s facing. Centene, he observed, “was displaced as the lowest priced plan in a number of markets,” and so the insurer “will have to rely on retention and new market entry to offset competitive pressures, which could prove challenging and may stunt growth relative to expectations.”

Centene Corp., which has come to dominate the Affordable Care Act exchange market by continuing to expand even when other carriers pulled back, is facing more competition now that the market has stabilized and insurer participation has increased, AIS Health reported.

Given that dynamic, Citi analyst Ralph Giacobbe advised investors recently that he was placing a “negative catalyst watch” on Centene due to the new competitive pressures it’s facing. Centene, he observed, “was displaced as the lowest priced plan in a number of markets,” and so the insurer “will have to rely on retention and new market entry to offset competitive pressures, which could prove challenging and may stunt growth relative to expectations.”

SVB Leerink analyst Stephen Tanal, however, takes a more optimistic view. “I’m pretty comfortable saying Centene’s likely to grow their overall HIX [health insurance exchange] earnings, because they’re going to be in so many more places with higher premiums,” he tells AIS Health.

According to Tanal’s analysis, Centene is increasing its county-level, member-weighted bronze plan premium by about 4% and raising premiums across all metal levels by 4% to 6%. Centene is also expanding its geographic footprint next year, a move that Tanal estimates will put the insurer in 61% more counties than it covered in 2020.

But Tanal did notes that the exchanges next year will feature “more competition in the form of fewer monopoly markets and a larger number of local market competitors.”

“It is definitely more competitive,” Kathy Hempstead, senior policy adviser at the Robert Wood Johnson Foundation, says of the 2021 ACA exchange market. “There’s more participants and it’s not just the Medicaid MCOs spreading out into more places.”

Radar On Market Access: New-to-Market Oral Drugs May Not Always Have a Leg Up on Injectables

December 17, 2020

In its latest quarterly Drug Pipeline Insights Report, OptumRx includes a diverse array of medications that the UnitedHealth Group-owned PBM believes are likely to make a market impact when they’re approved by the FDA, AIS Health reported. One interesting trend that applies to three of the five highlighted drugs is the fact that each is the first oral option in its respective category.

While oral medications tend to be thought of as more convenient than injectable or IV-administered therapies, that factor alone may not confer as much of a competitive advantage as one might think, according to one OptumRx executive.

In its latest quarterly Drug Pipeline Insights Report, OptumRx includes a diverse array of medications that the UnitedHealth Group-owned PBM believes are likely to make a market impact when they’re approved by the FDA, AIS Health reported. One interesting trend that applies to three of the five highlighted drugs is the fact that each is the first oral option in its respective category.

While oral medications tend to be thought of as more convenient than injectable or IV-administered therapies, that factor alone may not confer as much of a competitive advantage as one might think, according to one OptumRx executive.

Take roxadustat, which if approved would be the first novel therapy for chronic kidney disease-related anemia since 1989 and would offer an oral alternative to the injectable erythropoiesis-stimulating agents (ESAs) currently being used to treat the condition.

“Dialysis-dependent patients usually get their ESAs administered with dialysis via IV infusion, so the oral alternative in these patients doesn’t provide a convenience benefit necessarily,” says Bill Dreitlein, senior director of pipeline and drug surveillance at OptumRx. “However, there may be alternative benefits around safety.”

Then there’s Orladeyo (berotralstat), BioCryst Pharmaceuticals, Inc.’s treatment for hereditary angioedema (HAE) attacks. When the FDA approved Orladeyo on Dec. 3, it became the first oral plasma kallikrein inhibitor for the prevention of HAE attacks, Dreitlein says.

“The convenience benefit for berotralstat would have been more significant,” he says, but the 2018 approval of approval of Takhzyro, which is subcutaneously administered every two to four weeks and can be self-administered, “diminishes that because it already reduced the number of injections vs. older C1 concentrate products.”

The FDA is expected to decide on Dec. 20 whether to approve relugolix, which would be the first oral GnRH receptor antagonist on the market for advanced prostate cancer.

Relugolix’s oral administration gives it an advantage over Firmagon (degarelix), which requires monthly subcutaneous injections by a health care provider “and hasn’t garnered much commercial success because of the frequent injections and injection site reactions,” Dreitlein says.

The more common GnRH receptor agonists, on the other hand, require intramuscular injections at intervals ranging from one to six months. “Compared to these drugs, relugolix might confer some clinical advantages, but the convenience benefit is reduced because you are replacing an injection given potentially every six months with an oral daily medication,” Dreitlein adds.