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Radar On Market Access: Trump’s International Drug Pricing Order Is Still Missing; Rebate Order Draws Fire

September 16, 2020

A promised executive order that would tie drug prices to their costs in other countries has yet to emerge, although President Donald Trump has promoted the order as part of his re-election campaign. Meanwhile, payers and PBMs are continuing to push back against three executive orders the Trump administration issued in July with the intention of lowering drug prices, one of which would overhaul the Medicare Part D prescription drug rebate system, AIS Health reported.

“I think the purpose of these executive orders is to give the president some talking points going into the debates,” says Avalere Health founder Dan Mendelson. He adds that, regardless of their purpose, the orders will not make a difference in the real world any time soon.

A promised executive order that would tie drug prices to their costs in other countries has yet to emerge, although President Donald Trump has promoted the order as part of his re-election campaign. Meanwhile, payers and PBMs are continuing to push back against three executive orders the Trump administration issued in July with the intention of lowering drug prices, one of which would overhaul the Medicare Part D prescription drug rebate system, AIS Health reported.

“I think the purpose of these executive orders is to give the president some talking points going into the debates,” says Avalere Health founder Dan Mendelson. He adds that, regardless of their purpose, the orders will not make a difference in the real world any time soon.

Administration officials indicated during the rollout of the executive orders on July 24 that the international pricing order would be released within 30 days of the debut of the other three drug pricing orders. Yet the deadline passed and the administration at press time had not released the promised order.

Meanwhile, the executive orders that actually have been released are being criticized from stakeholders across health care. The order that would remove safe harbor protections from the Anti-Kickback Statute for prescription drug rebates in Medicare Part D has been panned even by conservatives.

Alex Brill, a resident fellow at the American Enterprise Institute (AEI), penned a white paper sponsored by PBM trade group Pharmaceutical Care Management Association (PCMA) that concluded the executive order would “restrict an important tool for providing savings to the federal government and Medicare Part D beneficiaries. Moreover, net drug costs and drug company revenues would rise significantly if the Medicare Part D safe harbor for rebates is eliminated.”

Mendelson says that the pharmaceutical industry is beginning to realize that it will have to change its business model one way or another.

“The pharmaceutical industry is facing a real pivot point where there are going to have to be more innovative ways to price for these products,” Mendelson observes. “…it’s really important that the industry start to figure out ways to engage positively with payers. And the government is the biggest payer.”

Radar On Market Access: Amazon Moves Further Into Health Care Data, Sharp Deal Shows

September 10, 2020

Health care industry insiders say that Amazon.com Inc.’s Aug. 27 deal to provide Halo fitness trackers to Sharp HealthCare indicates the retail and tech giant will make big bets on clinical and actuarial data analytics, AIS Health reported.

Sharp Chief Information and Innovation Officer Michael Reagin says that Amazon will provide the San Diego-based integrated plan and provider with about 500 of the wearable fitness trackers.

Health care industry insiders say that Amazon.com Inc.’s Aug. 27 deal to provide Halo fitness trackers to Sharp HealthCare indicates the retail and tech giant will make big bets on clinical and actuarial data analytics, AIS Health reported.

Sharp Chief Information and Innovation Officer Michael Reagin says that Amazon will provide the San Diego-based integrated plan and provider with about 500 of the wearable fitness trackers.

Sharp will use the devices in two pilot programs, Reagin says. The company will give “about 100” Halos to clinicians, who will wear them in order to track staff performance and prevent burnout. Reagin says the Halo’s much-discussed voice monitoring technology is an essential element of the clinician-focused effort.

The rest of the devices will go to Sharp Health Plan members for remote monitoring purposes.

Michael Abrams, co-founder and managing partner of health care consultancy Numerof & Associates, says that member engagement will be essential to the pilot program’s success. He says that remote monitoring can be stifled if patients don’t fully buy in.

Since the Halo will continually monitor members without any action in their part, Abrams is optimistic that the program will enjoy better adherence than other remote monitoring efforts.

“If plans can get member adoption and perseverance, this could be a great tool for seeing high-level, aggregated community trends and identifying specific interventions,” says Rajshri Ravi, the head of product and technology at ConsejoSano. “Population health management is all about data: the more, the better. It depends on how they use the data. Propensity modeling could predict member behavior and offer insights to increase retention.”

Friso van Reesema, a senior account executive for Eliza, Elli and Essette Solutions, says that Amazon is uniquely well-positioned to offer health plans technology and services that will process that data.

“In the next three years, we’’re going to see some really exciting artificial intelligence and improvement of these platforms that are leveraging these devices to power the platform and be able to roll out exciting algorithms, whether they’re retrospective, prospective, prescriptive,” van Reesema says.

He adds that the deal is likely an attempt by the tech giant to start training its AIs on population health models using data gathered from the Halo pilot.

Perspectives on Telehealth Executive Order

September 3, 2020

Recent events indicate the telehealth boom caused by the COVID-19 pandemic will result in a permanent expansion of virtual care. On Aug. 3, the Trump administration issued an executive order directing HHS to make permanent some of the telehealth regulations it relaxed for Medicare beneficiaries during the public health emergency, AIS Health reported.

The executive order directs officials to issue proposed regulations that will lock in some of the changes in telehealth policy that the Trump administration included as part of pandemic relief. In response to the order, CMS on Aug. 3 proposed a rule that would permanently allow Medicare to reimburse for certain services that are furnished virtually, “including home visits for the evaluation and management of a patient (in the case where the law allows telehealth services in the patient’s home), and certain types of visits for patients with cognitive impairments.”

Recent events indicate the telehealth boom caused by the COVID-19 pandemic will result in a permanent expansion of virtual care. On Aug. 3, the Trump administration issued an executive order directing HHS to make permanent some of the telehealth regulations it relaxed for Medicare beneficiaries during the public health emergency, AIS Health reported.

The executive order directs officials to issue proposed regulations that will lock in some of the changes in telehealth policy that the Trump administration included as part of pandemic relief. In response to the order, CMS on Aug. 3 proposed a rule that would permanently allow Medicare to reimburse for certain services that are furnished virtually, “including home visits for the evaluation and management of a patient (in the case where the law allows telehealth services in the patient’s home), and certain types of visits for patients with cognitive impairments.”

Avalere Health founder Dan Mendelson says that the order will have limited impact in the near term, but it speaks to the rapid entrenchment of telehealth.

“The administration is doing what they can with their existing authority. Notionally, it’s in the right direction,” says Mendelson. “It’s thoughtful and positive, but it’s also limited in terms of the practical effect because it’s focused on these rural geographies.”

Meanwhile, telehealth provider Teladoc Health Inc. reached a deal to acquire remote monitoring firm Livongo Health Inc. in a transaction announced Aug. 5, which the firms expect to close by the end of the year. In a July white paper prepared by members of its health care practice, KPMG predicted ample transactions in the telehealth space going forward.

James Gelfand, ERISA Industry Committee (ERIC) senior vice president for health policy, tells AIS Health via email that Congress needs to take telehealth reform further.

“ERIC urges Congress to follow the President’s lead and remove restrictions that ban employers from offering telehealth to all employees, opening up access to health care for millions of Americans nationwide permanently,” he wrote.

Mendelson makes a similar point. He says that Congress needs to set rules for complex, controversial issues like reimbursement. He adds that he expects action on telehealth after the election, if only for Medicare and Medicaid.

Radar On Market Access: Insurers Expand Flu Vaccination Outreach to Blunt COVID-19 Effects

September 3, 2020

Even as the COVID-19 crisis continues, public health officials are warning that an influenza pandemic might emerge this fall or winter. A double pandemic would kill even more people than COVID-19 on its own and strain the already overworked health care system. To prevent that deadly combination, plans have stepped up their usual flu-season member outreach programs, particularly for seniors, AIS Health reported.

In the Aug. 21 edition of its Morbidity and Mortality Weekly Report, the Centers for Disease Control and Prevention tied improved flu vaccination rates to reducing the strain that COVID-19 has put on the health care system.

Even as the COVID-19 crisis continues, public health officials are warning that an influenza pandemic might emerge this fall or winter. A double pandemic would kill even more people than COVID-19 on its own and strain the already overworked health care system. To prevent that deadly combination, plans have stepped up their usual flu-season member outreach programs, particularly for seniors, AIS Health reported.

In the Aug. 21 edition of its Morbidity and Mortality Weekly Report, the Centers for Disease Control and Prevention tied improved flu vaccination rates to reducing the strain that COVID-19 has put on the health care system.

Flu vaccines are fairly easy to access. However, Richard Hughes IV, managing director of Avalere Health’s vaccine team, says that payers need to consider how to make special accommodations for patients who are immunocompromised or have other viral infection comorbidities. He points out that those patients have the most need for the flu vaccine — but that they paradoxically have the highest risk from COVID-19 exposure.

“A lot of employers have workplace flu clinics,” Hughes adds. But now, he observes, “we have a lot of people working remotely in our economy. So I think you’re going to see some additional challenges to getting people vaccinated.”

UnitedHealth Group is taking a proactive approach to flu vaccination, according to Jennifer Brueckner, Pharm.D., head of the company’s Enterprise Flu Committee. She says the company will email all members who have an address on file and UnitedHealth will target certain at-risk members for extra communication.

Meanwhile, Cigna Corp. is also expanding its annual vaccine outreach. Cigna members do not pay any cost sharing for flu vaccinations if they get their shots at an in-network provider or pharmacy, according to a company statement.

Humana Corporate Medical Director Todd Prewitt, M.D., tells AIS Health via email that the insurer has expanded flu vaccination outreach beyond its usual scope.

“Humana has initiated our ‘Safer Sooner’ campaign theme to encourage all members to obtain the vaccination as soon as it is available through their local providers,” Prewitt explains. “As part of the campaign, we’ve distributed personal safety kits to over seven million members and associates including two cloth masks for personal protection,” he says.

Radar On Market Access: USPS Delivery Slowdown Is Unlikely to Cause Major Rx Fill Disruption

September 1, 2020

The recent, sudden disruption of U.S. Postal Service (USPS) deliveries has caused concern about people receiving their medications later than they normally would. While news reports and statements by lawmakers indicate that many Americans have lost prescriptions in the mail or received them late, drug benefit and supply chain experts tell AIS Health the disruption to the most vulnerable patients served by specialty and mail order pharmacies should be minimal.

An Aug. 24 Axios-Ipsos poll shows that one in five Americans received medication through the mail during the preceding week. One in four of that group, or 5% of Americans overall, didn’t receive their medication or got it late.

The recent, sudden disruption of U.S. Postal Service (USPS) deliveries has caused concern about people receiving their medications later than they normally would. While news reports and statements by lawmakers indicate that many Americans have lost prescriptions in the mail or received them late, drug benefit and supply chain experts tell AIS Health the disruption to the most vulnerable patients served by specialty and mail order pharmacies should be minimal.

An Aug. 24 Axios-Ipsos poll shows that one in five Americans received medication through the mail during the preceding week. One in four of that group, or 5% of Americans overall, didn’t receive their medication or got it late.

In addition, PBMs have not reported significant disruption to their supply chains.

“Most of the drugs shipped from a mail order pharmacy — a non-specialty pharmacy — you worry about them being perishable, but they tend to be pretty stable. They’re oral pills, things like that,” says Mike Schneider, a principal at Avalere Health.

Schneider also suggests that mail order pharmacies’ longer fills, which typically keep shipping costs down by filling for 90 days or more, should insulate patients from major disruptions. He adds that most mail order medication businesses also build logistical complications into their shipping schedules.

Omar Hafez, a principal at Avalere and a former supply chain executive at specialty pharmacy McKesson Specialty Health, says that time- and temperature-sensitive therapies have very specific delivery windows that are mandated by law. He says the strict requirements mean that the bulk of the supply chain for temperature-sensitive specialty drugs is managed by specialized logistics firms, not the USPS.

Schneider says the pharmacy supply chain as a whole has proved remarkably resilient over the course of 2020 — despite the tumult caused by the pandemic and the USPS brouhaha.

“I think a lot of supply chain issues never really materialized, at least not to my knowledge,” Schneider says. “There are a certain drugs that have shortages, but nothing that seemed like it was a national emergency. I think part of the reduced supply might have been everybody was going and filling their prescriptions as the virus was hitting, and everybody was getting some longer-term fills.”

Radar On Market Access: Large Employers Expect Cost Uncertainty, More Virtual Care in 2021

August 25, 2020

While the COVID-19 pandemic has not caused employers to significantly alter their health care cost estimates for the coming year, it has unquestionably intensified their interest in embracing virtual care. Those are just a couple of the major findings from the Business Group on Health’s 2021 Large Employers’ Health Care Strategy and Plan Design Survey, AIS Health reported.

Notably, 80% of respondents said they believe virtual health will play a significant role in how care is delivered in the future, up considerably from 64% last year. Further, when asked about actions they were taking to ease the burdens of COVID-19 for employees, the largest share of respondents — 76% — said they “made changes to allow for better access to virtual care solutions.”

While the COVID-19 pandemic has not caused employers to significantly alter their health care cost estimates for the coming year, it has unquestionably intensified their interest in embracing virtual care. Those are just a couple of the major findings from the Business Group on Health’s 2021 Large Employers’ Health Care Strategy and Plan Design Survey, AIS Health reported.

Notably, 80% of respondents said they believe virtual health will play a significant role in how care is delivered in the future, up considerably from 64% last year. Further, when asked about actions they were taking to ease the burdens of COVID-19 for employees, the largest share of respondents — 76% — said they “made changes to allow for better access to virtual care solutions.”

During an Aug. 18 press briefing, Business Group on Health President and CEO Ellen Kelsay attributed such findings to not only telehealth’s ability to offer more convenience and greater access for consumers, but also to the sheer necessity of pivoting to a different care modality amid widespread stay-at-home orders.

Regarding the controversial issue of telehealth reimbursement, which payers generally want to be lower than in-person visits but providers want to be equal, Kelsay said her organization supports payment flexibility over parity. In some cases, that “might mean less reimbursement for telehealth, and in other instances maybe increased reimbursement for telehealth if it’s a better modality for delivery, depending on the situation,” she added.

Kelsay also emphasized that there are still more questions than answers about how the pandemic will affect health care costs for companies and their workers. For 2021, the Business Group on Health is projecting the total cost of health benefits will rise by 5.3% — slightly higher than the 5% trend it predicted in the past few years.

“There is a lot of uncertainty around what is actually going to manifest itself in terms of costs, both this year and next year,” Kelsay said. “Many employers are having a really hard time from a budgeting and actuarial perspective working with their health plan and consulting partners, to really get a good handle of what that means.”