CVS Health: What Kind of Disruptor to Primary Care?

 While working at one of the nation's largest safety-net hospitals, I experienced first-hand how difficult it can be for people to access medical care. For many providers, the story of the patient with diabetes or a suspicious lump who couldn't get an appointment in time or wasn't able to take time off work will resonate all too well. Many hospitals have adopted initiatives to improve access, but innovation has been slow, confined to individual institutions, and hampered by regulation.

In the absence of a productive government, some believe it necessary to turn to industry. One industrial giant touting itself as the newest solution to healthcare is CVS Health. Its power unknown to many, CVS Health is a nation-wide conglomerate composed of 9,900 retail stores, which serves over 1 million customers a year through its senior pharmacy, runs 1,100 MinuteClinics, has 105 million plan members through its pharmacy benefit manager (PBM) Caremark, and manages health insurance for over 34 million people through traditional, voluntary, and consumer-directed health insurance products and related services, including Aetna. And now, CVS Health has unveiled its newest venture: primary care.

CVS Health wants to expand by transforming MinuteClinics into HealthHUB clinics, a one-stop-shop for primary care needs. Customers will be able to schedule primary care visits, browse CVS's 6,000 branded medical products, and receive education on chronic disease management. On November 5, 2021, CEO Karen Lynch announced CVS Health would be hiring primary care physicians for their new HealthHUBs, a move which will make CVS Health the first company to offer physician patient care coupled with a pharmacy, covered through its own insurance plan, and managed by its own PBM.

Can such a vertically integrated, for-profit company deliver on its promise to increase access to high-quality care while lowering healthcare costs? With the majority (71%) of Americans living within a 5-mile radius of a CVS, the company is poised to deliver local, convenient primary care. However, the complexity of incentives in the integrated CVS Health model pose reasons to approach this new model with caution.

First, the relationship between a healthcare provider integrated with an insurance company has implications for how high-quality care can be incentivized. While providing high-quality care that keeps patients out of the hospital will lower costs on the insurance provider, incentives could also be skewed to keep patients from accessing costly services. Current insurance companies do this with utilization controls, such as gatekeeping, prior authorization requirements, and step therapy. In theory, stricter utilization controls at CVS Health could result in telehealth first and in-person visits restricted to HealthHUBs, leaving Aetna members with little choice in primary care services, and reliance on an unknown quality of new HealthHUB practitioners. Additionally, having providers employed by both an insurer and PBM could incentivize reduced referrals out-of-network, preventing patients from getting the care they need. Meanwhile, the company's profits would likely offset any losses incurred from worsened patient health.

Second, complexities arise from the potential for induced demand. A provider service owned by a pharmacy could theoretically incentivize physicians to increase prescriptions, particularly those covered under the formulary negotiated by the PBM Caremark. While some may think physicians would not engage in such actions, multiple studies have shown that physicians, like all human beings, can be influenced by financial incentives.

Lastly, with an insurer providing care to its own patient population, it will be important to watch for any potential cream-skimming in which less healthy persons are de-incentivized to join the CVS Health plan. Cream-skimming has been widely reported in Medicare Advantage (MA) plans, and with a large portion of CVS's 2020 revenue stemming from MA benefits, it will be important to keep an eye out for any additional cream-skimming tactics.

Some may argue that such profit tactics are worth tolerating if they reduce U.S. healthcare costs. One argument is that, with its 105-million-member strong network, the Caremark PBM could negotiate with manufacturers and providers to drive down drug and hospital prices. However, research has not shown that for-profit vertical integration will pass on cost savings to patients. Rather, the current PBM structure incentivizes formulary coverage of whichever drugs the PBM can negotiate the highest percent rebate on, with rebates passed off to the insurer or PBM rather than patients. In fact, a lawsuit is alleging that CVS Health denied consumers low-cost generic medications, choosing only to cover higher-priced brand-name drugs, which increased profits for their pharmacy and PBM, and cost patients higher co-pays. Therefore, it is very possible that patients will not see savings through increased vertical integration, and that the promises of integration-driven efficiency may just be another example of for-profit "health-washing."

Is for-profit vertical integration the innovation the U.S. needs to increase access to quality care, deliver improved health outcomes, and lower overall healthcare costs? Despite incentives that could theoretically skew the company towards strict utilization controls, induced pharmaceutical demand, or cream-skimming, CVS Health has the potential to deliver on their promises by enacting tight internal controls.

The question then becomes: how will CVS Health be held accountable? Without transparency into CVS Health payment structures, quality measures, and health outcomes, the public will be left to question whether this new disruption will truly bring about the changes in primary care we have all been waiting for.

While the road ahead remains uncertain, one thing is clear: CVS Health is forcing traditional healthcare to adapt. One promising avenue may be state-wide global payment models, such as Accountable Care Organizations, that reimburse on value rather than volume. If the monopolization of privatized healthcare forces hospitals to accelerate their switch to such global payment models, then perhaps the public will glean benefits from the for-profit sector after all.

Lucia Ryll is a fourth-year medical student at Boston University School of Medicine, and a 2023 Boston University Questrom School of Business MBA Candidate.

https://www.medpagetoday.com/opinion/second-opinions/99374

Regenxbio started at Buy by Berenberg

 Target $61

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Cognition Therapeutics starts Phase 2 dementia trial

  Cognition Therapeutics, Inc. (Nasdaq: CGTX) today announced that the first patient has been dosed in its double-blind, placebo-controlled, randomized Phase 2 SHIMMER clinical trial of CT1812 in patients with dementia with Lewy bodies (DLB). CT1812 is an experimental, orally delivered small molecule therapeutic intended to address the underlying biology of DLB.

“Dementia with Lewy bodies is a devastating disease that has no disease-modifying treatments and impacts millions of people around the globe, yet remains under-funded and under-researched,” stated James E. Galvin, MD, MPH, the director of the Comprehensive Center for Brain Health at the University of Miami Miller School of Medicine and primary investigator in the Phase 2 study. “This Phase 2 study provides me and my colleagues at other sites in the Lewy Body Dementia Consortium an opportunity to investigate a unique mechanism of action that has the potential to impact the progression of DLB. I’m looking forward to working with the team at Cognition to assess this novel medication.”

DLB is a multi-faceted disorder characterized by the accumulation of α-synuclein fibrils, the major constituent of the Lewy bodies that occur inside brain neurons, which exert deleterious effects across brain structures. In addition, many patients with DLB also have a buildup of Aβ oligomers. Together, the accumulation of pathogenic proteins in DLB is believed to be due in part to a failure of autophagy and other key cellular functions. Further evidence suggests that these processes are regulated by the sigma-2 (σ-2) receptor, which is the biological target of CT1812. Cognition has previously published results supporting the use of σ-2 receptor modulators such as CT1812 to protect neurons from the toxic insults from α-synuclein and Aβ oligomers. It is anticipated that its mechanism of action may thus enable CT1812 to address the dual assault from α-synuclein and Aβ oligomers in patients with DLB.

https://finance.yahoo.com/news/cognition-therapeutics-doses-first-patient-113000766.html

Denali started at Buy by Berenberg

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BioNTech Gets Priority from EMA for CAR-T Candidate BNT211 in Testicular Cancer

 

• First BioNTech product candidate to receive priority medicines (PRIME) designation by the European Medicines Agency for enhanced regulatory support facilitating the clinical development of the investigational cell therapy candidate BNT211 in the third- or later-line setting in patients with heavily pretreated testicular cancer

• Designation follows positive interim Phase 1/2 data for BNT211 demonstrating an encouraging safety profile and early signs of anti-tumor activity in testicular cancer patients

• BNT211 combines two innovative approaches in one regimen, an autologous chimeric antigen receptor (CAR) T cell therapy targeting the oncofetal antigen Claudin-6 (CLDN6) and a CLDN6-encoding CAR-T cell amplifying RNA vaccine (CARVac) to improve persistence and functionality of the adoptively transferred cells

• The European Medicines Agency’s priority medicines status is granted to drug candidates that may offer a major therapeutic advantage over existing treatments, or benefit patients without treatment options

https://finance.yahoo.com/news/biontech-receives-priority-medicines-prime-150000772.html

Tyra Biosciences started at Buy by Wainwright

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CDC reform is long overdue

 The last two years have demonstrated the harms of politicizing public health and of the Centers for Disease Control and Prevention (CDC), which has drifted away from its mission and core function as the nation’s public health fire department. 

Over 1,000,000 Americans have died from COVID-19, and at the height of the pandemic, a $26 trillion economy contracted at an annualized rate of 3.5 percent mostly because of overreaching CDC-recommended infection control policies.

With roots stretching as far back as 1946 and expanded through the creation of the Epidemic Intelligence Center in 1951, the Communicable Disease Center, as it was then called, functioned to predict and protect America from infectious disease threats, most notably to fight malaria in war zones. Yet, over time, the agency’s core mission became diluted as bureaucracy expanded to encompass such concerns as environmental justice, health equity, and the social determinants of health.

Today, like a conglomerate of unrelated businesses lacking a clear strategic direction, the CDC tries to be all things to all people. Worryingly, this lack of strategic focus has produced a series of long-term operational failures, including the fact that despite investing over $1.1 billion in chronic disease prevention, the prevalence of diabetes and obesity in America has risen over the past decade. Other actions demonstrate a failure to understand basic strategy and operations, such as the creation of a disease forecasting center nearly two years into the worst global pandemic in a century.

And in the past two years, the COVID-19 pandemic has served as a prism, magnifying the CDC’s weaknesses in what were prior core functions — forecasting, detecting and managing disease outbreaks. Operationally hamstrung by an unwieldy organizational configuration with 15 offices and centers reporting to the agency director, the CDC needs to return to a more focused and nimble structure. During the pandemic, the CDC struggled with crisis communications, early diagnostic test development, and transparent, timely, and sensible public health guidance on non-pharmaceutical interventions.

Simultaneously, the CDC failed to both anticipate and estimate basic tradeoffs in public health policy, such as the harms of school closures on childhood mental health, or lockdowns resulting in worsening of substance abuse and increased overdoses, or the CDC’s eviction moratorium, which expired July 31, 2021, while eventually struck down by the Supreme Court, still cost hundreds of thousands of landlords billions. Unlike nearly every other federal agency, the CDC exercised regulatory power without an opportunity for public input or evaluation of the economic effects of its policy decisions. The CDC failed at its core mission while contributing to the pandemic’s economic hardship.

Public mistrust also deepened as a consequence of constantly changing risk mitigation guidance founded on an unclear evidence base. The involvement of teachers’ unions — and not parental groups — politicized the CDC’s recommendations regarding the masking of students, and worsened public perceptions of what was once the country’s premier public health agency. This was subsequently compounded by opaque decision-making and even bureaucratic inaccessibility when the Department of Health and Human Services removed all departmental staff emails from the agency directory. The CDC today lacks accessible channels for feedback from the very public whose behavior it strives to change.

Americans have suffered at the hand of the CDC over the past two years. While the agency did commission a month-long “external” review by a small team of federal civil servants to demonstrate contrition, other public agency failures have prompted more thorough and incisive external reviews featuring a wide variety of stakeholders, including those economically affected by the agency’s decisions.

The CDC’s behavior during the pandemic calls for a congressionally-chartered commission to transparently review its performance, mission, and programs and help set the agency on a path back toward accountability for its original public health mission.

Recent congressional actions also highlight the frustration of politicians with the performance of the CDC. The proposed bipartisan legislation, the Prepare for and Respond to Existing Viruses, Emerging New Threats (PREVENT) and Pandemics Act requires the CDC to write a strategic plan every four years.

The failure of the very agency that is supposed to protect the nation from infectious disease and other public health threats, specifically, the CDC’s lack of preparedness when facing the COVID-19 pandemic, and its ignorance of the economic tradeoffs in public health policy, must never be repeated. The CDC must change, and this change won’t happen without an external motivating force.

Brian J. Miller is an assistant professor of Medicine and Business (Courtesy) at the Johns Hopkins University and a nonresident fellow at the American Enterprise Institute. Phillip Phan is Alonzo and Virginia Decker Professor of Strategy and Entrepreneurship at the Carey Business School and professor of Medicine (Courtesy) at the Johns Hopkins University.

https://thehill.com/opinion/healthcare/3531422-a-plan-for-cdc-reform-is-long-overdue/