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Friday, August 21, 2020

Health Care Reform Articles - August 21, 2020

 

Reclaim Public Medicine for Public Health

By taking the vaccine industry into full public ownership, we can provide an internationalized response to this and future pandemics that properly recognizes vaccines as a global public good.


Far too many people have suffered and died because our medicines and medical products system was not prepared to respond to the COVID-19 pandemic with prompt and universal access to reliable tests, treatments, and vaccines. Governments, non-profits, and industry in the U.S. and around the world are working furiously to catch up. But their efforts have been hampered by fundamental flaws in our profit-driven pharmaceutical industry.

"We must transform the U.S. pharmaceutical sector so that our nation can successfully combat this crisis, prepare for the next one, and ensure that  millions of people have access to the essential medications they need to live healthy lives."

For Americans with diabetes, cancer, asthma, infectious diseases, mental illnesses, and a myriad of other health issues, those flaws have been causing suffering and even death for decades. From growing shortages in essential medicines, to lagging innovation, dangerous mislabeling and misbranding, and the highest prices in the world, America’s pharmaceutical sector is clearly not meeting the needs of our society. The current crisis has brought these problems into even sharper focus.

Now is the time to redesign our medicines system to effectively, equitably, and rapidly address and anticipate crises like the current pandemic. This can and must be done while also providing a safe, consistent, and affordable supply of essential medicines to all, including persons with health challenges beyond COVID-19.

Medicines were long considered a public good, off-limits to corporate profiteering, price-gouging, and monopolizing. It is time for us to reclaim them as such. We must transform the U.S. pharmaceutical sector so that our nation can successfully combat this crisis, prepare for the next one, and ensure that  millions of people have access to the essential medications they need to live healthy lives, and participate in society and the economy.

To do so, we must take these four steps:

1. Codify open science practices that accelerate innovation, reduce costs, and strengthen the evidence base on which our medicines system rests.

“Open science”—broad, ready, equitable access to scientific knowledge, and to the data that generates that knowledge, across a drug’s entire lifecycle—is essential to focusing research and development activity on the most crucial health needs, accelerating R&D, expanding competition and preventing monopolization, and reducing costs. We must provide access to the “means, methods, and materials” of biomedical innovation, including various preclinical, clinical, and financial data that is currently kept mostly hidden by industry, government, and academia.

This could be done in two phases. In phase one, the National Institutes of Health (NIH), the Food and Drug Administration (FDA), and other public agencies—including the public sector vaccine and pharmaceutical agencies we describe below—would begin discretionary sharing of preclinical and clinical data they hold. Government-held results of experiments and clinical trials, and information on the costs of this research, can and should be shared regardless of if the results are generated by government, industry, or academia. Such data sharing would make it easier for researchers to replicate research findings, reduce redundancy and other inefficiency, and speed the development of new therapies.

  Phase one could be achieved immediately, through agency discretion, without changes to existing law. However, Congress could maximize public benefit by making this data sharing mandatory.

  Phase two would extend open science to manufacturing. Sharing data and know-how on manufacturing processes would accelerate development of new drugs, especially biologics and biosimilars. This would break monopolies and lower sky-high prices.

  To achieve this, Congress should amend federal statute (such as the Food, Drug, and Cosmetic Act or the Biologics Price Competition and Innovation Act) to require manufacturers and the FDA to share information that is currently protected as trade secrets once the appropriate exclusivity period has passed. Congress should also provide the FDA and Department of Health and Human Services (HHS) discretion to share manufacturing information—and clinical data, too—sooner, before the exclusivity period expires, to accelerate competition in the event of anticompetitive conduct or pressing public health needs. The Patent Act should also be reformed to raise the bar to patentability, require patent owners to disclose more useful information, and discourage dense patent “thickets” that overprotect drugs’ manufacturing processes.

2. Create public sector capacity for full-cycle pharmaceutical innovation and production of essential medicines.

The U.S. should establish a public full-cycle pharmaceutical research and development institute and one or more public sector pharmaceutical manufacturers. These institutions would work together based on a new bottom line: the public good. The American public already funds many breakthroughs in the discovery and development of new drugs—far more than even the largest drug companies. But we currently depend on those companies, and the profit motive, to get those breakthroughs to patients.

Public sector institutions could work together to reimagine the innovation cycle from beginning to end. They could direct discovery efforts at the disease areas most important to public health, and lead the world on open science, embracing and expanding on the data sharing asked of industry. Additionally, as public sector actors, these institutions would benefit from the “patient capital”—investment not expected to turn a quick profit—needed to engage in the long-term, uncertain process of discovering and developing truly revolutionary science.

Public pharmaceuticals would lower prices, return revenues to public balance sheets and reduce inefficiencies while building in surge capacity for crises. They would foster a more resilient supply chain and ensure broad, equitable access to new drugs through public-interest management of its inventions. These institutions would be a source of stable, public sector jobs (themselves an upstream investment in health).

By breaking Big Pharma’s monopoly on our medicines supply, public sector institutions would also begin to erode its capture of our political system. The U.S. public sector has a long tradition of path-breaking innovation, from development of the internet to HIV prevention therapy to putting people on the moon. It is incumbent upon us to also wield the full power of that public sector innovation-engine to develop the medicines our society most needs, and assure equitable access to them.

3. Use the full power of compulsory licensing to ensure access to essential medicines.

The federal government should use its existing compulsory licensing power to either directly manufacture essential medicines or allow others to do so. This will ensure adequate supplies and equitable, affordable access. Under two different U.S. statutes, we already possess full legal rights to bypass the barriers of privately-held medicine patents.

There is a long history of the U.S. government issuing compulsory licenses to respond to crises like the one we face today, ensuring affordable access to medicines and technologies in the medical, energy, and other sectors.

In response to the COVID-19 pandemic, several nations are already taking steps to issue compulsory licenses for medicines (and other medical technologies). Beyond the present pandemic, we must also recognize the everyday crises of lack of access to many essential medicines—whether driven by shortages or prohibitive costs—and use compulsory licensing any time access issues jeopardize public health.

Extending the U.S. government’s compulsory licensing power beyond patents to trade secret manufacturing information and regulatory exclusivities (as described above) will ensure that these barriers do not jeopardize public health either. Compulsory licenses call for a reasonable royalty to be paid to the holder of the patent instead of the typical massive monopoly mark-up. Therefore, prescription drugs manufactured through compulsory licensing can be much cheaper, while innovators are nonetheless compensated for their work.

4. Take the vaccine industry into public ownership to assure its products are available to all.

Vaccines are not an effective market good; in fact, they are an essential public good. Only a robust, public program of vaccine development and production can meet our public health challenges. In a profit-driven pharmaceutical industry, vaccines for infectious diseases simply do not offer the kind of return on investment that owners believe they deserve.

This has led most major pharmaceutical companies to pull out of vaccine development altogether, leaving us with a highly consolidated and non-competitive oligopoly of producers–none with the capacity to alone produce a coronavirus vaccine at scale. Yet, current U.S. policy is built on the presumption that these same disinterested corporate actors are the only ones capable of bringing vaccines to market, despite many historical examples to the contrary. De-privatizing the vaccine industry would be a major step towards establishing the full public sector capacity needed to assure essential medicines are accessible to all.

Such de-privatizations in times of emergency are commonplace, and the U.S. has specific experience with public sector mobilization of vaccine development and production, including our highly successful vaccine program during World War II. A public laboratory in Canada recently led the development of the Ebola vaccine. And the U.S. public has already invested billions in vaccine development through federal agencies.

By taking the vaccine industry into full public ownership, we can provide an internationalized response to this and future pandemics that properly recognizes vaccines as a global public good. Vaccines developed in the public sector could be licensed through a global pool—or developed and marketed without patents altogether—so that they are available to all, ensuring the prompt and equitable access necessary for coherent public health interventions. A federal vaccine development agency could break with industry’s tradition of secrecy and commit itself to data sharing, accelerating innovation around the world.

Conclusion

The COVID-19 pandemic has revealed shocking deficiencies in our country’s commitment to the health of all Americans. The choice to prioritize corporate profits over the research, development, and distribution of effective, affordable medicines has proven deadly, just as it has for Americans who have been facing dire access challenges for decades. We are confronting the challenge of our lifetimes without the tests, treatments and vaccines we need. Yet, more and more public money is being pumped into a system best placed to produce duplicative “me-too” drugs that generate excessive profits but have little to no impact on public health.

The pandemic has taught us a brutal lesson: it is time to reclaim our medicines system for the public good. These four steps are the way to begin.

https://www.commondreams.org/views/2020/08/20/reclaim-public-medicine-public-health?cd-origin=rss&utm_term=AO&utm_campaign=Daily%20Newsletter&utm_content=email&utm_source=Daily%20Newsletter&utm_medium=email 

Covid-19 and the Mandate to Redefine Preventive Care

by Daniel M. Horn, M.D.,and Jennifer S. Haas, M.D. - NEJM - August 12, 2020

As the U.S. health care system defines the new normal for ambulatory care in the Covid-19 era, it needs a new approach to providing routine preventive care for adults. Concerns about contagion, competing demands, and shortages of personal protective equipment may limit preventive care visits — most commonly the “routine annual exam” and the Medicare Annual Wellness Visit. But given that routine physical examinations have been shown to have limited clinical value, we believe health care organizations should take this opportunity to advance alternative systems for promoting evidence-based prevention.1,2 Failure to do so will sustain or worsen the long-standing disparities in health that have been underscored by the pandemic.

Before Covid-19, many primary care clinicians believed that annual exams did not optimally make use of their skills. The visit often became an exercise in checking off regulatory boxes, performing a head-to-toe physical exam for which there is no evidence of benefit, and ordering “routine” lab tests, many of which also lack supporting evidence. Yet many clinicians value these exams as a time for establishing or maintaining relationships with patients and reviewing the results of and rationale for key preventive screening tests recommended (with a grade A or B) by the U.S. Preventive Services Task Force (USPSTF) — a list that is 25 items long and growing.

There are troubling disparities, however, in use of these evidence-based preventive services according to race, ethnicity, and socioeconomic status.3 Since use of annual exams is more common among White people than Black people and increases with household income, such exams won’t help address disparities in the delivery of preventive services.4 So we are faced with a long and growing list of evidence-based preventive services to deliver to a broad population but a low-efficiency, low-efficacy mechanism for doing so. And the pandemic has revealed the clear and pressing need for a revamped approach.

We believe the U.S. health care system should embrace this moment as an opportunity to shift the locus of preventive care from face-to-face annual exams to a strategy that focuses on population health: clinical registries that readily identify all preventive services for which a patient is due; annual prevention kits for patients that facilitate widespread deployment of home-based testing, shared decision making, and self-scheduling of preventive screening tests and procedures in more convenient and approachable community settings; and robust community-based strategies involving navigators to overcome health disparities in underserved populations.

The first step in this strategy is developing a robust, real-time clinical preventive care registry that allows tracking of care needs asynchronously from visits. At our institution, we have deployed a comprehensive registry that tracks all USPSTF grade A and B preventive services and their completion status for our approximately 250,000 primary care patients in eastern Massachusetts, including people who receive care at three community health centers in low-income neighborhoods. The registry is fully integrated into our electronic health records (EHRs) and has robust communication tools for patient outreach. Although many health systems and EHR vendors have established registry functionality, there is a pressing need for “smarter” registries that are interoperable across diverse health care settings, regardless of EHR vendor, and that can analyze utilization patterns, health conditions, and demographics to help link patients to the best prevention approach for them. These registries could also become shared, interactive tools for use by both clinicians and patients to facilitate preventive care.

The second step is to build the infrastructure for an annual “prevention kit” received by every patient. The kit should consist of a language-appropriate, culturally sensitive package that addresses all indicated USPSTF grade A and B preventive services as indicated by the clinical prevention registry. Point-of-care tests should be included to allow preventive care to happen from patients’ homes; these could include fecal immunochemical testing, glycated hemoglobin and lipid testing, and perhaps soon, self-sampling of human papilloma virus for cervical cancer screening. QR code links to standardized electronic questionnaires should be included for depression screening, tobacco and alcohol use, and personalized risk assessment for common conditions such as breast cancer and cardiovascular disease. Shared-decision-making materials for lung cancer screening, breast cancer screening intervals, and highly controversial topics such as prostate cancer screening are well studied and easily deployed.5 Self-scheduling instructions for all recommended procedures and imaging studies should be provided.

After receiving the prevention kit, patients could be invited to schedule a virtual encounter with their primary care provider to review recommendations, engage in shared decision making on nuanced topics such as when to start or stop each type of screening, discuss any findings that may be of concern, and plan necessary interventions. Immunizations and other high-value preventive care that cannot be delivered at home could be addressed during in-person patient visits or at dedicated immunization clinics, rather than during dedicated annual exams.

The third step is to create specific programs to address the known disparities in preventive care within a given population. There is a rich body of literature supporting the effectiveness of community-based patient navigators in closing gaps in cancer-screening rates affecting underserved patients.3 These navigators facilitate patients’ preventive care by using proactive outreach and motivational interviewing and by accompanying patients to procedures such as colonoscopies. Navigators are also well suited to systematically screening for and facilitating access to community-based resources for addressing social determinants of health. In addition, they can connect patients with community-based campaigns to promote prevention, such as screening vans. Though navigation programs cannot eliminate key social determinants of poor health, such as poverty, educational barriers, food insecurity, and racism, they can help make access to evidence-based preventive services more equitable.

The primary hurdles for implementation of our plan are payment reform and provider and patient acceptance. For a population-based prevention strategy to succeed, the health system needs to offer prospective payment for primary care with accountability for overall completion of evidence-based preventive care throughout a population and a demonstrable commitment to addressing disparities in preventive care. Services provided by patient navigators are not billable on any payer’s fee schedule and will not generate substantial fee-for-service revenue, since navigators may interact with only a small proportion of a health system’s patients. There is no reimbursable Current Procedural Terminology (CPT) code for a preventive care kit or shared-decision-making materials.

Health care centers that disproportionately provide care for disadvantaged populations may face additional barriers to implementing a population-based approach to prevention, since they may have more limited infrastructure and resources, particularly now that the dramatic drop in visit volume during the pandemic has left many safety-net providers in financial crisis. Payment reform should be prioritized to allow these sites to move away from visit-based payments and facilitate innovative community-based prevention programs. Perhaps the Centers for Medicare and Medicaid Services could offer such centers one-time incentive payments to facilitate investment in population health technology.

Gaining clinician and patient acceptance of a new model is a second hurdle. But a potential positive outcome of the current pandemic is that patients may demand a care system that is more comprehensive and accessible, promotes equity, and facilitates their engagement in preventive care from the comfort of their home or community. Providers will face a backlog of patients in need of management of acute and chronic health conditions and will realize that care has to be provided more efficiently and effectively. Both patients and clinicians will have discovered virtual visits’ potential for discussion and counseling. If we move to more sophisticated systems that can deliver convenient, personalized home-based testing strategies to patients, engage patients in their own care, and deploy evidence-based programs to ensure equitable access to preventive services, we believe our population’s health will be improved.

A large-scale shift to a population-based prevention strategy is long overdue. The Covid-19 pandemic is delaying life-saving preventive screening for millions of patients, and our health system will struggle to catch up. Perhaps this crisis will be the impetus for change.

https://www.nejm.org/doi/full/10.1056/NEJMp2018749?query=C19&cid=DM97080_Catalyst_Registered_Users_and_InActive&bid=241453354
 

Testing And Medical Insurance: A Profitable Disaster

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