Healthcare

The Policy Future for Telehealth After the Pandemic

April 14, 2023
COVID-19, Cyber Security, Data Privacy, Health, Healthcare, Healthcare Reform, Public Health

Jack Atterberry, MJLST Staffer

The Pandemic Accelerated Telehealth Utilization

Before the Covid-19 pandemic began, telehealth usage in the United States healthcare system was insignificant (rounding to 0%) as a percentage of total outpatient care visits.[1] In the two years after the beginning of the pandemic, telehealth usage soared to over 10% of outpatient visits and has been widely used across all payer categories including Medicare and Medicaid.[2] The social distancing realities during the pandemic years coupled with federal policy measures allowed for this radical transition toward telehealth care visits.

In response to the onset of Covid-19, the US federal government relaxed and modified many telehealth regulations which have expanded the permissible access of telehealth care services. After a public health emergency was declared in early 2020, the Center for Medicare & Medicaid Services (CMS) and the Department of Health and Human Services (HHS) modified preexisting telehealth-related regulations to expand the permissible use of those services.  Specifically, CMS temporarily expanded Medicare coverage to include telehealth services without the need for in-person visits, removed telehealth practice restrictions such as expanding the type of providers that could provide telehealth, and increased the reimbursement rates for telehealth services to bring them closer to in-person visit rates.[3] In addition, HHS implemented modifications such as greater HIPAA flexibility by easing requirements around using popular communication platforms such as Zoom, Skype, and FaceTime provided that they are used in good faith.[4]  Collectively, these changes helped lead to a significant rise in telehealth services and expanded access to care for many people that otherwise would not receive healthcare.  Unfortunately, many of these telehealth policy provisions are set to expire in 2024, leaving open the question of whether the benefits of telehealth care expansion will be here to stay after the public emergency measures end.[5]

Issues with Telehealth Care Delivery Between States

A big legal impediment to telehealth expansion in the US is the complex interplay of state and federal laws and regulations impacting telehealth care delivery. At the state level, key state differences in the following areas have historically held back the expansion of telehealth.  First, licensing and credentialing requirements for healthcare providers are most often licensed at the state level – this has created a barrier for providers who want to offer telehealth services across state lines. While many states have implemented temporary waivers or joined interstate medical licensure compacts to address this issue during the pandemic, many states have not done so and huge inconsistencies exist. Besides these issues, states also differ with regard to reimbursement policy as states differ significantly in how different payer types insure differently in different regions—this has led to confusion for providers about whether to deliver care in certain states for fear of not getting reimbursed adequately. Although the federal health emergency helped ease interstate telehealth restrictions since the pandemic started, these challenges will likely persist after the temporary telehealth measures are lifted at the end of 2024.

What the pandemic-era temporary easing of telehealth restrictions taught us is that interstate telehealth improves health outcomes, increases patient satisfaction, and decreases gaps in care delivery.  In particular, rural communities and other underserved areas with relatively fewer healthcare providers benefited greatly from the ability to receive care from an out of state provider.  For example, patients in states like Montana, North Dakota, and South Dakota benefit immensely from being able to talk with an out of state mental health provider because of the severe shortages of psychiatrists, psychologists, and other mental health practitioners in those states.[6]  In addition, a 2021 study by the Bipartisan Policy Center highlighted that patients in states which joined interstate licensure compacts experienced a noticeable improvement in care experience and healthcare workforces experienced a decreased burden on their chronically stressed providers.[7]  These positive outcomes resulting from eased interstate healthcare regulations should inform telehealth policy moving forward.

Policy Bottlenecks to Telehealth Care Access Expansion

The presence of telehealth in American healthcare is surprisingly uncertain as the US emerges from the pandemic years.  As the public health emergency measures which removed various legal and regulatory barriers to accessing telehealth expire next year, many Americans could be left without access to healthcare via telehealth services. To ensure that telehealth remains a part of American healthcare moving forward, federal and state policy makers will need to act to bring about long term certainty in the telehealth regulatory framework.  In particular, advocacy groups such as the American Telehealth Association recommend that policy makers focus on key policy changes such as removing licensing barriers to interstate telehealth care, modernizing reimbursement payment structures to align with value-based payment principles, and permanently adopting pandemic-era telehealth access for Medicare, Federally Qualified Health Centers, and Rural Health Clinics.[8]  In addition, another valuable federal regulatory policy change would be to continue allowing the prescription of controlled substances without an in-person visit.  This would entail modifying the Ryan Haight Act, which requires an in-person medical exam before prescribing controlled substances.[9]  Like any healthcare reform in the US, cementing these lasting telehealth policy changes as law will be a major uphill battle.  Nonetheless, expanding access to telehealth could be a bipartisan policy opportunity for lawmakers as it would bring about expanded access to care and help drive the transition toward value-based care leading to better health outcomes for patients.

Notes

[1] https://www.healthsystemtracker.org/brief/outpatient-telehealth-use-soared-early-in-the-covid-19-pandemic-but-has-since-receded/

[2] https://www.cms.gov/newsroom/press-releases/new-hhs-study-shows-63-fold-increase-medicare-telehealth-utilization-during-pandemic#:~:text=Taken%20as%20a%20whole%2C%20the,Island%2C%20New%20Hampshire%20and%20Connecticut.

[3] https://telehealth.hhs.gov/providers/policy-changes-during-the-covid-19-public-health-emergency

[4] Id.

[5] https://hbr.org/2023/01/its-time-to-cement-telehealths-place-in-u-s-health-care

[6] https://thinkbiggerdogood.org/enhancing-the-capacity-of-the-mental-health-and-addiction-workforce-a-framework/?_cldee=anVsaWFkaGFycmlzQGdtYWlsLmNvbQ%3d%3d&recipientid=contact-ddf72678e25aeb11988700155d3b3c69-e949ac3beff94a799393fb4e9bbe3757&utm_source=ClickDimensions&utm_medium=email&utm_campaign=Health%20%7C%20Mental%20Health%20Access%20%7C%2010.19.21&esid=e4588cef-7520-ec11-b6e6-002248246368

[7] https://bipartisanpolicy.org/download/?file=/wp-content/uploads/2021/11/BPC-Health-Licensure-Brief_WEB.pdf

[8] https://hbr.org/2023/01/its-time-to-cement-telehealths-place-in-u-s-health-care

[9] https://www.aafp.org/pubs/fpm/issues/2021/0500/p9.html

Mental Health Telehealth Services May Not Be Protecting Your Data

March 5, 2023
Administrative Law, COVID-19, Data Privacy, Health, Healthcare, Internet, New Technology, Privacy

Tessa Wright, MJLST Staffer

The COVID-19 pandemic changed much about our daily lives, and nowhere have those changes been more visible than in the healthcare industry. During the pandemic, there were overflowing emergency rooms coupled with doctor shortages.[1] In-person medical appointments were canceled, and non-emergency patients had to wait months for appointments.[2] In response, the use of telehealth services began to increase rapidly.[3] In fact, one 2020 study found that telehealth visits accounted for less than 1% of health visits prior to the pandemic and increased to as much as 80% of visits when the pandemic was at its peak.[4] And, while the use of telehealth services has decreased slightly in recent years, it seems as though it is likely here to stay. Nowhere has the use of telehealth services been more prevalent than in mental health services.[5] Indeed, as of 2022, telehealth still represented over 36% of outpatient mental health visits.[6] Moreover, a recent study found that since 2020, over one in three mental health outpatient visits have been delivered by telehealth.[7] And while this increased use in telehealth services has helped make mental health services more affordable and accessible to many Americans, this shift in the way healthcare is provided also comes with new legal concerns that have yet to be fully addressed.

Privacy Concerns for Healthcare Providers

One of the largest concerns surrounding the increased use of telehealth in mental health services is privacy. There are several reasons for this. The primary concern has been due to the fact that telehealth takes place over the phone or via personal computers. When using personal devices, it is nearly impossible to ensure HIPAA compliance. However, the majority of healthcare providers now offer telehealth options that connect directly to their private healthcare systems, which allows for more secure data transmission.[8] While there are still concerns surrounding this issue, these secure servers have helped mitigate much of the concern.[9]

Privacy Concerns with Mental Health Apps

The other privacy concern surrounding the use of telehealth services for mental health is a little more difficult to address. This concern comes from the increased use of mental health apps. Mental health apps are mobile apps that allow users to access online talk therapy and psychiatric care.[10] With the increased use of telehealth for mental health services, there has also been an increase in the use of these mental health apps. Americans are used to their private medical information being protected by the Health Insurance Portability and Accountability Act (HIPAA).[11] HIPAA is a federal law that creates privacy rules for our medical records and other individually identifiable health information during the flow of certain health care transactions.[12] But HIPAA wasn’t designed to handle modern technology.[13] The majority of mental health apps are not covered by HIPAA rules, meaning that these tech companies can sell the private health data from their apps to third parties, with or without consent.[14] In fact, a recent study that analyzed 578 mental health-related apps found that nearly half (44%) of the apps shared users’ personal health information with third parties.[15] This personal health information can include psychiatric diagnoses and medication prescriptions, as well as other identifiers including age, gender, ethnicity, religion, credit score, etc.[16]

In fact, according to a 2022 study, a popular therapy app, BetterHelp, was among the worst offenders in terms of privacy.[17] “BetterHelp has been caught in various controversies, including a ‘bait and switch’ scam where it advertised therapists that weren’t actually on its service, poor quality of care (including trying to provide gay clients with conversion therapy), and paying YouTube influencers if their fans sign up for therapy through the app.”[18]

An example of information that does get shared is the intake questionnaire.[19] An intake questionnaire needs to be filled out on BetterHelp, or other therapy apps, in order for the customer to be matched with a provider.[20] The answers to these intake questionnaires were specifically found to have been shared by BetterHelp with an analytics company, along with the approximate location and device of the user.[21]

Another example of the type of data that is shared is metadata.[22] BetterHelp can share information about how long someone uses the app, how long the therapy sessions are, how long someone spends sending messages on the app, what times someone logs into the app, what times someone sends a message or speaks to their therapists, the approximate location of the user, how often someone opens the app, and so on.[23] According to the ACLU, data brokers, Facebook, and Google were found to be among the recipients of other information shared from BetterHelp.[24]

It is also important to note that deleting an account may not remove all of your personal information, and there is no way of knowing what data will remain.[25] It remains unclear how long sensitive information that has been collected and retained could be available for use by the app.

What Solutions Are There?

The U.S. Department of Health and Human Services recently released updated guidance on HIPAA, confirming that the HIPAA Privacy Rule does not apply to most health apps because they are not “covered entities” under the law.[26]  Additionally, the FDA put out guidance saying that it is going to use its enforcement discretion when dealing with mental health apps.[27] This means that if the privacy risk seems to be low, the FDA is not going to enforce or chase these companies.[28]

Ultimately, if mental telehealth services are here to stay, HIPAA will need to be expanded to cover the currently unregulated field of mental health apps. HIPAA and state laws would need to be specifically amended to include digital app-based platforms as covered entities.[29] These mental health apps are offering telehealth services, similar to any healthcare provider that is covered by HIPAA. Knowledge that personal data is being shared so freely by mental health apps often leads to distrust, and due to those privacy concerns, many users have lost confidence in them. In the long run, regulatory oversight would increase the pressure on these companies to show that their service can be trusted, potentially increasing their success by growing their trust with the public as well.

Notes

[1] Gary Drenik, The Future of Telehealth in a Post-Pandemic World, Forbes, (Jun. 2, 2022), https://www.forbes.com/sites/garydrenik/2022/06/02/the-future-of-telehealth-in-a-post-pandemic-world/?sh=2ce7200526e1.

[2] Id.

[3] Id.

[4] Madjid Karimi, et. al., National Survey Trends in Telehealth Use in 2021: Disparities in Utilization and Audio vs. Video Services, Office of Health Policy (Feb. 1, 2022).

[5] Shreya Tewari, How to Navigate Mental Health Apps that May Share Your Data, ACLU (Sep. 28, 2022).

[6] Justin Lo, et. al., Telehealth has Played an Outsized Role Meeting Mental Health Needs During the Covid-19 Pandemic, Kaiser Family Foundation, (Mar. 15, 2022), https://www.kff.org/coronavirus-covid-19/issue-brief/telehealth-has-played-an-outsized-role-meeting-mental-health-needs-during-the-covid-19-pandemic/.

[7] Id.

[8] Supra note 1.

[9] Id.

[10] Heather Landi, With Consumers’ Health and Privacy on the Line, do Mental Wellness Apps Need More Oversight?, Fierce Healthcare, (Apr. 21, 2021), https://www.fiercehealthcare.com/tech/consumers-health-and-privacy-line-does-digital-mental-health-market-need-more-oversight.

[11] Peter Simons, Your Mental Health Information is for Sale, Mad in America, (Feb. 20, 2023), https://www.madinamerica.com/2023/02/mental-health-information-for-sale/.

[12] Supra note 5.

[13] Supra note 11.

[14] Id.

[15] Deb Gordon, Using a Mental Health App? New Study Says Your Data May Be Shared, Forbes, (Dec. 29, 2022), https://www.forbes.com/sites/debgordon/2022/12/29/using-a-mental-health-app-new-study-says-your-data-may-be-shared/?sh=fe47a5fcad2b.

[16] Id.

[17] Supra note 11.

[18] Id.

[19] Supra note 5.

[20] Id.

[21] Id.

[22] Id.

[23] Id.

[24] Id.

[25] Supra note 5.

[26] Id.

[27] Supra note 10.

[28] Id.

[29] Supra note 11.

The Apathetic Divide: Surrogacy and the Anglo-American Courtroom

February 20, 2023
Ethics, EU Law, Health, Healthcare, Reproductive Health

Kelso Horne, MJLST Staffer

The State of New York defines Gestational Surrogacy as “a process where one person, who did not provide the egg used in conception, carries a fetus through pregnancy and gives birth to a baby for another person or couple.” The process of surrogacy can be fraught with legal, technical, and moral issues, particularly when the surrogacy is paid for via contract with the surrogate, also called Compensated Gestational Surrogacy (CGS). Until 2020, this kind of contractual paid surrogacy was illegal in the state of New York. That year, it was legalized, and the regulatory regime normalized by the Child-Parent Security Act.  In contrast, the state of Louisiana has one of the harshest gestational surrogacy regimes in the world, outright banning CGS, and requiring both sets of gametes to come from a couple married residing in the state of Louisiana. But these competing regulatory regimes are not replicated across the nation. To the contrary, most states have not passed any laws legalizing or banning CGS or other fertility practices, like the sale of gametes. With sparse case law and frequent legal limbo, the question of “is CGS legal for me?” can be a difficult question for many Americans.

Across the Atlantic, the question used to be an easy one to answer. In 1985 the UK Parliament Enacted the Surrogacy Arrangements Act, which made it an offense to “initiate or take part in any negotiations with the view of making a surrogacy arrangement”, along with some related activities, like compiling information to assist in the creation of surrogacy arrangements. Critically, however, the Act did not criminalize the act of looking to hire a surrogate, or looking to become one, only being a middleman, or publishing advertisements on behalf of those looking to obtain the services of a surrogate. The Human Fertilisation and Embryology Act 1990 defined the mother of a child under UK law as “[t]he woman who is carrying or has carried a child… and no other woman”. In 2001, the Lords Appeal in Ordinary, which acted as the UK’s highest court until 2009, heard the appeal in Briody v. St Helens and Knowsley Area Health Authority. The question before the Lords was one of damages. A woman, rendered infertile as a result of medical negligence, sought £78,267 in order to obtain the services of a surrogate in California, which had legalized CGS in 1993 in the landmark case Johnson v. Calvert. The Lady Justice Hale, speaking for the court, foreclosed the use of CGS in California or elsewhere, as the proposal was “contrary to the public policy of the country”. While she did not entirely dismiss the idea of providing damages to pay for surrogacy procedures, she said it would be permitted only in the case of a voluntary, unpaid surrogate.

Few appellate court judges get to issue an opinion on the same facts twice in their career. In 2020, in one of her final cases prior to retiring, the Lady Justice Hale, now sitting on the UK Supreme Court, which by then had replaced the Lords Appeal in Ordinary, did just that.  In Whittington Hospital NHS Trust (Appellant) v XX, the court determined that a woman who had been rendered infertile as a result of medical negligence could claim damages, including the costs to pay a United States based surrogate to carry her children. CGS, while still entirely illegal in the UK, could now nevertheless provide the basis for damages in a UK court. The Court did note some factual differences between Whittington Hospital and Briody, notably, that the likelihood that a surrogacy arrangement would result in a child was higher in the former. However, the court’s main argument for its opposite ruling was a change in cultural attitude to surrogacy and its role in society, stating “[t]he use of assisted reproduction techniques is now widespread and socially acceptable.”

While admitting that surrogacy was now widely accepted in UK society, the dissent, authored by The Lord Justice Carnwath, nevertheless disagreed with the Court. It argued that the criminal law of the UK remained clearly averse to commercial surrogacy, and that by awarding damages for CGS in California the court misaligned the UK’s civil and criminal law. Thus, the CGS regimes of the UK and the U.S. are now bound together. UK citizens may seek surrogacy arrangements and have them compensated by the UK government through the UK’s National Health Service, but they must use an American “womb”. A financial arrangement which the UK itself deems too unethical to allow inside its own borders is nevertheless legalized and compensated when occurring in other countries. The deeply strange situation is mirrored in the opaque CGS law in the United States itself.

A quick glance at any 50-state review of laws, compiled either by supporters or opponents to commercial surrogacy, paint a similar picture. They show strange ad hoc mixes of case law which often cover ancillary issues or are at least 30 years old. Some scholars have started to publicly discuss the possible ethical pitfalls of “procreative tourism”, but without clear legal rules governing what arrangements are and are not allowed, it becomes difficult to discuss possible solutions. The dangers of this shadow regime were thrown into stark relief by the war in Ukraine, which prior to the Russian invasion was a major source of surrogate mothers. Mothers were paid on average $15,000 per child, which is considerable in a country where, prior to the invasion, the GDP per capita was less than $5,000. The United States needs to determine if it wishes to become a “destination” country for procreative tourism, as the result in Whittington would seem to suggest it is, and whether it wishes to allow its own citizens the opportunity to travel abroad to engage in CGS.

This blog has touched on only a small fraction of the issues which are faced when determining the ideal regulatory regime for surrogacy. However, a lack of discussion, and a failure to acknowledge possible risks leaves us ignorant of what the problems may be, let alone the route to potential solutions. States have largely failed to address the issue since the first CGS baby was born in their borders, usually in the late 1980’s and early 1990’s. It’s time for a serious examination of CGS regulation as it exists, as well as a meaningful discussion about safeguarding the health and wellbeing of those involved in such a transaction. The UK has now done the same, passing the buck without a serious response to the issues surrounding CGS. Regardless of one’s opinion on the results of the Louisiana and New York regulations, potential participants in a surrogacy arraignment in those two states know the boundaries. That should be the case nationwide.

Behind the “Package Insert”: Loophole in FDA’s Regulation of Off-Label Prescriptions

November 12, 2022
Agencies, Drug Policy, FDA, Healthcare, Industry, Pharmaceuticals, Public Health, Regulatory

Yolanda Li, MJLST Staffer

FDA Regulation of Drug Prescription Labeling and the “Package Insert”

Over the recent years, constant efforts have been made towards regulating medical prescriptions in an attempt to reduce risks accompanied with drug prescriptions. Among those efforts is the FDA’s revision of the format of prescription drug information, commonly known as the “package insert”.[1]

The package insert regulation, effective since 2006, applies to all prescription drugs. The package insert is to provide up-to-date information on the drug in an easy-to-read format. One significant feature is a section named “highlights”, which provides the most important information regarding the benefits and risks of a prescribed medication. The highlights section is typically half a page in length providing a concise summary of information including “boxed warning”, “indications and usage”, and “dosage and administration”.[2] The highlights section also refers physicians to appropriate sections of the full prescribing information. In this way, the package insert aims to draw both the physicians’ and the patients’ attention to the prescription of a drug, consequently accomplishing the ultimate purpose of managing medication use and reducing medical errors. Mike Leavitt, the Health and Human Services Secretary of the FDA commented that the package insert “help[s] ensure safe and optimal use of drugs, which translates into better health outcomes for patients and more efficient delivery of healthcare.”[3]

FDA Regulation of Off-Label Prescription and the Emergence of a Loophole

The FDA’s regulations relating to the labeling of prescription drugs, although systematic in its form, are cut short to a certain extent due to its lack of regulation on off-label prescriptions. Off-label prescriptions do not refer to a physician prescribing non-FDA approved drugs, a common misunderstanding by the public. Rather, off-label prescriptions are those that do not conform to the FDA-approved use set out in the FDA-approved label.[4] More specifically, off-label prescription generally refers to: “(1) the practice of a physician prescribing a legally manufactured drug for purposes other than those indicated on that drug’s FDA mandated labeling; (2) using a different method of applying the treatment and prescribing a drug, device, or biologic to patient groups other than those approved by FDA; and (3) prescriptions for drug dosages that are different from the approved label-recommended dosage or for time periods exceeding the label-recommended usage.”[5] For example if Drug A’s use, as mandated by the FDA, is to treat chronic headaches, and a physician prescribes it to treat a patient’s sprained ankle, that is an off-label prescription. However, such practice is common as estimated by the American Medical Association (AMA).[6]

The commonly approach is that the FDA and courts do not to interfere with physicians’ off-label uses.[7] Thus, when the FDA regulates the labeling of approved uses but does not regulate prescriptions for off-label uses, a loophole is formed. Andrew von Eschenbach, M.D., claims that because the FDA’s package insert regulation makes it easier for physicians to get access to important information about drugs, including drug safety and benefits, this regulation helps physicians to have more meaningful discussions with patients.[8] However, physicians’ discretion in prescribing off-label prescriptions would offset the proposed benefit of the FDA regulation because the regulation remains as guidance without force of law once physicians choose to go off from FDA’s approved uses of drugs. The easy-to-understand feature of the package insert and its benefit for a patient’s understanding of the drug becomes futile when physicians exercise discretion and prescribe drugs for uses not written on the inserts. In sum, when a patient receives an off-label prescription, the insert provides them little benefit as it addresses benefits and risks related to a different use of the drug.

It is undisputed that drug manufacturers have less discretion regarding drug labeling than physicians. If a manufacturer included an off-label use on a drug’s label, and promoted the off-label use of the drug, the drug would be considered misbranded. The manufacturer would then be subject to liability[9] as manufacturing a misbranded product in interstate commerce is prohibited.[10] However, the effect of regulations on manufacturers still fail to eliminate the loophole in off-label prescription: in response to the regulations, the manufacturer usually receives FDA approval for only a few drug uses and then relies on physicians prescribing off-label uses to ensure their profitability.[11] In this way, the manufacturer avoids liability under regulation and furthers the loophole in off-label prescription by encouraging physicians to prescribe more off-label uses in order to expand the manufacturer’s market.[12]

Why are Off-Label Prescriptions Difficult to Regulate?

One of the main reasons behind the lack of regulation of off-label prescriptions is the FDA’s objective in ensuring effective delivery of health care. Physicians are encouraged to use discretion and judgment in order to tailor prescription to patients’ individual conditions.[13] Another reason is to increase efficiency in treatments by avoiding the lengthy FDA approval process.[14] Aspirin was widely prescribed to reduce the risk of heart attack long before it was FDA-approved for this purpose; off-label prescriptions have also been proven effective in treatment of cancer, and off-label therapies have prolonged the lives of AIDS patients.[15] Another concern is drug prices in the United States, and promoting off-label uses has been found to help reduce drug prices as increased sales volume enables drug companies to lower their prices.[16] Indeed, off-label prescription has become a mainstream of medicine: “the FDA has long tolerated off-label drug use and has disclaimed any interest in regulating physicians’ prescribing practices.”[17] Today it is unclear whether the agency even has jurisdiction to regulate off-label prescription of drugs.[18]

In sum, there is clear guidance on the labeling of prescription drugs as a result of FDA regulation. However, because of difficulties in enforcement, the custom and widely accepted practice of off-label prescriptions and the inherent benefit of off-label prescription, the effects of the regulation are not as effective as what was firstly planned and proposed.

Notes

[1] The FDA Announces New Prescription Drug Information Format, U.S. Food & Drug Adm’ (Dec. 04 2015) https://www.fda.gov/drugs/laws-acts-and-rules/fda-announces-new-prescription-drug-information-format.

[2] Id.

[3] Id.

[4] Margaret Z. Johns, Informed Consent: Requiring Doctors to Disclose Off-Label Prescriptions and Conflicts of Interest, 58 Hastings L.J. 967, 968 https://plus.lexis.com/document?crid=35364c11-2939-4e58-bceb-dab7ae8f0154&pddocfullpath=%2Fshared%2Fdocument%2Fanalytical-materials%2Furn%3AcontentItem%3A4P0W-GY20-00CW-906B-00000-00&pdsourcegroupingtype=&pdcontentcomponentid=7341&pdmfid=1530671&pdisurlapi=true.

[5] Lisa E. Smilan, The off-label loophole in the psychopharmacologic setting: prescription of antipsychotic drugs in the nonpsychotic patient population, 30 Health Matrix 233, 240 (2020), https://plus.lexis.com/document/?pdmfid=1530671&crid=367cf8ad-295e-4f14-97fa-737618718d61&pddocfullpath=%2Fshared%2Fdocument%2Fanalytical-materials%2Furn%3AcontentItem%3A64BT-RR31-JWBS-61KV-00000-00&pdworkfolderid=5506aeec-9540-4837-89f0-5a1acfd81d8b&pdopendocfromfolder=true&prid=1d42abd0-b66e-43af-a61a-0d1fb94180f5&ecomp=gdgg&earg=5506aeec-9540-4837-89f0-5a1acfd81d8b#.

[6] Supra note 4.

[7] Sigma-Tau Pharms. v. Schwetz, 288 F.3d 141, 148, https://plus.lexis.com/document?crid=7d2a2b00-13ad-4953-968e-82a28724aa00&pddocfullpath=%2Fshared%2Fdocument%2Fcases%2Furn%3AcontentItem%3A45RF-5H50-0038-X1PB-00000-00&pdsourcegroupingtype=&pdcontentcomponentid=6388&pdmfid=1530671&pdisurlapi=true.

[8] Supra note 1.

[9] 21 CFR 201.5, https://plus.lexis.com/document/?pdmfid=1530671&crid=e02a99fb-be65-4525-b83c-a167f3e21b93&pddocfullpath=%2Fshared%2Fdocument%2Fadministrative-codes%2Furn%3AcontentItem%3A603K-BXD1-DYB7-W30Y-00000-00&pdcontentcomponentid=5154&pdworkfolderlocatorid=NOT_SAVED_IN_WORKFOLDER&prid=ff2b7e20-9dab-49b0-8385-627c16ee0ba2&ecomp=vfbtk&earg=sr2.

[10] 21 CFR 801.4, https://plus.lexis.com/document/?pdmfid=1530671&crid=721a586d-52a4-4228-b0c3-c464a77d6e6a&pddocfullpath=%2Fshared%2Fdocument%2Fadministrative-codes%2Furn%3AcontentItem%3A638R-X4S3-GXJ9-32FV-00000-00&pdcontentcomponentid=5154&pdworkfolderlocatorid=NOT_SAVED_IN_WORKFOLDER&prid=ff2b7e20-9dab-49b0-8385-627c16ee0ba2&ecomp=vfbtk&earg=sr6.

[11]  Supra note 4.

[12] Id.

[13]   Supra note 7.

[14]   Supra note 4.

[15]  Id.

[16] Supra note 4, at 981.

[17] ​​Kaspar J. Stoffelmayr, Products Liability And “Off-label” Uses Of Prescription Drugs, 63 U. Chi. L. Rev. 275, 279, https://plus.lexis.com/document?crid=a2181ffc-7f3e-4bce-b82e-08ba9111194f&pddocfullpath=%2Fshared%2Fdocument%2Fanalytical-materials%2Furn%3AcontentItem%3A3S3V-4CF0-00CV-K03W-00000-00&pdsourcegroupingtype=&pdcontentcomponentid=7358&pdmfid=1530671&pdisurlapi=true.

[18]  Id.

Predicted Effects of Price Transparency on Healthcare Economics

March 29, 2022
Administrative Law, Health, Healthcare

David Edholm, MJLST Staffer

In 2019, the Centers for Medicare and Medicaid Services (CMS) promulgated the Price Transparency Rule in order to allow patients to access healthcare pricing information. The stated purpose of the Price Transparency Rule is as follows:

By disclosing hospital standard charges [including payer-specific negotiated charges and discounted-cash prices], we believe the public (including patients, employers, clinicians, and other third parties) will have the information necessary to make more informed decisions about their care. We believe the impact of these final policies will help to increase market competition, and ultimately drive down the cost of healthcare services, making them more affordable for all patients.

There is significant debate whether compliance with the Price Transparency Rule will actuate its intended purpose.

On the proponent side, economic theory to support this purpose statement comes from a market advocacy perspective. In order to drive down the cost of healthcare through competition, consumers must know the prices in advance in order to bargain between providers. By giving consumers the ability to shop around and barter, the thinking goes, providers will undercut competitors by lowering their own prices, even slightly below a competitor’s rate.

Another theory that supports price transparency is that shining light onto healthcare pricing will lead to more public outcry, guilting providers to lower overinflated or unconscionable gross charges or hospital fees. Public outcry may also compel states to create global healthcare budget caps, which have been shown to have positive price-lowering effects. A recent study from Rice University found that Maryland’s all-payer global budget policy reduces costs while increasing quality of care.

Skeptics of the rule, however, including the American Hospital Association (AHA), argue that price transparency will induce institutions that currently charge less than competitors to increase their prices to match their competitors, ultimately raising costs. In litigation, the DC Circuit responded to that argument, holding that, based on available research, this result is unlikely. Secretary Azar was not required to rely on definitive rather than predictive data in writing the requirements because of the novelty of the price disclosure scheme and the unique complexity of healthcare pricing. The DC Circuit held that relying on studies of similar price disclosure schemes in other industries was sufficient to inform a stable policy judgment.

However, the healthcare service market is of a unique nature in that quality of care may be a consumer’s primary consideration before seeking treatment, trumping price considerations. Alternatively, a consumer may assume that paying more means receiving higher-quality care. Quality of care is incredibly hard to measure and report, and unless a consumer has access to quality-of-care information alongside pricing information, they are more likely to make fallacious assumptions about this correlation. Another unique factor about healthcare shopping is that many consumers have a strong relationship with their physician, thus would base their decision primarily on receiving advice from one they trust, rather than the out-of-pocket cost of care, especially if the difference is negligible.

Last is the complexity of healthcare viewpoint. Opponents of the price transparency rule emphasize the nature of healthcare as an unpredictable trade. For example, if a patient consumer undergoes surgery to fix one problem, a surgeon may discover another problem amidst the procedure. The standard of care likely prompts the surgeon to correct both problems, thus the patient consumer will be charged an amount higher than they could have reasonably predicted. The AHA brought this argument to court to support its assertion that the price transparency rule violated the Administrative Procedure Act (APA) by overstating the rule’s benefits. The DC Circuit court responded that the rule did not require hospitals to publish every potential permutation of finalized charges, rather that the baseline charges are publicized. Thus, in the surgery scenario, a patient consumer should have access to the payer-negotiated rate to fix the initial problem.

The jury is out, so to speak, on the effects that Price Transparency Rule compliance will have on healthcare economics. But from a consumer perspective, rapidly increasing healthcare costs are at the forefront of relevant political issues.

Build Back Better Act: A Request for Transparency of a Clearly Visible Issue

December 10, 2021
Healthcare, Healthcare Reform, Pharmaceuticals

Sara Pistilli, MJLST Staffer

On November 19, 2021, the House of Representatives voted to pass the “Build Back Better Act” which includes several provisions aimed at ever-rising healthcare prices. In trying to combat this concern, Congress included mandatory reporting provisions for pharmacy benefit managers (PBM) who bill Medicare and Medicaid insurance programs. PBMs will be required to provide reports every six months that include data on copays, dispensed drugs, rebates, and total out of pocket spending for patients. Speaker Nancy Pelosi states these provisions are aimed at “providing transparency regarding drug costs in private health plans” but is transparency helpful or even necessary when the effects PBMs have on healthcare costs are well known?

What is a PBM?

PBMs are third-party administrators that manage prescription drug benefits on behalf of both private and public healthcare payers. They have significant power to manipulate the healthcare market by acting as middlemen between payers (insurance companies), drug manufacturers, and dispensers (pharmacies). Originally, PBMs were meant to lower healthcare costs by streamlining transactions and attempting to create fair payment systems for dispensing pharmacies.Instead, PBMs have secretly contributed to increasing healthcare costs by inflating drug costs while concurrently decreasing pharmacy reimbursement rates leading to huge windfall profits for PBMs at the patients’ expense.

How do PBMs make millions in profits each year?

While some patients pay cash for medications, most are covered by Medicare, Medicaid, or private insurers. PBMs are paid by these insurers to determine how much a healthcare plan pays for a medication and in turn, how much the pharmacy gets reimbursed for the dispensed medication. For example, Bob receives a new prescription from his doctor for drug A. The pharmacy buys a bottle of drug A for $7. When Bob comes to pick up his prescription for drug A, his health insurer’s PBM pays $8 to reimburse the pharmacy, allowing them to gain a profit of $1. Concurrently, the PBM bills the health insurer $18 for the price of drug A, allowing them to make $10 in profit on Bob’s prescription. This practice, called spread pricing, results in PBMs making millions of dollars in profits each year.

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Picture: “The Secret Drug Pricing System Middlemen Use to Rake in Millions

How does PBM spread pricing increase healthcare costs for patients?

PBM spread pricing affects healthcare costs in two distinct ways: increased insurance premiums and decreased access to care. As PBMs continue to inflate the cost of prescription drugs, insurers are billed more and more by their PBMs. These expenses directly fall on the shoulders of the government and the healthcare companies, who represent the public and private payer sector. In turn, to keep up with increased billing, public and private payers turn to their beneficiaries to help them pay the PBMs via increased healthcare plan premiums, decreased coverage, and larger copays. Concurrently, as the PBMs reimburse pharmacies less and less for medication dispensing, pharmacies, especially independent ones, try to operate on thinner profit margins. Over time, the low reimbursement rates culminate in decreased clinical services or, in the worst case, pharmacies closing permanently.

What does the Build Back Better Act do to help?

Egregious billing practices by PBMs have been in the spotlight for several years now. In 2018, Ohio’s Department of Medicaid released a report showing that PBMs charged the state of Ohio $224 million in hidden spread pricing. The audit results led to Ohio terminating all PBM contracts with the Department of Medicaid and converting to a single-PBM system where spread pricing could be monitored better. Another report, this time in Utah, showed that PBM’s received $1.5 million from spread pricing in 2018. Similarly in 2019, a Kentucky report found that PBMs retained $123 million in spread pricing in that state. Several states have enacted laws targeting PBM spread pricing as the federal government continues to skirt around the issue. For example, Louisiana prohibits all PBMs from using spread pricing unless a PBM provides written notice of the practice to the health insurer and the policy holder. Louisiana also enacted a law stating that PBMs could not reimburse pharmacies at a lower rate than they do their affiliated pharmacies. This directly targets suspicions that CVS Caremark reimburses CVS pharmacies more to eliminate competition and steer patients towards filling their medications at CVS pharmacies. Like Louisiana, Maine enacted a law stating that PBMs could not participate in spread pricing without proper notice to the state. On October 1st, 2021, North Carolina’s Senate Bill 257 will take effect. This bill requires PBMs to apply for business licenses with the Commissioner of the Department of Insurance, subjecting them to more spread pricing regulations and threats of restitution to pharmacies they reimburse unfairly. While the states’ efforts are not perfect solutions, they are necessary efforts to regulate PBMs more. The federal government’s efforts to increase transparency is unnecessary due to the public recognition of PBM spread pricing. Every state audit that shows gross spread pricing is transparent enough to alert the federal government that PBMs pose a widespread problem to our healthcare system without greater restrictions. PBMs need to be controlled directly through regulations targeted towards preventing and prohibiting spread pricing, rather than asked to report every six months just how much they profit off their deceptive billing practices.

You Wouldn’t 3D Print Tylenol, Would You?

October 12, 2021
3-D Printing, Administrative Law, Bioethics, Biotechnology, FDA, Food and Drug Law, Health, Healthcare, Healthcare Reform, Medical Devices, Personalized Medicine, Pharmaceuticals, Uncategorized

By Mason Medeiros, MJLST Staffer

3D printing has the potential to change the medical field. As improvements are made to 3D printing systems and new uses are allocated, medical device manufacturers are using them to improve products and better provide for consumers. This is commonly seen through consumer use of 3D-printed prosthetic limbs and orthopedic implants. Many researchers are also using 3D printing technology to generate organs for transplant surgeries. By utilizing the technology, manufacturers can lower costs while making products tailored to the needs of the consumer. This concept can also be applied to the creation of drugs. By utilizing 3D printing, drug manufacturers and hospitals can generate medication that is tailored to the individual metabolic needs of the consumer, making the medicine safer and more effective. This potential, however, is limited by FDA regulations.

3D-printed drugs have the potential to make pill and tablet-based drugs safer and more effective for consumers. Currently, when a person picks up their prescription the drug comes in a set dose (for example, Tylenol tablets commonly come in doses of 325 or 500 mg per tablet). Because the pills come in these doses, it limits the amount that can be taken to multiples of these numbers. While this will create a safe and effective response in most people, what if your drug metabolism requires a different dose to create maximum effectiveness?

Drug metabolism is the process where drugs are chemically transformed into a substance that is easier to excrete from the body. This process primarily happens in the kidney and is influenced by various factors such as genetics, age, concurrent medications, and certain health conditions. The rate of drug metabolism can have a major impact on the safety and efficacy of drugs. If drugs are metabolized too slowly it can increase the risk of side effects, but if they are metabolized too quickly the drug will not be as effective. 3D printing the drugs can help minimize these problems by printing drugs with doses that match an individual’s metabolic needs, or by printing drugs in structures that affect the speed that the tablet dissolves. These individualized tablets could be printed at the pharmacy and provided straight to the consumer. However, doing so will force pharmacies and drug companies to deal with additional regulatory hurdles.

Pharmacies that 3D print drugs will be forced to comply with Current Good Manufacturing Procedures (CGMPs) as determined by the FDA. See 21 C.F.R. § 211 (2020). CGMPs are designed to ensure that drugs are manufactured safely to protect the health of consumers. Each pharmacy will need to ensure that the printers’ design conforms to the CGMPs, periodically test samples of the drugs for safety and efficacy, and conform to various other regulations. 21 C.F.R. § 211.65, 211.110 (2020). These additional safety precautions will place a larger strain on pharmacies and potentially harm the other services that they provide.

Additionally, the original drug developers will be financially burdened. When pharmacies 3D print the medication, they will become a new manufacturing location. Additionally, utilizing 3D printing technology will lead to a change in the manufacturing process. These changes will require the original drug developer to update their New Drug Application (NDA) that declared the product as safe and effective for use. Updating the NDA will be a costly process that will further be complicated by the vast number of new manufacturing locations that will be present. Because each pharmacy that decides to 3D print the medicine on-site will be a manufacturer, and because it is unlikely that all pharmacies will adopt 3D printing at the same time, drug developers will constantly need to update their NDA to ensure compliance with FDA regulations. Although these regulatory hurdles seem daunting, the FDA can take steps to mitigate the work needed by the pharmacies and manufacturers.

The FDA should implement a regulatory exception for pharmacies that 3D print drugs. The exemption should allow pharmacies to avoid some CGMPs for manufacturing and allow pharmacies to proceed without being registered as a manufacturer for each drug they are printing. One possibility is to categorize 3D-printed drugs as a type of compounded drug. This will allow pharmacies that 3D print drugs to act under section 503A of the Food Drug & Cosmetic Act. Under this section, the pharmacies would not need to comply with CGMPs or premarket approval requirements. The pharmacies, however, will need to comply with the section 503A requirements such as having the printing be performed by a licensed pharmacist in a state-licensed pharmacy or by a licensed physician, limiting the interstate distribution of the drugs to 5%, only printing from bulk drugs manufactured by FDA licensed establishments and only printing drugs “based on the receipt of a valid prescription for an individualized patient”. Although this solution limits the situations where 3D prints drugs can be made, it will allow the pharmacies to avoid the additional time and cost that would otherwise be required while helping ensure the safety of the drugs.

This solution would be beneficial for the pharmacies wishing to 3D print drugs, but it comes with some drawbacks. One of the main drawbacks is that there is no adverse event reporting requirement under section 503A. This will likely make it harder to hold pharmacies accountable for dangerous mistakes. Another issue is that pharmacies registered as an outsourcing facility under section 503B of the FD&C Act will not be able to avoid conforming to CGMPs unless they withdraw their registration. This issue, however, could be solved by an additional exemption from CGMPs for 3D-printed drugs. Even with these drawbacks, including 3D-printed drugs under the definition of compounded drugs proposes a relatively simple way to ease the burden on pharmacies that wish to utilize this new technology.

3D printing drugs has the opportunity to change the medical drug industry. The 3D-printed drugs can be specialized for the individual needs of the patient, making them safer and more effective for each person. For this to occur, however, the FDA needs to create an exemption for these pharmacies by including 3D-printed drugs under the definition of compounded drugs.

I’ve Been Shot! Give Me a Donut!: Linking Vaccine Verification Apps to Existing State Immunization Registries

April 18, 2021
COVID-19, Data Privacy, Healthcare, Human Rights Law, Public Health

Ian Colby, MJLST Staffer

The gold rush for vaccination appointments is in full swing. After Governor Walz and many other governors announced an acceleration of vaccine eligibility in their states, the newly eligible desperately sought vaccinations to help the world achieve herd immunity to the SARS-CoV-2 virus (“COVID”) and get back to normal life.

The organization administering a person’s initial dose typically gives the recipient an approximately 4” x 3” card that provides the vaccine manufacturer, the date and location of inoculation, and the Centers for Disease Control (“CDC”) logo. The CDC website does not specify what, exactly, this card is for. Likely reasons include informing the patient about the healthcare they just received, a reminder card for a second dose, or providing batch numbers in case a manufacturing issue arises. Maybe they did it for the ‘Gram. However, regardless of the CDC’s reason for the card, many news outlets have latched onto the most likely future use for them: as a passport to get the post-pandemic party started.

Airlines, sports venues, schools, and donut shops are desperate to return to safe mass gatherings and close contact, without needing to enforce as many protective measures. These organizations, in the short-term, will likely seek assurance of a person’s vaccination status. Aside from the equitable and scientific issues with requiring this assurance, these business will likely get “proof” with these CDC vaccination cards. The cardboard and ink security of these cards rivals social security cards in the “high importance – zero protection” category. Warnings of scammers providing blank CDC cards or stealing the vaccinated person’s name and birthdate hit the web last week (No scammers needed: you can get Missouri’s PDF to print one for free).

With so little security, but with a business-need to reopen the economy to vaccinated folks, businesses and governments have turned to digital vaccine passports. Generically named “digital health passes,” these apps will allow a person to show proof of their vaccination status securely. They “provide a path to reviving the economy and getting Americans back to work and play” according to a New York Times article. “For any such certificate or passport to work, it is going to need two things – access to a country’s official records of vaccinations and a secure method of identifying an individual and linking them to their health record.”

A variety of sources have undertaken development of these digital health passes, both governments and private firms. Israel already provides a nationwide digital proof of vaccination known as a Green Pass. Denmark followed suit with the Coronapas. In addition, a number of private companies and nonprofits are vying to become the preeminent vaccine status app for the world’s smartphones. While governments, such as Israel, have preexisting authority to access immunization and identification records, private firms do not. Private firms would require authorization to access your medical records.

So, in the United States, who would run these apps? Not the U.S. federal government. The Biden Administration unequivocally denied that it would ever require vaccine status checks, and would not keep a vaccination database. The federal government does not need to, though. Most states already manage a digital vaccination database, pursuant to laws authorizing them. Every other state, which doesn’t directly authorize them, still maintains a digital database anyway. These immunization information systems (“IIS”) provide quick access to a person’s vaccination status. A state’s resident can make a request for their vaccination status on myriad vaccinations for free and receive the results via email. Texas and Florida, who made big hubbubs about restricting any use of vaccine passports, both have registries to provide proof of vaccination. So does New York, who has already published an app, known as the Excelsior Pass, that does this for the COVID vaccine. The State’s app pulls information from New York’s immunization registry, providing a quick, simple yes-no result for those requiring proof. The app uses IBM’s blockchain technology, which is “designed to enable the secure verification of health credentials such as test results and vaccination records without the need to share underlying medical and personal information.”

With so many options, consumers of vaccine status apps could become overwhelmed. A vaccinated person may need to download innumerable apps to enter myriad activities. “Fake” apps could ask for additional medical information from the unwary. Private app developers may try to justify continued use of the app after the need for COVID vaccination proof passes.

In this competitive atmosphere, apps that partner with state governments likely provide the best form of digital vaccination verification. These apps have direct approval from the states that are required by law to maintain these vaccination records. They provide some authority to avoid scams. And cooperation to achieve state standardization of these apps may facilitate greater use. States seeking to reopen their economies should authorize digital interfaces with their pre-existing immunization registries. Now that the gold rush for vaccinations has started, the gold rush for vaccine passports is something to keep an eye on.

 

Intellectual Property in Crisis: Does SARS-CoV-2 Warrant Waiving TRIPS?

February 21, 2021
Bioethics, Biotechnology, COVID-19, Food and Drug Law, Health, Healthcare, Intellectual Property, Patents, Regulatory

Daniel Walsh, MJLST Staffer

The SARS-CoV-2 virus (which causes the disease COVID-19) has been a massive challenge to public health causing untold human suffering. Multiple vaccines and biotechnologies have been developed to combat the virus at a record pace, enabled by innovations in biotechnology. These technologies, vaccines in particular, represent the clearest path towards ending the pandemic. Governments have invested heavily in vaccine development. In May 2020 the United States made commitments to purchase, at the time, untested vaccines. These commitments were intended to indemnify the manufacture of vaccines allowing manufacturing to begin before regulatory approval was received from the Food and Drug Administration. The United States was not alone. China and Germany, just to name two, contributed heavily to funding the development of biotechnology in response to the pandemic. It is clear that both private and public institutions contributed heavily to the speed with which biotechnology has been developed in the context of the SARS-CoV-2 pandemic. However, there are criticisms that the public-private partnerships underlying vaccine manufacturing and distribution have been opaque. The contracts between governments and manufacturers are highly secretive, and contain clauses that disadvantage the developing world, for example forbidding the donation of extra vaccine doses.

Advanced biotechnology necessarily implicates intellectual property (IP) protections. Patents are the clearest example of this. Patents protect what is colloquially thought of as inventions or technological innovations. However, other forms of IP also have their place. Computer code, for example, can be subject to copyright protection. A therapy’s brand name might be subject to a trademark. Trade secrets can be used to protect things like clinical trial data needed for regulatory approval. IP involved in the pandemic is not limited to technologies developed directly in response to the emergence of SARS-CoV-2. Moderna, for example, has a variety of patents filed prior to the pandemic that protect its SARS-CoV-2 vaccine. IP necessarily restricts access, however, and in the context of the pandemic this has garnered significant criticism. Critics have argued that IP protections should be suspended or relaxed to expand access to lifesaving biotechnology. The current iteration of this debate is not unique; there is a perennial debate about whether it should be possible to obtain IP which could restrict access to medical therapies. Many nations have exceptions that limit IP rights for things like medical procedures. See, e.g., 35 U.S.C. 287(c).

In response to these concerns the waiver of a variety of IP protections has been proposed at the World Trade Organization (WTO). In October 2020 India and South Africa filed a communication proposing “a waiver from the implementation, application and enforcement of Sections 1, 4, 5, and 7 of Part II of the TRIPS Agreement in relation to prevention, containment or treatment of COVID-19.” The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) sets minimum standards for IP standards, acquisition, and enforcement and creates an intergovernmental dispute resolution process for member states. Charles R. McManis, Intellectual Property and International Mergers and Acquisitions, 66 U. Cin. L. Rev. 1283, 1288 (1998). It is necessary to accede to TRIPS in order to join the WTO, but membership in the WTO has significant benefits, especially for developing nations. “Sections 1, 4, 5, and 7 . . .” relate to the protection of copyrights, industrial designs, patents, and trade secrets respectively. Waiver would permit nation states to provide intellectual property protections “in relation to prevention, containment or treatment of COVID-19” that fall below the minimum standard set by the TRIPs Agreement. At time of writing, 10 nations have cosponsored this proposal.

This proposal has been criticized as unnecessary. There is an argument that patents will not enter effect until after the current crisis is resolved, implying they will have no preclusive effect. However, as previously mentioned, it is a matter of fact that preexisting patents apply to therapies that are being used to treat SARS-CoV-2. Repurposing is common in the field of biotechnology where existing therapies are often repurposed or used as platforms, as is the case with mRNA vaccines. However, it is true that therapies directly developed in response to the pandemic are unlikely to be under patent protection in the near future given lag between filing for and receiving a patent. Others argue that if investors perceive biotech as an area where IP rights are likely to be undermined in the event of an emergency, it will reduce marginal investment in vaccine and biotech therapies. Finally, critics argue that the proposal ignores the existing mechanisms in the TRIPS Agreement that would allow compulsory licensing of therapies that nations feel are unavailable. Supporters of the status quo argue that voluntary licensing agreements can serve the needs of developing nations while preserving the investments in innovation made by larger economies.

The waiver sponsors respond that a wholesale waiver would permit greater flexibility in the face of the crisis, and be a more proportionate response to the scale of the emergency. They also assert that the preexisting compulsory licensing provisions are undermined by lobbying against compulsory licensing by opponents of the waiver, though it is unlikely that this lobbying would cease even if a waiver were passed. The sponsors also argue that the public investment implies that any research products are a public good and should therefore be free to the public.

It is unclear how the current debate on TRIPS will be resolved. The voluntary licensing agreements might end up abrogating the need for a wholesale waiver of IP protections in practice rendering the debate moot. However, the WTO should consider taking up the issue of IP protections in a crisis after the current emergency is over. The current debate is a reflection of a larger underlying disagreement about the terms of the TRIPS Agreement. Further, uncertainty about the status of IP rights in emergencies can dissuade investment in the same way as erosion of IP rights, implying that society may pay the costs of decreased investment without reaping any of the benefits.

 

How the U.S. Government Broke Its Treaty Obligations Before the Pandemic Struck: COVID-19 illuminates how the U.S. government have failed Native communities

January 24, 2021
COVID-19, Health, Healthcare, Public Health

Ingrid Hofeldt, MJLST Staffer

As COVID-19 first began to ravage Native American tribal lands, the U.S. government’s treaty-solidified responsibility to protect tribes against external disasters was triggered. However, Native American communities’ reluctance to receive vaccinations showcases how the U.S. government’s treaty obligations require it to take proactive steps to ensure the advancement of healthcare on tribal lands and to attempt to mend the longstanding medical trauma of Native communities and resulting friction with the U.S. government.

Healthcare Disparities Before COVID-19

Since the invasion of Europeans, Native American communities have faced health crises. The European invaders both inadvertently spread smallpox, measles, and the flu, and launched biological warfare against Native communities. Around 90% of Native peoples were murdered or died through the spread of disease. Even after the most egregious periods of the genocide against Native Americans, indigenous communities continued to experience disparities in health outcomes. During the 1918 pandemic, the influenza struck Native populations with four times the severity of the general population, which resulted in 2% of Native peoples dying, and the near extinction of entire villages. 

Today, Native American communities continue to face disparities in health outcomes. Native Americans  have above average rates of immunocompromising diseases including diabetes, asthma, heart disease, cancer, respiratory diseases, hypertension, PTSD, and other mental health disorders. Native Americans are 600 times more likely than non-Native people to die of tuberculosis and 200 times more likely to die of diabetes. These rates exist in part because of the lack of resources available on reservations, which are home to 50% of the U.S. Native American population. Limited healthcare services, overcrowded housing, and lack of access to running water, proper sewage, and broadband internet[1] on reservations all contribute to reduced healthcare outcomes. A burgeoning elderly population, a quarter of whom lack health insurance, also adds to the difficulties facing Native healthcare services and tribal governments. 

The Crisis of COVID-19 for Native American communities and Reservations

Unsurprisingly, COVID-19 has spread across reservations like wildfire. Navajo Nation has had more deaths per capita than any state in the country. While Native Americans comprise 3% of Wyoming’s population and 6% of Arizona’s, they represent 33% and 16% of COVID-19 cases respectively. These disparities have emerged for a variety of reasons, from the higher rates of pre-existing conditions discussed above, which each exacerbate the severity and lethality of COVID-19, to lack of healthcare resources. Reservations experience the same shortages of doctors, hospitals, and medical resources common among rural areas. Additionally, limited grocery stores and multigenerational housing increase the risk of COVID-19 spread.

Beyond these existing disparities and lack of resources, the federal government’s mismanagement of resources designated for Native American communities has worsened the crisis of COVID-19 on reservations. While Congress distributed $80 million in COVID-19 relief funds to the Indian Health Services, 98% of tribal clinics have still not received their funds because of the federal government’s failure to properly disperse the funds. Testing has been largely absent from reservations, which causes cases to go unreported. Additionally, the federal government used census data, rather than tribal enrollment data,  to calculate distribution of resources in reservations. Because Native people are hugely undercounted in the census, reservations have received inadequate supplies of PPE, cleaning supplies, and tests. For example, the Sault Ste. Marie Tribe of Chippewa Indians only received 2 test kits for a population of 44,000. Meanwhile, the Seattle Indian Health Board was sent body bags in lieu of medical supplies. 

The U.S. Government’s Responsibility to Tribes

The U.S. government’s actions and inactions run afoul of multiple treaties, established case law, and the central tenants of Indian law. Numerous treaties between the U.S. government and tribal nations established tribes as sovereign political nations that the U.S. government must protect from external threats, ranging from foreign invasion to natural disasters. The Supreme Court has affirmed the dual sovereignty of tribal nations and the U.S. government’s obligations to tribes. 

Treaties between tribes and the U.S. government have both established this broad principle of the government’s responsibility to ensure the health and wellbeing of Native peoples and provided specific responsibilities requiring the U.S. government to provide vaccines, medicine, and physicians to Native peoples on reservations. In theory, the land tribes ceded to the U.S. government was a form of pre-payment for adequate healthcare. In 1955, the U.S. government established the Indian Health Services (IHS), to ensure that the U.S. government met its implied responsibility to ensure the adequate healthcare of Native peoples. Congress has also conceded that the U.S. government has a responsibility to “improve the services and facilities of Federal Indian health programs and encourage maximum participation of Indians” in those programs, which “the Federal Government’s historical and unique legal relationship with, and resulting responsibility to the American Indian people” requires. Congress has recognized that the current unmet health needs of tribes are “severe” and implicate “all other Federal services and programs in fulfillment of the Federal responsibility to Indians” which are “jeopardized by the low health status of the American Indian people.” 

How the U.S. Government Has Violated Its Treaty Obligations During the COVID-19 Crisis

As the U.S. government charges forward with the COVID-19 vaccination program, the COVID-19 healthcare disparities and the long history of medical trauma in Indian country compound one another. Many Native Americans living on reservations express skepticism over the vaccine program given the genocide committed against Native peoples through medicine and the government’s current mishandling of the COVID-19 crisis. Currently, an estimated 50% of people on the Spirit Lake Reservation do not plan to receive vaccinations. While the government spent centuries committing biological warfare against Native peoples, the medical community has enacted great harm against Native people relatively recently. Within the past 100 years, the U.S. government has conducted testing of radioactive iodine on Alaska Natives and widely distributed vaccines that proved less effective or ineffective for Native people. In the 1970’s, the U.S. government mass sterilized Native Americans without their consent. Further, in 2009, the U.S. government mishandled the H1N1 crisis on reservations, exacerbating this existing lack of trust. 

The tenuous relationship between tribes and the government has only worsened during the COVID-19 crisis as a result of the mismanagement of tribal healthcare. Many Native people worry that the federal government is withholding the risks of the COVID-19 vaccine. Native healthcare providers stress that the U.S. government must work to cultivate community support for its healthcare initiatives and ensure informed consent from each Native person for any medical procedure. The longstanding, positive relationship between Johns Hopkins University medical researchers and the Navajo people is a testament to the benefits of long standing relationships between tribes and researchers built on trust.

In light of the long history of healthcare issues and violations on reservations, the current mishandling of the COVID-19 crisis on reservations, and the fear of vaccination in many tribal communities, it becomes clear that the U.S. government’s treaty obligations related to healthcare must be rethought, recalibrated, and redefined. The U.S. government should not merely intervene when a pandemic strikes, but should take proactive, constructive steps before crisis strikes to ensure that Native peoples will receive adequate healthcare during both normal times and widespread calamities. It was no secret to the government that a pandemic would prove disastrous for tribes: public health experts have long foreshadowed the severity of a pandemic for tribal populations. Merely throwing money at tribes once disaster strikes will not solve the longstanding health and healthcare issues on reservations that complicate the virus. 

 Funds alone cannot solve the complex, socio-political healthcare issues complicated by historical trauma. Beyond dispersing funds through IHS, the U.S. government should consider organizing focus groups on reservations between elders, traditional healers, tribal government leaders, and immunologists from the CDC and public health officials to discuss steps moving forward. Additionally, to ensure treaty obligations, the U.S. government must tackle the more difficult long standing issues such as the lack of agency tribes hold over medical research and the distrust between the federal government and Native communities. To achieve equitable healthcare for tribes, Native people cannot merely be pushed to the sidelines as participants or involved minimally as nurses and doctors but not as researchers. The federal government should use funds to ensure that young Native Americans have available programming on science, STEM careers, and pathways into medicine. While not a conclusive end to the medical trauma Native communities have experienced, providing partnerships in medical research to researchers from Native communities will hopefully both shed a spotlight on healthcare disparities within Native communities and rebuild the frayed and broken trust between Native communities and medical researchers. 

Regardless of what steps are taken, the strength and organizing of Native communities during the COVID-19 pandemic deserves recognition. In the words of Jonathan Nez, Navajo Nation president, “We are resilient . . . our ancestors got us to this point . . .  now it is our turn to fight hard against this virus.”

 

[1] 13% of American Indian/Alaska Native homes lack running water or sewage compared to 1% of homes nationwide. In the Navajo Nation, ⅓ of homes lack running water.

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