COVID Law Briefing: Medicaid and the ACA- Summary

Earlier this year, Public Health Law Watch, in collaboration with members of the George Consortium and other partner organizations, hosted a series of legal briefings related to COVID-19 and legal and policy issues associated with the global pandemic. Experts and scholars joined us for bi-weekly livestreamed discussions on these issues. We invite you to read the summaries of selected episodes below! And, enjoy relistening to the series (linked below and archived on our #COVIDLawBriefing webpage).

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4/16/20: Medicaid and the ACA

Mod: Wendy Parmet

Speakers: Nicole Hubberfield, Sidney Watson

Professor Parmet moderates a discussion with Professor Hubberfield and Professor Watson on Medicaid and the ACA on this #COVIDLawBriefing. The talk began by going over the stability of Medicaid’s federal funding, and the programs ability to bail out the states that need the money most. It allows states to be “flexible” in a pandemic as the poorer states can get more from Medicaid. Since it was designed to be “a safety net program” it is more able, then private insurance, to be positioned to help people during this crisis. This is due to the fact that Medicaid does not need to balance its own budget and engages in “countercyclical spending” so it can be positioned to help people when need arises. Additionally, you can sign up for Medicaid at any time with your current income so it can help people who just lost a job. Unfortunately, for states that didn’t expand Medicaid, many people have been stranded. This is especially true in communities of color and lower income communities. One tool available for states would be to expand Medicaid, a process which even during the crisis would only take a simple state amendment. Calling a state of emergency is also essential as it will open up different avenues for states to get funding. On the federal level, congress recently passed a 6.2% increase in federal matching funds for Medicaid, a typical response to a public health crisis. After going through the congressional and state loopholes that allow them to influence the distribution of Medicaid funding, the conversation ended with a discussion of the Trump administration’s relationship with Medicaid. Despite the public health crisis we are facing, the Trump administration has been reluctant to change their stances about many of their health care policy goals including getting people off Medicaid. 

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Public Health Law Watch’s COVID Law Briefings are co-sponsored by the Center for Health Policy and Law at Northeastern University School of Law, the Center for Public Health Law Research at Temple University Beasley School of Law, the Network for Public Health Law, and the APHA Law Section.

Letter to Congress on WHO Withdrawal from Public Health, Law and International Relations Leaders

Members of the George Consortium were among 750 scholars and experts in global public health, U.S. constitutional law, and international law and relations who wrote to Congress in opposition to U.S. withdrawal from WHO.

June 30, 2020

The President has declared his intent to withdraw the U.S. from the World Health Organization (WHO). We are scholars and experts with long experience in global public health, U.S. constitutional law and international law and relations. As we outline below, the President lacks the legal authority to withdraw without congressional participation and approval. We therefore write to you with our deep concerns about the immediate hazards to health, safety, and security in the United States and globally from cutting ties with WHO. The WHO requires reforms, but as a founding member and the largest financial contributor, the U.S. is best poised to lead in these reforms if it remains in the WHO.

Withdrawing from or cutting funding to the WHO during a global pandemic would be a dangerous action for global health and U.S. national interests. Withdrawal cannot legally take effect for at least a year and requires the US to pay its outstanding contribution. Congress has the power to prevent this decision from going forward, and must not be silent and must not wait. We ask your committees, and other committees with jurisdiction over this matter, to hold hearings promptly to address the question of whether the attempt to unilaterally withdraw from the WHO is legal or in the national interest. We further look to your leadership on additional congressional action, including appropriating the full amount that the United States promised to WHO in FY2021 and passing a resolution expressly prohibiting withdrawal. Exiting from the WHO is antithetical to U.S. health and national security interests. COVID-19 has proven how the zoonotic leap of a single virus anywhere in the world can result in health and economic catastrophe in the U.S.

It is not overstatement to say that withdrawal will likely cost lives, American and foreign. Once outside the WHO, the U.S. would lose access to the WHO’s global system for sharing critical outbreak data and vaccines, slowing U.S. ability to return to normalcy from COVID-19, and to prepare and react to future pandemics. The rest of the world would be at heightened risk, too. The U.S. funds the largest portion of the WHO’s Health Emergencies Program, meaning that funding for testing and contact tracing, building health workforces, and vaccine development would be lost. Second or third waves of COVID-19 cases could repeatedly overwhelm health care systems and result in far more lives lost. When international travel resumes, many of these cases would find their way to the U.S., threatening Americans. Beyond COVID-19, the WHO will have less capacity to detect and control future outbreaks without U.S. support, marking a new era of pandemic risk. As COVID-19 has so vividly shown us, an uncoordinated response to health dangers beyond our borders will gravely affect the lives of those living in the U.S.

A number of other WHO programs would suffer enormously under U.S. withdrawal, especially as many global health resources are being redirected to fight COVID-19. Historically, the U.S. has served as a global health leader and the largest WHO donor (providing about 15% of its budget, or approximately $450 million annually). The U.S. has helped fund such initiatives as polio eradication, child nutrition, vaccines, HIV/AIDS, malaria, and tuberculosis. Pulling funding could reverse hard-won progress and erode the ability of the U.S. to shape and lead policy. For example, efforts to eradicate polio over the last two decades have reduced global cases by 99.9%, but loss of U.S. funding could potentially allow annual global polio cases to jump from a few hundred to 200,000 within a decade. This work has progressed with global leadership from Rotary Clubs in the U.S. and worldwide, partnering with WHO. Though the U.S. may attempt to remain a global health leader by rerouting funding directly to countries, or through global public-private partnerships, it will have far less ability to shape rules (such as the International Health Regulations), norms (such as the WHO Priority Bacterial Pathogen List), and programs. Even the President’s Emergency Plan for AIDS Relief, the U.S.’s signature achievement in responding to HIV/AIDS, has relied on WHO to deliver health messages, ensure quality medications, and set health workforce standards. As U.S. global health funding and leadership falters, the U.S. will lose capacity to engage in global health diplomacy, with China filling the leadership vacuum created by our departure.

Unilateral withdrawal from WHO also raises significant separation of powers concerns, for the President lacks the legal authority to do so without Congress. With the Constitution silent on the process of withdrawing from a treaty, the best understanding of the Constitution is a “mirror principle,” under which the same process the U.S. government uses to enter a treaty is required to withdraw from it. The United States joined WHO through a 1948 joint resolution of Congress. Therefore, a joint resolution would be required to withdraw.

Unilateral withdrawal from WHO raises separation of powers concerns for another reason as well. In Youngstown Sheet & Tube Co. v. Sawyer (1952), Justice Jackson famously wrote, “When the President takes measures incompatible with the expressed or implied will of Congress, his power is at its lowest ebb.” By unilaterally withdrawing from WHO, the President would be acting against the implied will of Congress.

In the joint resolution to join WHO, Congress set two conditions on withdrawing. First, withdrawal requires a year’s notice. Thus, any effort by the Trump Administration to withdraw could not take effect before July, 2021 at the earliest. Second, the United States must pay WHO dues in full for WHO’s current fiscal year. As Congress holds the power of the purse, this latter condition requires congressional action. Congress therefore clearly intended to retain a role in any decision to withdraw from WHO; it did not cede unilateral authority to the President. To ensure that the President may not claim that Congress’s FY2021 appropriations to WHO is acquiescing in or approving the President’s attempted withdrawal, we recommend that Congress expressly state both its opposition to withdrawal and its unambiguous support for continued U.S. membership.

A decision to withdraw the U.S. from or cut U.S. funding to WHO would threaten the health security of Americans as well as all other nations and could dismantle decades of global health progress. The public’s health as well as respect for our separation of powers requires congressional leadership on this question. We call on Congress to hold hearings on a matter vital to U.S. and global health security.

View the letter and full list of signatories here.

2020 Presidential Candidates: Policies for Addressing Prescription Drug Pricing

This post is third in a series aimed at identifying and exploring some of the public health issues and policies under consideration by candidates in the 2020 Presidential Election.

The goal of this series is to provide a deeper look at the ways in which candidates may or may not be including a public health framework in their healthcare reform policies, and encourage candidates to thoughtfully and purposefully develop nuanced, evidence-based, impactful policies. We also hope to inform the public as they continue to evaluate each candidate’s efforts to articulate plans that address healthcare and public health challenges in the U.S. Our goal is not endorse a particular candidate or political party; rather, our goal, as always, is to research, analyze, inform, and equip people with the knowledge they need to be engaged and thoughtful members of their communities and this nation.

Many of the policies championed by the candidates vying for the 2020 Democratic nomination have centered on healthcare reform. Particular emphasis has been placed on the need to address the immense financial burden faced by Americans as they try to meet their more basic medical needs. One need look no further than bankruptcy courts to understand the impact medical costs, and resulting debt, has on Americans. Medical debt is the greatest cause of bankruptcy in the United States, and some choose to forego necessary medical care. One in four Americans struggle to afford their medications, and three in ten skip doses or forgo refills due to costs. Many diabetics are forced to ration their insulin and elders are reducing their dosage to stretch a prescription. The pharmaceutical industry is one particularly problematic element of the American healthcare system that contributes greatly to the expenses levied on patients, as the industry itself comprises the most profitable companies in the entire healthcare system. This wealth is widely seen as having accrued at the expense of the American citizen.

In 2017 the United States spent $1,220 per person on pharmaceuticals. Americans paid, on average, $600 more each year for prescription drugs than residents of comparable high-income nations. Pharmaceutical companies are continuously able to arbitrarily hike prices, such as when Turing Pharmaceuticals raised the HIV medication Daraprim from $13.50 to $750 per tablet.

We reviewed the various prescription drug pricing policies of each candidates, all of which fall into one of the following categories:

• Increase regulation of the pharmaceutical industry

• Grant the Department of Health and Human Services (HHS) more power to engage with the pharmaceutical industry 

• Cap out-of-pocket drug costs

• Expand engagement with international markets 

INCREASE REGULATION OF THE PHARMACEUTICAL INDUSTRY

Revoke Patents from “Worst Offenders”:

Buttigieg and Warren have proposed using provisions from the Bayh-Dole Act of 1980 to revoke patents from companies that price their drugs unaffordably, thus harming patients. Under the Bayh-Dole Act, federal agencies have “march-in rights” that enable them to require patent holders who have received federal funds to grant licenses to third parties. There have been five march-in petitions since 1997 (all denied by NIH), including one signed by 51 Congressional Democrats in 2017. 

Increase Annual Branded Prescription Drug Fee:

Buttigieg has proposed increasing the Branded Prescription Drug Fee. The Branded Prescription Drug Fee Program (BPD) was enacted under the Affordable Care Act. Under the program, drug manufacturers and importers must pay a fee based on their share of branded prescription drug sales to government programs, including Medicare, Medicaid, and the VA. 

Charge Rebate for Prices Increasing Faster than Inflation:

Buttigieg and Biden have suggested that pharmaceutical companies pay a rebate for drugs with prices increasing faster than inflation. Buttigieg proposes withholding government payment until companies comply with the rebate. Biden proposes prohibiting companies from participating in Medicare and public option until companies comply with the rebate. 

Combat Anti-Competitive Practices:

Buttigieg, Warren, and Klobuchar have proposed measures to combat anti-competitive practices within the pharmaceutical industry, such as “pay-for-delay” deals, which occur when pharmaceutical companies compensate competitors to delay marketing their generic drugs. When generic manufacturers challenge brand-name manufacturers’ patents, the brand-name company will sue the generic company for patent infringement. The two companies will settle with a “reverse payment agreement,” where the suing brand-name company actually pays the generic company, and the generic company agrees to delay marketing their product until a specified date. According to the Federal Trade Commission, these deals result in consumers and taxpayers paying an additional $3.5 billion per year through higher drug costs. 

Warren says her administration will pursue antitrust action against companies such as AbbVie, who entered into a pay-for-delay settlement in 2019 to prevent generic competition for its drug Humira. Klobuchar sponsors the Preserve Access to Affordable Generics and Biosimilars Act, which prohibits pay-for-delay deals. Buttigieg says he supports the Protecting Consumer Access to Generic Drugs Act, which would make pay-for-delay deals illegal. 

End Tax Deductions for Prescription Drug Adverts:

Sanders, Warren, Biden, Klobuchar, and Steyer propose ending tax deductions for prescription drug advertisements. Under current law, pharmaceutical companies can deduct their advertisement costs from federal taxes. In 2016, these expenses reached $6 billion. Sanders, Warren, and Klobuchar cosponsor the End Taxpayer Subsidies for Drug Ads Act. 

Improve Transparency in Drug Pricing:

Buttigieg has proposed several measures to increase drug price transparency. This includes requiring pharmaceutical companies that sell prescription drugs to Medicaid, Medicare, and the public option to report information on sales volume, price, discounts, rebates, promotion, manufacturing costs, and R&D spending to the federal government. Additionally, companies would be required to report drug ingredient sources and manufacturing location on the drug label. Finally, pharmacy benefit managers (PBMs) that work with Medicaid, Medicare, and the public option would be required to report sales information, pricing, and rebates received to the federal government. 

Limit Brand-Name Patents

Bloomberg has proposed limiting brand-name drug companies to one 20 year patent. He would also require drug companies that use National Institutes of Health (NIH) IP to make a commercial drug product to pay royalties to NIH, with revenue going to fund additional research and lower Medicare drug costs.

Eliminate Drug Manufacturer Payments to Pharmacy Benefit Managers

Bloomberg has proposed eliminating drug company rebates to PBMs, companies that administer prescription drug benefits on behalf of health insurers. PBM rebates were singled out by President Trump as a cause of high prescription costs; however, he withdrew a proposal to eliminate such rebates for Medicaid and Medicare in July 2019. PBMs receive larger rebates for more expensive drugs, giving them an incentive to favor high-priced drugs. However, a 2019 GAO report found that “virtually all (99.6%) prescription drug rebates negotiated by PBMs with drug manufacturers in Medicare Part D are passed through to drug plan sponsors and used to lower costs for Medicare beneficiaries.”

CAP OUT-OF-POCKET DRUG COSTS

Cap Out-of-Pocket Drug Costs

Sanders, Buttigieg, Warren, and Bloomberg have proposed capping out-of-pocket drug costs. Sanders and Warren propose a cap for everyone, while Buttigieg proposes a cap for public option, Medicaid, and Medicare Part D recipients. Bloomberg also  proposes a cap for Medicare Part D recipients

Under Sanders’ Medicare for All plan, everyone’s out-of-pocket drug costs would be capped at $200 per year. Individuals or families with an income under 200% of the federal poverty level would not pay anything. Warren’s Medicare for All plan says there would be no cost sharing at all. 

Buttigieg would cap out-of-pocket drug costs at $200 per month and $2400 per year for seniors on Medicare, with lower caps for seniors with lower incomes. Those on public option would be capped at $250 per month. Co-payments for generic drugs would be $0 for those on Medicaid, and for low-income individuals on public option. Bloomberg would cap out-of-pocket drug spending for Medicare beneficiaries at $2000 per year. 

GRANT HHS MORE AUTHORITY TO ENGAGE WITH THE PHARMACEUTICAL MARKET

Empower the Federal Government to Negotiate Drug Prices:

Under the Medicare Modernization Act of 2003 (MMA), which established the Medicare Part D benefit, the HHS Secretary “1) may not interfere with the negotiations between drug manufacturers and pharmacies and PDP sponsors; and 2) may not require a particular formulary or institute a price structure for the reimbursement of covered part D drugs.” This section of the bill, known as the “noninterference clause,” prohibits the government from negotiating Medicare drug prices. Among voters, empowering this negotiation is a fairly uncontroversial measure; overall, 88% of Americans, including 92% of Democrats and 85% of Republicans, favor allowing the federal government to negotiate with drug companies for Medicare beneficiaries. Even Donald Trump campaigned on allowing Medicare to negotiate prices, later breaking from that strategy in 2018.

Currently, Medicaid and the Veterans Benefits Administration (VBA) are allowed to negotiate; Medicare pays 73% more than Medicaid and 80% more than the VBA on brand name drugs.  In December, the House passed a bill allowing the government to negotiate on Medicare prices.

All of the candidates have expressed support for allowing the federal government to negotiate on behalf of Medicare for lower drug prices. 

Empower the Federal Government to Manufacture Generic Drugs:

Under Warren’s Affordable Drug Manufacturing Act, HHS would be allowed to manufacture generic drugs when no company is manufacturing a drug, when only one or two companies manufacture it and the price has spiked, when the drug is in shortage, or when a medicine listed as “essential” by the WHO faces limited competition and high prices.

EXPAND ENGAGEMENT WITH INTERNATIONAL MARKETS

Permit Purchase of Low-Cost Prescription Drugs from Other Countries:

All of the candidates, except for Buttigieg, have expressed support for allowing the purchase of prescription drugs from other countries. 

Use International Prices to Benchmark Prices in the US

Sanders, Biden, and Steyer have suggested benchmarking prescription drug prices in the US against international prices in order to control costs. Sanders has suggested pegging US drug prices to the median drug prices in Canada, the UK, France, Germany and Japan. Biden has suggested using this method only in the case of new specialty drugs introduced without competition; an independent review board established by HHS would determine a reasonable price based on the average price in other countries. Medicare and the public option would pay this rate, and private plans in the individual marketplace would be able to access a similar rate. Steyer has not released any further details beyond stating that prescription drug prices will be benchmarked against international standards and price-capped. 

All candidate stances were sourced from their official campaign websites, accessible below:

• Senator Bernie Sanders

• Senator Elizabeth Warren

• Vice President Joe Biden

• Mayor Pete Buttigieg

• Senator Amy Klobuchar

• Tom Steyer

• Mayor Michael Bloomberg

2020 Presidential Candidates: Policies for Addressing the Opioid Overdose Crisis.

This post is first in a series aimed at identifying and exploring some of the public health issues and policies under consideration by candidates in the 2020 Presidential Election.

The goal of this series is to provide a deeper look at the ways in which candidates may or may not be including a public health framework in their healthcare reform policies, and encourage candidates to thoughtfully and purposefully develop nuanced, evidence-based, impactful policies. We also hope to inform the public as they continue to evaluate each candidate’s efforts to articulate plans that address healthcare and public health challenges in the U.S. Our goal is not endorse a particular candidate or political party; rather, our goal, as always, is to research, analyze, inform, and equip people with the knowledge they need to be engaged and thoughtful members of their communities and this nation.

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Each day, over 130 people die from opioid-related overdoses. This includes both prescription and illicit opioids. The National Institute on Drug Abuse attributes the opioid overdose crisis to unscrupulous pharmaceutical companies, who misled healthcare providers to believe opioid pain relievers were not addictive. Other researchers, while agreeing that increased drug supply was an important factor, argue that economic and social issues fueled the crisis, viewing the issue through the lens of a structural and social determinants of health framework.   

Public health experts and practitioners are increasingly pursuing support for and implementation of evidence-based harm reduction policies and programs to reduce harmful outcomes related to substance use disorders (SUD) and opioid use disorders (OUD). Our colleagues at the Health in Justice Action Lab (HIJAL) have identified a series of proven hard reduction programs. Below we offer a description for a few such programs and identify which of the 2020 Democratic Presidential Candidates support each program:

• Safe injection facilities

• Buprenorphine deregulation

• Increased access to SUD treatment in prisons and jails

• Decriminalization of opiates for personal use

Safe injection facilities

Safe injection facilities, also known as supervised consumption services (SCS), are legal facilities in which people can bring in and consume illicit drugs under the supervision of trained staff. The facilities provide clients with sterile injection supplies and a safe place to consume drugs, as staff members monitor for overdose and provide first aid as needed. Additionally, staff members are available to provide clients with referrals to drug treatment and other support programs. Although many studies have identified myriad public health benefits of safe injection sites, they remain controversial. Safe injection sites exist around the world, but due to legal issues (and specifically the Controlled Substance Act), not yet in the United States. However, that may be changing soon; a federal judge recently ruled that the Controlled Substance Act does not apply to Safehouse, a Philadelphia group seeking to open a safe injection facility

Candidates who have expressed support for safe injection facilities:

• Pete Buttigieg

• Bernie Sanders

• Elizabeth Warren

• Andrew Yang

Buprenorphine deregulation

Buprenorphine is an opioid partial agonist used in treating opioid use disorder (OUD). Under the Drug Addiction Treatment Act of 2000, prescribers must complete an approved training, attest to their referral capacity, and submit an application to SAMHSA in order to receive what is known as an “X-waiver.” As noted by Kevin Fiscella et al, “X-waivered prescribers face heightened scrutiny by federal and state law enforcement officials, including periodic audits that are intended to minimize diversion and misuse.” Fiscella articulates four reasons for deregulating buprenorphine:

“First, buprenorphine’s comparative safety undermines a critical rationale for regulation. Buprenorphine, regardless of prescribing intent, is safer than commonly prescribed full-opioid agonists.

Second, deregulation would improve access to buprenorphine during the opioid national emergency. Despite promotion and training initiatives by SAMHSA and legislation that has expanded patient limits and waivers to nurse practitioners and physician assistants, access to buprenorphine has not kept pace with the current epidemic, particularly in rural communities.

Third, buprenorphine regulation is premised on the faulty assumption that buprenorphine diversion is driven by a desire to “get high.” Yet, buprenorphine obtained illicitly is mostly used for self-medication to relieve withdrawal symptoms rather than for euphoria… This suggests that regulations constraining access to buprenorphine may paradoxically contribute to a market for illicit buprenorphine among those who seek treatment.

Lastly, deregulation could help integrate opioid disorder treatment into primary care. Regulations reinforce the stigma surrounding buprenorphine prescribers and patients who receive it while constraining access and discouraging patient engagement and retention in treatment.”

Candidates who have expressed support for buprenorphine deregulation:

• Michael Bloomberg

• Pete Buttigieg

• Amy Klobuchar

• Bernie Sanders

• Andrew Yang

Increased access to SUD treatment in prisons and jails

A federal report found that 58% of people in prison and 63% of people in jail suffer from drug use disorders (SUD) based on criteria from the Diagnostic and Statistical Manual of Mental Disorders. However, only 28% of people in prison who met this criteria and 22% of people in jail participated in any type of SUD treatment.

Candidates who have expressed support for increased access to SUD treatment in prisons and jails:

• Joe Biden

• Mike Bloomberg

• Pete Buttigieg

• Tulsi Gabbard

• Amy Klobuchar

• Bernie Sanders

• Elizabeth Warren

Decriminalization of opiates for personal use

Some advocates have proposed decriminalization as a measure to improve public health. The Drug Policy Alliance lists several benefits of decriminalization on their website:

 “Removing criminal penalties for drug possession and low-level sales would:

• Save money by reducing prison and especially jail costs and population size

• Free up law enforcement resources to be used in more appropriate ways

• Prioritize health and safety over punishment for people who use drugs

• Reduce the stigma associated with drug use so that problematic drug users are encouraged to come out of the shadows and seek treatment and other support

• Remove barriers to evidence-based harm reduction practices such as drug checking, heroin-assisted treatment, and medical marijuana.”

Candidates who have expressed support for decriminalization of opiates for personal use:

• Pete Buttigieg

• Andrew Yang

Healthcare and the 2020 Presidential Election blog series

U.S. Healthcare reform remains a central issue in any policy debate, especially during an election year, such that many candidates in the 2020 Presidential Election have indicated healthcare as one of their “signature issues.” To better understand where each candidate stands on issues, Public Health Law Watch is launching a new blog series aimed at identifying and exploring some of the public health issues and policies under consideration by candidates.

In the first part of the series, we will unpack issues like harm reduction, gun control, and more, and highlight where each candidate stands in support or opposition to law, policies, and/or programs that fall within those topic areas.

The second part of the series will dive deeper into each candidates’ proposed policies and offer critical analysis and commentary about the potential strengths and areas for improvement within those policies.

The goal of this series is to provide a deeper look at the ways in which candidates may or may not be including a public health framework in their overall healthcare reform policies, and encourage candidates to thoughtfully and purposefully develop nuanced, evidence-based, impactful policies. We also hope to inform voters as they continue to evaluate each candidate’s efforts to articulate plans to addressing healthcare and public health challenges in the U.S. Our goal is not endorse a particular candidate or political party; rather, our goal, as always, is to research, analyze, inform, and equip people with the knowledge they need to be engaged and thoughtful members of their communities and this nation.

This blog series will also link to related activities we have planned around social media, community engagement, and candidate outreach.

Please check back next week for the first post in this series:
2020 Presidential Candidates: Policies for Addressing the Opioid Overdose Crisis.

A Delicate Balance: Proposed Regulations May Upset the Tension Between Accessibility and Privacy of Health Information

This piece is part of a blog symposium featuring commentary from participants in the Center for Health Policy and Law’s annual conference, Promises and Perils of Emerging Health Innovations, held on April 11-12, 2019 at Northeastern University School of Law. The symposium was originally published on the Northeastern University Law Review Online Forum.

By Oliver Kim

Northeastern University School of Law’s “Promises and Perils” conference allowed my coauthor and me to continue the exploration of legal, policy, and ethical issues in the development and use of “disruptive technologies” in health care. See Ne. Univ. Sch. L., Promises and Perils of Emerging Health Innovations, (last visited Oct. 4, 2019); Oliver J. Kim, The Devil is in the Data, Balkinization (Nov. 3, 2018, 11:00 AM). The bedrock of the provider-patient relationship is trust, and that same level of trust must exist in the world of disruptive technology, such as digital health, if disruptive technologies will be welcomed by patients and consumers.

Consultant and health technology expert Susannah Fox argues that a “trust gap” has emerged because the narrative around digital health has negatively impacted people’s sense of trustworthiness due to “a steady drip-drip-drip of articles documenting how health apps are sharing data with third parties.” Susannah Fox, Trust Gap: Health Apps and Data Sharing (Apr. 29, 2019). Moreover, observers have raised concerns about how digital technologies affect women, people of color, and those of limited means in areas such as privacy, security, and criminal justice. See Emily Chang, What Women Know About the Internet, N.Y. Times (Apr. 10, 2019); Cat Zakrzewski, The Technology 202: Advocate Urges Congress to Protect Digital Rights of People of Color as it Crafts Privacy Bill, Wash. Post (Feb. 6, 2019); Mary Madden, The Devastating Consequences of Being Poor in the Digital Age, N.Y. Times (Apr. 25, 2019). For example, many questions about privacy arose when police were able to use a private company’s DNA ancestry tool to identify the Golden State Killer through partial matches from relatives’ genetic data. Avi Selk, The Ingenious and ‘Dystopian’ DNA Technique Police Used to Hunt the ‘Golden State Killer’ Suspect, Wash. Post (Apr. 28, 2018); Clare Wilson, Serial Killer Suspect Identified Using DNA Family Tree Website, New Scientist (Apr. 27, 2018). Some law enforcement agencies are building up their own DNA databases, and while the DNA may be taken consensually, individuals may not realize their DNA could be retained or used for other purposes. Jay Stanley, The Police Want Your DNA to Prove You’re Innocent. Do You Give it to Them?, ACLU (Sept. 16, 2016). As one physician noted after police swabbed his son, “My concern… is that it’s not just Adam’s DNA…. It’s my DNA, it’s my wife’s DNA, and our parents. Not to sound bad, but you just get nervous.” Lauren Kirchner, DNA Dragnet: In Some Cities, Police Go from Stop-and-Frisk to Stop-and-Spit, ProPublica (Sept. 12, 2016).

While improved healthcare interoperability is a priority for stakeholders, achieving it continues to be a vexing problem. Kate Monica, Top 5 Challenges to Achieving Healthcare Interoperability, EHR Intelligence (Aug. 14, 2017). After an extended comment period, the Centers for Medicare and Medicaid Services (CMS) and the Office of the National Coordinator (ONC) recently closed the long-awaited proposed regulations on interoperability as directed by the 21st Century Cures Act. Press Release, U.S. Dep’t of Health & Human Serv., HHS Extends Comment Period for Proposed Rules to Improve the Interoperability of Electronic Health Information (Apr. 19, 2019); Elise S. Anthony & Michael Lipinski, 21st Century Cures ACT: Interoperability, Information Blocking, and the ONC Health IT Certification Program Proposed Rule, The Office of the Nat’l Coordinator for Health Info. Tech. (last visited Oct. 8, 2019). These proposed regulations require certain payers— Medicare Advantage private plans, Medicaid and Children’s Health Insurance Program managed care organizations, Medicaid state agencies, and qualified health plans within Federally Facilitated Exchanges—to create open APIs (Application Programming Interfaces) that patients could use through a third-party app to access and compile their health data. Patient Protection, Interoperability and Patient Access for Medicare and Medicaid Programs, 84 Fed. Reg. 7610 (proposed Mar. 4, 2019) (to be codified at 40 C.F.R. pt. 156); 21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Program, 84 Fed. Reg. 7424 (proposed Mar. 4, 2019) (to be codified at 40 C.F.R. pt. 170 & 171).

While the use of APIs and third-party apps may make health data more accessible and help to eliminate the digital divide on how different racial and ethnic groups tend to access the Internet, there is concern about utilizing third-party apps because of their potential for harnessing consumers’ data. Eva Chang et al., Racial/Ethnic Variation in Devices Used to Access Patient Portals, 24(1) Am. J. of Managed Care e7 (2018); Rebecca Pifer, HHS Officials Defend Interoperability Rules to Senate Critics, Health Care Dive (May 7, 2019). Indeed, one of the reasons cited for the extension of the comment period was confusion over whether providers would be liable for how patients use their health data under HIPAA’s privacy law (which ironically does not contain the word “privacy” in its full title, the Health Insurance Portability and Accountability Act of 1996). Jessica K. Cohen, HHS Extends Comment Period for Interoperability Rules, Modern Healthcare (Apr. 19, 2018); Health Insurance Portability And Accountability Act of 1996, Pub. L. No. 104-191, § 110 Stat. 1936, (1996).

HIPAA protections do not necessarily apply to a third-party app simply because the app has received health information via the consumer. See Health App Developers, What Are Your Questions About HIPPA? (last visited Oct. 8, 2019). In some cases, it would be no different than if a patient handed a paper file to a stranger who promised to take care of the information. See Focal Point Insights, When Does HIPAA Apply to Health Apps?, Focal Point Blog (Oct. 3, 2018). In this instance, the consumer has voluntarily taken their patient data outside HIPAA’s world of covered entities. Instead, it would be up to the Federal Trade Commission (FTC) to take enforcement actions against those who may have violated an app’s terms and conditions with the consumer. See Federal Trade Commission, Privacy and Security Enforcement (last visited Oct. 8, 2019); G. S. Hans, Privacy Policies, Terms of Service, and FTC Enforcement: Broadening Unfairness Regulation for a New Era, 19 Mich. Telecomm. & Tech. L. Rev. 163 (2012).

As argued earlier, see Kim, supra, and as discussed in presentations, trust is a key component of ensuring that the digital health system will work, as well as building the data foundation necessary for new advances in healthcare, such as artificial intelligence. See Ne. Univ. Sch. L., supra; Ariz. St. Univ. C. L., Governance of Emerging Technologies & Science (GETS) (last visited Oct. 8, 2019). Many communities of color share concerns about the use of their health data due to historical inequities and unjust treatment by the medical system; yet, their data is needed to ensure that there is no digital divide in our healthcare databases. See J. Corey Williams, Black Americans Don’t Trust our Healthcare System – Here’s Why, The Hill (Aug. 24, 2017); Research America, New National Public Opinion Poll Shows Majority of Americans Would Participate in Clinical Trials if Recommended by Their Doctor, ResearchAmerica! Polls (June 12, 2013); Graham MacDonald & Ajjit Narayanan, We Need Better Tools to Measure Bias in Data that Drive Decisionmaking, Urban Institute (Mar. 5, 2019). The proposed regulations are unlikely to close that trust gap, particularly when consumer groups have raised concerns about certain apps, wearables, and their relationships with marketers and insurers. See Drew Harwell, Is Your Pregnancy App Sharing Your Intimate Data with Your Boss?, Wash. Post (Apr. 10, 2019); Allison V. Smith, With Fitness Trackers in the Workplace, Bosses can Monitor your Every Step – and Possibly More, Wash. Post (Feb. 16, 2019); Kaitlyn Tiffany, Period-Tracking Apps are Not for Women, Vox (updated Nov. 16, 2018); Smartphone Contraception: Policy Issues, National Women’s Health Network (last updated Oct. 2018).

Ideally, everyone would be an informed consumer, but the truth is most of us do not read or do not understand the terms and conditions that go along with downloading an app. Caroline Cakebread, You’re Not Alone, No One Reads Terms of Service Agreement, Business Insider (Nov. 15, 2017). And the current Administration has not signaled a willingness to intervene on behalf of consumers. For instance, the new head of the Consumer Financial Protection Bureau said the agency will help consumers “to help themselves [to] protect their own interests” rather than on focus on enforcement. David Lazarus, ColumnL CFPD head, Charged with Protecting Consumers, Says People Need ‘to Help Themselves’, LA Times (Apr. 19, 2019). Similarly, ONC director Don Rucker said it is up to individual patients to decide what types of third-party apps to use. See Cohen, supra.  Let the downloader beware!

While CMS and ONC do not have regulatory authority over third party apps, they could allow or require APIs to restrict third-party apps’ access based on whether they agree to limit the use of patients’ health data. As one consumer group has argued, that would give patients some real measure of choice in their notice and consent. And to build trust—particularly for women and people of color—in this digital revolution in healthcare, the government owes patients and consumers some sense of safety and security. See Michell Richardson, Notice and Choice Are No Longer a Choice, CDT Blog (Mar. 1, 2019).

Bio: Oliver Kim is an adjunct law professor at University of Pittsburgh School of Law and a principal with Mousetrap Consulting in Washington, D.C.

Handle: @mousetrapdc

The Trump Administration’s New Public Charge Rule: Implications For Health Care & Public Health [from Health Affairs Blog]

By Wendy E. Parmet

Although recent discussions about the Trump Administration’s immigration policies have focused on the treatment of undocumented migrants and asylum-seekers at the border and in detention, the Administration has also sought to curtail legal immigration and make conditions more onerous for non-citizens who are lawfully present. The most recent example of these restrictive efforts is the long-anticipated public charge rule, which was published in the Federal Register by the Department of Homeland Security (DHS) on August 14. Unless halted by litigation, the rule will take effect on October 15, creating punishing new challenges for immigrant patients and their health care providers.

The proposed rule purports to implement a longstanding provision of the Immigration and Nationalization Act (INA) that requires most immigrants (excluding refugees, asylees, and certain other groups granted special humanitarian status), to show that they are “not likely to become a public charge,” in order to gain entry into the United States or attain permanent resident status once they are here. Under a guidance issued by the Clinton Administration in 1999, the receipt of non-cash benefits, except to support institutional or long-term care, does not render one a “public charge.” As a result, non-citizens who are eligible for Medicaid or other public benefits (it is worth noting that federal law already restricts many non-citizens from receiving most federal benefits) have had no cause to worry that the receipt of such benefits would undermine their chances of obtaining permanent resident status.

Since President Trump’s inauguration, his Administration has sought to override the 1999 guidance. In January 2017,  a draft executive order that would have required DHS to revise the definition of public charge was leaked and widely circulated. That draft was never signed, but in January 2018, the State Department revised the manual used by consular offices for issuing visas to include in the definition of public charge the use of non-cash health benefits, including Medicaid and the Children’s Health Insurance Program (CHIP). That change alone has led to a significant decline in the number of visas issued. 

Then in October 2018, DHS published proposed public charge regulations. Under the sweeping proposal, the definition of public charge was expanded to include receipt of certain non-cash federally-funded benefits, including Medicaid, the Supplemental Nutrition Assistance Program (food stamps), Medicare Part D subsidies, and federal housing subsidies. The complex regulations would also have required DHS to consider past use of such benefits, as well as cash assistance, and an immigrants’ health and health insurance status, in determining whether an immigrant was likely to become a public charge by using such benefits in the future.

Over 260,000 individuals and institutions filed comments responding to the proposed rule. The vast majority opposed it. Many warned that the rule would lead millions of immigrants to drop their own health care coverage, as well as coverage for their children. Commenters also cited numerous studies predicting that the proposal would lead to more uncompensated care, increased financial hardship for safety-net providers, and a decline in public health.

[Read more]
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This post was originally published on the Health Affairs Blog on August 13, 2019. We have posted an excerpt. Visit the Health Affairs blog to read the full post.

Medicare-for-All wouldn’t be Medicare if it eliminated private insurance

By Robert I. Field

 
 Should Medicare-for-All replace private insurance?

 The question is central to health reform debates among Democratic presidential candidates, but it presents a fundamental contradiction. If Medicare-for-All were to eliminate private coverage, it wouldn’t truly be Medicare as we know it, which has made room for private insurers from the start.

 Medicare could have been designed as a pure single payer with comprehensive coverage for all health care needs, but that approach would have risked alienating several important constituencies, including the insurance industry. Before the program was enacted, private insurers enjoyed a sizable market through which they sold coverage of some sort to about half the nation’s elderly.

 Although Medicare eliminated that market, it created a profitable new one. Insurers were able to sell policies that filled important coverage gaps, such as for vision and dental care, and that reduced or eliminated sizable copayments and deductibles. Today, that coverage is known as “Medicare supplement” or “Medigap.” When the program launched, more than 80 percent of beneficiaries who had previously maintained private coverage purchased it. Medicare also gave some insurers the chance to earn additional revenue by administering claims.

 The role of private insurance companies in Medicare has continued to grow over time. They now provide coverage to almost a third of beneficiaries through an alternative to the traditional program known as Medicare Advantage, and they play the central role in providing coverage for prescription drugs. Plans offered through Medicare now account for almost a quarter of industry revenue.

 With this combination of public and private elements, Medicare has not only survived for more than half a century but become a mainstay of the entire health care system. It is also extremely popular. In a 2014 Kaiser Family Foundation poll, 77 percent viewed it as a very important government program, and 76 percent saw it as important to them personally. Its hybrid structure helps generate broad support across the political spectrum, appealing to Democrats with its government foundation and to Republicans with its element of private sector choice.

 Of course, the program faces its share of challenges, especially concerning costs. However, in this regard, it is largely a victim of its own success. Americans are living longer and therefore enjoying more years of Medicare eligibility in large part because the program has given them access to ever more sophisticated care. It also provides essential funding for the introduction of new forms of care, which are increasingly expensive, and for the training of new physicians who provide it. It would not be an overstatement to say that without Medicare, much of health care as we know it in the United States would not exist.

 As Medicare-for-All proponents are quick to note, Medicare’s private component remains controversial. Private insurers generate higher overhead costs than the program’s traditional, government-run coverage and are accused of trying to avoid sicker potential customers. Moreover, cost increases for private insurance tend to outpace those for Medicare. However, regulatory oversight of Medicare’s private component has helped to mitigate some of those concerns, and stronger oversight could fill remaining regulatory gaps without eliminating it.

 The premise behind Medicare-for-All should be simple. Take a successful program with a limited range of beneficiaries and extend it to everyone. Perhaps a pure single payer plan could improve on Medicare’s decades-long success, but it would be misleading to call such a plan “Medicare.” It would be something quite different. To bring Medicare-for-All to fruition, there is no need to mess with success.

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 Robert I. Field is professor of law and public health at Drexel University and author of the book “Mother of Invention: How the Government Created ‘Free-Market’ Health Care.” He is also founder, editor and lead writer of the Health Cents blog on the Inquirer.com.

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 This blog post first appeared as an op-ed in the Philadelphia Inquirer.

Trump returns Obamacare to the crosshairs and we are all in peril

By Robert I. Field, Ph.D., J.D., M.P.H.  

The Trump administration has returned with renewed vigor to its war against the Affordable Care Act. If the attack succeeds, the damage would touch almost all of us.

The latest line of attack is to side with the plaintiffs in a lawsuit challenging the law, who are urging an appeals court to strike down the entire ACA as unconstitutional. Originally, the administration had argued that only the protections for individuals with preexisting medical conditions should be tossed out.

This latest step is highly unusual. It ignores the time-honored bipartisan practice of presidential administrations to defend federal laws against legal challenges, even laws with which they disagree. It is rarer still for an administration to actively side with a challenge. And it is extraordinary for one to harden its position while a challenge is proceeding.

If the administration’s new stance prevails, almost everyone would feel the catastrophic effects. Its original position was destructive enough in pulling health insurance from millions of people who are sick. Its new position would wreak havoc throughout most of American health care.

Among the biggest losers would be millions of adult children kicked off their parents’ coverage, hundreds of hospital partnerships known as accountable care organizations forced to close, millions of seniors again facing the infamous doughnut hole in Medicare prescription coverage, and thousands of patients unable to buy cheaper generic versions of expensive specialty drugs. And, of course, millions of poor and disabled patients who would lose access to health care in states that expanded Medicaid.

All of this comes after the ACA has achieved remarkable success in reducing the number of uninsured, its popularity is at near record levels, and it has strengthened much of the health care industry.

The administration’s action doesn’t even have a coherent legal rationale. Its new argument defies both law and logic.

The argument goes that because the Supreme Court upheld the law’s mandate to obtain insurance as a tax, repeal of the tax by Congress in 2017 eliminated its constitutional basis. And because the mandate is central to the law’s overall scheme, it cannot be severed from the other provisions and everything must go.

This argument makes little sense. The Supreme Court ruled that as a tax, individuals are in full compliance whether they choose to pay the tax or to obtain coverage. With the amount of the tax now set at zero, everyone has automatically complied. In other words, the mandate as a compulsion to obtain coverage has disappeared. How can it be unconstitutional if it no longer exists?

Even if the now nonexistent mandate were found to be unconstitutional, Congress has expressed a clear desire to retain the rest of the law without it. Just a few months before voting to eliminate the tax, it rejected proposals to repeal the law in its entirety. If it had wanted all of the law to fall, it would have voted in favor of full repeal, not against it. In fact, the ACA’s insurance exchanges are continuing to function quite well without the mandate, providing coverage to millions of people.

Even if the mandate were found to be essential to the insurance coverage provisions, it is clearly not central to many of the law’s other elements that have nothing to do with insurance. How, for example, is it central to requiring calorie counts on restaurant menus?

Might anyone benefit from the new assault on the ACA? It’s hard to image who they would be.

Certainly not the millions of patients who would lose access to health coverage and pay higher prices for drugs. And certainly not the hospitals whose partnerships to improve the quality and efficiency of care would dissolve, the insurance companies that would see markets for individual policies disappear, or the drug companies whose generic specialty drugs could no longer be sold.

And probably not Trump’s fellow Republicans, who could face voters next year as the anti-health care party.

Trump can’t seem to keep the ACA out of his crosshairs, and his scorched earth policy could burn everyone. He might not care, but millions of Americans should.

This blog post first appeared in the Health Cents blog on Philly.com

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About the author: Robert I. Field is a member of the Inquirer’s Health Advisory Panel, and nationally known expert in health care regulation and its role in implementing public policy. He holds a joint appointment as professor of law at the School of Law and professor of health management and policy at the School of Public Health at Drexel University.

Gottlieb's threat of federal vaccine mandates: questionable legality, poor policy

By Wendy E. Parmet

As six outbreaks of measles raged in different parts of the country, Food and Drug Administration Commissioner Scott Gottlieb recently told reporters that the failure of some states to narrow vaccine exemptions was “going to force the hand of the federal health agencies.” Without offering many details, Gottlieb added that the federal government “could mandate certain rules about what is and isn’t permissible when it comes to allowing people to have exemptions.”

As someone who has researched and written about public health law, including vaccine mandates, for more than 30 years, I appreciate the sentiments behind Gottlieb’s comments. Vaccines have saved innumerable lives, and have led to the eradication or near eradication of once common scourges, such as smallpox and polio. Vaccine mandates have helped ensure that success by keeping vaccination rates high.

Religious and personal belief exemptions to vaccine laws have done the opposite. They are associated with decreased vaccination rates and increases in vaccine-preventable diseases.

With the number of measles cases rising, especially among unvaccinated children, it makes sense for states to narrow their exemptions, as a bill before the Washington state legislature would do, and as California did in 2015 following a measles outbreak linked to Disneyland. But that doesn’t mean federal health agencies should act as Gottlieb suggests. Doing so would likely violate the law. It could also worsen the problem of vaccination resistance.

First, the law. There is no question that states can require all children (except perhaps those with medical contraindications) to be vaccinated before entering school or day care. In 1905, in Jacobson v. Massachusetts, the U.S. Supreme Court upheld a Massachusetts law that compelled all individuals to be vaccinated against smallpox. In Zucht v. King, the court in 1922 relied on Jacobson to affirm a Texas law mandating vaccination for schoolchildren. Neither the Jacobson nor Zucht cases dealt with claims of religious liberty, since the court had not yet applied the First Amendment right of free exercise against the states, but in a 1944 in a case concerning child labor, the court proclaimed that religious freedom “does not include liberty to expose the community or the child to communicable disease.”

Courts today continue to uphold vaccine mandates, and rule that neither the religious exemptions that 47 states have nor the philosophical exemptions that exist in 17 states are constitutionally required. Paradoxically, state mandates have run afoul of the Constitution only when they contain religious, but not secular, exemptions, or when the religious exemptions favor one faith over another.

That the states are on firm constitutional ground in repealing personal belief or religious exemptions doesn’t mean the federal government can abolish such exemptions. In its 2012 ruling on the Affordable Care Act’s individual mandate, the U.S. Supreme Court said that the federal government’s authority over interstate commerce does not permit it to compel individual action. If Congress can’t require individuals to have health insurance, or eat broccoli, it can’t mandate vaccination either.

Perhaps Gottlieb was suggesting that the federal government could require the states to abolish religious or personal belief exemptions. That would also face significant constitutional problems. Under the 10th Amendment’s anti-commandeering doctrine, the federal government cannot force states to pass laws to its pleasing.

Congress could use its power of the purse to buy state compliance, perhaps by requiring states to get rid of philosophical and religious exemptions in order to receive federal public health funds. But any such conditional spending laws must give states a clear choice and can’t be coercive.

In addition, federal health agencies can’t act without congressional authority. Under current law, the FDA licenses vaccines. But it cannot regulate the practice of medicine, and it has no authority to mandate that individuals be vaccinated. Nor does the FDA have statutory authority to require states to enact specific vaccine laws. The CDC’s Advisory Committee on Immunization Practices (ACIP) is charged with making recommendations about vaccinations, but these are meant to advise, not dictate, state laws.

Nor should Congress give such authority to any federal health agency. Although mandates can save lives, they can also stoke backlashes. Conspiracy theorists already allege a nefarious relationship between vaccine makers and the federal government. These conspiracies have gained traction in part due to the fact that under the National Childhood Vaccine Injury Act, the federal government acts as the defendant in vaccine litigation. Federal mandates could enhance the perception of a conflict of interest, leading more parents to distrust federal officials and question vaccine safety.

The litigation that would almost certainly follow a federal mandate would add to the problem, providing anti-vaxxers with a new forum in which to question vaccine safety as well as the integrity of the federal regulatory process.

As we have seen in California and Washington, infectious disease outbreaks can lead parents and health professionals to work with their state legislatures to narrow or abolish vaccine exemptions. This democratic process, which can occur more organically in the states, helps debunk anti-vaccination misinformation and educates the public about the value and safety of vaccines, as well as the utility of strong state mandates. This process can also provide mandates with the political support and democratic legitimacy they need to succeed.

With measles cases on the rise, it’s no surprise that health officials want to shortcut the often slow and frequently unpredictable democratic process and instead take swift action to reduce exemptions — and increase vaccination rates. Unfortunately, there is no vaccine against vaccine resistance, and constitutionally dubious actions by federal officials can’t do the trick. But by working to improve public education around vaccines, enhancing transparency, educating and paying health professionals to talk to parents about vaccines, and ensuring vaccine safety, federal officials can help bolster trust in vaccines. Those efforts, more than anything, may lead to fewer exemptions.

This article was originally posted on STAT News

Wendy E. Parmet, J.D., is professor of law and director of the Center for Health Policy and Law at Northeastern University School of Law and professor of public policy and urban affairs at Northeastern’s School of Public Policy and Urban Affairs.