Healthcare

The Double-Helix Dilemma: Navigating Privacy Pitfalls in Direct-to-Consumer Genetic Testing

November 7, 2023
Bioethics, Data Privacy, FDA, Health, Healthcare, Privacy, Regulatory

Ethan Wold, MJLST Staffer

Introduction

On October 22, direct-to-consumer genetic testing (DTC-GT) company 23andME sent emails to a number of its customers informing them of a data breach into the company’s “DNA Relatives” feature that allows customers to compare ancestry information with other users worldwide.[1] While 23andMe and other similar DTC-GT companies offer a number of positive benefits to consumers, such as testing for health predispositions and carrier statuses of certain genes, this latest data breach is a reminder that before choosing to opt into these sorts of services one should be aware of the potential risks that they present.

Background

DTC-GT companies such as 23andMe and Ancestry.com have proliferated and blossomed in recent years. It is estimated over 100 million people have utilized some form of direct-to-consumer genetic testing.[2] Using biospecimens submitted by consumers, these companies sequence and analyze an individual’s genetic information to provide a range of services pertaining to one’s health and ancestry.[3] The October 22 data breach specifically pertained to 23andMe’s “DNA Relatives” feature.[4] The DNA Relatives feature can identify relatives on any branch of one’s family tree by taking advantage of the autosomal chromosomes, the 22 chromosomes that are passed down from your ancestors on both sides of your family, and one’s X chromosome(s).[5] Relatives are identified by comparing the customer’s submitted DNA with the DNA of other 23andMe members who are participating in the DNA Relatives feature.[6] When two people are found to have an identical DNA segment, it is likely they share a recent common ancestor.[7] The DNA Relatives feature even uses the length and number of these identical segments to attempt to predict the relationship between genetic relatives.[8] Given the sensitive nature of sharing genetic information, there are often privacy concerns regarding practices such as the DNA Relatives feature. Yet despite this, the legislation and regulations surrounding DTC-GT is somewhat limited.

Legislation

The Health Insurance Portability and Accountability Act (HIPAA) provides the baseline privacy and data security rules for the healthcare industry.[9] HIPAA’s Privacy Rule regulates the use and disclosure of a person’s “protected health information” by a “covered entity.[10] Under the Act, the type of genetic information collected by 23andMe and other DTC-GT companies does constitute “protected health information.”[11] However, because HIPAA defines a “covered entity” as a health plan, healthcare clearinghouse, or health-care provider, DTC-GT companies do not constitute covered entities and therefore are not under the umbrella of HIPAA’s Privacy Rule.[12]

Thus, the primary source of regulation for DTC-GT companies appears to be the Genetic Information Nondiscrimination Act (GINA). GINA was enacted in 2008 for the purpose of protecting the public from genetic discrimination and alleviating concerns about such discrimination and thereby encouraging individuals to take advantage of genetic testing, technologies, research, and new therapies.[13] GINA defines genetic information as information from genetic tests of an individual or family members and includes information from genetic services or genetic research.[14] Therefore, DTC-GT companies fall under GINA’s jurisdiction. However, GINA only applies to the employment and health insurance industries and thus neglects many other potential arenas where privacy concerns may present.[15] This is especially relevant for 23andMe customers, as signing up for the service serves as consent for the company to use and share your genetic information with their associated third-party providers.[16] As a case in point, in 2018 the pharmaceutical giant GlaxoSmithKline purchased a $300 million stake in 23andMe for the purpose of gaining access to the company’s trove of genetic information for use in their drug development trials.[17]

Executive Regulation

In addition to the legislation above, three different federal administrative agencies primarily regulate the DTC-GT industry: the Food and Drug Administration (FDA), the Centers of Medicare and Medicaid services (CMS), and the Federal Trade Commission (FTC). The FDA has jurisdiction over DTC-GT companies due to the genetic tests they use being labeled as “medical devices”[18] and in 2013 exercised this authority over 23andMe by sending a letter to the company resulting in the suspending of one of its health-related genetic tests.[19] However, the FDA only has jurisdiction over diagnostic tests and therefore does not regulate any of the DTC-GT services related to genealogy such as 23andMe’s DNA Relatives feature.[20] Moreover, the FDA does not have jurisdiction to regulate the other aspects of DTC-GT companies’ activities or data practices.[21] CMS has the ability to regulate DTC-GT companies through enforcement of the Clinical Laboratory Improvements Act (CLIA), which requires that genetic testing laboratories ensure the accuracy, precision, and analytical validity of their tests.[22] But, like the FDA, CMS only has jurisdiction over tests that diagnose a disease or assess health.[23]

Lastly, the FTC has broad authority to regulate unfair or deceptive business practices under the Federal Trade Commission Act (FTCA) and has levied this authority against DTC-GT companies in the past. For example, in 2014 the agency brought an action against two DTC-GT companies who were using genetic tests to match consumers to their nutritional supplements and skincare products.[24] The FTC alleged that the companies’ practices related to data security were unfair and deceptive because they failed to implement reasonable policies and procedures to protect consumers’ personal information and created unnecessary risks to the personal information of nearly 30,000 consumers.[25] This resulted in the companies entering into an agreement with the FTC whereby they agreed to establish and maintain comprehensive data security programs and submit to yearly security audits by independent auditors.[26]

Potential Harms

As the above passages illustrate, the federal government appears to recognize and has at least attempted to mitigate privacy concerns associated with DTC-GT. Additionally, a number of states have passed their own laws that limit DTC-GT in certain aspects.[27] Nevertheless, given the potential magnitude and severity of harm associated with DTC-GT it makes one question if it is enough. Data breaches involving health-related data are growing in frequency and now account for 40% of all reported data breaches.[28] These data breaches result in unauthorized access to DTC-GT consumer-submitted data and can result in a violation of an individual’s genetic privacy. Though GINA aims to prevent it, genetic discrimination in the form of increasing health insurance premiums or denial of coverage by insurance companies due to genetic predispositions remains one of the leading concerns associated with these violations. What’s more, by obtaining genetic information from DTC-GT databases, it is possible for someone to recover a consumer’s surname and combine that with other metadata such as age and state to identify the specific consumer.[29] This may in turn lead to identity theft in the form of opening accounts, taking out loans, or making purchases in your name, potentially damaging your financial well-being and credit score. Dealing with the aftermath of a genetic data breach can also be expensive. You may incur legal fees, credit monitoring costs, or other financial burdens in an attempt to mitigate the damage.

Conclusion

As it sits now, genetic information submitted to DTC-GT companies already contains a significant volume of consequential information. As technology continues to develop and research presses forward, the volume and utility of this information will only grow over time. Thus, it is crucially important to be aware of risks associated with DTC-GT services.

This discussion is not intended to discourage individuals from participating in DTC-GT. These companies and the services they offer provide a host of benefits, such as allowing consumers to access genetic testing without the healthcare system acting as a gatekeeper, thus providing more autonomy and often at a lower price.[30] Furthermore, the information provided can empower consumers to mitigate the risks of certain diseases, allow for more informed family planning, or gain a better understanding of their heritage.[31] DTC-GT has revolutionized the way individuals access and understand their genetic information. However, this accessibility and convenience comes with a host of advantages and disadvantages that must be carefully considered.

Notes

[1] https://www.reuters.com/world/us/23andme-notifies-customers-data-breach-into-its-dna-relatives-feature-2023-10-24/#:~:text=%22There%20was%20unauthorized%20access%20to,exposed%20to%20the%20threat%20actor.%22

[2] https://www.ama-assn.org/delivering-care/patient-support-advocacy/protect-sensitive-individual-data-risk-dtc-genetic-tests#:~:text=Use%20of%20direct%2Dto%2Dconsumer,November%202021%20AMA%20Special%20Meeting

[3] https://go-gale-com.ezp3.lib.umn.edu/ps/i.do?p=OVIC&u=umn_wilson&id=GALE%7CA609260695&v=2.1&it=r&sid=primo&aty=ip

[4] https://www.reuters.com/world/us/23andme-notifies-customers-data-breach-into-its-dna-relatives-feature-2023-10-24/#:~:text=%22There%20was%20unauthorized%20access%20to,exposed%20to%20the%20threat%20actor.%22

[5] https://customercare.23andme.com/hc/en-us/articles/115004659068-DNA-Relatives-The-Genetic-Relative-Basics

[6] Id.

[7] Id.

[8] Id.

[9] https://go-gale-com.ezp2.lib.umn.edu/ps/i.do?p=OVIC&u=umn_wilson&id=GALE%7CA609260695&v=2.1&it=r&sid=primo&aty=ip

[10] https://www.hhs.gov/sites/default/files/ocr/privacy/hipaa/administrative/combined/hipaa-simplification-201303.pdf

[11] Id.

[12] Id; https://go-gale-com.ezp2.lib.umn.edu/ps/i.do?p=OVIC&u=umn_wilson&id=GALE%7CA609260695&v=2.1&it=r&sid=primo&aty=ip

[13] https://www.eeoc.gov/statutes/genetic-information-nondiscrimination-act-2008

[14] Id.

[15] https://europepmc.org/backend/ptpmcrender.fcgi?accid=PMC3035561&blobtype=pdf

[16] https://go-gale-com.ezp2.lib.umn.edu/ps/i.do?p=OVIC&u=umn_wilson&id=GALE%7CA609260695&v=2.1&it=r&sid=primo&aty=ip

[17] https://news.yahoo.com/news/major-drug-company-now-access-194758309.html

[18] https://uscode.house.gov/view.xhtml?req=(title:21%20section:321%20edition:prelim)

[19] https://core.ac.uk/download/pdf/33135586.pdf

[20] https://go-gale-com.ezp2.lib.umn.edu/ps/i.do?p=OVIC&u=umn_wilson&id=GALE%7CA609260695&v=2.1&it=r&sid=primo&aty=ip

[21] Id.

[22] https://www.law.cornell.edu/cfr/text/42/493.1253

[23] https://go-gale-com.ezp2.lib.umn.edu/ps/i.do?p=OVIC&u=umn_wilson&id=GALE%7CA609260695&v=2.1&it=r&sid=primo&aty=ip

[24] https://www.ftc.gov/system/files/documents/cases/140512genelinkcmpt.pdf

[25] Id.

[26] Id.

[27] https://go-gale-com.ezp2.lib.umn.edu/ps/i.do?p=OVIC&u=umn_wilson&id=GALE%7CA609260695&v=2.1&it=r&sid=primo&aty=ip

[28] Id.

[29] https://go-gale-com.ezp2.lib.umn.edu/ps/i.do?p=OVIC&u=umn_wilson&id=GALE%7CA609260695&v=2.1&it=r&sid=primo&aty=ip

[30] Id.

[31] Id.

NC Gives Medicaid Expansion a Foothold in the Southeast While Giving Many North Carolinians a Helping Hand

October 27, 2023
Health, Healthcare, Healthcare Reform, Insurance

Matt Buechner, MJLST Staffer

North Carolina is set to take a step to address structural racism in communities across the state when it begins Medicaid expansion implementation on December 1. Governor Roy Cooper championed expansion in his state and signed a bipartisan Medicaid expansion bill in March. This signaled the state’s intention to expand the government-sponsored health insurance program for low-income people to roughly 600,000 additional North Carolinians.[1] However, the bill required the legislature to pass a separate state budget law to appropriate funds and implement the plan.[2] The Republican-controlled state legislature passed a delayed two-year budget deal on September 22, which went into effect October 3 after Cooper declined to veto the bill.[3]

Implementation of Medicaid expansion should help North Carolina see the reduction of uninsurance rates that other expansion states have seen since passage of the ACA.[4] A recent study found that while Medicaid expansion helps populations across a state, the eligibility expansion disproportionately helps residents of formerly redlined[5] neighborhoods gain access to coverage.[6] Coverage is essential, as greater access to health insurance leads to medical care, including preventive care and management of chronic illness.[7]

Meanwhile, recent analyses of health disparities and access to health insurance have shown that health disparities in the United States may be less tied to race itself, but rather to structural racism levied against non-white Americans.[8] One recent study showed that states with policies that reflect and reinforce structural racism also see significantly higher rates of premature death among their populations.[9] While these findings may not be surprising, policymakers and advocates can use this evidence to target investments and interventions, while working to disentangle the tapestry of discrimination at the state level.

Accessing Medicaid for Newly Eligible North Carolinians

The Medicaid program currently covers about 2.9 million North Carolinians.[10] But like most states that have yet to expand their Medicaid program, the maximum income requirements for North Carolina Medicaid eligibility for adults is quite low.[11] Adult caregivers of children or adult family members may earn a household modified adjusted gross income (MAGI)[12] up to 37 percent of the federal poverty level (FPL) to maintain North Carolina Medicaid eligibility, while non-caregiver adults do not qualify for Medicaid at all.[13] Medicaid expansion will increase the maximum household MAGI threshold to 138 percent[14] FPL to qualify for Medicaid coverage, regardless of whether an adult cares for an additional family member.[15]

North Carolina currently provides reproductive health care benefits for residents who earn up to 195 percent FPL through their Medicaid Family Planning Program (BE SMART).[16] Nearly half of the expected 600,000 new Medicaid-eligible North Carolinians are currently enrolled in BE SMART and have a qualifying-income under the new 138 percent FPL Medicaid eligibility threshold. These people will automatically be enrolled in full Medicaid coverage.[17] Newly qualifying individuals who do not take part in the BE SMART program must apply (online, in person, by telephone, or by mail) and await determination, which is set to take up to 45 days.[18]

Making Sense of the Federal Dollars at Play

State Medicaid programs are traditionally paid for through a partnership with the federal government. While the state administers the program, the federal government provides the state matching funding, without limit.[19] Matching funds are provided based on an algorithm that measures a state’s ability to pay for the program using the state’s per capita income compared to the per capita income of the nation. This rate is called the Federal Medical Assistance Percentage (FMAP).[20] A state’s FMAP is set by statute to be at least 50 percent, but not more than 83 percent.[21] Using FMAP allows a state with a theoretically lower tax base (relative to the size of their state population) to receive additional federal funding to offset the burden of providing for its residents.

To help states with the burden of paying for an increase in their Medicaid population after expansion, Congress established an enhanced FMAP calculation for a state’s Medicaid expansion population. Beginning with the implementation of expansion in 2014, the federal government provided states with a 100 percent FMAP for the expansion population, followed by a phased down approach.[22] The current FMAP for the expansion population is 90 percent.[23]

To help encourage remaining states to expand their Medicaid program, Congress included a 5 percent FMAP bump for two years post-expansion in the American Rescue Plan—not for the expansion population, but for the traditional Medicaid population.[24] This is particularly enticing for states, because this includes all Medicaid recipients, including children, seniors, people with disabilities, and all other non-expansion groups. On average, these populations account for nearly 80 percent of all Medicaid costs in expansion states, making this benefit likely more lucrative than a 100 percent FMAP rate for expansion populations.[25]

Looking at Health Equity Beyond Expansion

While North Carolina looks to expand its Medicaid population in the coming months, states across the country are purging Medicaid beneficiaries from their programs following the expiration of a federal disenrollment prohibition to qualify for a Covid-era enhanced FMAP.[26] Recent reports estimate that nearly 9 million people across the country have been disenrolled from Medicaid so far, including more than 120,000 North Carolinians–more than 20 percent of North Carolina’s current Medicaid population.[27]

While North Carolina has one of the lowest rates of churn among states across the nation, 87 percent of disenrolled North Carolinians lost coverage for procedural concerns–not eligibility concerns.[28] This means that North Carolina Medicaid beneficiaries are losing their health insurance coverage largely because they did not fill out a form properly or the state had an incorrect address on file.

Few states publicly report the racial and ethnic demographics of their Medicaid disenrollees. For those that do, most seem to be disenrolling Medicaid recipients at even rates based on race and ethnicity.[29] As disenrollment continues and North Carolina moves into expansion of their Medicaid program, policymakers, advocates, and observers will keep a keen eye on the state as it navigates its population’s fluctuating access to Medicaid. This expansion is but one step to ensure that people have equitable access to essential coverage and care.

Notes

[1] Gary D. Robertson, Medicaid Expansion to Begin Soon in North Carolina as Governor Decides to Let Budget Bill Become Law, Associated Press, Sept. 22, 2023, https://apnews.com/article/north-carolina-medicaid-expansion-governor-legislature-330ea1adef37a323b31a9cfe0d470a58.

[2] Id.

[3] In some states, inaction by a governor can lead to a pocket veto, however in others, inaction by a governor leads to passage of the bill. In North Carolina, a bill can become a law following inaction by a governor for ten days. Aimee Wall, The Governor’s Role in the Legislative Process, Coates’ Canons NC Gov’t Law (Jan. 11, 2017), https://canons.sog.unc.edu/2017/01/governors-role-legislative-process/.; Governor Roy Cooper, a Democrat, allowed the two-year budget bill to become law without action. See House Bill 259 / SL 2023-134, N.C. General Assembly, https://www.ncleg.gov/BillLookup/2023/H259 (last visited Oct. 15, 2023).

[4] The Far-Reaching Benefits of the Affordable Care Act’s Medicaid Expansion, Ctr. on Budget and Pol’y Priorities, https://www.cbpp.org/research/health/chart-book-the-far-reaching-benefits-of-the-affordable-care-acts-medicaid-expansion (last visited Oct. 15, 2023).

[5] Redlining occurred, beginning in the 1930s, when the federal government’s Home Owners’ Loan Corporation (HOLC) began the process of rating the investment desirability of various neighborhoods. The rating system used neighborhood racial demography to determine the grades, with the lowest grade reserved for neighborhoods that were “infiltrated with undesirable populations such as Jewish, Asian, Mexican, and Black families.” In turn, banks often refused to grant credit to prospective homeowners looking to purchase homes in those communities, or extended credit with excessive interest rates. Redlining was outlawed by the Fair Housing Act in 1968, but the impact on communities is still seen today. See Jason Semprini et al., Medicaid Expansion Lowered Uninsurance Rates Among Nonelderly Adults in the Most Heavily Redlined Areas, 42 Health Aff. 1439 (2023).

[6] Id.

[7] The Far-Reaching Benefits of the Affordable Care Act’s Medicaid Expansion, Ctr. on Budget and Pol’y Priorities, https://www.cbpp.org/research/health/chart-book-the-far-reaching-benefits-of-the-affordable-care-acts-medicaid-expansion (last visited Oct. 15, 2023).

[8] See Jason Semprini et al., Medicaid Expansion Lowered Uninsurance Rates Among Nonelderly Adults in the Most Heavily Redlined Areas, 42 Health Aff. 1439 (2023); Jaquelyn L. Jahn et al., Legislating Inequity: Structural Racism in Groups of State Laws and Associations with Premature Mortality Rates, 42 Health Aff. 1325 (2023).

[9] Jaquelyn L. Jahn et al., Legislating Inequity: Structural Racism in Groups of State Laws and Associations with Premature Mortality Rates, 42 Health Aff. 1325 (2023).

[10] Gary D. Robertson, N. Carolina Governor Signs Medicaid Expansion Bill into Law, Associated Press, March 27, 2023, https://apnews.com/article/north-carolina-medicaid-expansion-roy-cooper-legislature-f00242e5883bccf816a679a76584a5f9.

[11] The median maximum income limit for adults with family member caregiving responsibilities is 37 percent FPL in states that have not expanded Medicaid and childless adults remain ineligible in all of these states (except Wisconsin), regardless of income. Robin Rudowitz et al., How Many Uninsured Are in the Coverage Gap and How Many Could be Eligible if All States Adopted the Medicaid Expansion? Henry J. Kaiser Family Foundation. (Mar. 31, 2023), https://www.kff.org/medicaid/issue-brief/how-many-uninsured-are-in-the-coverage-gap-and-how-many-could-be-eligible-if-all-states-adopted-the-medicaid-expansion/.

[12] MAGI, as used to determine health care benefit eligibility, uses a different methodology than MAGI as used for tax purposes. For health benefit purposes, MAGI is adjusted gross income plus untaxed foreign income, non-taxable Social Security Benefits, and tax-exempt interest. Modified Adjusted Gross Income (MAGI), HealthCare.gov,  https://www.healthcare.gov/glossary/modified-adjusted-gross-income-magi/#:~:text=MAGI%20is%20adjusted%20gross%20income,%2C%20and%20tax%2Dexempt%20interest (last visited Oct. 15, 2023).

[13] Medicaid Income Eligibility Limits for Adults as a Percent of the Federal Poverty Level, Henry J. Kaiser Family Foundation. (Jan. 1, 2023), https://www.kff.org/health-reform/state-indicator/medicaid-income-eligibility-limits-for-adults-as-a-percent-of-the-federal-poverty-level/?currentTimeframe=0&sortModel=%7B%22colId%22:%22Location%22,%22sort%22:%22asc%22%7D.

[14] The Affordable Care Act established a 5 percent income disregard in determining eligibility for Medicaid and CHIP. The percent thresholds used in this blog post include the built-in income disregard used to establish Medicaid eligibility determinations. CMS Answers to Frequently Asked Questions: Telephonic Applications, Medicaid and CHIP Eligibility Policy and 75/25 Federal Matching Rate, Medicaid.gov. (Aug. 9, 2013),  https://www.medicaid.gov/faq/respect-magi-conversion-how-will-5-disregard-be-applied/index.html.

[15] Questions and Answers about Medicaid Expansion, NC Medicaid Div. of Health Benefits. https://medicaid.ncdhhs.gov/questions-and-answers-about-medicaid-expansion#:~:text=Quick%20Facts%20about%20North%20Carolina%27s,%2Fyear)%20may%20be%20eligible (last visited Oct. 15, 2023).

[16] Facts About the Medicaid Family Planning “BE SMART” Program, N.C. Dept. of Health and Human Svcs. Div. of Med. Assistance and Div. of Public Health. (Sept. 16, 2016), https://files.nc.gov/ncdma/BeSmart_Fact_Sheet-Beneficiaries_2016_09_15.pdf.

[17] Questions and Answers about Medicaid Expansion, NC Medicaid Div. of Health Benefits. https://medicaid.ncdhhs.gov/questions-and-answers-about-medicaid-expansion#:~:text=Quick%20Facts%20about%20North%20Carolina%27s,%2Fyear)%20may%20be%20eligible (last visited Oct. 15, 2023).

[18] Elizabeth Williams et al., Medicaid Financing: The Basics, Henry J. Kaiser Family Foundation, April 13, 2023, https://www.kff.org/medicaid/issue-brief/medicaid-financing-the-basics/.

[19] Elizabeth Williams et al., Medicaid Financing: The Basics, Henry J. Kaiser Family Foundation, April 13, 2023, https://www.kff.org/medicaid/issue-brief/medicaid-financing-the-basics/.

[20] Id.

[21] The District of Columbia and territories have statutorily set FMAPs and the territories each have a statutorily set per capita Medicaid funding cap. Elizabeth Williams et al., Medicaid Financing: The Basics, Henry J. Kaiser Family Foundation, April 13, 2023, https://www.kff.org/medicaid/issue-brief/medicaid-financing-the-basics/.

[22] Elizabeth Williams et al., Medicaid Financing: The Basics, Henry J. Kaiser Family Foundation, April 13, 2023, https://www.kff.org/medicaid/issue-brief/medicaid-financing-the-basics.

[23] Id.

[24] Katie Keith, Final Coverage Provisions in the American Rescue Plan and What Comes Next, Health Aff: Forefront (Mar. 11, 2021), https://www.healthaffairs.org/content/forefront/final-coverage-provisions-american-rescue-plan-and-comes-next.

[25] Id.

[26] Jennifer Tolbert & Meghana Ammula, 10 Things to Know About the Unwinding of the Medicaid Continuous Enrollment Provision, Henry J. Kaiser Family Foundation, June 9, 2023, https://www.kff.org/medicaid/issue-brief/10-things-to-know-about-the-unwinding-of-the-medicaid-continuous-enrollment-provision/#one.

[27] Medicaid Enrollment and Unwinding Tracker, Henry J. Kaiser Family Foundation, Oct. 11, 2023, https://www.kff.org/medicaid/issue-brief/medicaid-enrollment-and-unwinding-tracker/.

[28] Id.

[29] Sophia Moreno et al., What Do Medicaid Unwinding Data by Race and Ethnicity Show? Henry J. Kaiser Family Foundation, Sept. 28, 2023, https://www.kff.org/policy-watch/what-do-medicaid-unwinding-data-by-race-and-ethnicity-show/.

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.

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.

A Farm Bill for Hansel and Gretel

February 18, 2014
Food and Agriculture, Healthcare, Public Health

Ke M. Huang, MJLST Staff

Once upon a time, a farmer and his new wife, who had no means to support the farmer’s first wife’s children, decided to abandon the children in the woods. These children–Hansel and Gretel–found in the woods a charming little house made of sweets. A wicked witch lived in that house.

Earlier this month, President Obama signed into law the Farm Bill of 2014. According to a New York Times article, the President called the Farm Bill a “jobs bill,” and “innovation bill,” a “research bill,” and a “conservation bill.” Yet, amid the provisions of the Farm Bill that addressed topics such as crop insurance, conservation, and trade, there were also provisions that touched on the issue of healthy nutrition of families.

Senator Stabenow (D-MI), chairwoman of the Senate Agriculture Committee and the author of the Farm Bill, emphasized that part of the Bill’s purpose was to improve nutrition choices in families. Changes such as doubling SNAP benefits (formerly called food stamps) for buying healthier foods and financing new grocery stores in underserved areas reflect that purpose.

A question remains whether the Farm Bill of 2014 will be effective in achieving that purpose. Especially for nutrition among the children, the article by Termini et al. in the Volume 12, Issue 2 of the Minnesota Journal of Law, Science & Technology offers some answers. In other words, the article addresses the predicament of modern day Hansel and Gretel who are lured by sugared snacks, french fries, and company.

In Food Advertising and Childhood Obesity (2011), Termini et al. (1) provide some alarming data about nutrition-related health complications among American children, (2) discuss the relationship between the health complications and food advertising, and (3) propose several solutions to address these health complications. While Termini et al. mention advocates of consumer choice, the authors primarily propose measures for the food industry, the government, and parents. For example, akin to the SNAP benefits for buying healthier foods, Termini et al. propose tax incentives for buying healthy food.

In final analysis, even if the often-regarded villain in the story of Hansel and Gretel is the witch, at least the government was partly responsible for the predicament of the children. Had the government funded a SNAP benefit program for the children’s family, or even subsidized the family farm through a crop insurance program, the parents would not have to leave the children alone in the woods. Just some food for thought.

Is Obesity a Disease?

October 4, 2013
Healthcare, Public Health

by Katelyn DeRuyter, UMN Law Student, MJLST Note and Comment Editor

The fact that many Americans are obese is hardly news. Obesity in America has been a source of news reports, social commentaries and literature for well over a decade. In her book review of “The Omnivore’s Dilemma: A Natural History of Four Meals” by Michael Pollan, published in Issue 8.1 of the Minnesota Journal of Law, Science & Technology, Morgan Holcomb discusses how obesity rates in America were part of Pollan’s motivation to write “The Omnivore’s Dilemma.” More recently, American obesity has been described as an epidemic, and the health risks associated with obesity are gradually becoming common knowledge. Obesity is even compared, by some, to smoking and alcoholism. A recent LawSci blog post, “Is Food the New Tobacco: Science, Advertising, and the War against Obesity?” looks at Roseann Termini’s article, “Food Advertising and Childhood Obesity: A Call for Action for Proactive Solutions,” and draws parallels between the role of advertising in the rise of cigarette addiction and the current obesity epidemic.

A question that is overlooked in this dialogue is whether obesity is, in fact, a disease. Whether obesity is considered a disease has real consequences including altering social stigmas, increasing funds allocated for research and expanding treatment accessibility. The debate over whether obesity should be considered a disease is not new. However, new life has been breathed into the debate following the American Medical Association’s (AMA) official recognition of obesity as a disease. The New York Times quoted Dr. Harris, a member of the AMA’s board, as stating that “[r]ecognizing obesity as a disease will help change the way the medical community tackles this complex issue that affects approximately one in three Americans.” A recent Forbes article, “Declaring Obesity a Disease: the Good, the Bad, the Ugly,” provides a closer look at how the AMA reached its decision.

In reaching the conclusion that obesity is a disease, the AMA overruled its own council’s recommendation. The AMA’s Council on Science and Public Health (Counsel on Science) had been tasked with studying this issue over the past year. The Council on Science’s recommendation against categorizing obesity as a disease rested, in part, on the concern that body mass index (BMI) is a simplistic and inaccurate tool; BMI is the tool generally used to define obesity. The Council on Science was also concerned that recognizing obesity as a disease might increase reliance on drugs and procedures and decrease the emphasis on lifestyle changes.

From a legal perspective, this classification raises interesting questions regarding future interpretation of Congressional intent when “disease” is used without a specific definition. While only time will be able to tell the actual effects of this classification, this is certainly a “must watch” area for health law attorneys.

Reviving GRAS(E): Bringing Reform to the Drug Approval Process

April 3, 2013
Food and Agriculture, Healthcare, Healthcare Reform, Pharmaceuticals, Public Health

by Maya Suresh, UMN Law Student, MJLST Staff

Thumbnail-Maya-Suresh.jpgBringing new drugs to the market has turned into a time consuming and costly process. Resulting in a process that takes roughly 12 years and 1.2 billion dollars to develop a single new drug and move it through the approval process, the current laws administered by the FDA have the potential to stifle potential economic growth. Current laws and FDA regulations require new drugs to go through three phases of clinical trials focusing on safety, optimal dosage, and effectiveness. It is in the prolonged third phase (where effectiveness is tested through extensive clinical trials) that many manufacturers decide to pull the drug from the program as the clinical trials threaten the firm’s financial viability. Ultimately, it is consumers that are hurt by the process, as they are unable to benefit from the drugs.

The negative effect on consumers is what Emily Puchalski hopes to eliminate with the recommendation detailed in her note published in Issue 14.1 of the Minnesota Journal of Law, Science & Technology. In “Bringing Dormant GRAS(E) to Bloom: Reviving The GRASE Concept for Drugs,” Puchalski suggests that a revival of the Food and Drug Administration’s (FDA) “generally recognized as safe and effective” laws and regulations, commonly reffered to as “GRASE”, could minimize the negative effects on consumers. Many drugs, once discovered, have formulations found in earlier drugs that have already been established as safe for consumer use. The GRASE law is grounded in this understanding, and provides a way for these “already established as safe” drugs to get to the market quicker without having to go through extensive clinical trials.

The problem with GRASE however, is that it is very difficult for a drug to achieve GRASE status. Due to this difficulty, GRASE has fallen out of use as manufacturers have stopped trying to achieve the status. Puchalski suggests that if the FDA were to revive GRASE, it could convince manufacturers to apply for GRASE status, allowing already established safe and effective drugs to come to market more quickly, thus benefiting consumers.

It would appear that Puchalski’s recommendation is being heard. In late February Micropharma Limited was able to obtain GRASE status for their new heart health probiotic. Ryan Jones, CEO of Micropharma Limited, echoed Puchalski when he spoke of the benefits the company has been able to reap with the highly coveted status. GRASE status will allow the company to accelerate development of the drug within both the United States and international markets. Further, it provides strong reputational benefits for the company, as it makes clear to the public that Micropharma is committed to investing a significant amount of time and energy into providing safe and effective drugs to the market.

The ability for Micropharma to obtain GRASE status could serve as evidence of a potentially reformed drug approval process. However, the full benefits realized by consumers and the market will only become clear with time.

New Medicine Into Old Bottles, Quality and the US Medical System

March 12, 2013
Healthcare, Healthcare Reform, Public Health

by Eric Nielson, UMN Law Student, MJLST Staff

Thumbnail-Eric-Nielson.jpgThis entry discusses some of the challenges identified in Grout et al.’s article Mistake-Proofing Medicine: Legal Considerations and Healthcare Quality Implications from Volume 14.1 of the Minnesota Journal of Law, Science, and Technology. If you don’t have any health problems, have family with health problems, or pay taxes then the problem probably doesn’t impact you. The rest of this paragraph is about me establishing my credentials on the subject, if you don’t care, feel free to skip ahead. I have worked as an R&D engineer developing medical devices for more than 15 years. I have a Masters in Medical Engineering from the University of Washington. I am an inventor on several medical device patents. I have worked for a very large company and for several startups. I have conducted market research, physician training, product design, FDA filing preparation, process development, product development, and implementation, etc. I have worked at nearly every stage of medical device development. Devices I have worked on are in literally millions of people in the United States.

The medical delivery system in the United States is fundamentally unchanged in its approach to quality management since the sixties, with the notable exception of anesthesiology (consider how, malpractice pressure forced reform of anesthesiology in the 80s). The public sector of our economy had to make major revisions when foreign competition in the eighties meant that domestic manufacturing could not compete with other countries. American automotive manufacturers took it in the chops because they could not effectively compete with Japanese and Korean companies. Only in the last decade have the automotive manufactures achieved economic efficiencies similar to their competitors (and finally shed some of their legacy costs). Hospitals and private practices never had this wave of foreign competition and so have never had to reinvent themselves to stay in business. Hospitals are heavily subsidized both directly by the taxpayer and through the federal system. The result has been local monopolies with limited real competition, just like the big three automakers before the Japanese entered the picture.

Japan did not invent quality manufacturing. Japanese industry was known for cheap, poor quality goods well into the sixties. What changed is that Japan got serious about producing quality products as a way to compete internationally and move up the value chain. To do this they relied on the work of several notable Americans: Demming, Juran (University of Minnesota graduate), and Crosby. These three together with Taguchi constitute the key founders of the discipline of Quality Management. There are some key concepts that I want to explore in relation to medical providers.

1) “Quality is free.” It is inherently cheaper to do it right the first time than to have to fix it. It is cheaper to spend more on the process to make it so reliable that you don’t have to continue to monitor the output. Your current business is probably externalizing the costs or hiding them and thus minimizes the real cost of defects in the products you make. Time and money are spent to prevent customers from knowing what the actual quality of health care provided by hospitals.

2) Nobody understands the problem better than all of us together. To find the best solution, you need to understand the system from the point of view of everyone who interacts with it. This requires that line personal have the ability to discuss problems and solutions without fear of negative job impact. This does not exist in modern hospitals. Nurses and staff doing the work are not free to identify problems or concerns with physicians. Decisions are not made with consensus but are top down, command and control by people with very limited information. This prevents identification of effective, realistic solutions and instead encourages ineffective window dressing committees.

3) Quality improvement depends on good information and systematic effort. Bluntly Medical providers have systematically hidden outcomes information in an effort to prevent the consuming public from being aware of how bad a job they’ve done. This includes not gathering the information, not publishing information they have, and playing malpractice claims to keep quiet. Take a typical medical procedure and go find the published complication rate. Then take those numbers and talk with specialists in that field about those numbers. What you’ll find is that the published data invariably understates the prevalence of complications at top flight institutions. This is generally a result of selection bias, where only data sets with exceptional outcomes are submitted for publication (so as not to reflect poorly upon the institution). In the absence of good information, these Potemkin village studies underestimate the scope and cost of the problem and encourage administrators and staff to ignore the problem. Nobody ever says Institution X published a study with only a 3% complication rate for procedure Y, we need to get our numbers to that level. They instead say, I wonder what their real rate is or I wonder how they selected their patients for that study.

4) Management needs to lead or it will not happen. This is a system problem. This is not a problem of people not doing their jobs. It is not about people not trying to do their best. The highly complex medical delivery system does not hold anyone responsible for the error rate. It doesn’t not impact salaries, reputation, or stock price the way it does at private companies. Look at the response from hospitals that are killing people every day compared with Toyota’s response to the “sudden acceleration” fiasco. Is the executive team involved? Are resources focused on the problem? Etc. FDA holds management personally, legally responsible for failures of the quality systems at medical device companies. The same standard hasn’t been applied to medical delivery systems. Maybe it’s time to apply this principle outside of Anesthesiology.

Improving Healthcare Quality: Electronic Prescribing

February 26, 2013
Healthcare, Healthcare Reform, Pharmaceuticals

by Johanna Smith, UMN Law Student, MJLSTStaff

Thumbnail-Johanna-Smith.jpgA new study published online on February 20, 2013 in the Journal of the American Medical Informatics Association found that when hospitals used electronic prescribing, it prevented 17 million drug errors–and if implemented more widely and consistently, it could prevent more than 50 million drug errors. But as of 2008, only about one in three acute care hospitals used electronic prescribing. Although there are various methods suggested to improve healthcare quality, one of the simplest is to make medical errors public. If hospitals, and the general public, were more aware of the safety benefits of electronic prescribing, this could lead to increased use and standardization. Another option to increase the use of electronic prescribing is to connect funding or reimbursement to the use of electronic prescribing.

An article in the January 23, 2013 Journal of the American Medical Association reported that once Medicare and Medicaid stopped reimbursing costs due to certain medical errors, the number of times a foreign item was left in a surgical patient dropped by half. The authors note that this number may not be truly accurate, since the hospitals would have financial incentives to hide the errors. Currently, reporting relies mainly on self-reporting by the hospitals, which is not always accurate. A new article in the Minnesota Journal of Law, Science, and Technology (MJLST) by John R. Grout, John W. Hill, and Arlen W. Langvart entitled “Mistake-Proofing Medicine: Legal Considerations and Healthcare Quality Implications,” discusses how to mistake-proof medicine and looks at healthcare quality on a broader level, including electronic prescribing. The MJLST article highlights that many hospital administrators are concerned more with the finances of the hospital than with patient safety. Connecting these two items increases the probability that patient safety will become a priority for hospitals. Although electronic prescribing is not a complete fix for incorrect prescriptions, it is an important part of improving the process. Compared to the cost of medical errors–including incorrect prescriptions–mistake-proofing is generally less expensive.

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