Healthcare Reform

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

December 10, 2021
Healthcare, Healthcare Reform, Pharmaceuticals

Sara Pistilli, MJLST Staffer

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

What is a PBM?

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

How do PBMs make millions in profits each year?

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

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

How does PBM spread pricing increase healthcare costs for patients?

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

What does the Build Back Better Act do to help?

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

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

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

By Mason Medeiros, MJLST Staffer

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

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

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

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

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

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

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

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

Perpetuating Inequality and Illness Through Environmental Injustice

April 30, 2017
Environment, EPA, Healthcare, Healthcare Reform

Nick Redmond, MJLST Staffer

In Sidney D. Watson’s Lessons from Ferguson and Beyond, published in issue 1 of MJLST’s 18th volume, the author focuses on issues of inherent racial bias in access to health care for African Americans, and how the Affordable Care Act may be able to help. The author “explores the structural, institutional, and interpersonal biases that operate in the health care system and that exacerbate Black/white health disparities.” The article’s focus on health care in particular is a critical component of inequality in the U.S., but it also only briefly touches on another important piece of the disparity puzzle: environmental justice. Conversations about environmental justice have taken place in multiple contexts, and in many ways serve to emphasize the multiple facets of racial disparity in the U.S., including police violence, access to health care, access to education, and other issues which are all influenced by the accessibility and the dangers of our built environment.

Such systemic inequalities can include access to public transportation and competitive employment, but they can also be problems of proximity to coal plants or petroleum refineries or even a lack of proximity to public natural spaces for healthy recreation. Lack of access to safe, clean, and enjoyable public parks, for instance, can serve to exacerbate the prevalence of diabetes and obesity, and even take a toll on the mental health of residents trapped in concrete jungles (which the article refers to as “social determinants” of poor health). Though there is some indication that environmental factors can harm neighborhoods regardless of income, industrial zones and polluted environments tend to lie just around the corner from low-income neighborhoods and disproportionately affect those who live there, primarily communities of color.

Often the result of urban development plans, housing prices, and even exclusionary zoning, issues of environmental justice are an insidious form of inequality that are often on the periphery of our national political conversations, if addressed at all. Indeed, the U.S. Environmental Protection Agency’s Office of Civil rights (established in 1993) has not once made a formal finding of discrimination, despite President Bill Clinton’s executive order which made it the duty of federal agencies to consider environmental justice in their actions. When the primary federal agency tasked with ensuring access to environmental justice appears to be asleep at the wheel, what recourse do communities have? The answer, it seems, is depressingly little.

A high profile example in our current discourse, environmental justice appears to have failed Flint, Michigan, and it seems likely that the issue won’t be resolved any time soon. Other examples like Columbus, Mississippi and Anniston, Alabama, are becoming more and more prevalent at a disturbingly high rate. Impoverished people with little political or legal recourse struggle against the might of the booming natural gas industry and new advances in hydraulic fracturing, and as water runs out these communities will be the first to feel the squeeze of rising food prices and access to the most essential resource on the planet.

At risk of sounding apocalyptic, there is some hope. National groups like the NRDC or the ACLU have long litigated these issues with success, and more local or regional groups like the Minnesota Center for Environmental Advocacy or the Southern Environmental Law Center have made enormous impacts for communities of color and the public at large. But as Sidney Watson states at the end of her article: “[w]e need to talk about race, health, and health care. We need to take action to reduce and eliminate racial inequities in health care.” These same sentiments apply to our built environment and the communities that we have pushed to the periphery to take the brunt of the harmful effects of our dirty technologies and waste. Few people would choose to live near a coal plant; those who are forced to do so are often trapped in an endless cycle of illness, poverty, and segregation.

No Divorce Just Yet, But Clearly This Couple Has Issues: Medicaid and the Future of Federal-State Health Policy

March 28, 2017
Health, Healthcare, Healthcare Reform, Insurance

Jordan Rude, MJLST Staffer

With the recent demise of the American Health Care Act (AHCA), the Affordable Care Act (ACA) will remain in effect, at least for now. One of the crucial issues that divided the Republican caucus was Medicaid—specifically, whether the ACA’s expansion of Medicaid should remain in place or be rolled back (or eliminated entirely). Moderate or centrist Republicans, and particularly some Republican governors, wanted to retain the expansion, while the House Freedom Caucus and other conservatives wanted to eliminate it, either immediately or in the near future.

Sara Rosenbaum, in her article Can This Marriage Be Saved? Federalism and the Future of U.S. Health Policy Under the Affordable Care Act examined the changing relationship between federal and state health policy under the ACA. Two areas in which this relationship was most affected were the ACA’s health insurance marketplaces and expansion of Medicaid: In both, the ACA significantly increased the federal government’s role at the expense of state control. The Supreme Court’s ruling in National Federation of Independent Business v. Sebelius held that the federal government could not require states to expand their Medicaid coverage, pushing back against increased federal power in this area. As of today, approximately 20 states have taken advantage of this ruling and chosen not to expand their programs. Rosenbaum argued that the tension between the ACA’s promise of universal coverage and some states’ refusal to expand Medicaid would defeat the purpose of the ACA, and she proposed a federal “Medicaid fallback” to replace lost coverage in those states.

The AHCA proposed a different, and simpler, solution to this problem—phase out the Medicaid expansion over time until it is completely gone. As noted above, this did not have much of a positive reception. Now that the AHCA’s proposal has been shelved, if only momentarily, some states that had not previously expanded Medicaid (such as Kansas) are moving forward with plans to expand it now. Such plans still face stiff opposition from conservatives, but the failure of the AHCA, along with the ACA’s growing popularity, may shift the argument in favor of expansion.

The end result of this recent healthcare debate, however, was retention of the status quo: The ACA is still in effect, and a significant number of states have still not expanded Medicaid coverage. The underlying issue that Rosenbaum discussed in her article has still not been addressed. The clash between federal and state policy continues: The marriage is not over, but it is not clear whether it can be saved.

The Affordable Care Act, Meant to Increase Medical Care Accessibility, May in Practicality Hurt that Accessibility Through Narrow Networks

January 28, 2016
Competition, Healthcare, Healthcare Reform

Natalie Gao, MJLST Staffer

The Patient Protection and Affordable Care Act (PPACA) continues to perpetuate some of the issues of medical inaccessibility it was meant to fix. The PPACA uses insurers’ desire to dodge risk to make health insurance more widely available, preventing insurers from refusing coverage based on preexisting conditions and requires they guarantee renewalability without too extensive a waiting period. Although PPACA disincentive insurance companies to risk-select, insurance companies found new ways to compete.

Narrow Networks, the Very Sick, and the Patient Protection and Affordable Care Act: Recalling the Purpose of Health Insurance and Reform by Valarie Blake discusses the creation of narrow networks by insurance companies as new ways to compete, where insurance companies agree to better rates with a narrow group of providers. This allows them to give better prices and premiums to its customers, even if the potential consequences is that the customers actually end up with more restrictive coverage. PPACA theoretically regulates networks, guaranteeing network adequacy of by a minimum standard of care and that the network be with essential community providers. But PPACA does not require network adequacy of providers. Practically, narrow networks can affect the availability of specialize services that some patients need, and the quality and experience of those providers. Even if the need to compete for patients might also ensure that narrow networks never compromise the necessary care, tertiary and specialty care, and the quality of care and connection due the provider, can easily be limited.

“Network adequacy,” states Blake, “is not a debate about access of health insurance but rather access of healthcare.” One way to measure whether or not our health care system is doing what it is supposed to is to measure the health of the very sick, and it brings up the question of whether or not PPACA guarantees all the right of healthcare or the right to be healthy. And what does count as sufficient access and who should be responsible for paying the healthcare costs associated with that sufficient access? These questions evoke analysis for consumer choice and consumer rights. The article recommends that network adequacy standard in both State and Federal law include tertiary and specialized care, and not extra cost be added onto out-of-network care, and the article recommends a special standard for tertiary care be adopted into law. On principle and based the cases that have occurred already around PPACA, narrow networks can easily become an issue that, if left unregulated, can create the very thing it was meant to solve.

I’m Not a Doctor, But…: E-Health Records Issues for Attorneys

March 20, 2015
Cyber Security, Healthcare, Healthcare Reform, Intellectual Property, Litigation, Privacy

Ke Huang, MJLST Lead Articles Editor

The Health Information Technology for Economic and Clinical Health Act of 2009 (HITECH Act) generally provides that, by 2015, healthcare providers must comply with the Act’s electronic health record (EHR) benchmarks, or, the government would reduce these providers’ Medicare payments by one percent.

These provisions of the HITECH Act are more than a health policy footnote. Especially for attorneys, the growing use of EHRs raises several legal issues. Indeed, in Volume 10, Issue 1 of the Minnesota Journal of Law, Science & Technology, published six years ago, Kari Bomash analyzes the consequence of EHRs in three legal-related aspects. In Privacy and Public Health in the Information Age, Bomash discusses how a Minnesota Health Records Act amendment relates to: (1) privacy, especially consent of patients, (2) data security (Bomash was almost prescient given the growing security concerns), and (3) data use regulations that affect medical doctors.

Bomash’s discussion is not exhaustive. EHRs also raise legal issues running the gamut of intellectual property, e-discovery, to malpractice. Given that software runs EHRs, IP industry is very much implicated. So much so that some proponents of EHR even support open source. (Another MJLST Article explains the concept of open source.)

E-discovery may be more straightforward. Like other legal parties maintaining electronic stored information, health entities storing EHR must comply with court laws governing discovery.

And malpractice? One doctor suggested in a recent Wall Street Journal op-ed that EHR interferes with a doctor’s quality of care. Since quality of care, or lack thereof, is correlated with malpractice actions, commentators raised the concern that EHR could raise malpractice actions. A 2010 New England Journal of Medicine study addressed this topic but could not provide a conclusive answer.

Even my personal experience with EHRs is one of the reasons that lead me to want to become an attorney. As a child growing up in an immigrant community, I often accompanied adult immigrants, to interpret in contract closings, small-business transactions, and even clinic visits. Helping in those matters sparked my interest in law. In one of the clinic visits, I noticed that an EHR print-out of my female cousin stated that she was male. I explained the error to her.

“I suppose you have to ask them to change it, then,” she said.

I did. I learned from talking to the clinic administrator the EHR software was programmed to recognize female names, and, for names that were ambiguous, as was my cousin’s, the software automatically categorized the patient as male. Even if my cousin’s visit was for an ob-gyn check-up.

America’s First Flu Season Under the ACA

October 18, 2014
Healthcare, Healthcare Reform, Public Health

Allison Kvien, MJLST Staff Member

Have you seen the “flu shots today” signs outside your local grocery stores yet? Looked at any maps tracking where in the United States flu outbreaks are occurring? Gotten a flu shot? This year’s flu season is quickly approaching, and with it may come many implications for the future of health care in this country. This year marks the first year with the Patient Protection and Affordable Care Act (ACA) in full effect, so thousands of people in the country will get their first taste of the ACA’s health care benefits in the upcoming months. The L.A. Times reported that nearly 10 million previously uninsured people now have coverage under the ACA. Though there might still be debate between opponents and proponents of the ACA, the ACA has already survived a Supreme Court challenge and is well on its way to becoming a durable feature of the American healthcare system. Will the upcoming flu season prove to be any more of a challenge?

In a recent article entitled, “Developing a Durable Right to Health Care” in Volume 14, Issue 1 of the Minnesota Journal of Law, Science, and Technology, Erin Brown examined the durability of the ACA going forward. Brown explained, “[a]mong its many provisions, the ACA’s most significant is one that creates a right to health care in this country for the uninsured.” Another provision of the ACA is an “essential benefits package,” in which Congress included “preventative and wellness services,” presumably including flu shots. For those that will be relying on the healthcare provided by the ACA in the upcoming flu season, it may also be important to understand where the ACA’s vulnerabilities lie. Brown posited that the vulnerabilities are concentrated mostly in the early years of the statute, and the federal right to health care may strengthen as the benefits take hold. How will the end of the ACA’s first year go? This is a very important question for many Americans, and Brown’s article examines several other questions that might be on the minds of millions in the upcoming months.

Halbig v. Burwell Revisited

September 17, 2014
Healthcare, Healthcare Reform

Roma Patel, Note and Comment Editor

The Supreme Court’s decision in Hobby Lobby took the health law spotlight this summer. As the Court’s opinion was dissected every which way in the weeks following its release, something else was brewing at the Court of Appeals for the D.C. Circuit in Halbig v. Burwell.

On its face, the Halbig case challenges the federal tax credits, which are available to qualified individuals, enrolled in the health insurance exchange programs. The provision, established by the Patient Protection and Affordable Care Act, references the payment of credits to individuals who enroll through an Exchange established by the state. The legal challenge claims these credits are not available to the 36 states that chose to let the federal government manage their exchanges.

With millions of Americans relying on these tax credits in order to afford health insurance under the mandate, the case’s outcome could be devastating. One concern few are addressing is whether Halbig presents a legitimate legal question in the first place. While the plaintiff, senior policy advisor to the Department of Health and Human Services under President George W. Bush, paints this as a matter of statutory language and intent. Advocates for the ACA feel opponents are making a last ditch effort to invalidate the entire law based on imperfect legislative wording. The incessant politicization of health care reform has left most Americans frustrated and disillusioned. Regardless of the outcome, perhaps Halbig represents an opportunity to shine a light on the rhetoric surrounding the healthcare debate itself.

Oops! They Did it Again . . .

February 4, 2014
First Amendment, Healthcare, Healthcare Reform

Roma Patel, MJLST Staff
The Affordable Care Act is making its way back to the Supreme Court, this time with a different mandate under judicial scrutiny. In November the Court announced it would hear Sebelius v. Hobby Lobby Stores, Inc., regarding the comprehensive, yet controversial, health care law. Unlike National Federation of Independent Business v. Sebelius, where the Court upheld the ACA’s individual mandate to buy health insurance as a constitutional exercise of Congress’s taxing power, the Hobby Lobby case involves a religious liberty challenge against the ACA’s requirement that employers provide insurance coverage for contraception and some drugs that some believe cause abortions.

Hobby Lobby is a private corporation that owns arts-and-crafts stores throughout the country. The company is owned by the Green family, Evangelical Christians who believe that life begins at fertilization. Because Hobby Lobby is a for-profit employer of more than 50 people, the ACA will require it to provide insurance coverage of a full range contraception.

In June 2013 the U.S. Court of Appeals for the 10th Circuit ruled in favor of Hobby Lobby, stating that corporate entities are entitled to religious freedom. The 3rd and 6th Circuits split from the 10th Circuit and held that for-profit corporations do not have religious rights on two other cases challenging the ACA. On September 19, both Hobby Lobby and the 3rd Circuit case, Conestoga Wood Specialties Corp. v. Sebelius, were appealed to the Supreme Court.

Commentary on the Hobby Lobby case can best be described as dicey. Conservative and religious bloggers have hurled phrases such as, “atheist bullies” and “an attack on First Amendment rights” while the left cry, “war on women” and “crazed bible thumpers.” The broader issues at stake here are understandably divisive and extremely personal.

Amidst the often-exacerbated discussion of the case and the issues surrounding it is a desperate need to set the record straight: this is not a First Amendment issue, per se. What the Supreme Court will decide is Whether the Religious Freedom Restoration Act of 1993 (RFRA), 42 U.S.C. §§ 2000bb et seq., which provides that the government “shall not substantially burden a person’s exercise of religion” unless that burden is the least restrictive means to further a compelling governmental interest, allows a for-profit corporation to deny its employees the health coverage of contraceptives to which the employees are otherwise entitled by federal law, based on the religious objections of the corporation’s owners.

Hobby Lobby argues the provision forces it to pay for methods of contraception which the owners find religiously immoral; namely the Plan B morning-after pill, an emergency contraceptive called Ella, and two different kinds of intrauterine devices (IUDs) that may sometimes work by preventing a fertilized egg from implanting into the uterus.

Counsel for the government argues that rights to religious freedoms do not apply to for-profit corporations and that health decisions should be between a woman and her physician, there is no place to an employer to impose his or her personal beliefs on someone else’s.

Amicus briefs have been flooding the Supreme Court’s doors defending both sides of the issue. Questions of corporate personhood and whether the Court’s decision could open a huge hole in the longstanding history of religion and the practice of medicine remain relevant. For example, some religions don’t believe in blood transfusions, so does that mean business owners with such beliefs can refuse to provide insurance coverage for an employee’s transfusion? Religious beliefs are personal and deeply subjective, how can health policy makers expand on patient coverage without being at odds with subjective beliefs?

The ultimate question is whether the ACA unduly infringes on the right to religious expression or if it pursues the least restrictive means of enforcing its provision on contraception with regard to the First Amendment. The result of Hobby Lobby will be close and the case will be one to watch.

The Affordable Care Act “Death Spiral”: Fact or Fiction?

November 10, 2013
Healthcare, Healthcare Reform

by Bryan Morben, UMN Law Student, MJLST Managing Editor

A major criticism about the Patient Protection and Affordable Care Act of 2010 (“Affordable Care Act” or “ACA”) is that it will lead to a premium “death spiral.” Because the Affordable Care Act proscribes health insurance companies from discriminating against individuals with preexisting health conditions, some believe that people might just wait until they’re sick before signing up for coverage. If that happens, everyone else’s premiums will rise, causing healthy people to drop their coverage. With only sick individuals left paying premiums, the rates go up even more. And so on . . .

On the other hand, supporters of the ACA cite its other provisions to safeguard against this scenario, specifically, the subsidy/cost sharing and “individual mandate” sections. The former helps certain individuals reduce the amount of their premiums. The latter requires individuals who forego buying minimal health insurance to pay a tax penalty. The penalty generally “is capped at an amount equal to the national average premium for qualified health plans which have a bronze level of coverage available through the state Exchange.” Therefore, the idea is that enough young, healthy individuals will sign up if they would have to pay a similar amount anyway.

States that have guaranteed coverage for everyone with preexisting conditions before have seen mixed results. New York now has some of the highest individual health insurance premiums in the country. Massachusetts, which also has an individual mandate, has claimed more success. But it still leaves some residents wondering whether breaking the law might make more sense.

There are notable differences between the ACA and the Massachusetts law as well. For example, the subsidies are larger in Massachusetts than they are with the ACA, so there’s less of an incentive for healthy people to sign up for the federal version. In addition, the ACA’s individual mandate seems to have less of a “bite” for those who elect to go without insurance. The penalty is enforced by the Treasury, and individuals who fail to pay the penalty will not be subject to any criminal penalties, liens, or levies.

Finally, the unveiling of the HealthCare.gov website, a health insurance exchange where individuals will learn about insurance plans, has been a catastrophe so far. There is also some concern that “only the sickest, most motivated individuals will persevere through enrollment process.” Since high enrollment of young, healthy participants is crucial to the success of the marketplace, the website problem, and any negative effect it has on enrollment, are just the latest contributor to the possible looming spiral.

In all, it remains to be seen whether the Affordable Care Act will succeed in bringing about a positive health care reform in the United States. For an excellent discussion on the ACA’s “right to health care” and additional challenges the law will face, see Erin C. Fuse Brown’s article Developing a Durable Right to Health Care in Volume 14, Issue 1 of the Minnesota Journal of Law, Science & Technology.

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