Author: hljwebcontent

A New York Judge Declines the DOJ’s Attempt to Delay Purdue Pharma’s Bankruptcy Settlement

David Brust, Class of 2022, Belmont Law.

On Wednesday, October 13, 2021, a federal judge in New York declined to grant the Department of Justice’s attempt to delay Purdue Pharma’s bankruptcy settlement. Purdue Pharma, founded and owned by the Sackler family, invented OxyContin and has received sharp criticism for the drug’s role in the ongoing opioid crisis in the United States. The bankruptcy settlement plan was confirmed by a federal bankruptcy judge in September 2021 and contains several provisions that were objected to by the Department of Justice. These provisions include immunity from opioid lawsuits for members of the Sackler family in exchange for giving up ownership of Purdue Pharma and paying around $4.3 billion to support drug treatment and addiction programs.

The Department of Justice’s main issue with the settlement is the release of liability for individual members of the Sackler family. The Sackler family generated approximately $10 billion in wealth from their roles in the opioid industry. The Sackler family and Purdue Pharma’s biggest money maker, OxyContin, was approved by the FDA and released in 1995. Prior to its release, Purdue Pharma conducted zero clinical studies as to how addictive the drug could be. Additionally, Purdue Pharma was able to get FDA approval for a package insert that stated OxyContin was safer than rival painkillers. Lastly, Purdue Pharma engaged in an aggressive marketing campaign to make OxyContin one of the most, if not the most popular pain medication available. It is noted that “public health experts believe Purdue Pharma’s aggressive and at times illegal marketing of OxyContin played a key role ushering in the opioid crisis that has killed hundreds of thousands of people.”

Due to the Sackler family’s role in the opioid crisis, the Department of Justice believes that granting immunity to the family will violate due process because individuals and the government will lose their right to directly sue the family. While the District Court judge refused to delay the bankruptcy settlement, she did note there may be an issue as to whether the release of liability is constitutional. The Department of Justice can still appeal this issue to the Second Circuit and further hearings are scheduled in the federal bankruptcy court. Thus, this will likely not be the last the public hears of this case.

Works Cited:

https://www.npr.org/2021/10/13/1045260292/federal-judge-rejects-a-government-bid-to-delay-purdue-pharmas-bankruptcy-settle

https://www.newyorker.com/magazine/2017/10/30/the-family-that-built-an-empire-of-pain

 

A Primer: The No Surprises Act

Will Brandt, Class of 2022, Belmont Law

The following will serve as a primer on the “No Surprises Act” (“The Act”) that Congress passed on December 27, 2020. The Act goes into effect on or after January 1, 2022. At the highest level, The Act seeks to protect patients from surprise medical bills and deter out-of-network provider payments. As a preliminary matter, it is important to define “surprise medical bills” and “out-of-network provider payments.”

First, let us establish an example. In the example, a person is in a bad car accident. The person is rushed to the hospital and has emergency treatment. The patient is well-insured and believes that she will only be responsible for paying the deductible. However, at the hospital the patient was taken to the doctor the patient saw was “out-of-network.” This means that the patient’s health plan will not cover, or cost-share, like it would have if the doctor was an “in-network” provider. Because the patient expected the costs of emergency care to be covered by her health plan, she will be surprised with a bill indicating that her health plan did not cover this scenario.

With that example as background, let us now look at how The Act seeks to protect patients from these surprise bills. The Act contains key provisions that ban surprise billing in some, but not all, emergency situations. Specifically, “. . . . it will be illegal for providers to bill patients for more than the in-network cost-sharing due under patients’ insurance in almost all scenarios where surprise out-of-network bills arise, with the notable exception of ground ambulance transport.” Further, The Act includes provisions that protect against the cost of surprise medical bills. Once The Act goes into effect, patient health plans must treat in-network and out-of-network services the same when evaluating cost-sharing.

The Act seeks to protect patients who lack a meaningful choice. For most elective procedures, a patient can choose the provider and make sure that the provider is covered under their health plan. Even then, the Physician Assistant, Anesthesiologist, or other attendant staff may not be covered.  So, The Act is absolutely a win for patients who won’t be surprised by large out-of-network bills when receiving emergency care or elective procedures or being transported by an air ambulance. However, this does create a problem. If the patient visits an out-of-network provider for emergency services, the patient can’t be denied. So, the provider will charge the patient (or their health plan) some amount of money for those services. However, because this is out of network, there is not an agreed upon price between the insurer and the provider. Therefore, The Act includes a process to resolve payment disputes. First, insurers have thirty days after they receive a bill to either pay the “out-of-network rate” directly to the provider or deny the claim. If the insurer denies the claim, then the provider and insurer enter an Independent Dispute Resolution (IDR) process.

According to United Healthcare, the IDR process functions as follows. Both the insurer/health plan and the provider will submit an offer along with any documentation supporting their position to the IDR entity, which will choose between them. In choosing either the insurer/health plan or provider offer, the IDR can consider certain factors such as the median contracted rate for the disputed items and services, the provider’s market share, the provider’s training and qualifications, and the severity of the patient’s condition. When making a decision, the IDR entity cannot consider government program rates (Medicare, Medicaid, Tricare), provider billed charges or usual and customary charges.

Works Cited

https://www.brookings.edu/blog/usc-brookings-schaeffer-on-health-policy/2021/02/04/understanding-the-no-surprises-act/.

https://www.kff.org/private-insurance/fact-sheet/surprise-medical-bills-new-protections-for-consumers-take-effect-in-2022/.

https://pahealthaccess.org/top-ten-things-you-need-to-know-about-the-no-surprises-act/.

https://www.vitacompanies.com/blogs/the-vita-blog/no-surprises-act/.

What is the HIPAA Right of Access Initiative?

David Brust, Class of 2022, Belmont Law

On September 10, 2021, the Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services (HHS) announced that it settled its twentieth HIPAA Right of Access Initiative investigation. The investigation stemmed from a March 2020 complaint made by a parent alleging that Children’s Hospital & Medical Center (CHMC) in Omaha, Nebraska “failed to provide her with timely access to her minor daughter’s medical records” despite multiple requests. To settle this potential HIPAA Privacy Rule violation, CHMC agreed to pay OCR $80,000 and to take corrective actions. These corrective actions include CHMC updating procedures for providing individuals with their health information, training its workforce on receiving, reviewing, processing, or fulfilling records requests, and reporting to HHS any future compliance failures.

Under the HIPAA Privacy Rule, covered entities are required to allow individuals to access their medical records and other private health information (PHI). Typically, covered entities, such as health care providers, require the individual to request their medical records in writing before the information will be provided. Once an individual requests their medical records, the covered entity has thirty calendar days, from receiving the request, to provide the individual access to their medical records. The covered entity may extend this deadline for another thirty calendar days one time per request. Additionally, covered entities may only impose reasonable costs to cover the labor of copying the PHI, the supplies used for making the copy or electronic media, the postage if mailed, and the preparation of a summary of the PHI. Failure to comply with the rules regarding an individual’s request for PHI can result in a violation of the HIPAA Privacy Rule.

In 2019, OCR announced that it would begin the Right of Access Initiative. The aim of the initiative is to enforce individuals’ rights to access their health information in a quick and easy way. As stated, since the initiative began, OCR has now settled twenty investigations of covered entities failing to provide individuals with their health information in a timely manner. These settlements have ranged from as low as $5,000 to $200,000. The most recent settlement was the seventh settlement in 2021 alone, and brings the total amount recovered in 2021 to $525,000. OCR has made it clear that it intends to keep enforcing the right of individuals to access their health information. Thus, covered entities should review their policies regarding fulfilling individuals’ requests for health information to make sure they comply with the HIPAA Privacy Rule and avoid potential hefty settlements with OCR.

Works Cited:

https://www.accountablehq.com/post/the-ocrs-dedication-to-the-right-of-access-initiative

https://www.hhs.gov/about/news/2021/09/10/ocr-resolves-twentieth-investigation-in-hipaa-right-of-access-initiative-with-settlement.html

https://www.hhs.gov/hipaa/for-professionals/privacy/guidance/access/index.html

https://www.hhs.gov/hipaa/for-professionals/compliance-enforcement/agreements/chmc-ra-cap/index.html

The FTC’s New Attitude Toward Mergers and Acquisitions: Showing Us They Are Serious

Maddie Gilmore, Class of 2023, Belmont Law

On July 9, 2021 President Joe Biden issued an Executive Order with seventy-two new initiatives for the purpose of promoting competition in the American economy while simultaneously reducing the trend of corporate consolidation and control. Among these initiatives, he called on the Department of Justice (“DOJ”) and the Federal Trade Commission (“FTC”) to “enforce antitrust laws vigorously.” President Biden’s executive order demonstrates his concern that lack of competition in the healthcare market often leads to price increases without improving quality of care. Furthermore, while consolidating hospitals and other large healthcare facilities benefits the industry by reducing costs, it provides an access barrier and leaves many communities, “especially rural communities, without good options for convenient and affordable healthcare service.” The White House said it is urging antitrust regulators to recognize that “the law allows them to challenge prior bad mergers that past Administrations did not previously challenge.”

The executive order was prompted by the “tidal wave” of premerger filings suggesting rapidly increasing hospital consolidation. Indeed, the FTC received 343 premerger filings in the month of July, more than three times the amount from July of last year, when 112 transactions were submitted for review. The size and number of deals were only accelerated by the COVID-19 pandemic which caused smaller companies to go out of business and become an acquisition target. However, the order alone was not enough. “Thanks to unchecked mergers, the ten largest healthcare systems now control a quarter of the market,” said the White House in its release.

Attempts to rein in the industry have either been met with resistance or not effectively policed. For example, the Trump Administration’s price transparency rule, which was upheld by the U.S. Court of Appeals for D.C., requires hospitals to act transparently and post two lists of prices: “(1) A comprehensive, “machine-readable” list of various charges for all items and services. (2) A consumer-friendly list of prices for a smaller set of “shoppable” services.” Biden’s executive order specifically “directs HHS to support existing hospital price transparency rules,” indicating that the new administration intends to police transparency more rigorously. However, a substantial majority of hospitals are not following the price transparency protocol.

Subsequent crack-down measures on behalf of the FTC are being taken in response to a trend of noncompliance in the industry. Such measures include working on legislation to address and punish ‘surprise’ hospital billing; expanding the applicability of premerger notice requirements; and even, in its latest attempt to regulate, sending letters to monitoring entities informing them that if mergers are not properly investigated or investigated at all, the FTC retains the ability to investigate later. This means that companies who go forward with intended mergers which cannot get investigated in a timely manner, through no fault of their own, run the risk of the merger later being declared unlawful.

This has a significant, and potentially adverse impact on the healthcare industry in its mergers and acquisitions. This impact has already been felt by various entities and has spurred one of the nation’s most influential lobbyist groups to call for more freedom in hospital mergers. The American Hospital Association (“AHA”) sent a letter on August 18, 2021 to the White House which included a study. Although many challengers are saying that the data contained in the accompanying study is cherry-picked, the study tends to show that contemporary hospital mergers result in cost savings and quality improvements, without a corresponding increase in revenue consistent with the acquisition of market power.

Considering the competing interests of the White House and healthcare entities, as well as the competing bases for support of these interests, the arguments raised by the AHA’s August 18th letter may well become of vital importance for ensuing litigation. Consider the case of Hackensack Meridian Health, the largest health system in New Jersey. Hackensack attempted to acquire a close competitor, but the deal was blocked by a preliminary injunction on the ground that the deal is harmful and would reduce competition and quality of care, while making it more costly for patients. Indeed, the merger, if successful, would put Hackensack in control of half of the county’s acute care hospitals, which leaves insurers with very few options. FTC administrative proceedings are set to begin on October 12, 2021.

While the agency’s directives from the White House are clear, the FTC might yet be persuaded by arguments raised in the August 18th AHA letter, which ultimately implores the FTC to switch its focus to commercial health plans themselves, rather than providers.

Works Cited:

https://www.gao.gov/products/gao-21-93

https://www.healthcaredive.com/news/new-jersey-hospitals-appeal-ftc-merger-challenge/605774/

https://www.whitehouse.gov/briefing-room/presidential-actions/2021/07/09/executive-order-on-promoting-competition-in-the-american-economy/

https://www.whitehouse.gov/briefing-room/statements-releases/2021/07/09/fact-sheet-executive-order-on-promoting-competition-in-the-american-economy/

 

 

 

 

 

Office of Inspector General Discusses Plan to Assess Telehealth Services for the Future

Anthony Huber, Class of 2021, Belmont Law

On February 26, 2021, Principal Deputy Inspector General Christi Grimm of the Department of Health and Human Services – Office of the Inspector General (“OIG”) released a statement regarding telehealth and the potential to expand its coverage in the future.  In its statement, OIG recognized that telehealth coverage and services have expanded in response to the consequential decisions made in response to emergencies surrounding the COVID-19 pandemic.  In the early stages of the pandemic, OIG submits that it realized the value of increasing options related to accessing health care services.  OIG stated: “Where telehealth and other remote access technologies were once a matter of convenience, the public health emergency made them a matter of safety for many beneficiaries.”

In its statement, OIG claims that the conversation concerning coverage expansion for telehealth services is mostly positive because it offers opportunities to increase access to services, decreases burdens for both patients and providers, and enables better care—including enhanced mental health care.  OIG pointed to its own 2019 study to claim that “telehealth can be an important tool to improve patient access to behavioral health services.”

In its statement, OIG addressed its commitment to ensure that any additional telehealth policies and technologies are not compromised by fraud, abuse or misuse.  OIG claims that it is conducting “significant oversight work assessing telehealth services” during the current public health emergency.  Once OIG completes its assessments, it states that its reviews will “provide objective findings and recommendations that can further inform policy makers and other stakeholders considering what telehealth flexibilities should be permanent.”

Finally, as the national conversation surrounding telehealth continues, OIG maintains there is one shared goal: “ensuring that telehealth delivers quality, convenient care for patients and is not compromised by fraud.”

 

Works Cited:

https://oig.hhs.gov/coronavirus/letter-grimm-02262021.asp?utm_source=oig-home&utm_medium=oig-hero&utm_campaign=oig-grimm-letter-02262021

https://www.hallrender.com/2021/03/02/oig-leadership-discusses-its-2021-plan-to-assess-telehealth-services/

OIG and Hospice Compliance

Alisha Patel, Class of 2022, Belmont Law

In recent years, the U.S. Centers for Medicare and Medicaid Services and the U.S. Department of Justice began carefully analyzing hospice providers’ claims to ensure compliance with anti-fraud measures such as the Stark Law, Anti-Kickback Statute, and the False Claims Act. As a result of hospice providers finding an increase in live discharges and re-certifications, CMS has increased its number of audits, OIG investigations, and litigation.

Allstate Hospice and Verge Home Health Care Fraud Allegations

In January 2021, the OIG completed one of its first fraud investigations of the new year. The investigation yielded significant issues pertaining to Stark Law in two large Texas-based hospice providers, Allstate Hospice and Verge Home Health Care. The organizations paid nearly $1.85 million dollars to resolve allegations related to the submission of improper Medicare claims, resulting from unlawful patient referrals.

The hospice founders faced two significant regulatory and compliance issues. The first involves Stark law, commonly known as the physician self-referral law, which prohibits a physician from referring patients to receive specific health services payable by Medicare or Medicaid to an entity a physician or his family member has a financial relationship, unless the relationship satisfies one of the law’s statutory or regulatory exceptions. Stark Law violations may result in civil penalties. Second, the founders faced issues involving the Anti-Kickback statute, which prevents anyone from knowingly and willfully offering, paying, soliciting, or receiving remuneration to induce patient referrals for services reimbursed by Medicare, Medicaid, and other Federal health care programs. Anti-Kickback Statute violations may result in criminal and civil penalties. Both the Stark Law and Anti-Kickback statute intend to ensure that financial incentives do not compromise a patient’s medical decision-making process and that health care costs do not increase as a result of fraud.

OIG Investigations

The FBI investigations of Allstate Hospice and Verge Home Health Care began in 2016. Investigators quickly discovered that the hospice founders compensated physicians who issued the most referrals to their hospice and home health organizations. The founders allegedly made monthly payments, in excess of fair market value, for physicians’ services provided to their patients. The physicians then referred patients to either Allstate Hospice or Verge Home Health Care.

The founders employed different methods to compensate physicians for improper referrals. Primarily, physician payments for referrals were made pursuant to medical directorship agreements with both hospice organizations. Also, the founders improperly provided physicians other gifts and benefits, such as travel and tickets to sporting events, to incentivize health care providers to make improper referrals to each hospice organization. Lastly, the founders sold interests of Allstate Hospice to different physicians, earning them substantial quarterly dividends. Facing extensive allegations of fraud from the OIG, both Allstate Hospice and Verge Home Health Care settled the federal government’s claims.

Issues regarding compliance with health regulatory laws are a leading cause of hospice involvement in fraud cases. These complications directly result from hospice organizations facing improper billing allegations for Medicare services for which patients were not eligible. In 2018, this led to several multi-million-dollar settlements, ranging from $1.24 million to $8.5 million, between hospice organizations and the federal government.

Works Cited:

https://hospicenews.com/2021/01/20/allstate-hospice-founders-settle-fraud-case-for-1-8-million/

https://www.justice.gov/usao-sdtx/pr/hospice-home-health-agency-and-owners-pay-over-18m-resolve-claims-concerning-physician

Department of Justice Announces False Claims Act Recoveries

David Brust, Class of 2022, Belmont Law

The False Claims Act was enacted in 1863 in order to combat fraud against the US Government during the Civil War. The act prohibits any person from knowingly submitting false claims to the government. Any person who violates the False Claims Act is “is liable for treble damages plus a penalty that is linked to inflation.” Additionally, the act allows whistleblowers to file suit for the government and if successful, the whistleblower may receive 15 to 30 percent of the recovery. The act plays a vital part in combatting fraud within the health care industry.

Recently, the United States Department of Justice announced that during the 2020 fiscal year it recovered over $2.2 billion in settlements by enforcing the False Claims Act. Of note, are recoveries from Novartis Pharmaceutical Corporation, Gilead Sciences, and Practice Fusion, Inc. Novartis Pharmaceutical, who was accused of paying high-volume prescribers to serve as speakers in exchange writing more prescriptions, settled for over $591 million. Additionally, Novartis, along with Gilead Sciences, settled claims for $148 million for illegally paying patient copays. Lastly, Practice Fusion paid $145 million for accepting kickbacks from Purdue Pharma in exchange for designing its electronic health records software in a way that would increase prescriptions for OxyContin (a Purdue Pharma drug).

Additionally, the Department of Justice announced that it has billions of dollars in pending settlements not included in the 2020 total. Of these settlements, the most notable is an unsecured bankruptcy claim for $2.8 billion from Purdue Pharma. This settlement is to “resolve allegations that Purdue caused false claims to be submitted to federal health care programs arising from its conduct in promoting and unlawfully inducing prescription opioids.” Additionally, members of the Sackler family, the founders of Purdue Pharma, have agreed to pay $225 million for their roles in suspect marketing schemes. Thus, the Department of Justice is set to recover even more money under the False Claims Act in 2021.

Sources:

https://www.justice.gov/opa/pr/justice-department-recovers-over-22-billion-false-claims-act-cases-fiscal-year-2020

https://www.justice.gov/civil/false-claims-act

Rural Hospitals at Risk of Financial Ruin as Medicare Loans Come Due

Alisha Patel, Class of 2022, Belmont Law

A recent report by the Kaiser Health News reported that rural health hospitals are struggling to keep doors open or even pay back their Medicare Accelerated and Advance Payment loans they received to assist navigating the pandemic. However, repayment of these loans is officially due this month and if they are not paid, federal regulators may stop reimbursing the hospital for Medicare patients’ treatments until the loan is fully repaid.

Medicare’s Accelerated and Advance Payments Program existed before the pandemic, and hospitals would only access these funds in times of emergencies such as hurricanes or tornadoes. The Coronavirus Aid, Relief, and Economic Security (CARES) Act expanded the Accelerated Payment Program to include during a public health emergency acute care hospital, but also critical access hospitals and cancer hospitals. The CARES Act also issued more flexible payment and repayment terms for these providers. The Centers for Medicare & Medicaid Services (CMS) provided $59.6 billion in accelerated payments to Medicare Part A providers, including hospitals, during the early weeks of the pandemic. These payments provided critical funding to our hospitals and health systems and were used to support front-line health care workers, build new sites of care to minimize the spread of the virus, and purchase the ventilators, drugs and supplies necessary to care for critically ill patients. Full repayment of a hospital’s loan is technically due one hundred and twenty days after it was received. If it is not paid, Medicare will stop reimbursing claims until it recoups the money it is owed, as detailed in the program’s rules. Currently, Medicare reimburses several payments in health care providers nationwide.

At the end of April, CMS halted all new loan applications to the program in April. As the pandemic continues, many hospitals are left wondering when will the next funds come to them or how will they pay these owed funds in a timely fashion when still dealing with the impacts of the ongoing pandemic.

More than 65% of the nation’s small, rural hospitals were operating at a deficit before the pandemic. These hospitals looked to these loans as an avenue to utilize the funds to provide services to those in need, but also to alleviate the debts the entities were already facing. For several hospitals, Medicare payments consist of forty percent or more of their revenue and rely on Medicare reimbursements to remain afloat. As must as health administrators need the funds for their hospitals, they feared the inability to return the funds to CMS, but especially did not expect or prepared for the pandemic to continue for this long.

Initially, as elective procedures were prohibited, employees were furloughed, and hospitals prepared for a pandemic to last months, hospitals aimed to cope with situation the faced. One hospital administrator stated that the Medicare loan helped them “survive.”

Trade groups, committee proposals, and conversations continue to urge lawmakers to push back these payments. Though the federal government navigated away from a federal shutdown, the House and Senate have not approved or heard a continuing resolution to relieve hospitals of the loan repayment.

United States Supreme Court Hears Oral Arguments in Landmark Pharmacy Benefit Manager Regulation Case

Anthony Huber, Class of 2021, Belmont Law

On October 6, 2020, the Supreme Court of the United States listened to oral arguments from opposing parties in the Rutledge v. Pharmaceutical Care Management Association (“Rutledge”) case.  The issue in the Rutledge case is whether the 8th Circuit erred in holding that Arkansas’ statute regulating pharmacy benefit managers’ drug-reimbursement rates is preempted by the Employee Retirement Income Security Act of 1974 (“ERISA”)

In 2015, the Arkansas Legislature passed Act 900, a law which effectively regulates the practices and conduct of pharmacy benefit managers (“PBMs”).  PBMs are entities that function as intermediaries between health plans and pharmacies.  PBMs process claims, disburse drugs, and contract with pharmacies to create pharmacy networks.  In addition, PBMs create a maximum allowable cost (“MAC”) list to set reimbursement rates to pharmacies dispensing generic drugs.

Sometimes, when a pharmacy contracts with a PBM, the result is that the pharmacy is reimbursed for a drug at a lesser amount than it paid to a wholesaler for that same drug.  As a result, independent and rural pharmacies in Arkansas began to decrease.  Arkansas recognized this and sought to remedy the issue through Act 900.  Some of the provisions in Act 900 provide: (1) pharmacy reimbursements should be at a rate which is at least equal to a drug’s acquisition cost; (2) MAC lists should be updated within seven days of a ten (10) percent increase in a pharmacy’s acquisition cost from sixty (60) percent of wholesalers; and (3) pharmacies can challenge MAC reimbursements through an administrative appeal process.

In response to the provisions of Act 900, Pharmaceutical Care Management Association (“PCMA”), a pharmacy trade association, filed a lawsuit against Arkansas Attorney General Leslie Rutledge arguing that Act 900 is preempted by ERISA.  The gravamen of PCMA’s claim is that Act 900 is impermissibly connected to ERISA, and, as a result, ERISA should preempt Act 900 because it is a state law.  PCMA argues, among other things, that Act 900 directly regulates the administration of prescription-drug benefits on behalf of ERISA-governed plans.  In its brief, PCMA claims that Act 900 “establishes state-specific rules controlling the amount plans must pay for benefits, the methodology for determining the amount to be paid, the timing and procedures for updating payment schedules, and dispute-resolution processes and remedies—matters that are central to plan administration.”

On the other hand, Arkansas Attorney General Rutledge claims that Act 900 does not have an impermissible connection to ERISA plans, and, therefore, it is not preempted by ERISA. Arkansas argues that Act 900 does not regulate plan administration because it simply regulates reimbursement rates, and other provisions, such as the appeal provision, are merely incidental to that primary purpose.

It will be interesting to see where the Supreme Court draws the line on preemption, and its reasoning for doing so, because many other states have already passed statutes similar to Arkansas’ Act 900.  If Act 900 is struck down, the Supreme Court’s decision could have a domino effect on the states which have already implemented pharmaceutical regulations similar to Arkansas.  On the other hand, if the Supreme Court does not find that Act 900 is preempted by ERISA, its decision and reasoning may provide clarity and guidance for states who seek to regulate the practices and conduct of PBMs in the future.

 

Works Cited:

https://www.scotusblog.com/case-files/cases/rutledge-v-pharmaceutical-care-management-association

https://www.c-span.org/video/?470375-1/rutledge-attorney-general-arkansas-v-pharmaceutical-care-management-association-oral-argument

https://www.law.cornell.edu/supct/cert/18-540

https://www.supremecourt.gov/DocketPDF/18/18-540/139090/20200325115916809_18-540%20bs.pdf

 

Amy Coney Barret and the Future of the ACA

Jacob Freeland, Class of 2021, Belmont Law

As a result of President Donald Trump’s latest pick for the United States Supreme Court: Amy Coney Barrett, there has been a great deal of discussion regarding the implication that this appointment could mean for the future of the Affordable Care Act.

The appointment of Barrett is surely going to shift the Supreme Court more to the right, if she is in fact confirmed to replace the late Justice Ruth Bader Ginsburg. Based on their views, if Barrett is appointed, the Supreme Court will be compromised of six justices that were appointed by Republican presidents and three justices that were appointed by Democratic presidents.

If Barrett is confirmed, she could potentially be the deciding vote in a case that is being heard just days after the election, which seeks to overturn and strike down the Affordable Care Act. The Central issue in the case is whether the individual mandate, which requires individuals to have medical insurance, is constitutional. If the Supreme Court determines that it is not constitutional, the justices must then also decide whether the individual mandate can be separated from the law or if its unconstitutionality means the rest of the law is also invalid. Previously when hearing cases regarding these challenges, the Supreme Court has left the ACA largely intact.

It is relevant to note that Barrett has been critical of the ACA in the past. During her time as a law professor at Notre Dame, Barrett wrote a twenty-five-page article that reviewed a book by a legal scholar who was considered one of the main architects of one of the prior challenges brought against the ACA. In this article, Barrett wrote that, “Chief Justice Roberts pushed the Affordable Care Act beyond its plausible meaning to save the statute.” Further, she stated that had Roberts “treated the payment as the statute did – as a penalty – he would have had to

invalidate the statute as lying beyond Congress’s commerce power.” Barrett essentially argued that judges should not defer to what is popular in their judicial decisions. In furtherance of this point, she stated, “The author is surely right that deference to a democratic majority should not supersede a judge’s duty to apply clear text.”

While it is clear that Barrett has had some harsh words regarding the court’s previous rulings regarding the ACA, it still is not known whether or not she thinks there is lawful justification to throw out the whole ACA simply because the individual mandate is ruled as unconstitutional. Further, even if Barrett is appointed and holds against the totality of the ACA, the Court would still have to secure a 5-4 majority for throwing out the entirety of the ACA in order to do so, which previous holdings have shown the court has been reluctant to do as a result of the justices differing views regarding severability.

Thus, ultimately there is still no guarantee that the Supreme Court will rule against the Affordable Care Act, even with a conservative majority of justices on the court. However, it is still something that should be closely monitored and watched going forward with the appointment of the next Supreme Court Justice of the United States.

 

Works Cited

Samantha Liss, What Trump’s SCOTUS pick could mean for the ACA challenge, Healthcare Drive (Sep. 28, 2020), https://www.healthcaredive.com/news/what-trumps-scotus-pick-could-mean-for-the-aca-challenge/585977/.

Sam Baker, If Trump Replaces Ginsburg, the ACA Really is at Risk, Axios (Sep. 21, 2020), https://www.axios.com/supreme-court-trump-rbg-affordable-care-act-062fc3a6-0b5a-4ba2-b739-8d2ac17d7f22.html.

Amanda Holpuch, Fears for Obamacare if Amy Coney Barrett Confirmed to Supreme Court, The Guardian (Aug. 19, 2020), https://www.wallerlaw.com/news-insights/3738/Tennessee-enacts-COVID-19-Recovery-Act.