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Sarah Beth S. Kuyers

Associate

[email protected]

+1.202.434.7453

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Sarah Beth’s practice involves a variety of regulatory, transactional, and enforcement defense matters for clinical laboratories, hospitals, pharmacies, insurers, and other health care clients.

Sarah Beth routinely advises clients on a wide variety of federal and state health care regulatory issues, including anti-kickback and self-referral laws, licensure and scope of practice rules, telemedicine, certificate of need applications, food and drug law, and HIPAA compliance. She also handles licensure and regulatory filings for clinical laboratories and other health care providers.

On the transactional side, Sarah Beth provides regulatory counsel for mergers and acquisitions involving pharmacies, pharmacy benefit managers, and other health care providers. She has assisted clients with due diligence, licensing, change of ownership, and contract drafting and negotiation.

Sarah Beth’s enforcement defense experience includes representing health care clients in criminal and administrative actions brought by federal and state agencies for potential violations of the federal anti-kickback statute, the Stark Law, and the False Claims Act. She has also has experience in internal investigations and compliance programs.

Sarah Beth actively participates in Mintz’s pro bono program. Currently, Sarah Beth represents children seeking Special Immigrant Juvenile (SIJ) Status from the U.S. Citizenship and Immigration Services. The SIJ program is available for foreign children who have been abused, abandoned, and neglected and have come to the United States.

Prior to joining Mintz, Sarah Beth worked as a law clerk with the health staff of the US Senate Committee on Finance, where she researched policy, regulations, and legislation regarding commercial insurance reform, health IT, Medicare, Medicaid, and the Affordable Care Act. During law school, Sarah Beth interned with a large, nonprofit health care system and with the International Trade Administration of the US Department of Commerce.

Education

  • American University (JD, cum laude)
  • University of North Carolina - Chapel Hill (BSPH, honors)

Languages

- French

Viewpoints

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As we’ve previously discussed on the blog, telehealth is playing a critical role in delivering care during the COVID-19 pandemic. Both Congress and states continue to take action to expand the use and reimbursement of telehealth services. The Coronavirus Aid, Relief, and Economic Security Act (CARES Act) passed by Congress last Friday includes many provisions that further expand the use and reimbursement of telehealth during this public health emergency. Congress previously took action to start waiving certain telehealth requirements in the Coronavirus Preparedness and Response Supplemental Appropriations Act (Appropriations Act) passed on March 6, 2020, which we previously discussed here. In this post, we’ll cover the key ways that the CARES Act continues to remove barriers to telehealth, in addition to other recent federal and state actions.
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The Department of Health and Human Services (HHS) has taken many actions to loosen or waive requirements on the provision of health care during the current coronavirus pandemic, as we discussed yesterday and Tuesday. In addition to HHS’s waiver of certain HIPAA requirements, HHS’s Office for Civil Rights (OCR) recently announced that it will not be imposing penalties for providers who use communication devices or other technologies that do not meet HIPAA’s requirements in order to treat patients via telehealth.
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Telehealth is going to play a critical role in the delivery of care in the coming weeks and months as health care providers respond to the COVID-19 pandemic. As the CDC and other public health agencies continue to recommend social distancing and self-quarantine after exposure, telehealth is a vital tool for getting both sick and healthy individuals access to health care services they need if in-person services are not necessary. The use of telehealth services should help alleviate the ever-growing pressures on health care systems as they respond to the outbreak.  In light of these benefits, the Emergency Appropriations Bill passed by Congress last week includes provisions that allow the Secretary of Health and Human Services (HHS) to lift certain restrictions that are currently required for Medicare  reimbursement of telehealth services. 
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Last week, the Third Circuit joined several other appellate courts in finding that medical opinions related to medical necessity of hospice services can be subject to scrutiny and found to be “false” for purposes of proving a violation of the False Claims Act (FCA) in U.S. ex rel. Druding v. Care Alternatives. Our Health Care Enforcement Defense Group has been closely tracking recent qui tam cases brought under the FCA based on allegations that health care services or procedures lacked the requisite medical necessity, including the conclusion of the landmark AseraCare case last week.  As we’ve previously discussed on the blog, several district courts across the country have determined that differences of opinions between physicians and medical experts alone cannot be used to prove the FCA’s falsity requirement. However, some appellate courts have reached different conclusions. The Third Circuit’s decision last week in Care Alternatives joins those appellate courts in rejecting this argument and finding that “a difference of medical opinion is enough evidence to create a triable dispute of fact regarding FCA falsity.”
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Health Care Data Breaches Are Increasing Both in Number and Cost

February 20, 2020 | Blog | By Sarah Beth Kuyers

It feels like we’ve been seeing a lot more health care breaches caused by hackers and other IT security incidents recently, and there’s a good reason why: a recent report by cloud security company Bitglass confirms that both the number of breaches and individuals affected by breaches caused by hackers and IT incidents grew significantly last year.  Bitglass analyzed data from the breach portal, affectionately known as the “Wall of Shame,” published by the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR).  Pursuant to the HITECH Act, HHS is required to post a list of all reported breaches that affect 500 or more individuals. OCR classifies the types of breaches reported on the Wall of Shame, and the "Hacking/IT Incident" category includes a variety of breaches, including malicious intrusion, malware, ransomware, phishing, and general IT security failures.
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Practice Hero Artificial-Intelligence Mintz

Artificial Intelligence in Health Care

February 5, 2020 | Blog | By Rachel Irving Pitts

Artificial Intelligence is a growing part of our day-to-day life. And AI promises to improve our health care system. ML Strategies Vice President Christian Tomatsu Fjeld recently sat down with other experts for a panel discussion hosted by the San Francisco Business Times to discuss AI and some business and policy considerations across multiple industries. This viewpoint considers some of the impacts on health care specifically, and links out to the panel's discussion.
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A New Decade of HIPAA: What Can We Expect?

December 23, 2019 | Blog | By Sarah Beth Kuyers, Dianne Bourque, Ellen Janos

As the decade winds down, it’s hard to believe that the HIPAA Privacy and Security Rules are almost twenty years old.  It has been ten years since the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) published the first breach notification rule – the one based on the harm standard.   And the Omnibus Rule’s “low probability of compromise” standard is almost seven years old!   Regulators and regulated entities are heading into the new year and decade with a lot of momentum on some important issues.  As we prepare to welcome 2020, we’d like to indulge in a bit of hindsight – as well as speculation – about what the new decade might hold for HIPAA-regulated entities. 
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Key Takeaways from CMS’s Final Rule Requiring the Disclosure of Affiliates during Provider Enrollment

September 12, 2019 | Blog | By Daryl Berke, Sarah Beth Kuyers, Karen Lovitch

The Centers for Medicare & Medicare Services (CMS) recently published a final rule with comment period (the “Final Rule”) that is designed to increase CMS’s ability to identify and prevent bad actors from participating in Medicare, Medicaid, and CHIP. Providers and suppliers should take note because implementation will be costly and burdensome. Among other things, the Final Rule requires the disclosure of certain provider and supplier affiliations and permits CMS to revoke or deny enrollment where those affiliations pose an undue risk of fraud and abuse. The Final Rule also grants CMS several additional authorities to revoke or deny a provider’s Medicare enrollment and increases the duration of such revocations and denials. The Final Rule takes effect on November 4, 2019. Comments on the Final Rule are due by 5:00 p.m. on that same day.
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OIG Reports Focus on Hospice Quality of Care

July 25, 2019 | Blog | By Sarah Beth Kuyers

Earlier this month, the Office of Inspector General for the U.S. Department of Health and Human Services (OIG) released two reports regarding its concerns and recommendations related to quality of care at hospice facilities. These reports follow a portfolio report that the OIG released last summer regarding significant vulnerabilities in the Medicare hospice benefit. In these reports, the OIG outlines several quality of care issues and recommends several ways that CMS should strengthen safeguards, all of which may further increase enforcement in an already heavily scrutinized area.
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The HHS Office for Civil Rights (OCR) released a new guidance document regarding which HIPAA violations business associates (BAs) can and cannot be held directly liable for.  In the guidance, OCR states that BAs can be held directly liable for a list of 10 violations but notes that certain other violations, like the reasonable cost requirement for a patient’s access to their PHI, cannot be enforced directly by OCR against a BA.  The covered entity (CE) is still on the hook for violations of this type, however, so CEs should carefully review their BAAs to ensure that it covers requirements that don’t directly apply to BAs but are still enforceable against CEs.  Large data breaches also continue to dominate the press.
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