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
Recent Insights
Viewpoints
HHS Keeps On Sprinting with Proposed Modifications to the HIPAA Privacy Rule
December 14, 2020 |Blog
Indictment of Pharmacy Marketer Reveals Unsuccessful Efforts to Conceal Kickbacks
August 31, 2020 |Blog
The Future of Telehealth
July 24, 2020 |Video
Events
Join WBL, Mintz and MDLive for a webinar that will examine how COVID-19 has transformed the delivery of telehealth services in just six months and predict which changes are likely to be permanent.
Viewpoints
HHS Keeps On Sprinting with Proposed Modifications to the HIPAA Privacy Rule
December 14, 2020 | Blog | By Dianne Bourque
The Department of Health and Human Services (HHS) is pushing ahead in its Regulatory Sprint to Coordinated Care with a new proposed rule, announced by HHS’ Office for Civil Rights on December 10, to modify the HIPAA Privacy Rule. This proposed rule follows HHS’ 2018 Request for Information on Modifying HIPAA Rules to Improve Coordinated Care, which sought to identify regulatory impediments to value-based care presented by HIPAA. With this proposed rule, HHS aims to “reduce burden on providers and support new ways for them to innovate and coordinate care on behalf of patients, while ensuring that [HHS] uphold[s] HIPAA’s promise of privacy and security,” according to HHS Deputy Secretary Eric Hargan. It would achieve these objectives through a variety of updates to the Privacy Rule, which we highlight in this blog post, along with initial reactions from our HIPAA privacy team.
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Indictment of Pharmacy Marketer Reveals Unsuccessful Efforts to Conceal Kickbacks
August 31, 2020 | Blog | By Sarah Beth Kuyers
The U.S. Department of Justice and U.S. Health and Human Services Office of Inspector General recently announced the indictment of a pharmacy marketer who allegedly received and paid kickbacks in violation of the federal Anti-Kickback Statute (AKS). While the alleged fraudulent scheme isn’t anything new, the actions that the marketer allegedly took to try to cover up the scheme serve as a good lesson.
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The Future of Telehealth
July 24, 2020 | Video | By Sarah Beth Kuyers
Sarah Beth Kuyers discusses the actions taken at the federal and state level to increase access to telehealth in response to the COVID-19 pandemic and takes a look at the recent movement to make some of these changes permanent.
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HHS Further Amends 42 CFR Part 2, Easing Some, But Not All, Burdens on Substance Use Disorder Treatment Providers
July 17, 2020 | Blog | By Sarah Beth Kuyers, Dianne Bourque
The U.S. Department of Health and Human Services (HHS) recently released a final rule further amending 42 CFR Part 2 regulations (Part 2) to allow greater sharing of patient records related to substance use disorder (SUD) treatment. For the past few years, we have seen a push to better align the incredibly strict requirements of Part 2 with HIPAA in order to increase care coordination and promote patient outcomes, particularly in light of the opioid epidemic, which has unfortunately escalated during the COVID-19 pandemic. HHS has been inching toward the harmonization of Part 2 with HIPAA and has now adopted a final rule to address some of the confusion caused by differences between the two regulatory schemes. In conjunction with the release of the final rule, HHS also issued a helpful fact sheet explaining the major changes.
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Massachusetts Adopts Permanent Telehealth Policy for the First Time
July 1, 2020 | Blog | By Sarah Beth Kuyers, Ellen Janos
Last Thursday, the Massachusetts Board of Registration in Medicine (BORIM) approved its first permanent telehealth policy. The Board had previously approved this policy on an “interim” basis in response to the COVID-19 pandemic on March 16, 2020. This policy is an important step for the Massachusetts BORIM as it had previously hesitated to provide any formal guidance on the practice of telehealth.
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Telehealth Reimbursement Continues to Expand for Medicare and Medicaid
May 6, 2020 | Blog | By Sarah Beth Kuyers, Ellen Janos
Last week, the Centers for Medicare and Medicaid Services (CMS) announced additional waivers of limitations on Medicare reimbursement of telehealth services and updated its summary of COVID-19 blanket waivers. We’ve previously blogged about actions by CMS and other federal and state agencies to increase access to and encourage utilization of telehealth services during the COVID-19 pandemic through loosening of restrictions on telehealth reimbursement (see here and here). CMS is now taking additional steps to further these goals. Below is a summary of the major changes that CMS announced last week.
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Barriers to Telehealth Continue to Fall After CARES Act and Other Federal and State Actions
April 3, 2020 | Blog | By Sarah Beth Kuyers, Ellen Janos
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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OCR Exercises HIPAA Enforcement Discretion for Telehealth Services During the Coronavirus Emergency
March 19, 2020 | Blog | By Sarah Beth Kuyers
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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Congress Loosens Telehealth Reimbursement Restrictions in Response to Coronavirus, but State Law Practice Requirements Remain
March 17, 2020 | Blog | By Sarah Beth Kuyers, Ellen Janos
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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Third Circuit Rejects AseraCare’s “Objective Falsity” Requirement, Allows Scrutiny of Medical Opinions in Hospice False Claims Act Case
March 12, 2020 | Blog | By Sarah Beth Kuyers
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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News & Press
Events
Panelist
Dec
1
2020
Telehealth: What's Next?
Women Business Leaders of the U.S. Health Care Industry Foundation (WBL) Event
Online Event
Mar
25
2020
Telehealth: Keeping Up with the Fast-Moving Federal and State Regulatory Landscape During the COVID-19 Pandemic
View the Webinar Recording