Health Care

Our clients include a full spectrum of actors in the health care sector including health systems and hospitals, nursing home and long-term care facilities, academic medical centers, medical schools, health care professionals, clinics and ambulatory facilities, federal qualified health centers, independent practice associations, managed care organizations, hospices, home care agencies, early intervention agencies, regional health information and data system integration organizations, pharmacies, medical device and technology companies, and professional societies and trade associations.

HSE’s health care team includes lawyers who have served as in-house counsel at a regional health system, litigators who have shaped significant health care legislation, health care association board members, and seasoned investigators including a former Manhattan-based Assistant U.S. Attorney.

  • Health Care Transactions.  Our lawyers advise on mergers, acquisitions and joint ventures of health care organizations, including the sales of and changes in affiliation of medical practices.
  • Business and Operations.  We provide counsel on corporate structuring and practice formation, captive professional corporations, corporate governance, provider agreement review, reimbursement, Certificate of Need establishment and construction applications, tax planning, patient accounts management and collections, and patient issues including ethics, treatment decisions and guardianship.
  • Regulatory Compliance and Government Investigations.  Members of the HSE Health Care team advise on the development and implementation of compliance programs, federal (OIG and DOJ) audits and investigations, New York State (MFCU, OMIG and Justice Center) audits and investigations, Medicare and Medicaid programs, reimbursement issues and appeals, 340B drug discount program, fraud and abuse allegations, Stark and anti-kickback laws, and compliance with HIPAA, HITECH and other laws and regulations.
  • Medical Staff Issues and Licensure.  We help health care clients address issues surrounding credentialing, medical staff bylaws, professional privileges, internal disciplinary proceedings, peer review, and state and National Practitioner Data Bank reporting obligations.  We draft and negotiate employment agreements for physicians and other health care professionals and assist with immigration and professional licensure matters.
  • Privacy and Data Security.  Our team has deep experience advising on all aspects of breach response, remediation, and reporting of data breaches and improper disclosure of protected health information, risk assessments and audits, electronic health records management, and HIPAA and HITECH compliance.
  • Litigation.  HSE litigators have defended clients in administrative and court proceedings related to compliance and regulatory issues, False Claims Act and whistleblower lawsuits, and New York State Medicaid reimbursement challenges among other issues.
  • Ancillary Support.  In advising our health care clients, we draw on the experience of all the attorneys in our full-service firm who provide support in areas including labor and employment (including union issues), foundations and non-profit organizations, real estate, employee benefits (including ERISA), cybersecurity and intellectual property.

What We See on the Horizon

Contact our HSE health care team for our latest insights about the following:

  • Skilled Nursing Facilities and Medicare Reimbursement.  Medicare reimbursement to skilled nursing facilities (SNFs) through a prospective payment system (PPS) has shifted such that the financial incentives for SNFs to provide therapy to residents have been greatly reduced.  At the same time, government regulators at the Centers for Medicare and Medicaid Services have made clear that they will be monitoring the amount of therapy SNFs provide under the new system compared to what they provided under the old. SNFs that reduce the amount of therapy without regard to the needs of their residents could face significant liability.  The HSE health care team regularly advises SNFs regarding audits and related compliance issues and is well-positioned to assist facilities navigating this change in reimbursement policy.

  • Health Information Exchange and Systems Integration.  With an eye toward integrating the services available from health care providers, social services agencies, and schools and universities, organizations are already exploring how the data systems for these entities might be integrated.  HSE’s health care lawyers were at the forefront of creating a regional health information organization (RHIO) and now work toward even more extensive integration of data systems and exchanges.

  • Health Care Transactions.  We expect a continuation of the trends to increase provider scale and broaden continuums of services that were spurred by the shift to the “pay for performance” reimbursement models that became more widespread after the passage of the Affordable Care Act.  Mergers and acquisitions will continue to play an important role in the expansion of larger health care providers in New York and across the country.  We also anticipate that both payors and providers will continue to look to expand into each other’s industries in an effort to control both the quality and price of care.  HSE’s Health Care team works regularly and closely with other firm practice groups to lead large and complex transactions to successful completion.

Overcoming Regulatory Hurdles to Launch a Telemedicine Service

Where we started:  Our client, a non-profit federally qualified health center look-alike, provides comprehensive and integrated care to underserved communities and vulnerable populations.  A county clinic located outside of our client’s service area sought to partner with our client to offer our client’s specialized clinical services to underserved patients in the county.  These patients did not have access to transportation to visit a clinic.  To better serve these patients, our client obtained grant funds to establish a telemedicine service to meet the unserved need which involved, in part, providing telehealth equipment and infrastructure to the county clinic.  Because our client was providing equipment at no cost to the county clinic, it had to obtain an advisory opinion from HHS’s Office of the Inspector General (OIG) permitting the implementation of the telemedicine program.  Given the binding nature of such opinions and the fact that such opinions are relied upon by others in the industry as guidance, the OIG is often reluctant to issue them.

Our strategy:  Working closely with our client and officials at the OIG, HSE’s health care team gathered the necessary facts to demonstrate the unique needs of the underserved population and how those needs could be met through the implementation of the telemedicine program and the provision of this equipment to the county clinic.  We also addressed several other significant regulatory issues raised by federal authorities.  After extensive documentation production and interaction with the officials at the OIG, our client was able to secure a favorable advisory opinion.

The outcome:  The telemedicine program provides access to specialized treatment for at-risk individuals in New York State who are geographically limited in seeking treatment.

Patient Data Disclosed – Quickly Containing the Damage

Where we Started:  Our client, a health care provider, called us to report that one of the independent contractors working for them had records containing highly sensitive protected health information of almost 800 of our client’s patients stolen from the contractor’s car.  

Our strategy:  Within hours, members of our health care team were onsite at the client’s offices and had developed a comprehensive action plan that considered both the client’s legal compliance obligations and the practical aspects of the client’s business.  Specifically, we advised our client on how to meet its obligations under state and federal law including the timing and notice requirements of the affected patients and the media, and the breach reporting requirements to the appropriate regulatory authorities.  We also offered practical, strategic advice in response to specific responses to patient questions and concerns.  In addition, anticipating questions from the U.S. Department of Health and Human Services (HHS), Office of Civil Rights, we proactively helped our client assess and update its privacy policies and procedures to prevent a future breach, and retrained our client’s workforce.

The outcome:  Working quickly and decisively, we were able to help the client implement a plan of action that helped avoid what could have been significant regulatory fines while at the same time preserving relationships with patients.  We also set our client up for success in the future by tightening up aspects of the client’s privacy program.

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Disclaimer

This website presents only general information not intended as legal advice. Although we encourage calls, letters and emails from prospective clients, please keep in mind that merely contacting Harter Secrest & Emery LLP (HSE) does not establish an attorney-client relationship between us. Confidential information should not be sent to HSE until you have been notified in writing by HSE that a formal attorney-client relationship has been established. Information sent to us before then may not be treated as confidential by HSE or the court.

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