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Health Care Regulatory and Compliance

Attorneys in the health care practice group have an in-depth knowledge of the complicated regulatory requirements facing health care providers and a solid working relationship with regulators.  We provide analysis and counseling regarding state and federal regulatory matters and compliance issues.

We regularly design, implement and manage corporate compliance programs.  We have reviewed, revised and implemented effective compliance plans resulting in reduced penalties following investigations.  We analyze fraud and abuse, false claims, anti-kickback, self-referral and EMTALA issues. We respond quickly to compliance issues, including questions on complicated interactions between hospitals and providers and suppliers.

Our practice includes counseling our clients with respect to maintaining the privacy and security of their business and patient records in accordance with state and federal law, including security breaches, mitigation of risk, conducting breach investigations and responding to inquiries and investigations from law enforcement authorities and the media when breaches occur.  We have also counseled our clients on establishing health information exchanges and electronic health record systems and donation programs. 

Issues of noncompliance frequently involve internal or governmental investigations. We regularly work with Medicare or its contractors (e.g. fiscal intermediaries, RACs), Medicaid, OIG, U.S. Attorney, licensure agencies, attorneys general, and the Joint Commission. We advise our clients on overpayment issues, including refunds and self disclosures. On licensure and other matters involving quality, we are responsive in developing Quality Assessment Performance Improvement Plans.  We have responded to difficult billing inquiries and have negotiated consent orders and corporate integrity and compliance agreements.

We represent applicants and intervenors in certificate of need matters related to change of ownership, corporate affiliation, joint ventures, technology acquisitions and introduction and termination of services.

We advise our clients in handling difficult patient issues, including ethical issues relating to end-of-life decision making, competency and informed consent issues.

We advise health care providers and life sciences companies on clinical and translational research issues involving conflicts of interest, research misconduct, institutional review boards (IRBs), informed consent, privacy and data issues, and sponsor and investigator agreements.

Publications

October 11, 2016  Providing Transgender-Inclusive Health Care
October 27, 2016  October 17th Compliance Deadline for HHS Nondiscrimination Notifications Approaches
April 2016  Communicating Protected Health Information Via Text Messaging
December 9, 2015  Stark Law Update
October 13, 2015  EPA Proposes Long-Awaited Rule Addressing Management of Hazardous Waste Pharmaceuticals by Healthcare Facilities
November 11, 2014  Health and Human Services Addresses Ebola and Other Public Health Emergencies
September 2, 2014  CMS Proposes Short-Term Inpatient Admission Settlement Process for Hospitals
August 1, 2014  Connecticut Expands Transparency Reporting Obligations to APRNs
July 9, 2014  Connecticut Health Law 2014 Legislative Update
March 2014  Living with the Medical Device Excise Tax
February 3, 2014  CMS Delays the 2-Midnight Rule For At Least Another 2 Midnights
December 4, 2013  DSS Releases Proposed FQHC Reimbursement Regulations
November 19, 2013  Court Rules that Hospital's Incentive Payments for its Oncologists Violated the Stark Law
November 8, 2013  CMS Delays Post-Payment Reviews for "Short-Stay" Inpatient Admissions
November 6, 2013  Medicare Conditions of Participation for Community Mental Health Centers
August 8, 2013  Health Law 2013 Legislative Update
June 25, 2013  FDA Releases Draft Cybersecurity Guidance for Medical Devices
May 22, 2013  Lessons Learned From "U.S. ex rel., Drakeford v. Tuomey Healthcare System, Inc."
May 16, 2013  Certificate of Need Regulations Finalized and Released
February 12, 2013  HIPAA Final Rule
August 13, 2010  June 2010 Connecticut Health Law Legislative Update
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