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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

June 30, 2020  U.S. Supreme Court Strikes Down Louisiana Law that Imposed Restrictions on Abortion Providers
June 9, 2020  Governor Lamont Suspends Involuntary Discharge of Nursing Home and Residential Care Home Residents to Homeless Shelters
June 9, 2020  New Laboratory Data Reporting Guidance for COVID-19 Testing From HHS
June 9, 2020  Governor Lamont Orders Nursing Homes, Managed Residential Communities, and Assisted Living Services Agencies to Test Staff for COVID-19
June 8, 2020  CT DPH Issues Order Allowing for Flexibility of Certification Requirements for Unlicensed Assistive Personnel in Residential Care Homes
June 1, 2020  HHS OIG Issues Fraud Oversight Strategic Plan for COVID-19 Response and Recovery
May 29, 2020  Governor Lamont Issues Order Creating Temporary Nurse Aide Position
May 29, 2020  CT DPH Issues Order Modifying Administrative Procedures and Deadlines
May 27, 2020  CT Department of Health Issues Order Modifying Requirements for Behavioral Health Facilities and Nursing Homes
May 19, 2020  CT DPH Issues Orders Suspending Licensure Requirements for Certain Providers
May 18, 2020  OCR Bulletin Reminds Health Care Entities of Rights of Individuals With Limited English Proficiency During COVID-19 Pandemic
May 15, 2020  Connecticut DPH Acting Commissioner Gifford Reinstates Requirement that a Licensed Provider Order COVID-19 Test
May 13, 2020  Connecticut DPH Modifies Visitor Restrictions at Nursing Homes, Residential Care Homes, and Chronic Disease Hospitals
May 12, 2020  CMS Announces Additional Blanket Waivers during COVID-19 Public Health Emergency
May 11, 2020  Governor Lamont Suspends Regulations to Expand COVID-19 Testing
May 7, 2020  OIG Recommends Recovery of Medicare Overpayments Made in Violation of 72 Hour Rule
May 6, 2020  OCR Reminds Healthcare Providers about Media Access Restrictions
May 2, 2020  OCR Reminds Organizations of Available Cyber Threat Resources
April 24, 2020  COVID-19: Governor Issues Two New Executive Orders Impacting Health Care Providers
April 22, 2020  COVID-19 Clinical Trial Data Qualifies for CMS Quality Payment Program
April 22, 2020  FDA Issues EUA for Limited Use Face Masks
April 21, 2020  HHS Issues Advisory Opinion Regarding PREP Act Tort Liability Immunity During COVID-19 Pandemic
April 18, 2020  OCR Resolves Civil Rights Complaints Amid COVID-19 Pandemic
April 10, 2020  COVID-19: CMS Guidelines to Protect Patients and Health Care Workers in Outpatient Settings
April 9, 2020  COVID-19: CMS Guidelines to Protect Patients and Health Care Workers in Hospitals
April 9, 2020  COVID-19: Governor Lamont's Executive Order 7V for Health Care Providers
April 7, 2020  Protections from Civil Liability for Healthcare Providers and Financial Protections for Patients
April 4, 2020  FCC Announces Program for Health Care Providers to Receive Up to $1 Million to Cover Telehealth Costs
April 2, 2020  CARES Act: Summary of Provisions for Health Care Providers
April 1, 2020  New Waivers and Rules to Allow Hospitals to Respond to the COVID-19 Crisis
March 29, 2020  COVID-19: CMS Advances Payments to Providers and Suppliers
March 27, 2020  COVID-19 Update: N95 Masks and PPE: Guidelines for Use And Importation
March 26, 2020  COVID-19: CMS Provides Quality Reporting Program Relief
March 25, 2020  CMS FAQs and Guidance for COVID-19 Response
March 23, 2020  COVID-19: CMS Issues Telemedicine Toolkit
March 20, 2020  Governor Expands Access to Telehealth Services Executive Order No. (7G)
March 20, 2020  DEA's Expansion of Prescribing Controlled Substances Via Telemedicine
March 19, 2020 - Updated March 20, 2020  COVID-19: OCR HIPAA Enforcement Discretion for Telehealth
March 18, 2020  Medicaid Telehealth Expansion and Guidance
March 17, 2020  COVID-19: New HHS Waivers
March 17, 2020  Expansion of Medicare Telehealth Benefits and Co-Pay Waivers During the COVID-19 Outbreak
March 16, 2020  Determining Work Restrictions for Healthcare Personnel Exposed to COVID-19: CDC Recommendations
March 15, 2020  Governor Lamont Issues Two Executive Orders In Response to Ongoing COVID-19 Developments in Connecticut
March 15, 2020  COVID-19: New CMS Waivers
March 14, 2020  COVID-19: Privacy Considerations for Health Care Providers
March 13, 2020  Major Insurers Waive Coronavirus Testing Costs, Unpacked
March 11, 2020  Guide for an Organizational Response to Coronavirus
September/October 2019  Fair Market Value: It Is Not As Easy As You May Think
January 3, 2019  Physician Practice Liable for Violating its Duty of Confidentiality to a Patient
November 6, 2018  What Does the Partial Repeal of the Medicaid IMD Exclusion Mean for Providers?
October 2018  New Compliance Training Requirements for Medicare Advantage
August 6, 2018  CMS Mandates Hospitals to Post Standard Charges Online
January 24, 2018  HHS Takes Action to Protect Religious Beliefs and Moral Convictions
January 17, 2018  Connecticut Supreme Court Recognizes New Cause of Action for Patient Privacy Breach
January 10, 2018  OIG Scrutiny of Patient Assistance Programs
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

Events

June 25, 2020  Webinar: 2020 HHS Patient Access Rule - What Hospitals Need to Know
May 22, 2019  HFMA Region 1 Eighteenth Annual Healthcare Conference
March 7, 2019  CT HFMA's Winter Symposium Featuring Telemedicine
December 13, 2018  CT HFMA Winter Revenue Summit with AAHAM
October 25, 2018  Subpoenas: What You Need to Know to Respond
September 14, 2018  2018 Community Health Summit: Working Together for a Healthier Connecticut
May 22, 2018  Model Agreements & Guidelines International (MAGI) Clinical Research Conference
April 13, 2018  Community Health Center Association of Connecticut
March 26-29, 2017  Health Care Compliance Association's 21st Annual Compliance Institute
February 23, 2017  Recent Privacy and Security Developments in Human Subjects Research
November 30 - December 2, 2016  OCR Audits Phase 2 With Real Life Experience - How to Navigate?
November 10, 2016  CT Community Nonprofit Alliance, Inc. Behavioral Health CFO Forum
September 20, 2016  CT Community Nonprofit Alliance, Inc. Compliance Roundtable
April 6, 2016  Stark Update at Boston Medical Center
December 2, 2015  Webinar: Business Associates: How to Differentiate Your Organization Using HIPAA Compliance
September 24, 2015  Webinar: How to Effectively Negotiate a Business Associate Agreement: What's Important/What's Not
July 14, 2015  Webinar: HIPAA Compliance and Non-Business Associate Vendors - Strategies and Best Practices
June 11, 2015  Feldman & Roberts to Speak about The Physician Payments Sunshine Act
November 20, 2013  CT-HFMA: Annual Healthcare Legal Conference
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