HDJN The health law solution.

Areas of Practice

Regulatory Affairs

The Regulatory Affairs Group is responsible for representing healthcare providers before both state and federal agencies, and for guiding clients through the maze of complex state and federal healthcare regulations. Attorneys at Hancock, Daniel, Johnson & Nagle, P.C. have successfully represented clients in all areas of healthcare regulation for more than three decades.

Representative recent projects include:

  • Obtaining COPN approval for two new hospital facilities involving the transfer of existing beds in the face of vigorous opposition.
  • Successfully representing hospital, rehabilitation nursing facility, cancer center, outpatient diagnostic facility and equipment providers through the COPN process, ranging in scope from hospital replacements to orthopedic lithotripsy.
  • Obtaining favorable appeal results on Department of Medical Assistance Services (DMAS) cost report and specialized care issues before DMAS and in the Court of Appeals of Virginia.
  • Advising clients on OIG self-disclosure protocol requirements applicable following the employment of a Medicare-excluded party.
  • Preparing health professional board licensees for Board appearances on issues ranging from quality of care to continuing education.
  • Assisting facility licensees in addressing quality of care, staffing, and management deficiencies, as well as retaining their licenses with the Virginia Departments of Health; Mental Health, Mental Retardation and Substance Abuse Services; and Social Services.
  • Resolving mixed issues of facility licensure and reimbursement, such as assisting a public facility in obtaining Medicare rehabilitation facility certification in order to address patient needs and staffing.
  • Responding to potential and actual decertification of a nursing facility, delicensure of group homes and drug treatment facilities, and denial of payment to individual patients and facilities by DMAS and third-party payors.
  • Representing skilled nursing facilities at informal dispute resolution proceedings,

The Regulatory Affairs Group may be broken into the following specific practice groups:

Long Term Care

The Long Term Care Team of Hancock, Daniel, Johnson & Nagle, P.C. provides nursing facilities, skilled nursing facilities and assisted living facilities with day-to-day advice on transactional, risk management and regulatory issues.  Our attorneys have experience in representing both for-profit and tax-exempt long term care providers in a variety of legal matters.

Representative Practice Areas for the Long Term Care group include:

  • Regulatory Compliance
  • Licensing Matters
  • Survey and Certification Preparedness and Response
  •  Informal Dispute Resolution and Subsequent CMS Appeals
  • Medicare and Medicaid Reimbursement
  • Certificate of Public Need
  • Representation before Department of Health Professions Boards
  • Mergers and Acquisitions
  •  Joint Ventures
  • Tax-exempt Status Issues
  • Risk Management Issues
  • Fraud and Abuse
  • HIPAA Compliance
  • Medical Director Contracts
  • Labor and Employment Law Issues
  • Vendor Contracts/Arrangements
  • Real Estate Matters Including Purchases and Leases
  • Medical Malpractice Defense
  • Medicare and Medicaid Enrollment and Certification

Representative recent projects include:

  • Assisting long term care facilities in developing Plans of Correction to address cited deficiencies following licensure and certification surveys.
  • Providing Informal Dispute Resolution assessments to evaluate likelihood of success; representing facilities at Informal Dispute Resolution proceedings and negotiating reductions in scope and severity of deficiencies.
  • Responding to potential and actual decertification of a skilled nursing facility.
  • Obtaining favorable appeal results on Medicare and Medicaid reimbursement matters.
  • Assisting facilities with changes of ownership, including Medicare/Medicaid enrollment, licensure and accreditation status changes, and certificate of public need implications. 
  • Preparing health professional board licensees, such as nurses and long term care administrators, for formal and informal Board hearings on issues ranging from quality of care to continuing education.
  • Drafting and reviewing contracts between nursing facilities and their Medical Directors.
  • Creation and ongoing support of Compliance Programs for long term care facilities.
  • Assisting with various employment matters including development/review of employee handbooks, and union avoidance training.
  • Enhancing/improving communication issues with residents and family members.
  • Advising clients on OIG self-disclosure protocol requirements.
  • Reviewing and revising facility resident Admission Agreements including Arbitration Agreements.
  • Assisting facilities with appropriate discharge processes.

Our team routinely gives education presentations on topics relevant and timely to the long term care industry.  Recent presentations include:

  • Arbitration Agreements
  • Realigning the Stars, Managing the Public’s Perception of the CMS Five Star Rating
  • F-Tag 309, Survey Outcomes and Opportunities
  • Advance Directives, Prioritizing End of Life Decisions
  • Medical Records Documentation, American Healthcare Association (Oct. 2010)
  • When Things Go Wrong – Communicating With Family Members
  • Legal Requirements for Clinical Records
  • Balancing Resident’s Rights and Facility Responsibilities

We have developed an array of valuable relationships throughout the long term care industry among consultants, regulators and industry leaders.  We maintain memberships in:

  • VHCA
  • VANHA
  • LTC Risk Legal Forum
  • American Health Lawyers Association
  • AHLA Long Term Care Senior Housing, In-Home Care and Rehabilitation Practice Group
  • AHLA Regulation, Accreditation and Payment Practice Groups

Members of our team serve on VHCA’s Regulatory and Quality Committees and Educational Committee to stay abreast of industry developments.

Certificate of Public Need (COPN)

Healthcare planning is one of several focal points of the firm’s Regulatory Affairs Practice.  It is an area of concentration in which the team chairman, Tom Hancock, has practiced for thirty-five years.  While primarily a Virginia practitioner, he has represented clients seeking authority to construct new health care facilities or introduce new services in more than a dozen states.  In the process, he has trained a cadre of attorneys whose experience and professionalism is well respected in the Commonwealth.

The COPN practice has involved all manner of reviewable projects.  Recent engagements include applications and related administrative proceedings seeking the authorization to:

  • Establish, relocate, and reconfigure general acute care hospitals;
  • establish long term acute care hospitals;
  • introduce specialty care nursery services into a general hospital;
  • establish psychiatric units in general hospitals;
  • establish outpatient surgical hospitals (ASCs);
  • introduce or expand diagnostic services including CT, MRI, PET, and cardiac catheterization;
  • introduce or expand radiation therapy services including stereotactic radiosurgery.
  • relocate nursing facilities and assist in COPN implications of changes of ownership;
  • establish open heart surgical services.

The COPN team is frequently engaged to provide advice on issues of COPN applicability and to address issues regarding compliance with conditions such as charity care conditions which are frequently placed upon COPNs.  We frequently represent providers in navigating challenges to and responses to letters of intent, represent providers seeking good cause party status and defend against petitions seeking good cause party status to intervene in  COPN proceedings. HDJN’s COPN attorneys appear at regional health planning agency board meetings, public hearings and informal fact finding conferences before the Virginia Department of Health on a routine basis. HDJN also maintains an extensive library of COPN decisions and other applicable precedent not otherwise readily available.

The COPN team has also developed expertise in successfully handling COPN appeals through all levels of the Virginia court system.  Representative cases include:

Doctors’ Hospital of Williamsburg, LLC v. Stroube, 52 Va. App. 599, 665 S.E. 2d. 862 (2008)
Loudoun Hospital Ctr. v. Stroube, 50 Va. App. 478, 650 S.E. 2d. (2007), aff’d Record No. 072540 (Va. 2008), pet. for reh’g den. (Va. 2008)
Health Sys. Agency of N.Va., Inc. v. Stroube 47 Va. App. 299, 623 S.E. 2d. 444 (2005)

Reimbursement:

HDJN assists its healthcare clients in structuring their operations and making strategic decisions to optimize their reimbursement in compliance with state and federal regulations.  We provide day-to-day advice to clients on Medicare, Medicaid and TRICARE regulatory compliance and reimbursement issues. We also represent all types of healthcare providers in every level of reimbursement appeals, including Medicare, Medicaid, TRICARE and commercial insurance appeals.  We have experience representing clients before state and federal administrative agencies, courts and commercial insurance companies.

HDJN’s Reimbursement Group also assists all types of healthcare providers through the Medicare and Medicaid enrollment and certification processes.  On behalf of our clients, we complete Medicare and Medicaid enrollment applications and troubleshoot problems that may arise as the Medicare contractor processes the applications.  We also maintain frequent communications with state surveying agencies in an effort to facilitate and expedite the certification process. 

HDJN has been actively counseling clients regarding the Medicare Recovery Audit Contractor (RAC) and Medicaid Integrity Contractor (MIC) Programs.  We maintain a team of RAC preparedness experts and have provided RAC and MIC educational programs to hospitals, physicians and nursing facilities in numerous states.  We have assisted numerous clients with RAC and MIC preparedness self-auditing and have counseled clients regarding RAC appellate and repayment strategies.

Recent representative projects include:

  • Preparing healthcare provider’s Request for Redetermination of denied Medicare claims before Medicare contractors.
  • Preparing healthcare provider’s Request for Reconsideration of denied Medicare claims before a Qualified Independent Contractor.
  • Obtaining favorable appeal results in arguments of medical necessity of Inpatient Rehabilitation Facility services before Administrative Law Judges and Medicare Appeals Council.
  • Representing hospitals, physicians, dentists, home health agencies, nursing facilities, hospices, psychiatric facilities and other healthcare providers in all levels of Virginia Medicaid’s administrative appeals process.
  • Obtaining favorable appeals results on Virginia Medicaid cost report and specialized care issues before the Virginia Department of Medical Assistance Services and the Court of Appeals of Virginia.
  • Completing Medicare and Medicaid enrollment forms for new providers, providers undergoing changes of ownership, providers requiring change of information submissions, and providers wishing to terminate participation in the Medicare programs.
  • Assisting Critical Access Hospitals in electing Type II billing for professional services.
  • Advising and assisting physician group practices on reassignment of benefit issues and related supplier enrollment forms.
  • Advising hospitals and other healthcare providers on self reporting of Medicare and Medicaid overpayments to program contractors and/or the Office of Inspector General.
  • Advising clients on the conversion of freestanding clinics to provider-based clinics and subsequently completing and submitting the Medicare provider-based attestation statements.
  • Preparing RAC policies and procedures for a multi-hospital health system, including RAC preparedness, record release, concurrent self-auditing and appeals procedures.
  • Providing state-wide RAC educational programs to hospitals, physicians, nursing facilities and other healthcare providers.
  • Advising clients on day-to-day compliance questions relating to Medicare Conditions of Participation and coverage criteria.
  • Advising clients regarding CMS’ changes to direct physician supervision Medicare coverage requirements in provider-based hospital departments.
  • Advising hospital clients regarding Medicare bad debt cost reporting requirements and application of the Bad Debt Moratorium.
  • Advising hospitals on obtaining and maintaining CMS designation as Sole Community Hospital, Critical Access Hospital and/or Disproportionate Share Hospital. 
  • Advising clients on Medicare and Medicaid payment and enrollment of mid-level practitioners, including nurse practitioners, physician assistants and CRNAs.

Regulatory Compliance:

HDJN attorneys are at the forefront of developments in regulatory compliance for the health care industry.  We handle a variety of regulatory compliance issues on a daily basis for hospitals, nursing facilities, clinics, physician practices, home health agencies and other health care providers. We represent clients on a broad spectrum of regulatory compliance issues ranging from fraud and abuse prevention to internal compliance investigations.  Examples of our work in the area include the following:

  • Development, Support and Assessment of Compliance Programs
  • Development and Review of Operational Policies and Procedures
  • Fraud and Abuse including Transactional Analysis
  • Internal Compliance Investigations and Development of Corrective Action Plans
  • Hotline Administration
  • HIPAA Compliance
  • EMTALA Compliance
  • Medicare, Medicaid and Private Payor Reimbursement
  • OSHA Compliance
  • Conditions of Participation Compliance
  • Self-Disclosure
  • Government Settlements

HDJN attorneys spend considerable time staying up to date on the numerous changes, updates and clarifications that arise in the health care environment in order to assist our clients in complying with the vast number of regulatory requirements affecting health care organizations.

Health Regulatory Board Representation

The attorneys at Hancock, Daniel, Johnson & Nagle, P.C. routinely represent health care providers and other professionals in Virginia who are facing investigations or licensing issues at the Board of Medicine, Board of Dentistry, Board of Nursing, Board of Pharmacy, Board of Optometry, Board of Physical Therapy, Board of Psychology, Board of Social Work, Board of Long-Term Care Administrators (Nursing Homes), Board of Audiology and Speech Pathology, Board of Counseling, Board of Funeral Directors and Embalmers, or Board of Veterinary Medicine. All of these regulatory Boards operate under the umbrella of the Virginia Department of Health Professions.

Given the rapid growth of complaints filed against physicians, dentists, nurses, pharmacists and other professionals, these regulatory Boards are increasingly active. Our team of experienced lawyers has represented hundreds of professionals before their respective Boards. We can help you navigate the investigation process and prepare you for your informal or formal conference (regulatory hearing). We can also provide a wide range of services on other regulatory issues including licensing, credentialing, self-referral, business practices, advertising, scope of practice, pain management, the drug-control act, record keeping, and the Health Practitioners Intervention Program (HPIP) for impaired practitioners.

In addressing the needs of our clients we are sensitive to the difficult issues they face and strive to provide high quality legal services in a timely and effective manner.

Licensing Matters

HDJN attorneys assist a variety of healthcare organizations through the state licensure process and with compliance questions relating to licensure requirements.  HDJN has assisted hospitals, nursing facilities, outpatient surgical hospitals, home care organizations, assisted living facilities, hospices and a variety of mental health and substance abuse treatment facilities with licensure matters.  Examples of our work in this area include the following:

  • Completing initial licensure application and assisting new healthcare facilities through the initial licensure process. 
  • Reviewing and/or drafting Plan of Correction in response to licensure deficiencies cited during on-site licensure surveys of facilities.
  • Successfully obtaining variances from licensure requirements on behalf of an outpatient surgical hospital client. 
  • Drafting and communicating notices to state licensing agencies regarding changes in name, ownership or services.