Healthcare Regulatory & Compliance

We work tirelessly to stay abreast of the countless and complex healthcare state and federal laws and regulations that our clients face on a daily basis. We develop thorough and forward-thinking compliance strategies.

Overview

In this highly-regulated industry, we are proactive and not afraid to approach tough situations, making a point to address each issue one by one. Our fraud and abuse lawyers provide analysis and compliance counseling while helping clients navigate critical government investigations and self-disclosures.

Serving often as outside operations or regulatory counsel, we also guide hospitals and health systems, hospices, home health, and other post-acute providers through complex provider reimbursement issues arising under Medicare, Medicaid, and other health programs. We have a successful track record in defending ZPIC and RAC audits, Medicare, OIG, and other governmental agency investigations. We also work closely with our Healthcare Transactions and Change of Ownership Teams to address pre-transaction due diligence analysis and transaction structure.

The privacy and security issues faced by healthcare companies continue to evolve while the risk of greater penalties increases. We provide guidance on issues arising under HIPAA, HITECH, and other laws governing the privacy of personal medical information. We also advise on the development and implementation of compliance programs and corporate governance issues involving compliance (including negotiating and navigating complex CIAs).

Experience

  • Counseled a national provider of long-term care services in a multi-state restructuring and acquisition of a large national provider of nursing home and rehabilitation services, which included consideration of change of ownership, certificate of need, Medicare, and Medicaid regulatory issues.
  • Advised a large pharmacy operator in its acquisition of more than 20 Missouri pharmacies out of bankruptcy. In order to effect the acquisition, AGG handled preparation of transaction documents, filings, and interactions with the U.S. Drug Enforcement Administration, Centers for Medicare and Medicaid Services, State Board of Pharmacy, and the State Medicaid Agency. AGG also reviewed the purchase agreement from both a healthcare regulatory and FDA-perspective.
  • Represented a healthcare operator in its acquisition of a Georgia continuing care retirement community (CCRC) and provided transaction support, including limited diligence, the filing of certificate of need, Medicare, Medicaid, and multiple licensure applications, as well as ancillary license applications, structuring advice, and negotiated regulatory components of the underlying deal documents. The CCRC had a skilled nursing facility, assisted living community, personal care home, and independent living component and was regulated by both the Georgia Department of Community Health and Office of Insurance and Safety Fire Commissioner. The transaction required a unique focus on the nursing facility’s certificate of need, which was initially obtained in the 1990s during changing certificate of need requirements. The client ultimately received a favorable determination from the Georgia CON agency and closed the transaction on its originally scheduled closing date.
  • Assisted a national REIT in its minority investment in a portfolio of a variety of healthcare providers, including assisted living, memory care, hospice, and private-pay in-home care. The providers were located in multiple states, including Arizona, California, Illinois, Texas, Utah, Washington, and Wisconsin. AGG’s involvement included in-depth diligence, including a review of the providers’ licenses, permits, certifications, and accreditations, PEPPER reports, government investigations and surveys, hospice cap calculations, compliance program, background screening, HIPAA, medical directorships, admission agreements, commercial payor audits, and corporate practice of medicine. AGG also assisted with preparing the underlying investment agreement and related disclosure schedules.
  • Represented a longstanding long-term care provider in its sale of over 50 facilities, which included skilled nursing, assisted living, and independent living facilities in 11 states, including Florida, Georgia, Louisiana, Maryland, New Jersey, New York, Pennsylvania, South Carolina, Tennessee, Texas, and Virginia. AGG prepared all filings associated with the stock transfer of the providers, including all pre- and post-closing filings, and advised on regulatory components of the deal document. The transaction was valued at over $400 million.
  • AGG advised on an asset transaction for a skilled nursing facility operator which operates senior-care facilities in several small Georgia communities. Because the transaction involved a hospital authority owner of the real estate, AGG handled the filing of a full certificate-of-need application, a 60-day process that requires gathering a significant amount of information and data.
  • Represented a national medical practice and management company in the evaluation and response to federal and multi-state HIPAA security and privacy matters, including review of the alleged breach, assembly of patient and business partner communications, notification of state and federal parties.
  • Represented a national medical practice’s and management company’s expansion into multiple states, including advice regarding provider licensing and state corporate practice of medicine issues, including formation of new corporate entities as appropriate and drafting and negotiating provider employment agreements.
  • Represented a national medical practice and management company in the evaluation and response to federal and state HIPAA security and privacy matters.
  • Represented a national medical practice and management company in the analysis of accountable care organizations and advice regarding necessary corporate and regulatory structures to permit participation in multiple ACOs.
  • Represented multiple, large medical practices in the development of medical directorship agreements.
  • Represented a national medical practice and management company with regard to the negotiation of a new billing and collection agreement, including privacy and security matters and related indemnity obligations.
  • Represented a national medical practice and management company in the transfer of ownership among designated “friendly physicians”, including advice regarding applicable CON and licensing requirements.
  • Representation of a Georgia medical practice in formation and structure issues related to relocation of a medical practice and establishment of a physician-owned single specialty ambulatory surgery centers and submissions of requests for letters of non-reviewability including advice regarding applicable corporate structures applicable to the involvement of other non-specialists and related specialty physicians.
  • Served as healthcare regulatory counsel for a large national for-profit hospice provider on day-to-day operational and compliance matters, including issues related to certification, reimbursement, payor audits and appeals, and de novo growth, as well as in acquisitions and the restructuring of the company related to private equity investment.
  • Represented a large hospital system in the development of a regional urgent care joint venture arrangement, including tax strategy, corporate structure and regulatory analysis.
  • Advice to national hospice provider regarding compliance with breach reporting and notice requirements and indemnification rights where a potential breach was caused by an IT vendor Business Associate.
  • Assisting with regulatory filings for national provider of provider of short-term post-acute, rehabilitation, skilled nursing and long-term care services.
  • Represented a large regional hospital system in the development of a professional services arrangement, including all aspects of the transaction, including due diligence, negotiation of primary agreements, regulatory filings (state and federal).
  • Provided legal and policy counsel to the Department of Community Health related to Georgia’s Health Information Exchange.
  • Serves on multiple client promotional review boards for pharmaceutical and medical device companies as the legal representative to ensure  regulatory compliance of FDA’s labeling and promotional requirements.
  • Serving as health regulatory counsel to private equity group in the acquisition of home health provider, including transfer of all necessary operational licenses. Purchase price was in excess of $5 million.
  • Served as health regulatory counsel advising investor in a provider of management services to physician practices in thirteen states; worked with corporate counsel to draft and negotiate appropriate healthcare representations and warranties, escrow and indemnification provisions. Advised on risk under state laws applicable to the model, including corporate practice of medicine, fee-splitting and scope of practice,  as well as federal Anti-kickback issues as applied to management models in OIG advisory opinions and other guidance.
  • Provided legal and policy counsel, with particular focus on health information privacy and security issues, to the Department of Community Health related to Georgia’s Health Information Exchange.
  • Serving as health regulatory counsel to private equity group in acquisition of substantially all of the assets of a national hospital chain. Transaction value in excess of $1 billion.
  • Assisted multi-state provider of outpatient physical therapy services with more than 200 outpatient clinics in preparing for sale of company to the private equity arm of  a foreign pension fund. Regulatory counseling included seller-side due diligence and implementation of a compliance program and HIPAA compliance plan.
  • Served as health regulatory counsel on private equity investor’s acquisition of a Southwest-based provider of outsourced third-party eligibility, revenue cycle management and billing services for 300 hospitals in 33 states. Focus included compliance with Social Security disability advocacy requirements, permissibility under state law of percentage fees for billing and impact of need to obtain new biller submitter IDs on timing of closing and structure of transaction.
  • Advised multi-state hospital system on various regulatory matters, including credit balances and state unclaimed-property requirements.
  • Advised national hospital system in structuring charity policies for state compliance.
  • Advising a home health client on its successful application for participation in the Medicare Independence at Home Demonstration.
  • Counseled a non-profit healthcare provider on the Georgia Hospital Authority Act, including related Certificate of Need, licensure, and Medicaid rules and regulations related to a corporate reorganization.
  • Obtained regulatory approval for the replacement of a nursing facility operator on an expedited timeline on behalf of a REIT (accomplished in three weeks with a typical state timeline of three months.)

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