David Harlow’s practice includes health care business and regulatory counseling, representation and consulting. He focuses on health care data privacy and security policy development and implementation under HIPAA and otherwise, business structuring, counseling in the avoidance of fraud and abuse, facilities development, acquisition, disposition and financing, determination of need, licensure, certification, Medicare and Medicaid rate matters, legislative strategies and development of a broad range of policies and procedures to maintain compliance with health care regulatory requirements. As appropriate, David works closely with other attorneys and other professionals (including, for example, accountants, architects, real estate brokers and lobbyists) in order to assure clients are served by a responsive team able to achieve success in all aspects of any particular case or transaction.
Some representative matters are described below:
- Develop policies and procedures for digital health and other clients that manage or process protected health information on web-based platforms, in order to maintain compliance with HIPAA, HITECH and other regulatory frameworks. Learn more about our HIPAA and related services.
- Counsel health care providers on the use of social media, and facilitate development of compliant policies and procedures. Learn more about our Health Care Social Media services.
- Counsel clients on short-term and long-term planning efforts needed to comply with – and to succeed under – health reform, under the Affordable Care Act and under other legislative and regulatory initiatives at the federal and state levels.
- Structure numerous transactions for providers of MRI, PET and other imaging modalities to achieve clients’ business goals while complying with applicable state and federal law, including Stark, fraud and abuse, and determination of need laws.
- Enabled a client to manage and expand a group of interrelated diagnostic imaging facilities on one site by structuring, negotiating and closing a series of real estate and corporate transactions.
Regulatory and Transactional Counsel to Institutional Providers
- Represent nursing facilities, clinics, and hospitals (acute and non-acute) in formal and informal interactions with the state and federal authorities, regarding licensure, survey and certification, reimbursement and determination of need issues.
- Represent owners, managers, lenders and REITs in the purchase, sale, lease, development, and financing of health care facilities.
- Assisted clients in several acquisitions of groups of health care facilities out of bankruptcy.
- Served as counsel to seller/developer in tax-exempt bond financed construction and acquisition of replacement nursing facility.
Physicians; Clinics; Community Health Centers
- Handle acquisitions and dispositions of physician practices, physician-hospital joint ventures, physician practice structuring and restructuring, buyins and buyouts.
- Counsel physicians, and negotiate with hospitals and their medical staffs, concerning privileges; appear before Board of Registration in Medicine.
- Represent community health center in acquisition of a physician group practice.
Manage clinic licensure process in concert with clients’ managers.
Medicare Advantage; Managed Care
- Handle provider network contracting for a Medicare Advantage product for ten years, beginning with launch of product. Train client staff on implementation and compliance. Negotiated individual provider agreements. Troubleshoot difficult provider relationships.
- Review and negotiate Medicare Advantage, PACE and other managed care contracts for clinical labs, nursing facilities, hospitals, community health centers and other providers.
- Advise managed care organization on structuring dental benefits.
Emergency Medical Services
- Counsel providers and provider association on public and private payor rules.
- Negotiate with state and federal agencies on behalf of providers and provider association.
- Handle both short-term and long-term policy and legislative initiatives on behalf of clients in the public and private sectors, from policy development and consensus-building within interested communities, to developing legislative strategies and drafting legislation. Engagements have included projects concerning determination of need, long term care, diagnostic imaging and emergency medical services, on behalf of providers and industry associations.
- Work closely with registered lobbyists to help clients achieve their goals.
- In addition to working with clients in the midst of transactions or enforcement actions, David advises clients on the issues that arise daily in their businesses and on structuring future activities and transactions in order to maintain a low regulatory profile and maximize reimbursement for services rendered. These day-to-day issues run the gamut from employment matters to state licensing issues; real estate issues to constantly-changing Medicare and Medicaid reimbursement rules — including self-referral and fraud and abuse matters; patient self-determination/refusal of treatment issues to scope of practice of nurse practitioners; general corporate questions to unique regulatory issues ranging from HIPAA compliance to rules for on-line medical control of paramedics and flight nurses aboard helicopter ambulances to rules on surgical implantation of tissue in patients.