Healthcare is one of the most highly-regulated industries and the regulations come from all directions. There are laws concerning licensing and, for new projects, certificates of need. There are anti-referral laws such as the anti-kickback statute and Stark II. In addition, providers who are tax exempt have to deal with tax exemption law and intermediate sanctions. Other issues that can intensely affect providers are OSHA (e.g., latex gloves), pharmaceutical law, False Claims Act, the Medicare Conditions of Participation and "deemed" accreditation status requirements, legal restrictions on nuclear energy devices, and antitrust in a market that continues to become more financially concentrated. These laws combine to make conducting business and executing transactions considerably more difficult for healthcare providers than for businesses in most other industries.
The Kitch firm guides providers through these requirements. We do this by applying our knowledge and experience, using that knowledge to educate our clients in a way they can understand, and working through issues thoughtfully and efficiently. Sometimes this involves taking the law apart and trying to ascertain the regulators' meaning so that if a decision or process could go in either direction, the regulators' intent is met. Other times it requires creating an alternate approach that substantially achieves the same goal but avoids the regulatory scheme entirely. Whatever it takes, we are committed to finding a solution that complies with the law and works for our clients.
Certificate of Need
- Advise on review standards
- Agent in the application process
Clinical Research
- Draft and negotiate research agreements
- Adise on Institutional Research Board (IRB) guidelines
- Work on research consents, protocols and compliance standards
EMTALA
- Advise on EMTALA requirements
- Draft EMTALA policies and procedures
Licensure/Certification
- Health professional licensing matters
- Nuclear Regulatory Commission
- State Health Department regulations
- Medicare terminations
Accreditation Standards
- Advise on accreditation standards, including JCAHO and AOA (HFAP)
Managed Care
- Draft and negotiate provider contracts
- Advise on regulatory requirements
- Permissible payment arrangements
Medicare and Medicaid
- Federal and state fraud and abuse laws, including Anti-kickback Statute
- Federal and state "Stark" laws, which prohibit physician self-referrals
- Analyze and structure transactions to comply with Fraud and Abuse and Stark laws
- Medicare billing issues
- Compliance issues and compliance plan development
Patient Care Issues
- Patient consent issues and policies
- Guardianship proceedings
Patient Confidentiality
- Advise on federal and state requirements, including physician patient privilege and HIPAA
Privacy Rule
- Policies and procedures
- Confidentiality agreements
Record Retention and Record Destruction
- Creation of comprehensive "soup to nuts" record retention and routine destruction guide, covering every type of document for Michigan, Maryland, Ohio, California, Iowa, Illinois and Idaho.
Tax Exemption Issues
- Tax Exemption Law - Private Inurement and Private Benefit
- Intermediate Sanctions
- Tax Exempt Bond Financing
