FLYING UNDER THE RADAR FEDERAL AND STATE REGULATIONS (TO KNOW AND AVOID )

1. FLYING UNDER THE RADARFEDERAL AND STATE REGULATIONS(TO KNOW AND AVOID ) Eric J. Plinke Buckingham, Doolittle & Burroughs, LLP Attorneys & Counselors at Law 191 West Nationwide Blvd., Suite 300 Columbus, Ohio 43215-8120 Direct Dial: (614) 227-4213 Direct Fax: (614) 227-7334 eplinke@bdblaw.com

2. STATE LAWS & REGULATIONS • Health providers have historically been regulated primarily by the states, so much of the regulation you will face will be under the rules and regulations of the state in which you practice. Some examples for Ohio are as follows: • Ohio Medical Practices Act - ORC Ch. 4731 • Establishes standards and parameters for conduct through grounds for discipline. • A model act has been adopted by most states so there is similarity between the various state jurisdictions. In other words, Ohio’s Act will be similar, but not identical, to other states medical practice acts. Subject areas of discipline are attached for the State Medical Board of Ohio. • For more information regarding the State Medical Board of Ohio, go to: www.med.ohio.gov/ • If you are planning on accepting a position in another state, research that state’s board and regulations beforehand.

3. Rules Governing the Practice of Medicine in Ohio – OAC Ch. 4731 • These are topic specific rules that are the effect of law and violation of them can lead to disciplinary action as a violation of the medical practices act.The current rules govern the following specific areas: OAC ChapterChapter Subject: 4731-1 Limited practitioners 4731-2 Public notice of proposed adoption, amendment, or rescission of rules 4731-4 Physician assistants 4731-5 Administration of examinations 4731-6 Medical and osteopathic licensure 4731-7 Notice of meetings 4731-8 Personal information systems

4. OAC ChapterChapter Subject: 4731-9 Record of board meetings 4731-10 License registration and reinstatement 4731-11 Controlled substances; general provisions 4731-12 Podiatry licensure 4731-13 Conduct of hearings 4731-14 Pronouncement of death 4731-15 Rules governing mandatory reporting 4731-16 Rules governing impaired practitioners and approval of treatment programs 4731-17 HIV and Hepatitis B virus exposure precautions

5. OAC ChapterChapter Subject: 4731-18 Surgery standards 4731-19 Licensees infected with HIV or HBV: reporting requirements and duty of care 4731-20 Podiatry 4731-21 Intractable pain 4731-22 Emeritus status 4731-23 Delegation 4731-24 Anesthesiologist assistants 4731-25 Office based surgery 4731-26 Sexual misconduct 4731-27 Termination of physician-patient relationship

6. Reporting Laws • Under certain situations, physicians will have a duty to report information and/or incidents to governmental and other agencies. These duties typically arise from state statutes. For example, in Ohio, there are duties to report other physicians, felonies, elder abuse, child abuse, and certain injuries stemming from gun shots, stab wounds, and acts of violence. Some duties also arise from case decision, such as Morgan v. Fairfield Counseling, which created a duty to report in outpatient mental health patients threats to harm others. • Testimonial Privilege • Prior to HIPAA, these state law limitations on the ability of a physician to testify were one of the major legal authorities for the physician-patient privilege. This section is still the law and survives under HIPAA and limits testimony on the subject of physician-patient communications.

7. Ethical Codes and Opinions • These are made applicable through the Medical Practices Act and are mandatory provisions under the Act. Whether you are an M.D., D.O., and D.P.M., your national association has a code of ethics with which you should be familiar. Check them out on line. • State Agency Position Statements • Short of Statutes and Rules, an Agency may also publish a position statement or policy. While the legal effect of these is subject to debate, the position statement itself is a good guide for various practice issues and it is a recommended practice to be aware of them. See attached summary of State Medical Board of Ohio position papers.

8. FEDERAL REGULATIONS AND STATUTES While not historically a common source of health care provider regulation, the federal government has taken a much more active role as a source of regulation which you need to be aware of. • Anti-kickback Statute / Stark Law • These laws regulate referrals by physician and the monetary benefits associated with such referrals. Penalties are civil under the Stark Law and criminal under the Anti-kickback Statute. • To learn more go to: http://oig.hhs.gov/ and www.cms.hhs.gov/PhysicianSelfReferral/ • HIPAA • The Privacy Regulations are well known and include a relatively comprehensive set of rules governing the use and disclosure of protected health information by covered entities (which includes health care providers). Penalties are both civil and criminal. HIPAA is governed and enforced by the US Dept. of Health and Human Services, Office of Civil Rights. • To learn more go to: www.hhs.gov/ocr/hipaa/

9. NPDB / HIPDB • The NPDB defiens itself best at its own website where it states: • The NPDB is primarily an alert or flagging system intended to facilitate a comprehensive review of health care practitioners' professional credentials. The information contained in the NPDB is intended to direct discrete inquiry into, and scrutiny of, specific areas of a practitioner's licensure, professional society memberships, medical malpractice payment history, and record of clinical privileges. The information contained in the NPDB should be considered together with other relevant data in evaluating a practitioner's credentials; it is intended to augment, not replace, traditional forms of credentials review. • To learn more go to : www.npdb-hipdb.hrsa.gov/ • Medicare / Medicaid Exclusion • Exclusion from the federal payors can be devastating on a physician’s career. Chemical dependency cases that are handled satisfactorily on the state level can be redefined on the federal level to essentially end a career as it unleashes a chain of events which prevent or vastly limit your employability. • To learn more go to: http://oig.hhs.gov/ • DEA • The DEA has become the most recent federal agency to take on a more active role in physician regulation.

10. PRIVATE REGULATION The most prominent source of private regulation will come from your employer and your hospital. In a surgical specialty you will be subject to the policies and procedures established in your departments of surgery. Your performance of cases will depend on obtaining and maintained medical staff privileges. You should be familiar with the protocols of your surgical departments and the requirements of your medical staff bylaws. Lastly, medical malpractice claims are also a means of private regulation. Either of these forms of private regulation can unleash a series of events that result in state and/or federal regulation.