Provided below is a description of a number of federal laws that often apply to the practice of medicine. This survey of laws should not be a considered a complete or exhaustive source of information. The information outlined below is intended to be general in nature, and in no way is the information intended to serve as legal advice. Each of these issues is fact-sensitive, and, thus, it is important that physicians contact their medical malpractice insurance provider and/or their health care attorney for specific guidance.
Americans with Disabilities Act ( ADA)
The ADA gives civil rights protections to individuals with disabilities similar to those provided to individuals on the basis of race, color, sex, national origin, age and religion. It guarantees equal opportunity for individuals with disabilities in public accommodations, employment, transportation, state and local government services and telecommunications. This law impacts how physicians treat patients with disabilities, including hearing impairments (See Legal FAQs).
The purpose of the anti-kickback law is to protect patients and the federal health care programs from fraud and abuse by limiting monetary influence on health care decisions. The law states that anyone who knowingly and willfully receives or pays anything of value to influence the referral of federal health care program business, including Medicare and Medicaid, can be held accountable for a felony. This law has a lot of safe harbors, and, therefore, compliance is very fact-sensitive.
The basic premise behind antitrust laws is to protect competition. Any conduct that reduces or eliminates competition, such as monopolies or price-fixing, is generally prohibited under antitrust laws. Physicians must be aware of the federal antitrust provisions because they may affect their private practices. For instance, physicians may not share information about employment compensation, reimbursement or discounts. Physicians also may not conspire or collaborate about contracting with payers.
Emergency Medical Treatment and Active Labor Act (EMTALA)
EMTALA is a law that governs the treatment and transfer of unstable patients who enter an emergency department. The Act primarily functions as a non-discrimination statute. It requires hospitals and physicians to treat patients who present at an emergency department in an unstable condition, without consideration of payment or health insurance coverage. It also addresses on-call requirements for physicians.
False Claims Act
The Act imposes liability upon any person or entity that improperly receives from or avoids payments to the federal government (e.g., Medicare or Medicaid). The Act enables individuals with insider information regarding false claims in health care, military or other government spending programs to file an action and subsequently be rewarded.
Family Medical Leave Act (FMLA)
The purpose of this law is to encourage the stability and economic security of families. The Act states that any employer who engages in commerce and employs at least fifty (50) employees must grant an eligible employee up to a total of 12 work weeks of unpaid leave during any 12-month period. This leave may be provided for any of the following reasons: (1) for the birth and care of the newborn child of the employee; (2) for placement with the employee of a son or daughter for adoption or foster care; (3) to care for an immediate family member (spouse, child, or parent) with a serious health condition; or (4) to take medical leave when the employee is unable to work because of a serious health condition.
Food Drug and Cosmetic Act (FD&C Act)
Among other things, the FD&C Act sets the quality and safety standards required for drugs and medical devices distributed to consumers in the United States. In recent years, there has been increased scrutiny of physicians who utilize or are involved in the importation of drugs or devices that fail to meet these standards, are not FDA-approved and that are often imported from other countries, including Canada. For more information on this topic, including examples of the severe fines that can be involved with violations of the FD&C Act, see the news articles below.
- Physician indicted for use of Canadian, misbranded products
ISMA Reports, (May 13, 2013)
- Physicians to pay $4.25 million for allegedly using misbranded,
unapproved Canadian drugs, ISMA Reports, (July 22, 2013)
- Seven Ohio Oncologists Ordered To Pay $2.6 Million
United States Department of Justice, (Jan. 29, 2014)
- Local Doctor Sentenced For Making False Statement To Agent,
United States Department of Justice, (Feb. 21, 2014)
Health Care Quality Improvement Act of 1986 (HCQIA) (federal peer review law)
Peer review committees are responsible for evaluating qualifications of professional health care providers, patient care and complaints against health care providers. A peer review committee that meets the standards under the HCQIA is immune from civil liability for its peer review activities conducted in good faith. Under the HCQIA, due process must be afforded to a practitioner prior to substantive action being taken against him or her. The communications of the committee are confidential.
Indiana also has a peer review law. IC 34-30-15-1 et seq.”
HIPAA goes HITECH: Practical Application of the HITECH Final Rule
This webinar by Hall Render will give insight and details into the HITECH Final Rule.
The Stark Law prohibits physicians from referring Medicare and Medicaid patients for “designated health services” to an entity with which the referring physician or an immediate family member of the referring physician has a financial relationship. The Stark Law contains approximately 35 exceptions. Thus, the guidance for and compliance with the law is extremely fact-sensitive