Regulatory

Healthcare is one of the most regulated industries in the country. These regulations impact the ways in which health care related business can get paid, promote their business and make investments. We can help providers identify and comply with these regulations. Some of the major regulations impacting the health care industry are:

Stark Self-Referral Prohibition

As discussed on our Stark Physician Self-Referral law page, the Stark law is potentially implicated when a physician makes a referral to an entity in which he or she (or an immediate family member) has a financial interest, where the services are payable by Medicare or Medicaid, and where the referral is for designated health services.

Anti-Kickback Statute

The federal anti-kickback statute makes it illegal to offer, receive or solicit anything of value to induce business payable by Medicare or Medicaid. A violation of the anti-kickback statute could result in fines of up to $25,000, imprisonment of up to five years, or both. In addition, a violation could result in exclusion from the Medicare program. Some types of conduct that have been deemed to violate the anti-kickback statute include: giving or accepting gifts or things of value from referral sources, providing free services or waiving co-payments for patients as an inducement to utilize a provider’s services.

There are also state laws that make the same kind of conduct illegal with regard to other third party payors.

Beneficiary Inducements

Although it may seem like a nice thing to do, offering gifts or other financial remuneration to Medicare or Medicaid beneficiaries can result in the imposition of Civil Monetary Penalties. Civil Monetary Penalties are imposed where the person making the offering knows or should have known that the gift or remuneration will likely influence the beneficiary’s decision to receive treatment from a certain provider.

There are some limited exceptions to this prohibition where certain preventive services are involved or where there is a demonstrated financial need on the part of the patient. The Affordable Care Act also created a new exception for certain services that improve access to care and present a low risk to federal health care programs. When relying on an exception, arrangements must be carefully analyzed to determine whether all conditions of the exception have been met.

Other State and Federal Regulations

Depending on the provider type, there are many more regulations which must be considered when conducting health care business. Some regulations that must be taken into account include:

  • The anti-markup rule
  • Corporate practice of medicine
  • State and federal false claims acts
  • State fee-splitting statutes
  • Medicare mandatory claims submission rules
  • State licensure laws
  • State certificate of need (CON) laws
  • HIPAA and state privacy and breach notification laws
  • CLIA regulations
  • Meaningful use regulations
  • Medicare Shared Savings Program (MSSP) regulations and waivers
  • Medicare conditions of participation (COP)