Health Care Compliance
HC Corporate Compliance, LLC is available to work in compliance matters with healthcare entities and providers across the country in multiple areas of the healthcare industry.
Anti-Kickback Statute
The anti-kickback statute, 42 U.S.C. §1320a-7b, provides criminal penalties for certain acts impacting Medicare and Medicaid reimbursable services. The law prohibits the offer or receipt of certain remuneration in return for referrals for or recommending purchase of supplies and services reimbursable under government health care programs.
Several "safe harbor" rules or exceptions have been promulgated whereby arrangements that appear to violate the law would be exempt from sanction because the regulators do not believe the arrangements would pose much risk in violating the spirit of the law.
Stark Law (Physician self-referral)
Section 1877 of the Social Security Act (42 U.S.C. 1395nn), also known as the physician self-referral law and commonly referred to as the “Stark Law”:
1. Prohibits a physician from making referrals for certain designated health services (DHS) payable by Medicare to an entity with which he or she (or an immediate family member) has a financial relationship (ownership, investment, or compensation), unless an exception applies.
2. Prohibits the entity from presenting or causing to be presented claims to Medicare (or billing another individual, entity, or third party payer) for those referred services.
3. Establishes a number of specific exceptions and grants the Secretary the authority to create regulatory exceptions for financial relationships that do not pose a risk of program or patient abuse.
The Stark Law and anti-kickback statute deter abuse of federal health care programs by prohibiting certain conflicts of interest. While the Stark Law prevents a physician’s personal financial interests from influencing the type and quality of care that patients receive, the anti-kickback statute provides criminal sanctions. Violations of the anti-kickback statute and Stark Law can be pursued under the federal and some state False Claims Acts. Compliance with the anti-kickback statute and the Stark Law is a condition for reimbursement under federal health care reimbursement programs.
HHS Office of Inspector General
In the health care industry, the Office of Inspector General (OIG) of the United States Department of Health and Human Services (HHS) has developed over time a series of voluntary compliance program guidance documents directed at various segments of the health care industry, such as hospitals, clinical laboratories, nursing homes, home health agencies, third-party billers, pharmaceutical manufacturers, physicians, hospices, ambulance suppliers and durable medical equipment suppliers, to encourage the development and use of internal controls to monitor adherence to applicable statutes, regulations, and program requirements. The OIG has supplemented original guidance with supplemental guidance for hospitals and nursing facilities.
The purpose of these guidance documents is to curtail the submission of erroneous claims, identify fraud and abuse risk areas, and to provide the industry with general guidelines for establishing effective programs for compliance with federal health care program rules and regulations.
The OIG and other Federal and State regulatory authorities may view entities that have "effective" compliance programs as having exerted good faith efforts to comply with governing laws which might, in turn, impact decisions to initiate enforcement actions, the willingness to entertain settlement discussions, as well as the extent of any penalties/remedies sought and the terms of any settlement agreements.
Summary-Elements of Effective Corporate Compliance Program
1. Adoption and implementation of well-written and easily-understood code of conduct
2. Support and buy-in by the organization's leadership - tone at the top in support of a culture of compliance and ethical conduct
3. Development and distribution of policies and procedures to promote the organization's commitment to compliance
4. Designation of chief compliance officer
5. Development and continuous education/training for employees
6. Auditing and monitoring of the compliance program
7. Immediate investigation of complaints and remediation of identified problems
8. Use and maintenance of anonymous "hotline" for complaints
9. Adoption and enforcement of a "no-retaliation" policy for complaints or use of the "hotline"
10. Adoption of clear policy for record creation and retention
11. Accountability and enforcement: disciplinary action for employees who violate the code of conduct or the law
12. Periodic, continuing communication to, and continuing education of, all employees, including senior management and board of directors, about compliance