Physician Referral: Laws, Rules, and Ethics

Transcription

1 Physician Referral: Laws, Rules, and Ethics Nabil El Sanadi, MD, MBA, FACEP Chairman, Council on Ethical and Judicial Affairs, Florida Medical Association Chief of Emergency Medicine, Broward Health Clinical Professor of Medicine, Florida International University EMS Medical Director, Broward Sheriff s Office and the City of Fort Lauderdale

2 Physicians: The Practice The Art: We do Not Know all the Answers The Science: Standards of Care, Evidence Based Medicine (Published Scientific Articles in Peer Reviewed Journals, e.g. prospective double-blind drug efficacy trials) 27 Specialties: Internal Medicine, Surgery, Pediatrics, etc. Outpatient vs. Inpatient Services (e.g. Internal Medicine vs. Orthopedics) Cognitive vs. Procedural Services (e.g. Psychiatry vs. Thoracic Surgery) Ancillary & Support Services e.g. Laboratory, Radiology Highly Regulated: Center for Medicare Services Heavily Scrutinized: O.I.G. Medicare/Medicaid Fraud

3 Federal & State Funding Total Medicare beneficiaries: 47.5 million Medicaid is a joint federal-state program : Some 43 million Americans (19.7 million of them children) A Compliance Officer & Internal Auditor in Every Hospital

4 Federal Stark Law The Stark Law generally prohibits physicians from referring patients to entities in which they have a financial stake, with certain exceptions. Doctors are generally barred from referring patients to entities in which they have a financial stake. Medicare Funds are Taxpayer's $$. Office of Inspector General: Medicaid Fraud Control Units - MFCUs

5 Federal Stark Law The Centers for Medicare & Medicaid Services, in an August 2008 final rule, instituted broad revisions to the Medicare hospital in-patient prospective payment system that will restrict: So-called "under arrangements," in which hospitals contract with physician-owned entities to provide a wide range of ancillary services, such as clinical labs or imaging services. Per-use or "per-click" payments for equipment and space leases. Compensation deals based on a percentage of revenue generated by space or equipment use.

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7 O.I.G. Reporting Fraud Office of Inspector General: Department of Health & Human Services PO Box Washington, DC Phone: HHS-TIPS ( ) TTY:

8 O.I.G. Most Wanted Fugitives This web page contains information about O.I.G.'s most wanted health care fugitives. In all, we are seeking more than 170 fugitives on charges related to health care fraud and abuse. Click any of the photos below for more information about the fugitives or view captured fugitives.

9 O.I.G. Kickback and Physician Self-Referral (Recent Settlements) May 11, After it self-disclosed conduct to the O.I.G., Pacifica Hospital of the Valley (Pacifica), California, agreed to pay $764,250 for allegedly violating the Civil Monetary Penalties Law provisions applicable to physician selfreferrals and kickbacks. The O.I.G. alleged that Pacifica paid indirect improper remuneration to a physician in the form of payments to a marketing firm for marketing services that were never rendered under joint marketing agreements. The remuneration created a financial relationship between Pacifica and the physician that caused Pacifica to present claims for health services that resulted from prohibited referrals in violation of the Stark law.

10 O.I.G. Kickback and Physician Self-Referral (Recent Settlements) March 24, After it self-disclosed conduct (Internal Auditor) to the O.I.G., Fairview Northland Regional Health Care (FNRHC), Minnesota, agreed to pay $50,000 for allegedly violating the Civil Monetary Penalties Law provisions applicable to physician self-referrals and kickbacks. The O.I.G. alleged that FNRHC entered into an unwritten lease agreement with a physician practice.

11 O.I.G. Kickback and Physician Self-Referral (Florida Cases) South Florida DURABLE MEDICAL EQUIPMENT Suppliers Audit. Department of Health and Human Services Office of Inspector General -Audit. Review of Outpatient Cardiac Rehabilitation Services - Central Florida Regional Hospital, Sanford, Florida (A ) Office of Inspector General Audit of Pathology Laboratory Services Claimed by Florida Urology Physicians, P.A. for the Period September Through December 2004," (A ) Law Judge Upholds HHS O.I.G.'s Exclusion of Owner of Orlando, Florida, Diagnostic Imaging Services Company

12 Florida Board of Medicine Grounds for disciplinary action; action by the Florida Board of Medicine and Department of Health. (i) Paying or receiving any commission, bonus, kickback, or rebate, or engaging in any split-fee arrangement in any form whatsoever with a physician, organization, agency, or person, either directly or indirectly, for patients referred to providers of health care goods and services, including, but not limited to, hospitals, nursing homes, clinical laboratories, ambulatory surgical centers, or pharmacies. The provisions of this paragraph shall not be construed to prevent a physician from receiving a fee for professional consultation services.

13 Florida Board of Medicine Grounds for disciplinary action; action by the Florida Board of Medicine and Department of Health. (k) Making deceptive, untrue, or fraudulent representations in or related to the practice of medicine or employing a trick or scheme in the practice of medicine. (l) Soliciting patients, either personally or through an agent, through the use of fraud, intimidation, undue influence, or a form of overreaching or vexatious conduct. A solicitation is any communication which directly or implicitly requests an immediate oral response from the recipient. (n) Exercising influence on the patient or client in such a manner as to exploit the patient or client for financial gain of the licensee or of a third party, which shall include, but not be limited to, the promoting or selling of services, goods, appliances, or drugs.

14 Florida Board of Medicine (2007 Declaratory Statement) Florida s Patient Self Referral Act, like the Federal Stark Law, prohibits physicians from referring patients to entities in which they have a financial interest. Both Stark and the Self Referral Act, however, allow for exceptions. The Florida Board of Medicine stated that the referring physician or a member of the physician s group practice must be present in the office suite and immediately available, except for brief unexpected or routine absences of short duration. This applies the direct supervision rules to all ancillary services and self referrals in Florida. Therefore, many ancillary services requiring only general supervision under CMS rules (i.e., no physician presence) such as sleep studies, X-rays, and other diagnostic tests, will now require direct supervision under the Self Referral Act. In fact, any service provided by an entity in which the referring physician has a financial interest must be scrutinized under the Self Referral Act.

15 AMA Code of Medical Ethics Opinion Referral of Patients A physician may refer a patient for diagnostic or therapeutic services to another physician, limited practitioner, or any other provider of health care services permitted by law to furnish such services, whenever he or she believes that this may benefit the patient. As in the case of referrals to physician-specialists, referrals to limited practitioners should be based on their individual competence and ability to perform the services needed by the patient. A physician should not so refer a patient unless the physician is confident that the services provided on referral will be performed competently and in accordance with accepted scientific standards and legal requirements. (V, VI) Report: Issued prior to April 1977

16 AMA Code of Medical Ethics Opinion Physician-Hospital Contractual Relations: There are various financial or contractual arrangements that physicians and hospitals may enter into and find mutually satisfactory. A physician may, for example, be a hospital employee, a hospital-associated medical specialist, or an independent practitioner with staff privileges. The form of the contractual or financial arrangement between physicians and hospitals depends on the facts and circumstances of each situation. A physician may be employed by a hospital for a fixed annual amount, for a certain amount per hour, or pursuant to other similar arrangements that are related to the professional services, skill, education, expertise, or time involved. (VI) Report: Issued March 1981; Updated June 1994

17 AMA Code of Medical Ethics Opinion Advertising and Publicity Because the public can sometimes be deceived by the use of medical terms or illustrations that are difficult to understand, physicians should design the form of communication to communicate the information contained therein to the public in a readily comprehensible manner. Aggressive, high-pressure advertising and publicity should be avoided if they create unjustified medical expectations or are accompanied by deceptive claims. The key issue, however, is whether advertising or publicity, regardless of format or content, is true and not materially misleading. The communication may include (1) the educational background of the physician, (2) the basis on which fees are determined (including charges for specific services), (3) available credit or other methods of payment, and (4) any other nondeceptive information.

18 AMA Code of Medical Ethics Opinion Advertising and Publicity: There are no restrictions on advertising by physicians except those that can be specifically justified to protect the public from deceptive practices. A physician may publicize him or herself as a physician through any commercial publicity or other form of public communication (including any newspaper, magazine, telephone directory, radio, television, direct mail, or other advertising) provided that the communication shall not be misleading because of the omission of necessary material information, shall not contain any false or misleading statement, or shall not otherwise operate to deceive.

19 AMA Code of Medical Ethics Opinion E Physicians' Self-Referral Business arrangements among physicians in the health care marketplace have the potential to benefit patients by enhancing quality of care and access to health care services. However, these arrangements can also be ethically challenging when they create opportunities for self-referral in which patients' medical interests can be in tension with physicians' financial interests. Such arrangements can undermine a robust commitment to professionalism in medicine as well as trust in the profession.

20 AMA Code of Medical Ethics Opinion E Physicians' Self-Referral In general, physicians should not refer patients to a health care facility that is outside their office practice and at which they do not directly provide care or services when they have a financial interest in that facility. Physicians who enter into legally permissible contractual relationships including acquisition of ownership or investment interests in health facilities, products, or equipment; or contracts for service in group practices are expected to uphold their responsibilities to patients first. When physicians enter into arrangements that provide opportunities for self-referral they must: (1) Ensure that referrals are based on objective, medically relevant criteria.

21 AMA Code of Medical Ethics Opinion E Physicians' Self-Referral (2) Ensure that the arrangement: (a) is structured to enhance access to appropriate, high quality health care services or products (b) within the constraints of applicable law: (i) does not require physician-owners/investors to make referrals to the entity or otherwise generate revenues as a condition of participation. (ii) does not prohibit physician-owners/investors from participating in or referring patients to competing facilities or services. (iii) adheres to fair business practices vis-à-vis the medical professional community for example, by ensuring that the arrangement does not prohibit investment by non-referring physicians.

22 AMA Code of Medical Ethics Opinion E Physicians' Self-Referral (3) Take steps to mitigate conflicts of interest, including: (a) ensuring that financial benefit is not dependent on the physicianowner/investor's volume of referrals for services or sales of products (b) establishing mechanisms for utilization review to monitor referral practices; (c) identifying or if possible making alternate arrangements for care of the patient when conflicts cannot be appropriately managed/mitigated. (4) Disclose their financial interest in the facility, product, or equipment to patients; inform them of available alternatives for referral; and assure them that their ongoing care is not conditioned on accepting the recommended referral. (II, III, VIII) Issued June 2009 based on the report "Physicians' Self-Referral," adopted November 2008.

23 References Grounds for disciplinary action; action by the Florida Board American Medical Association's Code of Medical Ethics: Opinions on Inter-professional Relations Opinions on Hospital Relations Opinions on Confidentiality, Advertising, and Communications Media Relations Opinions on Fees and Charges