49 Pa. Code § 33.214

Current through Register Vol. 54, No. 45, November 9, 2024

Section 33.214 - Disclosure of financial or ownership interest-statement of policy

(a)Purpose. This section provides guidelines for compliance with the act of May 26, 1988 (P. L. 403, No. 66) (35 P. S. §§ 449.21-449.23), which requires practitioners of the healing arts, before referring a patient to a facility or entity engaged in providing health-related services, tests, pharmaceuticals, appliances or devices, to disclose to the patient any financial or ownership interest of the practitioner in the facility or entity.

(b)Definitions. The following words and terms, when used in this section, have the following meanings, unless the context clearly indicates otherwise:

Appliances or devices-The term includes therapeutic equipment, instruments and prosthetic appliances.

Disclose to the patient-The practitioner of the healing arts makes known to the patient at the time a referral is made that the practitioner has a financial or ownership interest in the facility or entity to which the patient is referred. The practitioner shall also inform the patient of the patient's freedom to choose an alternate provider.

Facility or entity-The term includes another practitioner of the healing arts, licensed health care practitioner, partnership, association, group practice, business corporation and professional corporation not on the premises of the practitioner.

Financial interest of the practitioner or ownership by the practitioner in the facility or entity-A financial or ownership interest to any extent or degree, including interests held by the practitioner, the practitioner's spouse or the practitioner's minor children.

Health-related services-The term includes radiologic services, physical therapy, counseling and laboratory services.

Pharmaceutical-Pertaining to a drug or pharmacy.

Practitioner of the healing arts-A dentist or dental hygienist.

Referral-The act of prescribing, ordering, directing, redirecting or recommending to a patient a specific facility or entity which provides a health-related service, test, pharmaceutical, appliance or device, either by means of prescription, recommended course of treatment, or direction concerning diagnostic or therapeutic treatment or services.

Test-The term includes a test necessary for dental diagnosis or treatment.

(c)Use of patient disclosure forms.

(1) It is the practitioner's responsibility to disclose to the patient a financial or ownership interest when making a referral covered by the act. Meaningful disclosure shall be given to each patient at the time a referral is made. The disclosure may be made orally or in writing. In either event, the Board recommends that the disclosure be memorialized, dated and signed at the time of referral by the practitioner and the patient, and that the practitioner maintain written evidence of the disclosure. If the practitioner delegates the disclosure to another person in the practitioner's office, the Board recommends that the disclosure be memorialized, dated and signed by the person making the disclosure and the patient.

(2) The memorialization of the disclosure shall be substantially in the following form:

I ACKNOWLEDGE THAT I HAVE BEEN ADVISED BY MY DENTIST/DENTAL HYGIENIST THAT HE/SHE HAS A FINANCIAL OR OWNERSHIP INTEREST IN THE FACILITY OR ENTITY TO WHICH HE/SHE HAS REFERRED ME, AND THAT HE/SHE HAS ADVISED ME THAT I AM FREE TO CHOOSE ANOTHER FACILITY OR ENTITY TO PROVIDE THE SERVICE, DRUG, DEVICE OR EQUIPMENT.

(3) In an enforcement proceeding before the Board, the memorialization referred to in paragraphs (1) and (2) shall constitute presumptive evidence that the practitioner made the required disclosure. The disclosure to the patient is not, however, the act of the patient signing the form but is, rather, the act of the practitioner disclosing to the patient the practitioner's financial or ownership interest and advising the patient of the patient's freedom of choice.

(d)Guidelines for disclosure. With regard to patients who are minors, unconscious, of unsound mind or otherwise incompetent to understand their freedom of choice in selection of a facility or entity, disclosure shall be made to the guardian, spouse or closest adult next of kin. Disclosure of a practitioner's interest cannot be accomplished unless patients are competent to understand their freedom of choice. A practitioner will not be disciplined for failure to disclose in the event of an emergency which prevents consulting the patient or the patient's representative.

49 Pa. Code § 33.214

The provisions of this §33.214 adopted May 13, 1977, effective 5/14/1977, 7 Pa.B. 1284; amended June 23, 1995, effective 6/24/1995, 25 Pa.B. 2492.