PART 2.7. PHYSICIAN PRESCRIBING PRACTICES ACT
57.
This part shall be known and may be cited as the “Physician Prescribing Practices Act.”58.
(a)For purposes of this part:(a) “Data vendor” means any California or out-of-state entity that acquires physician prescription data from pharmacies or other sources and sells or transfers that data directly, or through intermediaries, to pharmaceutical companies or pharmaceutical benefits managers for any commercial purpose and whose primary business is the collection of this data.
(b) “Licensee” means a person described in Section 4036 or 4037 of the Business and Professions Code.
(c) “Physician” means a person described in Section 2041 of the Business and Professions Code.
(d) “Physician prescribing data” means information that sets forth a prescription written on or after the operative date of this part by a physician in combination with any data that individually identifies the physician, including a unique identifier assigned for tracking purposes, telephone number, e-mail address, medical identification number, business or home address, or any other information that can reasonably be used to identify the physician or track the prescribing habits of the physician.
(e) “Release to a third party” or “release” does not include communication or use of physician prescribing data among covered entities that participate in an organized health care arrangement, as defined in 45 C.F.R. 160.103.
59.
A person or entity, including a licensee, may sell, release to a third party, or exchange for remuneration, any physician prescribing data only as provided in this part.60.
A person or entity, including a licensee, may sell, release to a third party, or exchange for remuneration, physician prescribing data to a data vendor, only if all of the following apply:(a) The data vendor voluntarily assumes a duty to review and comply with the “Do Not Use” list described in Section 71 at least once every six months and owes this duty to a licensee who sells, releases to a third party, or exchanges for remuneration, physician prescribing data, and every physician who voluntarily joins the list described in this part.
(b) The data vendor enters into a contract with the licensee or the licensee’s agent or subcontractor not to sell, release to a third party, or exchange for remuneration, physician prescribing data of any physician included on the list described in Section 71 that does all of the following:
(1) Requires the data vendor to be subject to the jurisdiction of this state for enforcement by private parties and by the Attorney General of this state for a violation of this part.
(2) If the data vendor is not a California corporation, or is not engaged in business activity in California, includes a provision authorizing the Attorney General of the state of incorporation, on its own or in conjunction with the Attorney General of this state, to prosecute violations of this part, as well as providing for private enforcement in the state of incorporation.
(3) Provides that the data vendor agrees to comply with this part.
(c) The data vendor is not licensed in California or any other state or country to manufacture or distribute dangerous drugs, as defined in Section 4022 of the Business and Professions Code.
61.
(a) Nothing in this part may be construed to limit or restrict the release of physician prescribing data necessary for any local, state, or federal governmental oversight or regulatory activity, including, but not limited to, the release of physician prescribing data to a local, state, or federal law enforcement or public health authority in furtherance of its regulatory activity.(b) Nothing in this part shall be construed to limit or restrict the transfer, sale, or release of physician prescribing data, including data from physicians on the “Do Not Use” list, obtained from a licensee or data vendor to a vendor whose use of the data is limited to making that data available exclusively to local, state, or federal governmental law enforcement and regulatory agencies for legitimate law enforcement purposes.
62.
Nothing in this part may be construed to limit or restrict the release of physician prescribing data necessary for the processing of a health care claim. Any person or entity that receives physician prescribing data pursuant to this section may sell, release to a third party, or exchange for remuneration that data only if the entity agrees to review and comply with the “Do Not Use” list described in Section 71 at least once every six months, and acknowledges that it owes this duty to every physician who voluntarily joins the list as described in this part.63.
Nothing in this part is intended to prohibit or limit an individual patient or a physician from releasing any identifiable information relating to a prescription that the patient received, or that the physician wrote, that is not otherwise restricted or prohibited by law.64.
Nothing in this part is intended to limit or restrict the otherwise lawful activities of a licensee.65.
(a) Nothing in this part may be construed to limit or restrict the release of physician prescribing data to any of the following:(1) A licensed health care professional, if the release is directly related to providing health care to a patient.
(2) A health insurer or disability insurer, health care service plan, pharmacy benefit manager, employer-sponsored health benefit plan, or their contractors, if the data is directly related to administering or monitoring the use of a health care benefit.
(3) An authorized operator of a program related to the treatment of chronic and seriously debilitating or life-threatening conditions, as defined in subdivisions (d) and (e) of Section 1367.21 of the Health and Safety Code.
(4) An employee benefit plan or any other person or private entity responsible for paying for health care services rendered to the patient, if the physician prescribing data is reasonably necessary to complete or verify a health care transaction related to the prescription information sought to be disclosed.
(5) Any health care, health care service plan, contractor, or other health care professional or facility exclusively for purposes of diagnosis or treatment of a patient.
(6) Use by a health care service plan or health insurer or disability insurer or its contractor for quality review purposes as as permitted or required by Section 1367.01 or 1370 of the Health and Safety Code or Section 10123.135 or subdivision (d) of Section 10133 of the Insurance Code.
(b) Any entity receiving physician prescribing data pursuant to paragraph (2) of subdivision (a) is authorized to release or sell the data only pursuant to the restrictions set forth in Section 60. Any other disclosure of the data, which is not otherwise lawful, is prohibited. data if:
(1) Each entity voluntarily assumes a duty to review and comply with the “Do Not Use” list described in Section 71 at least once every six months, and owes this duty to every physician who voluntarily joins the list described in this part.
(2) (A) If the entity is a California corporation or is engaged in business activity in California, it is presumed to have consented to the jurisdiction of this state for enforcement by private parties and by the Attorney General of this state for a violation of this part.
(B) If the entity is not a California corporation, or is not engaged in business activity in California, but receives prescriber data of a physician licensed in this state, the entity agrees to authorize the Attorney General of the state of incorporation, on its own or in conjunction with the Attorney General of this state, to prosecute violations of this part, as well as provide for private enforcement in this state and in the state of incorporation.
(c) Nothing in this part is intended to limit or restrict the release of prescriber data for purposes of otherwise lawful pharmacovigilence programs.
(d) Nothing in this part is intended to limit or restrict the release of prescriber data of injectable drugs administered in a physician’s office.
66.
Nothing in this part may be construed to prohibit the release of aggregate prescription data to any individual or entity, provided that data does not include identifiable physician prescribing data as described in this part.67.
(a) Nothing in this part may be construed to prohibit the release of physician prescribing data if it is solely intended to be used for clinical trials or established research projects conducted in accordance with protocols, guidelines, or standards recognized by the federal Health and Human Services Agency, the federal Food and Drug Administration, the National Institutes for Health, the National Cancer Institute, or the Centers for Disease Control. The data acquired for clinical trials or established research projects shall not be used for any other purpose except as described in this section.(b) Any entity receiving physician prescribing data pursuant to this section may not use the data for any other purpose.
68.
Nothing in this part may be construed to limit or restrict the release of physician prescribing data for the purposes of providing the physician with information regarding action by the state or by the federal Food and Drug Administration limiting or disallowing the sale or use of a specific drug, or to provide the physician with information regarding adverse events related to a specific drug or medical device.69.
Nothing in this part shall prohibit the otherwise lawful use or release of physician prescribing data for litigation purposes.70.
Any physician included on the list described in Section 71 may enforce the provisions of this part, on his or her own behalf, if his or her physician prescribing data has been used, sold, or otherwise released in violation with this part.71.
(a) The Medical Board of California shall maintain a “Do Not Use” list on which physicians licensed in this state may register. Registration on the “Do Not Use” list is intended to limit the release of physician prescribing data pursuant to this article. The Medical Board of California shall publish on its Web site an electronic process not connected with the license renewal process to allow physicians in this state to place their names on the list. The Medical Board of California may contract with a third party for the creation or maintenance of the list.(b) The Medical Board of California may charge a physician a reasonable fee for the listing of a physician’s name on the “Do Not Use” list, and may charge a person or entity a reasonable fee for the right to access the information contained on the list.
(c) The Medical Board of California may promulgate all necessary regulations to carry out the requirements of this part.
(d) Registration on the list established pursuant to this section shall last for no less than one year, and no more than two years, as determined by the Medical Board of California.
72.
The Medical Board of California shall pay for all start-up costs of implementing this part by a loan from the Contingent Fund of the Medical Board of California. The loan, the terms of which shall be set by the board, shall be paid back from the fees authorized by this part. If the board contracts for the creation and maintenance of the “Do Not Use” list by a third party, the board may authorize that third party to assess and collect fees authorized pursuant to Section 71.