PRINTER'S NO. 1506
No. 1194 Session of 1999
INTRODUCED BY MURPHY, MOWERY, KASUNIC, ROBBINS, WAGNER, COSTA,
EARLL, TOMLINSON, WHITE, KUKOVICH, TARTAGLIONE, LEMMOND,
WAUGH, STOUT, THOMPSON, O'PAKE, SCHWARTZ, WENGER AND SLOCUM,
NOVEMBER 16, 1999
REFERRED TO PUBLIC HEALTH AND WELFARE, NOVEMBER 16, 1999
AN ACT
1 Providing for the confidentiality of patient prescription
2 records; authorizing disclosures of prescription records
3 under certain conditions; and providing for penalties.
4 The General Assembly of the Commonwealth of Pennsylvania
5 hereby enacts as follows:
6 Section 1. Short title.
7 This act shall be known and may be cited as the Prescription
8 Records Confidentiality Act.
9 Section 2. Definitions.
10 The following words and phrases when used in this act shall
11 have the meanings given to them in this section unless the
12 context clearly indicates otherwise:
13 "Benefit manager." Any person or entity that administers a
14 pharmacy benefit on behalf of an insurance company, health
15 maintenance organization, employer-sponsored plan or government
16 entity.
17 "Disclosure." The release, transfer or provision of access
1 in any manner to a prescription record to a person other than
2 the subject of that record. The term does not include the use of
3 health information for a permitted purpose by an authorized
4 person or entity or by its employees, agents or contractors.
5 "Medical practitioners." A physician, dentist or any other
6 individual duly authorized and licensed by law to prescribe
7 drugs.
8 "Patient." A natural person for whom, at the direction of a
9 medical practitioner, a pharmacist fills and dispenses a
10 prescription.
11 "Person." A natural person, a sole proprietor, a
12 partnership, association, corporation, limited corporation,
13 limited partnership and any other entity recognized by law. The
14 term includes the Commonwealth and any political subdivision of
15 the Commonwealth.
16 "Pharmacist." A person duly licensed by the State Board of
17 Pharmacy to engage in the practice of pharmacy.
18 "Prescription." A written or oral order issued by a duly
19 licensed medical practitioner in the course of professional
20 practice for a controlled substance, other drug or device or
21 medication which is dispensed for use by a consumer.
22 "Prescription record." The unique written and electronic
23 information compiled by a pharmacist for each prescription
24 dispensed by that pharmacist to a patient that directly
25 identifies the patient. This term does not include any such
26 information from which all patient identifiers have been removed
27 or that does not directly identify the patient, including
28 information that has been aggregated, encrypted or encoded.
29 Section 3. Confidentiality of prescription records.
30 (a) General rule.--The prescription record of any patient
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1 for whom a prescription is dispensed is confidential and, except
2 as provided in section 4, not subject to disclosure.
3 (b) Retention of confidentiality.--Any prescription record
4 disclosed under section 4 retains its confidential nature after
5 disclosure.
6 Section 4. Disclosure of prescription record.
7 (a) General rule.--Except as provided in sections 5 and 6, a
8 prescription record shall not be disclosed to any person without
9 the specific authorization, whether written, electronic or such
10 other form as indicating the patient's authorization, of the
11 patient for whom the prescription is dispensed. In the case of a
12 patient under the age of 18, authorization may be given by a
13 parent or legal guardian. Nothing in this act shall be construed
14 to prohibit disclosure of prescription records to researchers
15 operating pursuant to Federal or State laws and regulations.
16 (b) Content of disclosure authorization.--Prescription
17 records may be disclosed under subsection (c) upon the approval
18 of the patient as evidenced by a signed authorization which
19 complies with the provisions of this subsection. The disclosure
20 authorization shall be in writing and shall contain all of the
21 following elements:
22 (1) The name and signature of the patient and the date
23 of signature. If the authorization is in electronic form, a
24 unique identifier of the patient and the date the patient
25 authenticated the electronic authorization must be stated in
26 place of the patient's signature and date of signature.
27 (2) The persons authorized to disclose prescription
28 record information and the nature of the prescription record
29 information to be disclosed.
30 (3) The identity or description of the third party to
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1 whom the prescription record information is to be disclosed.
2 (4) The specific purpose or purposes of the disclosure
3 and whether any subsequent disclosures may be made pursuant
4 to the same authorization.
5 (5) The duration of the authorization.
6 (6) A statement that the patient may refuse
7 authorization to disclose all or some prescription record
8 information but that refusal may result in denial of coverage
9 or a claim for benefits or other insurance or other adverse
10 consequences.
11 (7) A statement that the authorization may be revoked at
12 any time by the patient by executing a written revocation,
13 subject to the right of any person who acted in reliance on
14 the authorization prior to receiving notice of revocation,
15 instructions on how to revoke an authorization and a
16 statement that revocation may be the basis for denial of
17 benefits or other insurance coverage or benefits.
18 (8) A statement that the patient is entitled to a copy
19 of the authorization form.
20 (c) Duration of disclosure information.--A written
21 disclosure authorization under this section is valid for a
22 period of 24 calendar months unless otherwise specified in the
23 disclosure authorization. Any period of time less than or in
24 excess of the 24-calendar-month period must be conspicuously
25 noted and is subject to revocation by the patient in the manner
26 set forth in subsection (d).
27 (d) Revocation of disclosure authorization.--A patient may
28 revoke a written authorization to disclose at any time, subject
29 to the rights of any person who acted in reliance on the
30 authorization prior to receiving notice of revocation. A
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1 revocation of authorization must be in writing and must be
2 signed and dated by the patient. In the case of a patient under
3 the age of 18, authorization may be given by a parent or legal
4 guardian. If the revocation is in electronic form, a unique
5 identifier of the patient and the date the patient authenticated
6 the electronic revocation must be stated in place of the
7 patient's signature and date of signature. A revocation of
8 authorization must be retained with the patient's authorization
9 and prescription record information.
10 Section 5. Disclosure with valid authorization.
11 Upon receipt of a valid disclosure authorization under
12 section 4, a pharmacist or a benefit manager shall have
13 authority to and may disclose prescription record information
14 relating to the patient who signed the disclosure authorization.
15 Any prescription record information disclosed under this section
16 shall not be used for the purpose of marketing or sales
17 unrelated to the practice of pharmacy or to the administrative
18 or compliance responsibilities as set forth or as part of a
19 benefit plan or benefit programs under a health plan.
20 Section 6. Disclosure without valid authorization.
21 A pharmacist or a benefit manager shall have the authority to
22 and may disclose patient specific prescription record
23 information to any of the following:
24 (1) To a pharmacist or another medical practitioner or
25 health care facility for the diagnosis, treatment or care of
26 the patient.
27 (2) To a family member when the patient is receiving
28 diagnosis, treatment or care in a health care facility.
29 (3) To Federal, State or local governmental entities in
30 order to protect the public health and welfare when reporting
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1 is required or authorized by law.
2 (4) To Federal, State or local governmental entities
3 pursuant to statute, subpoena or court order for use in an
4 investigation relating to the patient, medical practitioner
5 or health care facility, pharmacist, pharmacy, a health,
6 life, disability insurance or health care benefits entity.
7 (5) To a court when directed by a court order or
8 subpoena.
9 (6) To a third party pursuant to a court order or
10 subpoena.
11 (7) To a person conducting a clinical trial which is
12 sponsored, authorized or regulated by the Federal Food and
13 Drug Administration, provided that the released prescription
14 record information may not include the identification of the
15 patient.
16 (8) To a third party for the purposes of encoding,
17 encrypting or otherwise anonymizing the information.
18 (9) To an agent or contractor for the purpose of
19 fulfilling or performing any permitted function or use of the
20 information.
21 (10) To a third party as necessary to conduct
22 administration of a benefit plan or benefit programs under a
23 health plan.
24 (11) As otherwise permitted by law.
25 Section 7. Civil action.
26 Any patient whose prescription record information is
27 disclosed contrary to the provisions of this act shall have a
28 civil cause of action against the pharmacist or benefit manager
29 who discloses the information and any person who is the
30 recipient of the information. A cause of action under this
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1 section must be brought within four years of the date the
2 disclosure occurred or within four years of the date the patient
3 knew or should have known of the disclosure.
4 Section 8. Effective date.
5 This act shall take effect in one year.
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