BILL ANALYSIS
AB 2191
Page 1
Date of Hearing: April 23, 2002
ASSEMBLY COMMITTEE ON JUDICIARY
Ellen M. Corbett, Chair
AB 2191 (Migden) - As Amended: April 1, 2002
SUBJECT : MEDICAL RECORDS: CONFIDENTIALITY
KEY ISSUES :
1)SHOULD THE CONFIDENTIALITY OF MEDICAL INFORMATION ACT (CMIA)
BE AMENDED SO THAT PHARMACEUTICAL COMPANIES, LIKE HEALTH CARE
PROVIDERS, HEALTH PLANS AND CONTRACTORS, MAY NOT DISCLOSE
MEDICAL INFORMATION REGARDING A PATIENT WITHOUT FIRST
OBTAINING AUTHORIZATION, EXCEPT IN SPECIFIED CIRCUMSTANCES?
2)SHOULD PHARMACEUTICAL COMPANIES BE PROHIBITED, LIKE HEALTH
CARE PROVIDERS, HEALTH PLANS, AND CONTRACTORS UNDER CURRENT
LAW, FROM REQUIRING A PATIENT, AS A CONDITION OF RECEIVING
PRESCRIPTION DRUGS, TO SIGN A WAIVER THAT WOULD PERMIT THE
DISCLOSURE OF MEDICAL INFORMATION?
SYNOPSIS
This bill amends the CMIA to provide that pharmaceutical
companies, like health care providers, health plans, and
contractors, may not disclose medical information regarding a
patient without first obtaining authorization except in
specified circumstances. The bill also prohibits pharmaceutical
companies from requiring a patient, as a condition of receiving
health services, to sign an authorization, release, consent or
waiver permitting the disclosure of medical information. The
author and her supporters argue that pharmaceutical companies
should be held to the same confidentiality standards as other
health care providers and assert that the bill is needed to also
ensure that consent cannot be required of patients as a
condition of receiving needed medications.
The analysis suggests amendments to ensure that the author's
intent to hold pharmaceutical companies to the same
confidentiality standards as doctors, health insurers and
pharmacists is carried out. In addition, the author has agreed
to amend the bill to address concerns regarding the bill's
definition of pharmaceutical company to avoid duplicative
treatment of certain entities.
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SUMMARY : Seeks to enhance the confidentiality protections of
the Confidentiality of Medical Information Act. Specifically,
this bill :
1)Adds pharmaceutical companies to the list of entities that may
not disclose medical information regarding patients without
first obtaining authorization except in specified
circumstances.
2)Defines "pharmaceutical company" as any company or business,
or an agent or representative, that manufactures, sells, or
distributes pharmaceuticals, medications, or prescription
drugs.
3)Adds pharmaceutical companies to the list of entities that may
disclose medical information in specified circumstances.
4)Adds pharmaceutical companies to the list of entities that are
prohibited from requiring a patient, as a condition of
receiving health care services, including pharmaceuticals,
medications, or prescription drugs, to sign an authorization,
release, consent, or waiver that would permit the disclosure
of medical information that otherwise could not be disclosed
under the CMIA.
EXISTING LAW :
1)Prohibits, under CMIA, a provider of health care, health care
service plan, or contractor from disclosing medical
information regarding a patient of the provider of health care
or an enrollee or subscriber of a health care service plan
without first obtaining an authorization, except as specified.
(Civil Code section 56.10(a). All further statutory
references are to this Code.)
2)Requires a provider of health care, health care service plan,
or contractor to disclose medical information if the
disclosure is compelled as specified. (Section 56.10(b).)
Existing law also permits a provider of health care or health
care service plan to disclose medical information in specified
circumstances. (Section 56.10(c).)
3)Prohibits a provider of health care, health care service plan
or contractor from requiring a patient, as a condition of
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receiving health care services, to sign an authorization,
release, consent, or waiver that would permit the disclosure
of medical information that otherwise could not be disclosed
under the CMIA. (Section 56.37.)
4)Defines "contractor" as any person or entity that is a medical
group, independent practice association, pharmaceutical
benefits manager, or a medical service organization and is not
a health care service plan or provider of health care.
"Contractor" does not include insurance institutions or
pharmaceutical benefits managers licensed pursuant to the
Knox-Keene Act. (Section 56.05.)
FISCAL EFFECT : The bill as currently in print is keyed fiscal.
COMMENTS : This bill was heard and approved by the Health
Committee on April 16, 2002 by a vote of 18-0. In support of
the measure, the author writes:
AB 2191 would simply extend the Confidentiality of
Medical Information Act (CMIA) to include pharmaceutical
companies and require that they be held to the same
confidentiality standards as doctors, health insurers and
pharmacists. Further, pharmaceutical companies, like
other providers of health care, would be prevented from
requiring medical information as a condition of
dispensing drugs that may otherwise not be disclosed
under any other provision of law. ?
Currently, pharmaceutical companies collect
patient-identifiable information for the purposes of
managing the distribution of drugs that are limited in
supply; coordinating free medication under various
patient-assistance programs; and managing participation
in clinical trials of new drugs. These practices leave a
potentially dangerous loophole within the CMIA because
pharmaceutical companies or their representatives can
collect sensitive medical information but are not held to
the same confidentiality standards that other health care
providers must adhere to under the law.
Ensuring author's intent is carried out. This bill extends the
confidentiality protections of the CMIA by adding pharmaceutical
companies to the list of entities that may not disclose medical
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information regarding patients without first obtaining
authorization except in specified circumstances. The author's
intent is to ensure that pharmaceutical companies are held to
the same confidentiality standards as doctors, health insurers
and pharmacists. In order to ensure this intent is carried out
and pharmaceutical companies are included in the CMIA in the
same manner and to the same extent as health care providers,
health plans and contractors, the Committee may wish to discuss
with the author the benefits of amending the bill to also add
pharmaceutical companies to several other important CMIA
sections.
Should the author and Committee agree, the bill should be
amended to add pharmaceutical companies to the following:
Civil Code section 56.101, dealing with the preservation of
confidentiality of records;
Civil Code section 56.11, relating to requirements for
authorizing release of medical information; and
Civil Code section 56.12, providing for a copy of an
authorization to the patient.
Amendments to address duplicative treatment. This bill adds a
new definition of pharmaceutical company to the CMIA, providing
that a pharmaceutical company means "any company or business, or
an agent or representative thereof, that manufactures, sells or
distributes pharmaceuticals, medications or prescription drugs."
Three pharmaceutical benefit management companies, AdvancePCS,
Express Scripts, and Merck-Medco, have raised concerns about
this definition, arguing that they are already included under
the CMIA's current definition of contractor and they should not
now also be covered under the new definition of pharmaceutical
company. In addition, the companies argue that if defined as a
pharmaceutical company, they would be subject to an increased
level of restriction in discharging their responsibilities and
their ability to administer drug benefits would be disrupted.
In order to address these concerns, the author has agreed to
amend the bill as follows:
On page 3, line 27 after "drug." add: "Pharmaceutical company
does not include a pharmaceutical benefits manager, as
included in subdivision (c) or a provider of health care as
included in subdivision (i)."
With these amendments, AdvancePCS and Express Scripts remove
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their opposition and are neutral on the bill. Although it has
not been verified, it appears that Merck-Medco's concerns have
been addressed by the most recent amendments to the bill as
well.
ARGUMENTS IN SUPPORT : Privacy Rights Clearinghouse supports the
measure stating, "The ability to control the use and flow of
confidential medical information is one of the most frequently
expressed consumer concerns. Potential adverse effects from
unfettered flow of such sensitive information are many."
In support of the measure, Hepatitis C Action & Advocacy
Coalition writes:
People should not have to fear that a drug company would
sell, share, or use their personal medical information
for marketing or other purposes. Nor should they be
coerced into providing such information to a drug company
or its representatives in order to be provided prescribed
medication or treatment. This bill will help protect our
privacy, especially about personal health information.
The Congress of California Seniors supports the measure, noting
that it is "important that this consumer information be
protected as it is with other groups covered by CMIA."
Prior Related Legislation. SB 19 (Figueroa), Ch. 526, Stats. of
1999 significantly strengthened the CMIA by: (1) applying the
rules regarding disclosure of medical information to any
contractor with providers of health care providers; (2)
prohibiting an HMO from conditioning health care services upon
the enrollee waiving medical information confidentiality
protections; (3) prohibiting health care service plans and their
contractors from using medical information for commercial
purposes; and (4) increasing the sanctions for unauthorized
disclosures.
REGISTERED SUPPORT / OPPOSITION :
Support
American Civil Liberties Union
California Academy of Family Physicians
California School Employees Association
City and County of San Francisco
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Congress of California Seniors
Foundation for Integrative Aids Research
Frontline Hepatitis
Hep C Advocate Network
Hepatitis C Action & Advocacy Coalition
Planned Parenthood Affiliates of California
Privacy Rights Clearinghouse
Project Inform
Survive Aids
Opposition
AdvancePCS (unless amended)
Express Scripts (unless amended)
Merck-Medco (prior version)
Analysis Prepared by : Saskia Kim / JUD. / (916) 319-2334