Bill Text: MS HB1328 | 2011 | Regular Session | Engrossed

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Bill Title: Electronic Prescription Adoption Act; enact.

Spectrum: Partisan Bill (Democrat 3-0)

Status: (Failed) 2011-03-01 - Died In Committee [HB1328 Detail]

Download: Mississippi-2011-HB1328-Engrossed.html

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MISSISSIPPI LEGISLATURE

2011 Regular Session

To: Public Health and Human Services

By: Representatives Dedeaux, Scott, Clark

House Bill 1328

(As Passed the House)

AN ACT TO BE KNOWN AS THE ELECTRONIC PRESCRIPTION ADOPTION ACT; TO DESCRIBE THE APPLICATION OF THE ACT, STATE THE PURPOSE OF THE ACT, AND MAKE LEGISLATIVE FINDINGS; TO DEFINE CERTAIN TERMS FOR THE PURPOSES OF THE ACT; TO PROVIDE THAT ELECTRONIC PRESCRIBING DEVICES SHALL BE ESTABLISHED IN A MANNER TO SUPPORT MEANINGFUL USE OF ELECTRONIC HEALTH RECORDS AS REQUIRED BY FEDERAL LAW; TO DIRECT THE STATE BOARD OF PHARMACY TO WORK IN CONJUNCTION WITH THE MISSISSIPPI HEALTH INFORMATION NETWORK (MS-HIN) IN CARRYING OUT ITS DUTIES UNDER THIS ACT, IN ORDER TO ENSURE THAT THE ELECTRONIC TRANSMISSION OF PRESCRIPTIONS AND ELECTRONIC PRESCRIBING DEVICES ARE COMPATIBLE WITH THE MS-HIN; TO PRESCRIBE THE STANDARDS FOR ELECTRONIC TRANSMISSION OF PRESCRIPTIONS; TO PROVIDE THAT NO PHARMACY MAY BE ASSESSED A FEE FOR ACCEPTING AN ELECTRONIC PRESCRIPTION OF ANY TYPE; TO PROVIDE WHAT CONSTITUTES ACCEPTABLE ALERTS AND MESSAGES PROVIDED TO A PRESCRIBER; TO PRESCRIBE THE STANDARDS FOR PRIOR AUTHORIZATION AND THE REQUIREMENTS FOR AN ELECTRONIC PRIOR AUTHORIZATION SYSTEM; TO PROVIDE FOR THE APPOINTMENT OF AN ADVISORY COUNCIL TO THE STATE BOARD OF PHARMACY; AND FOR RELATED PURPOSES.

     BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MISSISSIPPI:

     SECTION 1.  This act shall be known and may be cited as the Electronic Prescription Adoption Act.

     SECTION 2.  (1)  This act applies to all electronic prescribing devices used within this state, and to all software and hardware vendors and content managers with respect to those e-prescribing devices regardless of location.  Relevant sections of this act shall also apply to all requirements for prior authorization requests used within this state, and to all software and hardware vendors and content managers with respect to electronic prior authorization requests regardless of location.

     (2)  Through the adoption of this act, the Legislature intends to:

          (a)  Align health information technology systems with the provision of quality care;

          (b)  Reduce administrative barriers to timely and effective care;

          (c)  Ensure that appropriate information regarding medical decisions is available at the time and place of care;

          (d)  Improve the coordination of care and information between hospitals, patients, physicians, payers, laboratories and pharmacies through a secure and effective infrastructure for the exchange of health care information;

          (e)  Allow for access to data for research purposes without compromising patient confidentiality;

          (f)  Ensure that medical decisions remain a joint decision between a patient and his or her health care professional; and

          (g)  Otherwise positively influence the quality, safety and efficiency of health care provided to the citizens of the State of Mississippi.

     SECTION 3.  The Legislature finds and declares that:

          (a)  Significant challenges face the current health care system, including medical errors, poor coordination between health care providers, inefficiency and waste as a result of unneeded and redundant tests, excessive paperwork, and increasing difficulty in managing the growing volume of health information.

          (b)  Health information technology, such as electronic medical records, can greatly improve the quality and safety of care that patients receive, help promote efficiencies in medical practice, and allow for improved tracking of health care data and trends.

          (c)  Prior authorization programs can offer a valuable tool in managing the care of individual patients to make sure that certain therapies are verified before administration.

          (d)  There is a diversity of approaches to prior authorization programs among health plans that can lead to confusion among health care professionals that act as an inappropriate barrier to care, suggesting the need to uniform procedures to submit such requests.

          (e)  Information about what constitutes an acceptable reason for a prior authorization request is not universally known to prescribers and should be made readily available to those providers.

          (f)  Electronic prescriber and electronic medical record systems do not typically allow the granting of prior authorization at the point-of-care.

          (g)  As federal health reform implementation advances in the states, health information technology (HIT), including electronic medical records (EMRs) and electronic prescribing systems (eRx), will play a growing role in facilitation of medical decisions.  Although most federal provisions for HIT implementation were included in the American Recovery and Reinvestment Act of 2009 (Public Law 111-5) (ARRA) stimulus package, its coordination with federal health care reform implementation, the Patient Protection and Affordable Care Act (Public Law 111-148), can be expected to have significant implications for patient care.

          (h)  Sustained leadership on the part of federal and state government, aligned with financial and other incentives, will be needed to accelerate the broader use and implementation of health information technology, particularly electronic medical records.

     SECTION 4.  As used in this act, the following terms shall be defined as provided in this section:

          (a)  "Authorized practitioner" means an individual authorized by state law to write a prescription for a patient under his or her direct care.

          (b)  "Dispenser" means a person or other legal entity licensed, registered or otherwise permitted by the jurisdiction in which the person practices or in which the entity is located to dispense drugs for human use by prescriptions.
          (c)  "Electronic health record" or "EHR" means the aggregate electronic record of health-related information on an individual that is created and gathered cumulatively across more than one (1) health care organization and is managed and consulted by licensed clinicians and staff involved in the individual's health and care.  By these definitions, an EHR is an electronic medical record with interoperability, for example, integration to other providers' systems.

          (d)  "Electronic prescribing," "electronic prescription" or "eRx" means the transfer of prescription information from the prescriber to the pharmacy, and to the final payer, by electronic means, instead of by paper, phone, or fax.

          (e)  "Electronic transmission" means transmission of information in electronic form or the transmission of the exact visual image of a document by way of electronic equipment.

          (f)  "Electronic transmission device" means any mechanism used to facilitate the electronic transmission of a prescription by any individual authorized to prescribe in this state.

          (g)  "Medication" means a drug that may not be dispensed for human use without a prescription under the laws of the United States and of this state.

          (h)  "Patient" means the individual for whom the prescriber issues a prescription.
          (i)  "Prescriber" means a physician, dentist or other person licensed, registered or otherwise permitted by the laws of the United States and of this state to issue prescriptions for drugs for human use.

          (j)  "Prescription drug order" means a prescription for a medication in the State of Mississippi as defined under Section 73-21-73(cc).

          (k)  "Prior authorization" means the process of obtaining prior approval for coverage of a prescription drug or other medical product or procedure.

     SECTION 5.  Electronic transmission devices shall transmit information to prescribers and dispensers in accordance with Section 1860D-4(e)(2) of the federal Social Security Act, as amended, applied without regard to whether the patient is eligible for benefits under Title XVIII of the federal Social Security Act, as amended, or whether the drug is a "covered Part D drug" within the meaning of the federal Social Security Act, as amended, or any other covered drug. 

     SECTION 6.  (1)  Electronic prescribing devices shall be established in a manner to support meaningful use of electronic health records as required as part of the ARRA. 

     (2)  The state shall provide financial incentives to Medicaid providers as described in Section 4201 of the ARRA and pursue available Federal Financial Participation for these incentives and the state's administrative costs associated with the program.

     (3)  The State Board of Pharmacy shall promulgate regulations aligning the state rules for the electronic transmission of prescriptions with the most recent regulations for those transmissions with the federal Drug Enforcement Administration [21 CFR Parts 1300, 1304, 1306 and 1311].

     (4)  The State Board of Pharmacy shall work in conjunction with the Mississippi Health Information Network (MS-HIN) established under Section 41-119-1 et seq. in carrying out its duties under this act, in order to ensure that the electronic transmission of prescriptions and electronic prescribing devices are compatible with the MS-HIN.

     SECTION 7.  (1)  All prescription drug orders communicated by way of electronic transmission shall:

          (a)  Be transmitted directly to a pharmacist in a licensed pharmacy of the patient's choice with no intervening person having access to the prescription drug order;

          (b)  Identify the transmitter's phone number or any other suitable means to contact the transmitter for verbal and/or written confirmation, the time and date of transmission, and the identity of the pharmacy intended to receive the transmission, as well as any other information required by federal or state law;

          (c)  Be transmitted by an authorized practitioner or the designated agent of the prescriber; and

          (d)  Be deemed the original prescription drug order, provided that it meets the requirements of this subsection.

     (2)  All electronic transmission devices used to communicate a prescription to a pharmacist shall:

          (a)  Allow any legal prescription drug order to be written and entered into the device without interference or limitations, including a medication limited pick list, multiple prescriptions per electronic transmission or multiple messaging, prior to submission to a pharmacist.

          (b)  Allow the prescription to be written through a neutral and open platform that does not use any means, program, or device, including, but not limited to, advertising, instant messaging, and pop-up messaging, to influence or attempt to influence, through economic incentives or otherwise, the prescribing decision of a health care professional at the point of care.  This paragraph shall apply if such means, program, or device is triggered by, initiated by, or is in specific response to, the input, selection, and/or act of a prescribing health care professional or his agent prescribing a covered outpatient drug or selecting a pharmacy for a patient. 

          (c)  If the pharmacy that a patient wishes to use is unable to receive the intended prescription, a system for printing a copy of the prescription for the patient to bring to the pharmacy shall be provided.

          (d)  Notwithstanding the provisions of paragraph (b), individuals or entities may show information regarding a plan's formulary so long as:    

              (i)  All covered outpatient drugs and pharmacies (in and out of network) available are readily disclosed to the health care professional;

              (ii)  Nothing is designed to preclude or make more difficult the health care professional's or patient's selection of any particular pharmacy or covered outpatient drug; and
              (iii)  An electronic prior authorization process for allowing approval of an exception to the plan formulary or other restriction is available on the device as described in Section 10 of this act, providing real-time adjudication.

          (e)  As set forth in paragraph (b), be limited to messages to the prescriber and his or her staff that are consistent with the label, substantially supported by scientific evidence, accurate, up to date, and fact-based, including a fair and balanced presentation of risks and benefits, and support for better clinical decision-making, such as alerts to adverse events and access to formulary information.  This information must be consistent with the United States Food and Drug Administration regulations for advertising pharmaceutical products and not be selectively or competitively pushed to the prescriber.  The distribution of that information must not diminish the patient's right to appeal.

          (f)  The prescribing practitioner may authorize his agent to communicate a prescription drug order orally or by way of electronic transmission to a pharmacist in a licensed pharmacy, provided that the identity of the transmitting agent is included in the order.

          (g)  The pharmacist shall exercise professional judgment regarding the accuracy, validity, and authenticity of the prescription drug order communicated by way of electronic transmission consistent with existing federal or state laws and rules.

          (h)  All electronic equipment for the receipt of prescription drug orders communicated by way of electronic transmission shall be maintained so as to ensure against unauthorized access.

          (i)  Persons other than those bound by a confidentiality agreement pertaining to a patient's medical record shall not have access to pharmacy records containing protected health information concerning the pharmacy's patients.

     (3)  No pharmacy may be assessed a fee for accepting an electronic prescription of any type.

     SECTION 8.  (1)  Alerts and messages provided to a prescriber must be meaningful to the appropriate delivery of care to a patient.  Acceptable alerts and communications include:

          (a)  Categorized or prioritized based on their clinical importance, including severity and likelihood of any adverse events;

          (b)  Individually suppressible by the prescriber, if they relate to either rare or minor adverse events;

          (c)  Able to be overridden by the prescriber so that the prescriber can prescribe his or her medication of choice for the patient;

          (d)  Display the date that the decision support rules underlying each alert or message were last updated, as well as a link to a general description of the decision support rules and the source of any financial support received in connection with the development of those rules;

          (e)  Clearly indicate whether the alert or other message relates to the medication's safety or efficacy for the patient.

     (2)  Information provided to a prescriber through an e-prescribing device shall not contain any material false statements or omissions.  For purposes of this section, a "material false statement or omission" means an untrue statement of a material fact or an omission to state a material fact necessary in order to make the statements made under the circumstances in which they are made not misleading.

     (3)  Any information provided to a prescriber through an e-prescribing device relating to the safety or efficacy of any drug (including any alerts or other messages) shall include a readily accessible citation to any sources that support the accuracy of the information. 

     SECTION 9.  (1)  Requests for prior authorization must use a standard format for those requests as defined by the State Board of Pharmacy.

     (2)  In accordance with subsection (1) of this section, key elements to be captured in prior authorization request form, whether electronic or paper, shall include:

          (a)  Patient information data fields, including:

              (i)  Patient name, date of birth, address and gender;

              (ii)  Patient health plan or pharmacy plan name; and

              (iii)  Patient health plan or health plan identification number.

          (b)  Prescriber data fields, including:

              (i)  Prescriber name, phone number and National Provider Identifier (NPI);

              (ii)  Point of Contact (POC) name and phone number, if different than the prescriber;

              (iii)  Clinic name and address; and

              (iv)  Prescriber business address and fax number.

          (c)  Pharmacy information data fields, if transmitting the prescription electronically:

              (i)  Pharmacy name, phone number and Pharmacy National Provider Identifier; and

              (ii)  Pharmacy address.

          (d)  Prescription drug information data fields, including:

              (i)  Name, strength, quantity and dosing schedule of requested drug;

              (ii)  Other medications tried and explanation of results;

              (iii)  Drug allergies; and

              (iv)  Current clinical findings and management.

     (3)  Specific information shall be provided to the prescriber pertaining to acceptable reasons for a prior authorization approval upon the request of the prescriber.

     (4)  At a minimum, prior authorization shall be granted if the preferred drug:

          (a)  Has been ineffective in the treatment of the covered person's disease or medical condition, or based on both sound clinical evidence and medical and scientific evidence; or

          (b)  Is expected to be ineffective based on the known relevant physical or mental characteristics of the covered person and known characteristics of the drug regimen, is likely to be ineffective or adversely affect the drug's effectiveness or patient compliance; or

          (c)  Has caused or based on sound clinical evidence and medical and scientific evidence is likely to cause an adverse reaction or other harm to the covered person.

     SECTION 10.  In accordance with Section 9 of this act, an electronic prior authorization system shall:

          (a)  Be required as a part of systems that facilitate electronic submission of prescriptions;
          (b)  Use a universal format for prior authorization requests to be developed by the State Board of Pharmacy under Section 9 of this act;
          (c)  Provide specific feedback to the provider on acceptable and approvable reasons for approval of a prior authorization request for a medication prescribed for a patient; and
          (d)  Provide real-time feedback on the prior authorization request that facilitates an explanation of benefits for the patient with information on how to appeal the denial of the requested medication.
     (2)  The State Board of Pharmacy shall appoint an advisory committee to provide input to the board on the design of the universal prior authorization format, including a comparable paper form when an electronic prescribing device is not used.  Members of the advisory committee shall include:
          (a)  Two (2) physicians;

          (b)  Two (2) pharmacists, including one (1) member of the State Board of Pharmacy and one (1) member of the Mississippi Independent Pharmacies Association;

          (c)  Two (2) patient advocates;

          (d)  One (1) representative of the insurance industry; and

          (e)  One (1) member of the Board of Directors of the Mississippi Health Information Network (MS-HIN) established under Section 41-119-1 et seq.

     SECTION 11.  Sections 1 through 10 of this act shall stand repealed from and after July 1, 2014.

     SECTION 12.  This act shall take effect and be in force from and after July 1, 2011.