Massachusetts Pharmacists Association: MA Legislative Issues

H.2111, S.835, AN ACT REGULATING PHARMACY AUDITS
Sponsor: Representative Peter Koutoujian and Senator Joan Mendard
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Background:
Pharmacies are routinely audited to ensure that prescriptions are filled in compliance with operating procedures stipulated by regulatory requirements or contractual arrangements with health plans. The audits are generally performed by a Pharmacy Benefits Manager (PBM), a third party that is hired by the health plan to serve as the administrator of prescription benefits for the plan’s members. Pharmacies, who cannot afford to lose the members of a health plan as customers, are forced to comply with intrusive and unfair auditing procedures. The PBMs, unregulated entities in Massachusetts, generally retain the money they recoup from pharmacy audits and therefore have a financial incentive to abuse the process. Pharmacists, in addition to impromptu onsite audits, are subjected to numerous faxed requests for information, often on the same prescription. Failure to comply with any one of these requests enables the PBM to recoup the reimbursement for that prescription. Pharmacies do not have a legitimate process by which to appeal a disputed audit; and PBMs routinely withhold future reimbursements as a means to recoup funds. Intrusive and unfair audits often interfere with the pharmacy’s business and thereby threaten rather than support the accuracy and quality of services provided.
Purpose:
This legislation establishes minimum standards for pharmacy audits to ensure that the process protects the legitimate interests of both health plans and pharmacies; and thereby provides an important quality control mechanism for our health care system.
Highlights:
Requires that audit procedures are detailed in the contract between PBMs and pharmacies;
Ensures that the auditor’s procedures are the same for all pharmacies, independent or chain;
Protects pharmacies from interference with the delivery of pharmacy services during audits;
Enables pharmacists to utilize hospital and physician records to validate pharmacy records;
Details the reporting requirements;
Establishes an appeals process;
Requires the disclosure of the amount of money recovered through audits to the plan sponsor;
Protects pharmacies from the withholding of future reimbursements as a means to recoup funds.

Summary:
H.1080 would allow pharmaceutical companies to offer discount coupons and programs to patients in Massachusetts. These coupons are designed to hold down the cost of medications for patients and provide trial opportunities. By extending to all residents of Massachusetts the federal prohibition on the use of coupons and discount programs by patients covered by Medicaid and Medicare Part D, Massachusetts is the only state in the nation that prohibits its residents from taking advantage of these opportunities.

H.2156, AN ACT PROVIDING FOR THE ESTABLISHMENT AND OPERATION OF A CANCER DRUG REPOSITORY PROGRAM
Sponsor: Representative John W. Scibak
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This bill would provide for a voluntary cancer drug repository program in which donated cancer drugs would be received, stored, and dispensed by prescription to residents of the Commonwealth who meet the eligibility standards established by regulations. A pharmacy or a medical facility with a licensed pharmacy may fully participate in the cancer drug repository program by accepting, storing, and dispensing donated drugs. Donations of cancer drugs may come from any entity, such as a drug manufacturer or medical facility, as long as it is in an unopened container, with at least a 6-month out expiration date, and non-misbranded as determined by an examining pharmacist. The drugs may only be dispensed with a valid prescription by the patients prescriber. Under this act, if the donator, storage facility, and dispenser have all acted in good faith, they are not subject to criminal or civil liability relating to injury, death, or loss to a person caused by the donated drugs.

H.3599, AN ACT ESTABLISHING A PRESCRIPTION MONITORING PROGRAM TASK FORCE
Sponsor: Rep. Christopher N. Speranzo
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Summary:
The prescription monitoring program (PMP) allows officials to track the prescribing and dispensing of Schedule II medications to ensure that they are being used appropriately. This act would create a special task force to investigate the work of PMP, study similar programs in other states, and explore the possibility of expanding PMP beyond Schedule II to include all scheduled substances, in order to ensure more appropriate use of controlled substances and possibly decreased diversion. This task force will be compromised of 12 people and shall include one member each from the department of public health and the office of Medicaid, the Secretary of Health and Human Services or his designee, the House and Senate Chairs of the Joint Committee on Health Care Financing, and a representative from each of the following: Massachusetts Hospital Association, Massachusetts Association of Community Hospitals, Massachusetts Medical Society, Massachusetts Association of Health Plans, Office of the Attorney General, the Massachusetts Pharmacists Association, and the Massachusetts Independent Pharmacist Association. Within 120 days of their first meeting, the task force will file a report with its recommendations and any proposed legislation.

H. 3670, AN ACT TO FORM A SPECIAL COMMISSION TO STUDY PHARMACEUTICAL AND PERSONAL CARE PRODUCT CONTAMINATION IN OUR WATER SUPPLY
Sponsor: Representative Mary E. Grant
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MPhA Position: Support

Summary:
This bill would create a special commission consisting of 14 members: Commissioner of the Department of Public health or a designee, the commissioner of the Department of Environmental Protection or a designee, two academic experts with background in aquatic chemistry and public health, one representative of the Massachusetts Pharmacists Association, one representative of the Massachusetts Medical Society, one oncologist licensed to practice in the Commonwealth, one pharmacist licensed to practice in the Commonwealth, two representatives of manufacturers of pharmaceuticals and/or personal care products, one representative of the Massachusetts Biotech council, one representative of the Massachusetts Water Works Association, one representative of the Massachusetts Watershed Coalition, and one representative of the Massachusetts Water Resources Authority. This commission will examine legal and regulatory changes to current processes that add pharmaceutical and personal care product waste into our water supply thereby contaminating it. These processes may include water filtration, waste water management, proper disposal of pharmaceuticals and medical and human waste, including that of patients on more danger and potent drugs such as chemotherapy, and personal care products. The commission will report its findings and recommendations to the legislature within 12 months of the bills passage.

Sponsor: Representative Bradley H. Jones, Jr.
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MPhA Position: Support

Summary
This bill would establish a state pharmacy council for purpose of reducing prescription drug costs for the state. The council would coordinate agencies in the Executive Office of Health and Human Services and the Division of Insurance to improve program access and quality, and achieve reductions in prescription drugs costs for the state. The council would also review and comment on legislation and regulations with respect to their impact on prescription costs. The council would also recommend policies for ongoing communication and conduct between local, state, and federal agencies that are related to prescription drug programs. The council would be comprised of the Commissioner of Public Health or designee, the Commissioner of Insurance or designee, the Secretary of Elder Affairs or designee, Secretary of Health and Human Services or designee, three consumers appointed by the governor, and one member each from the following: Massachusetts Medical Society, Massachusetts Pharmacists Association, Massachusetts Independent Pharmacists Association, Massachusetts Chain Pharmacy Council, Massachusetts Society of Health-System pharmacists, Massachusetts Biotechnology council, Harvard Pilgrim Health Care, Blue Cross Blue Shield, Tufts Health Plan, Commonwealth Communities, and Massachusetts Association of Health Plans.

H.2067, AN ACT RELATIVE TO ELECTRONIC PRESCRIPTIONS
Sponsor: Representative Bradley H. Jones, Jr.
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Summary
This bill would require all pharmacies in the Commonwealth to have and utilize an electronic prescription system by January 1, 2012. Each system must be approved by the Massachusetts e-health institute which will oversee the installation and must be compatible with the statewide interoperable electronic health records network. The institute is also responsible for informing physicians of the pharmacies that have the system available and how to operate the system. Pharmacies that meet certain criteria may apply to the institute for financial assistance in an amount no greater than $2,000.

H.2091, AN ACT RELATING TO INTERNET PRESCRIPTION CONSUMER PROTECTION
Sponsor: Representative Peter Koutoujian
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Summary
This bill would provide protections to consumers by requiring all internet pharmacies to make certain disclosures to patients, such as listing all affiliated parties, e.g., pharmacists and physicians working with or for the site. All internet pharmacies will need to meet the following requirements before being allowed to dispense prescription medications:
1) The Site and electronic mail service used must be in complete compliance with federal law as it applies to sites or electronic mail;
2) The pharmacy must be in complete compliance with all relevant state law and will be regulated by the Massachusetts Board of Registration in Pharmacy;
3) If a foreign entity, must be registered with the secretary of state and in compliance with all requirements for foreign corporations provided in any applicable state law;
4) Any affiliate practitioner who sells, dispenses, delivers, or distributes the prescription-only product must be in compliance with all requirements of relevant state law;
5) Any practitioner who writes a prescription through an Internet site or electronic mail for a person located in this state that is not an established patient, must be licensed by the applicable licensing board and in compliance with all applicable laws.

1) Clearly display the name, principal place of business address, telephone number, and permit number appointed by the board or Certification by the National Association of Boards of Pharmacy (NABP) as a Verified Internet Pharmacy Practice Sites (VIPPS) site with the VIPPS seal with a link to the NABP’s verification site displayed, of each pharmacy making the sales, dispensing, or delivering the products;

2) Will not be allowed to waive, limit, or disclaim any liability to which any other pharmacy practicing within the state is subject.

Funding will be provided through a separate fund which will be established to hold all monies collected from licensing fees associated with the internet pharmacy.

H.2152, AN ACT RELATIVE TO THE SAFE DISPENSING OF PAIN MANAGEMENT MEDICATION
Sponsor: Representative John W. Scibak

Summary

This bill would permit Schedule II and III medications to be filled for a maximum 90 day supply at each fill. Currently, Schedule II and III can be filled for only a 30 day supply.