Massachusetts Pharmacists Association: MA Regulatory Issues

Notice of Public Hearing: July 28, 2009
The Division of Health Care Finance and Policy (“Division”) will hold a public hearing on Tuesday, July 28, 2009 at 10 A.M. at the Division, 2 Boylston Street, Boston, MA relative to proposed amendments to:

The proposed amendments, effective August 1, 2009, alter the Usual and Customary Charge to ensure that payment for MassHealth and worker’s compensation do not exceed prices that a pharmacist has agreed to accept from any other payer. In addition, the amendment requires that Medicare prices be part of the Uniform and Customary Charge calculation for payment for blood clotting factors. Also, the amendments add language to the 340-B section that describes payment to 340-B providers of blood clotting factor as the cost of the factor plus $.09 per unit. This language is currently contained in a special contract MassHealth has with these providers and folding this language into the regulations eliminates the need for the special agreement. Finally, these amendments expand the definition of the term “provider” to eliminate the need for a similar term “eligible provider”. [View Notice]

Stores or pharmacies engaged in the drug business, as defined in section 37, shall inform the department of public health of any improper dispensing of prescription drugs that results in serious injury or death, as defined by the department in regulations, as soon as is reasonably and practically possible, but not later than 15 working days after discovery of the improper dispensing. The department of public health shall promulgate regulations for the administration and enforcement of this section.

Massachusetts State Board of Registration in Pharmacy License Fees
The following changes to licensing fees were adopted:

(1) Pharmacist License - Application $150 per application
(2) Pharmacist License - Original (all type classes) 150 per license
(3) Pharmacist License - Renewal 150 biennial
(4) Certification of Fitness Registration (all types) and Renewal 180 biennial
(5) Controlled Substance Registration (all types) and Renewal 225 biennial
(6) Wholesale Drug Distributors (all types) and Renewal 900 annual
(7) Drug Store Permit/Nuclear Pharmacy (all types) and Renewal 525 biennial
(8) Pharmacy Reciprocity - Application 300 per application
(9) Pharmacy Law Examination Fee 47 per examination
(10) Pharmacy Technician - Application/Original Certificate 60 per application
(11) Pharmacy Technician - Renewal 60 biennial

Frequently asked questions regarding (PMP) regulations are contained in the this document: [FAQ]
This document responds to questions regarding the 2008 amendments to the Massachusetts Prescription Monitoring Program Regulations asked by:

Participants in the September 24 & 26 MA PMP Teleconference with software providers and pharmacy directors.
Pharmacy community members during PMP outreach site visits and presentations.
Attendees at continuing education programs offered through Northeastern University Bouve College of Health Sciences School of Pharmacy and Massachusetts College of Pharmacy and Health Sciences.
E-mails sent to the DCP e-mail address (dcp.dph@state.ma.us)

This FAQ provides information that can assist software providers as they make software revisions and pharmacists and pharmacy technicians when they inspect customer identification and enter data elements into computers.

Among the questions addressed in the FAQ is how pharmacies may collect Customer ID information for residents in long-term care and individuals in other facilities (see “4.4 Customer ID for residents in Long Term Care Facilities and other DPH Licensed Health Care Facilities”). Part of the resolution involves permitting pharmacies to use facilities’ DPH Health Care Quality license numbers. Please contact Atlantic Associates for licensees’ numbers.

You are encouraged to check periodically for updates in the FAQ, changes in the Handbook, and other information by following the “Prescription Monitoring Program (PMP)” link at http://mass.gov/dph/dcp. The download links will contain the dates of the most recent updates.

Emergency Contraception

Dispensing Guidelines

Model Standing Order

Dispensing Annual Report

Beginning April 1, 2008, in order for outpatient medications to be reimbursable by the federal government through Medicaid it is required that all written, non-electronic prescriptions be executed on tamper-resistant blanks.

This requirement does not apply to prescriptions that are:
• electronic, verbal, or faxed;
• reimbursed through a Mass Health Managed-Care Organization (MCO);
• for drugs reimbursed as part of a bundled rate, and,
• for refills when the original prescription was filled before October 01, 2008.

Emergency fills are allowed as long as a prescriber provides a verbal, faxed, electronic, or compliant written prescription within 72 hours.

CMS outlined requirements for tamper-resistant prescriptions, but allowed each state to define the requirements for tamper-resistant prescription. By April 1, 2008, prescription blanks need to meet one of these baseline requirements set by CMS. By October 1, 2008, all three requirements must be met for prescriptions to be considered tamper-resistant. (Click here for details.)

MPhA and other organizations met with MassHealth to discuss a recommendation for a tamper-resistant blank that would be easily recognizable to all providers. As a result, MassHealth recommends the following standards:

• A heat sensitive feature that will either change color or disappear and then reappear when rubbed (e.g. sensing imprint or thermochromic ink) ;
• Erasure protection, such that the prescription has a background that resists alteration and erasure (e.g. special security paper)
• Use of a latent, repetitive printed word “Void” that will appear across the front of the prescription if it is scanned or photocopied. This feature must be patterned in such a way as not to obscure prescribing information; and
• A warning band describing the security features on the prescription.

MassHealth does not plan to endorse specific suppliers of tamper-resistant blanks. The Mass Medical Society, however, has posted some websites to help providers find vendors for tamper-resistant blanks.

NEW! The Department of Public Health OK'd regulations for Limited Service Clinics

In January, state health officials OK'd regulations to allow for limited service clinics, or "minute clinics" in pharmacies or other settings. At least one MA chain, CVS, has said it plans to open up clinics throughout the state this year.

Joint Policy of the Department of Public Health, Drug Control Program and Board of Registration in Pharmacy regarding Issuance of Multiple Prescriptions for Schedule II Controlled Substances

Effective December 19, 2007, amendments to 21 CFR 1306 allow practitioners to provide individual patients with multiple prescriptions, to be filled sequentially, for the same Schedule II controlled substance, with such multiple prescriptions having the combined effect of allowing a patient to receive over time up to a 90-day supply of that controlled substance.

DOWNLOAD THE PHARMACY FACTS ON THIS TOPIC HERE. MassHealth released a clarification for hospitals here.