Massachusetts Department of Public Health (MDPH) Prescription Monitoring Program (MA PMP) and Drug Control Program (DCP) April 8, 2014

MA PMP Pharmacy Data Entry and Data Submitter s FAQ Utilizing ASAP 4.2 Supplement to the MA PMP Pharmacy Data Entry and Data Submitter s Guide Utilizing ASAP 4.2 Massachusetts Department of Public Health (MDPH) Prescription Monitoring Program (MA PMP) and Drug Control Program (DCP) April 8, 2014 The MA PMP Pharmacy Data Entry and Data Submitter s FAQ Utilizing ASAP 4.2 (MA PMP Pharmacy FAQ) addresses questions regarding data submission to the Massachusetts Prescription Monitoring Program (MA PMP) as well as general MA PMP implementation issues. The MA PMP Pharmacy FAQ contain references to names and code values of fields from the Implementation Guide for the ASAP Standard for Prescription Monitoring Programs, Version 4 Release 2 (ASAP 4.2 Implementation Guide). Field names and code values are technical references for software providers. It is expected that data entry screens will often be customized to display more user-friendly terminology and choices for pharmacists and technicians. The software will, in many cases, translate the user-friendly codes to the ASAP values for submission to the MA PMP. Pharmacy personnel should consult with their software providers if they have questions about how field names or field codes are handled in their pharmacy software. 1 General implementation questions 1.1 Copies of Regulations 1.1.1 Q) Is it possible to obtain an official copy of the 2010 amended regulations? A) To obtain official copies of the regulations, you can go to the Massachusetts State Bookstore on the web at: http://www.sec.state.ma.us/spr/sprcat/catidx.htm The MA PMP is authorized by M.G.L. Chapter 94C 24A. Implementing regulations for the DCP and the Massachusetts Board of Registration in Pharmacy (Board) are found at 105 CMR 700.000, 105 CMR 701.000, 247 CMR 2.00 and 247 CMR 5.04. 1.2 Guidance for pharmacies 1.2.1 Q) Is there a website or update document that we can receive or access? A) The principal resources can be found by following the MA PMP link on the DCP website listed below. Updates will be available there for the MA PMP Pharmacy Data Entry and Data Submitter s Guide Utilizing ASAP 4.2 (MA PMP Pharmacy Guide) and this MA PMP Pharmacy FAQ document. Check the MA PMP website for additional content. The DCP website address is: http://www.mass.gov/dph/dcp MA PMP Pharmacy FAQ Last updated::april 8, 2014 Page 1 of 10

The Board of Registration in Pharmacy website address is: http://www.mass.gov/dph/boards/pharmacy 1.3 MA PMP staff contact information 1.3.1 Q) Can you provide MA PMP staff contact information? A) E-mails can be sent to: dcp.dph@state.ma.us. Please call the main MA PMP number for questions: 617-983-6700 For general questions, ask for Adele Audet; For technical questions, ask for Arnold Bilansky. For software or submission of data questions, contact Atlantic Associates, Inc. (AAI). AAI can be reached at (800) 539-3370. 2 Prescription records that must be submitted to the MA PMP 2.1 Dispensed prescriptions to non-residents of Massachusetts 2.1.1 Q) When a pharmacy in Massachusetts dispenses a Schedule II V prescription to a nonresident of Massachusetts, does the pharmacy have to submit the prescription information to the MA PMP? A) Yes. Information on all Schedule II V prescriptions dispensed by a pharmacy located in Massachusetts must be submitted to the MA PMP regardless of the location or residence of the patient or the prescriber. 2.2 Registered Massachusetts Health Care Facilities 2.2.1 Q) What constitutes a registered health care facility that is required to submit data on Schedule II V prescriptions to the MA PMP? A) A registered health care facility (i.e., a hospital or clinic) must have a Massachusetts Controlled Substances Registration from the DCP. A pharmacy in a registered health care facility that dispenses any Schedule II V controlled substances pursuant to a prescription is required to submit data to the MA PMP. 2.3 Medication orders for inpatients 2.3.1 Q) Are hospital or clinic inpatient pharmacies required to submit data if they only fill medication orders for their inpatients? A) Pharmacies in registered health care facilities that dispense to according medication orders that are administered within the facility (i.e., inpatients) are not required to submit the medication order data to the MA PMP. MA PMP Pharmacy FAQ Last updated::april 8, 2014 Page 2 of 10

2.4 Prescriptions for research subjects 2.4.1 Q) Does a hospital pharmacy have to report prescriptions from clinical trials? The drug product s NDC number is often not known or it has not been assigned by the FDA. A) No. MDPH is waiving MA PMP reporting requirements for prescriptions dispensed to patients who are research subjects of Institutional Review Board (IRB) approved research protocols. 2.5 Long-term care facility reporting 2.5.1 Q) Do prescriptions for residents of long-term care facilities have to be reported to the MA PMP? A) Pharmacies that dispense prescriptions to residents of long-term care facilities must submit reports to the MA PMP. 2.6 Mail order pharmacies 2.6.1 Q) Are mail order pharmacies located in Massachusetts required to submit data on prescriptions for Schedule II V drugs shipped to patients in other states? A) Yes. Pharmacies located in Massachusetts are required to report all the prescriptions for Schedule II V drugs they dispense, regardless of a patient s location/residence. 2.6.2 Q) Are mail order pharmacies located outside Massachusetts required to submit data to the MA PMP when prescriptions for Schedule II V drugs are delivered to patients in Massachusetts? A) Yes. Effective January 1, 2011, MA PMP reporting requirements also apply to any pharmacy located in another state, commonwealth, district or territory that delivers a Schedule II V prescription to a person in Massachusetts. Pharmacies that meet the above criteria must collect and submit data to the MA PMP. This includes, but is not limited to, mail-order pharmacies. 2.6.3 Q) Are out-of-state mail order pharmacies required to submit ASAP Zero Reports to the MA PMP? A) Yes. Out-of-state pharmacies that deliver prescriptions to persons located in Massachusetts are required to submit ASAP Zero Reports to MA PMP for those weeks when no qualifying Schedule II V prescriptions are dispensed. Out-of-state pharmacies that rarely or never deliver such prescriptions to patients in Massachusetts should contact AAI to request a Zero Reporting Exemption form for an annual exemption from the ASAP Zero Report submissions. The Zero Reporting Exemption does not exempt them from reporting the few prescriptions that they do deliver to Massachusetts patients. MA PMP Pharmacy FAQ Last updated::april 8, 2014 Page 3 of 10

3 Customer identification 3.1 Requiring customer to show identification 3.1.1 Q) When a customer presents a written prescription at the pharmacy, will the pharmacist or technician have to determine if the prescription is for a Schedule II V drug product before the person leaves? A) A pharmacy that routinely inspects and records the customer identification when written prescriptions for Schedule II V drugs are presented at the pharmacy, should determine if the prescription is for a Schedule II V drug before the customer leaves. If the pharmacy determines the prescription is for a Schedule II V drug after the customer has left, the pharmacy will have to inspect the identification and enter the data of the customer who receives the prescription. 3.1.2 Q) If a prescription is presented at the pharmacy by one individual but another individual takes possession of the filled prescription, does the pharmacy have to report the customer identification of both individuals? A) No. Information is required for one or the other, not both. 3.1.3 Q) According to the MA PMP Pharmacy Guide, Customer ID information is not required to be reported on refills. Does this exception apply for the following circumstance: All of the refills have been dispensed on a Schedule III V prescription or the prescription has expired, and the patient obtains a new prescription from the prescriber that continues the drug therapy or treatment? A) No. A new prescription that continues a drug therapy or treatment is a new prescription and not a refill. 3.2 ID Qualifier field 3.2.1 Q) When using the MA Registry of Motor Vehicles Identification in the AIR05 [Customer ID] field, what value do we use in the AIR04 [ID Qualifier] field? A) Use 02 for State issued ID. 3.3 Customer ID field 3.3.1 Q) If a pharmacy already has an identifier entered for a customer (e.g. Driver s License Number), is it permissible for the pharmacy system to automatically populate the retained ID or must the ID be manually entered for each prescription? A) A previously stored ID should never be automatically entered. The ID information must be specific to the valid ID of the customer and contemporaneous with the presenting or receiving of the prescription. MA PMP Pharmacy FAQ Last updated::april 8, 2014 Page 4 of 10

3.4 Issuing Jurisdiction of Customer ID field 3.4.1 Q) Where is there a list of valid country codes to enter into field AIR03 [Issuing Jurisdiction (of Customer ID)]? For example, for a Japanese passport, would we enter JP or JAP? A) The List of Jurisdictions is published as Appendix A of the ASAP 4.2 Implementation Guide. Most of the codes on that list are for United States Postal System, for U.S. states, for Canadian provinces, and for current or previous U.S. territories or protectorates. For a federally issued ID, use US. Very few foreign countries are listed. For any jurisdiction not explicitly stated in the List of Jurisdictions use the code 99 for Other. Please note that the code for Other in this field has changed to 99 in ASAP 4.2 in order to be consistent with the code for Other used elsewhere in ASAP 4.2. ASAP has granted permission to freely distribute the copyrighted List of Jurisdictions. 3.5 Deliveries 3.5.1 Q) Previously there were customer ID fields for different delivery situations (patient residence, hospice facilities, long-term care facilities, other DPH licensed health care facilities, assisted living residences, boarding schools, prisons, jails, community programs, etc.). What fields are used for deliveries now? A) All of the delivery situations listed above have been simplified and are now treated collectively as deliveries. Please see the topic Exceptions to the Customer ID Requirement and the specific Deliveries topic in the MA PMP Pharmacy Guide for details. 3.5.2 Q) The MA PMP Pharmacy Guide indicates that when utilizing the Delivery exemption to Leave blank fields AIR03 and AIR04. My data entry screen has dropdown choices. How do I leave those blank? A) The software provider needs to configure the data entry screen to permit no code as a choice. For a Leave blank situation, the software provider needs to populate the field in the same manner that a middle name field would be populated when a person has no middle name (i.e., Data Element Separator only with no text). Stated another way, Leave blank, means the software provider should treat the field the same way they would treat a Not Used field. 3.6 Customer ID for hospital outpatients 3.6.1 Q) Can a hospital outpatient pharmacy use the hospital issued identification card? A) No. The pharmacy may not substitute the hospital issued identification card for a valid form of identification. For patients/customers without an MA PMP approved ID, the pharmacy will have to follow the procedures described for the waiver in item No. 1 in the MA PMP Pharmacy Guide, under topic heading Exceptions to the Customer ID Requirement (i.e., cust signed rx detail). 3.6.2 Q) Often prescriptions are left at the hospital pharmacy by a physician, nurse, or office assistant, or received via pneumatic tube. Could we use the patient s hospital identification number in these instances? A) No, the hospital patient identification number may NOT be used as a substitute for a valid form of identification. MA PMP Pharmacy FAQ Last updated::april 8, 2014 Page 5 of 10

While the pharmacy s routine practice may be to inspect customer ID and enter the information into the computer when the written prescription is presented, the pharmacy is not required to do this for all prescriptions (e.g., for some prescriptions the pharmacy will inspect the customer ID and enter the information when the customer receives the filled prescription). To provide an appropriate level of accountability, it is preferable for the hospital pharmacy to provide ID information regarding the person who receives the filled prescription, rather than a hospital staff member who presents the prescription to the pharmacy. 3.7 Utilizing the cust signed rx waiver when the Customer ID cannot be presented 3.7.1 Q) When a customer cannot show an ID, where does the pharmacist document the reason (as required in the regulations) for dispensing a Schedule II V prescription? A) To promote consistency and compliance with regulations, each pharmacy should develop its own internal procedure for documenting, in a readily retrievable format; the reason the pharmacist determined that failure to dispense the controlled substance would result in a serious hardship for the ultimate user or agent of the ultimate user. Examples of where to record the documentation would be on the hard-copy prescription or in the pharmacy software system. In addition, the pharmacy must: Have the customer print his or her name and address and sign his or her name on the reverse side of the prescription. Enter cust signed rx in the Customer ID field rather than leaving the field blank. 3.7.2 Q) When utilizing cust signed rx waiver, how should other fields requiring customer information be populated? A) Populate the relevant fields as follows: AIR03 [Issuing Jurisdiction (of Customer ID]: Leave blank AIR04 [ID Qualifier (of Customer ID)]: Leave blank. AIR05 [(Customer) ID]: Enter the term cust signed rx. Please be careful to enter cust signed rx exactly, incorrect entries interfere with the ability to retrieve and analyze prescription data. AIR06 [Relationship of the customer to the patient] Enter either 01 when the customer is the patient or 99 when the customer is someone else. 3.7.3 Q) Does the complete term, cust signed rx need to be populated in the Customer ID field? The Customer ID field for the particular pharmacy system in question is currently 12 characters wide and cust signed rx is 14 characters wide. A) Yes, the exact wording, cust signed rx, is required. In ASAP 4.2 (and all previous ASAP versions) the Customer ID field is required to accommodate up to 20 characters. This width was established because a Customer ID may be issued by any of a large number of jurisdictions including foreign countries. The field must be able to accommodate the widths of all of the possible ID s. MA PMP Pharmacy FAQ Last updated::april 8, 2014 Page 6 of 10

3.7.4 Q) Who is the Massachusetts regulation referring to when it states the ultimate user or agent of ultimate user in the Exceptions to the Customer ID Requirement box of the MA PMP Pharmacy Guide? A) The ultimate user is the individual who is being treated with the Schedule II V controlled substance(s). The agent of the ultimate user is a person who presents the prescription or receives the filled prescription on behalf of the ultimate user. The ultimate user or agent of ultimate user is statutory language (M.G.L. Chapter94C). 3.7.5 Q) If the customer only has a passport ID, does the MA PMP have a preference as to whether the pharmacy should enter cust signed rx in the customer ID field or the passport ID? A) Enter the passport ID if it is current and valid. If a customer has any of the MA PMP approved ID s (driver s license, RMV ID, military ID, passport, Permanent Resident Card, or MA Commission for the Blind ID), that ID must be used for data entry. 3.8 Customer ID for Health Safety Net recipients who do not have any of the required forms of ID 3.8.1 Q) Can the MassHealth Recipient Identification card number or the Eligibility Verification System (EVS) be inspected by pharmacies and be entered in the Customer ID data fields, especially for non-citizens who obtain prescription drug coverage under the Commonwealth s Health Safety Net Trust fund pursuant to 114.6 CMR 13.00? A) No. The MassHealth Recipient Identification card is not one of the MA PMP-approved customer ID s. This identification card lacks a photograph, which increases the potential for fraud(e.g., forgery). If the customer cannot show one of the six approved forms of identification, then follow the procedures described for the waiver in item No. 1 in the MA PMP Pharmacy Guide under the topic Exceptions to the Customer ID Requirement concerning when a positive ID cannot be obtained. 4 OTHER FIELDS 4.1 Patient Location Code 4.1.1 Q) What are the descriptions and acceptable values used to report PAT21 - Patient Location Code? A) The code values that the MA PMP requires are provided in the ASAP 4.2 Implementation Guide. If the list of codes does not have a code that precisely describes the patient s location, the pharmacist should use professional judgment in determining the closest applicable code to use. MA PMP Pharmacy FAQ Last updated::april 8, 2014 Page 7 of 10

4.2 Method of Payment 4.2.1 Q) If a third-party payer pays for some part of a prescription but there is a co-pay paid by the patient, should the code entered in DSP16 [Classification Code for Payment Type] be 01 for Private Pay or 99 for Other? A) Use the code 99 for other. If any amount of the prescription payment is covered by a third party - even when the patient makes a copayment - use the code 99 for other. If the entire amount of the prescription price is paid by the customer or patient, use the code 01 for private pay. If, for some other pharmacy claims purpose, a pharmacy needs to enter another more specific payment type code (besides 01 or 99 ), the MA PMP will not reject that code as long as it is one of the ASAP 4.2 standard DSP16 approved codes. 4.3 Prescriber DEA number for Buprenorphine 4.3.1 Q) Should pharmacies submit the DEA X number for buprenorphine prescriptions? A) With respect to prescriptions for buprenorphine drug products prescribed for opioid maintenance therapy, when both the physician s primary DEA number and the DATA 2000 waiver ID ( X ) number appear on the prescription, the MA PMP prefers that the X number be submitted to the MA PMP rather than the physician s primary DEA number. For buprenorphine drug products dispensed for treatment of pain, use the prescriber s primary DEA number. 4.4 Electronic Prescriptions 4.4.1 Q) The MA PMP Pharmacy Guide says that the fields DSP18, DSP19, DSP20, DSP21, and DSP12 need to be populated when dispensing an electronically received prescription. When we receive a faxed prescription, we can manually enter DSP12, but we do not receive the information for DSP18, DSP19, DSP20, and DSP21. A) Faxes are not electronic prescriptions. The DEA rules for Electronic Prescriptions for Controlled Substances are at 21 CFR Parts 1300, 1304, 1306, and 1311. 5 Data quality and usefulness 5.1 Adding descriptive information into data fields 5.1.1 Q) Is it helpful to the patient s nickname in parenthesis to the first name field? A) No. Sorting and searching in the MA PMP database relies on all pharmacies submitting names accurately for the each patient. For constancy across pharmacies, a good rule of thumb for patient name fields, when possible, is to enter the name the same way it appears on a patient s insurance card or drivers license. It is also counter-productive to enter anything in the customer ID field other than the ID number itself. For the Exception cases where cust signed rx or delivery are to be entered into the customer ID field, please try to spell them exactly that way. MA PMP Pharmacy FAQ Last updated::april 8, 2014 Page 8 of 10

A substantial amount of time and resources are expended by the MA PMP on attempting to clean up extraneously entered data, as well as in educating pharmacy staff to avoid adding extra text to any fields. 6 Data Corrections / Resubmissions / Deletions 6.1 Prescriptions not picked up 6.1.1 Q) A pharmacy submits data for a prescription that has been prepared but never picked up. The pharmacy returns the medication to stock. How should the pharmacy proceed to reverse or cancel the data submitted to the MA PMP? Should the transaction be re-sent with a negative quantity? A) If the pharmacy has a need to void out any prescriptions submitted to the MA PMP, they should use the DSP01 [Reporting Status] field and enter 02 Void. The other data elements must be entered exactly as initially reported. (i.e., if the metric quantity initially reported as dispensed was 30, in the cancel record also report it as 30). Do NOT use negative numbers. 6.2 Pharmacy prescription corrections 6.2.1 Q) After submitting information to the MA PMP, what should a pharmacy do if they find that a prescription record must be changed or corrected? A) Pharmacies submitting changed or corrected data will use the DSP01 [Reporting Status] field and enter 01 Revise or 02 Void. If using the 02 code, also follow the procedure described in 6.1.1 above. 6.3 Externally requested corrections 6.3.1 Q) Prescribers and dispensers can now retrieve patient information from the MA Online MA PMP. If a discrepancy is discovered in the data for a particular MA Online MA PMP prescription record (for example, the identity of the prescriber or the name of the patient appears to be incorrect) how can a person request correction(s) to the data? A) If the MA PMP is alerted by anyone other than the submitting pharmacy regarding incorrect information, MA PMP staff will contact the pharmacy with a request to verify the information and, if neededto resubmit the prescription record with a correction. 6.3.2 Q) There have been problems with data submissions because the NDC numbers are not padded properly. How should NDC numbers be submitted? A) NDC numbers are listed on product packages as ten numerals separated by hyphens into three segments. The first segment represents the labeler, the second segment represents the product and the third segment represents the package size. Depending upon the product, the NDC will appear in one of three configurations: 4-4-2, 5-3-2, or 5-4-1. In order to standardize an equal width for each segment, the NDC needs to be reported as an 11 character numeric field with no hyphens (i.e., 5-4-2 with the hyphens omitted). So a 4-4-2 NDC configuration must be reported with a zero padded in front of the first segment; a 5-3-2 configuration must be reported with a zero padded in front of the second segment; and a 5-4-1 configuration must be reported with the last segment padded in front with a zero. MA PMP Pharmacy FAQ Last updated::april 8, 2014 Page 9 of 10

7 ASAP 4.2 issues 7.1.1 Q) Our pharmacy MA PMP software is based upon ASAP 4.1. In calendar year 2014 MA PMP is transitioning to accept the ASAP 4.2 format. What are the main data entry differences pharmacists will find when entering prescription data? A) As indicated earlier in this document, it is difficult to precisely describe the changes that pharmacists (and pharmacy technicians) will see because the software provider may customize the interface such that only user friendly names for field names and code values rather than more cryptic ASAP field names and code values are visible. Most of the new field information is related to electronic prescriptions. Since that data is sent electronically to the pharmacy computer system, the required fields for electronic prescriptions should automatically populate behind the scenes. Please check with the software vendor. (Please be aware that when entering prescription information for an electronic prescription, the DSP12 field with must still be coded to indicate that it is an electronic prescription.) Perhaps the only noticeable difference in data entry will be for the partial fill field, DSP13, which is now coded differently in ASAP 4.2. In ASAP 4.2; a nonpartial fill is 00 ; a first partial fill is 01 ; second partial fill is 02, etc. Please check with the software provider, because there may a difference in how to enter a split-fill as opposed to a partial fill. MA PMP Pharmacy FAQ Last updated::april 8, 2014 Page 10 of 10