|Audit Avoidance and Protection|
Fraud Waste and Abuse Compliance
If you are in need of FWA compliance tools, check out PAAS National's www.fwacertification.com.
Having Trouble with Auditors? File Complaints With The Insurance Commissioners Office
Here is the link to the website to file complaints to the WA Insurance Commissioner.
Audit Alert- DEA New Interpretation: Pharmacies Cannot Add DEA Number
No rules have changed but a recent interpretation of 21CFR1306.05 as to whom can be the agent of the prescriber might have significant ramifications on pharmacies. In November 2010, following an inquiry by National Audit, the DEA sent a memo which states that written controlled substance prescriptions must have the DEA regristration number of the prescriber before it is received by the pharmacy and that only an agent of the prescriber may add information to the prescription. The memo clarified that pharmacists are not considered "agents of the prescriber". We have been told by the local DEA office that a clarification will be added to the Federal Register soon. Despite the BOP clarification on what pharmacists can add or change on a CII prescription, we are told the DEA is not retracting this memo. We understand that several audit companies are using this information to target audits on pharmacies. Many pharmacies have begun denying prescriptions that do not include the necessary information. The WSPA is working with the BOP, WSMA, local DEA, and National Organizations to address this critical issue.
DEA Offers Clarification on CII Prescriptions - Missing Information
The DEA finally provided clarification in the form of a letter of what information a pharmacists may add when it is missing from a CII prescription.
Washington Pharmacy Quality Assurance Commission Reaffirms Guidance on Changes to CII Prescriptions
Making Changes to Controlled Substance PrescriptionsAt the June 8, 2011, meeting the board clarified the recent confusion around Schedule II (CII) controlled substance prescriptions and prescribers’ federal Drug Enforcement Administration (DEA) registration numbers. The DEA published in November 2007 a Final Rule titled Issuanceof Multiple Prescriptions for Schedule II Controlled Substances. In the preamble to that rule, the DEA stated that ‘the essential elements of a Schedule II prescription written by the practitioner such as the name of the controlled substance (CS), strength, dosage form, and quantity prescribed may not be modified orally.’ The instructions in the rule’s preamble are in opposition to the DEA’s previous policy, which allows a pharmacist to make the same changes to schedule II controlled prescriptions as to schedules III-V controlled substance prescriptions after oral consultation with the prescriber. A policy letter, written in October 2008 by Joe Rannazzisi, DEA Deputy Chief of Operations, Office of Diversion Control states, “The DEA recognizes the resultant confusion regarding this conflict and plans to resolve this matter through future rulemaking. Until that time, pharmacists are instructed to adhere to state regulations or policy regarding those changes that a pharmacist may make to a schedule II prescription after oral consultation with the prescriber.” The October 2008 policy letter remains in effect. Nothing has changed since the issuance of that letter regarding the DEA registration numbers and other required information on CS prescriptions. These instructions apply until the rule is updated and a notice is issued by the DEA.
Washington State Board of Pharmacy reaffirms its long held guidance and interpretation regarding changes to a CII prescription.
A pharmacist in consultation with the prescriber may change all elements of Schedule II prescriptions except the patient’s name, the drug, or the prescriber’s signature. The pharmacist shall note the consultation on the prescription. A pharmacist may add the patient’s address or the prescriber’s DEA registration number to the prescription without consulting the prescriber.
Question:What changes may a pharmacist make to a prescription written for a controlled substance in schedules III-V?
Answer: The pharmacist may add or change the dosage form, drug strength, drug quantity, directions for use, or issue date only after consultation with and agreement of the prescribing practitioner. A pharmacist may add or change the patient’s address and may add the prescriber’s DEA registration number to the prescription without consulting the prescriber. The pharmacist should note all consultations and corresponding changes on the prescription. Pharmacists and practitioners must comply with any state/local laws, regulations, or policies prohibiting any of these changes to controlled substance prescriptions. If you have additional question, please contact Tim Fuller or Cathy Williams, Pharmacist Consultants for the Washington State Pharmacy Quality Assurance Commission. Tim Fuller – 360.236.4827 Tim.Fuller@doh.wa.gov
Cathy Williams 360.236.4875 Cathleen.Williams@doh.wa.gov
What Does the DEA Q&A Say?
Excerpts taken from DEA website at http://www.deadiversion.usdoj.gov/faq/general.htm#rx-7
Question: What changes may a pharmacist make to a prescription written for a controlled substance in schedule II?
Answer: On November 19, 2007, the DEA published in the Federal Register (FR) the Final Rule entitled Issuance of Multiple Prescriptions for Schedule II Controlled Substances (72 FR 64921). In the preamble to that Rule, DEA stated that "the essential elements of the [schedule II] prescription written by the practitioner (such as the name of the controlled substance, strength, dosage form, and quantity prescribed)…may not be modified orally."
Answer: The pharmacist may add or change the patient’s address upon verification. The pharmacist may add or change the dosage form, drug strength, drug quantity, directions for use, or issue date only after consultation with and agreement of the prescribing practitioner. Such consultations and corresponding changes should be noted by the pharmacist on the prescription. Pharmacists and practitioners must comply with any state/local laws, regulations, or policies prohibiting any of these changes to controlled substance prescriptions. The pharmacist is never permitted to make changes to the patient’s name, controlled substance prescribed (except for generic substitution permitted by state law) or the prescriber’s signature.
OIC and WSPA Lead Efforts to Simplify PA Processes
The WSPA, working in conjunction with the Office of the Insurance Commissioner and the Washington State Medical Association, has assembled a Rx Prior Auth Simplification Workgroup including public and private payers and pharmacists from multiple practice settings to outline on how best to standardize drug prior authorization request transactions between providers and group purchasers with the goal of maximizing administrative simplification and efficiency in preparation for electronic transmissions. This groups findings will be reported to the OIC's Administrative Simplification Program in June. For more information contact, Jeff Rochon at 425-228-7171.
BOP Issues Prompt Clarification On No. 1064 After WSPA Request
In response to the WSPA's request, the BOP issued the following clarification on April, 11th, 2011. The WSPA would also like to publicly acknowledge the BOP's willingness to listen to our concerns and extend our appreciation for the prompt response to our request. CLARIFICATION: The April 1, 2011 article from the Board of Pharmacy newsletter titled, No. 1064 Requirements of a Faxed Prescription, misstated that the signature requirements for legend drugs and controlled substance prescriptions are the same. WAC 246-870-050 addresses prescriptions sent by the prescriber using a fax machine and explicitly requires a signature by the prescriber for Schedule II controlled substances, but is silent on all other legend drug prescriptions. The article in the Board’s newsletter references WAC 246-870-050 as the basis for which a signature is required. While it is best practice, the rule does not explicitly require a signature for legend drug prescriptions. The pharmacist is responsible for assuring that each faxed prescription is valid and authenticity is verified with the prescriber whenever there is a question, WAC 246-870-050 (6). The other citation in the article refers to the DEA federal regulations on controlled substances 21 CFR 1306.21, which addresses Schedules III, IV and V controlled substances. Faxed or written Schedules III – V prescriptions must be signed by the prescriber. For any Schedule III - V with an electronic signature, pharmacists have the option of calling the prescriber to verify the prescription and making it an oral prescription. The Board’s extended care facility rule, chapter 246-865 WAC does not address the method of relaying new or refill drug orders to the pharmacy when received by the licensed nurse in writing or verbally from the prescriber as authorized in WAC 246-865-060(7)(e). WAC 246-865-060 (1)(b) requires all nursing homes without a licensed pharmacy or employing a director of pharmaceutical services to have a written agreement with one or more licensed pharmacists who provide pharmaceutical consultant services. The entire spectrum of pharmaceutical services for the nursing homes are the responsibility of the staff pharmacist or consultant pharmacist – including the process, policies and procedures for conveying prescription orders. Additional inquires can be sent to firstname.lastname@example.org for response.
WSPA Urges BOP To Retract Article in April 2011 BOP Newsletter
At the April 7 Board of Pharmacy (BOP) Meeting, WSPA CEO Jeff Rochon expressed members' concerns regarding a recent article published in the April 2011 Board of Pharmacy Newsletter, No. 1064 Requirements of a Faxed Prescription. In conjunction with the research and efforts of Bill Fassett, Rochon presented this letter to the BOP and requested the Board recall the article and distribute a revision that deals only with controlled substances, and does not conflate nursing home drug orders with ambulatory prescriptions. The article confuses concerns expressed by the DEA for controlled substances with procedures for issuing prescriptions, refill authorizations, or other clarifications for legend drugs. This article misstates the requirements of the relevant regulations, and overturns long-standing practices regarding legend drugs. This new interpretation could create significant problems for pharmacists who are subject to audits, and who have acted in good faith with repeated advice from Board staff to treat fax communications generally as if they were telephone calls. It also introduces restrictions on long-term care settings that are novel and not supported by statute or rule. A careful analysis of the Board’s rules indicates that signatures of the prescriber are not required on faxes which communicate refills or other information relating to an already-prescribed drug, and that rules for “prescriptions” should not necessarily apply to “orders” in institutional settings. The article recommends turning clearly communicated written information into verbal communication as a way to avoid violating alleged requirements for electronic transmissions. It suggests that an agent of the physician can only communicate orders by phone, which certainly restricts the agent to only one avenue of carrying out his or her prescriber’s directives. It forces the substitution of verbal exchanges (prone to miscommunication and sound-alike mix-ups) for information that is in writing. We don’t believe the Board can show a public interest that is served thereby – at least when controlled substances are not involved. Thank you to Bill Fassett for his hard work on this endeavor!
Erroneous DSHS Overpayment Notices
Multiple overpayment notices sent to Pharmacies for Sterile gloves “overpayments” were incorrect. The ProviderOne system incorrectly notified some pharmacies that they were overpaid for sterile gloves. For more information on recent Medicaid billing or audit issues, go to the WSPA Medicaid Resource Center. If you have other Medicaid concerns, email them to email@example.com.
DSHS Spenddown Liability Reporting
The Department is aware that the ProviderOne HIPAA 835 Batch Remittance Advice does not show prescription numbers and has been actively working to add this information to the 835. For more information on recent Medicaid billing or audit issues, go to the WSPA Medicaid Resource Center. If you have other Medicaid concerns, email them to firstname.lastname@example.org.