Utilize PAAS National for audit assistance needs.

Pharmacy Quality Commitment
PQC is a continuous quality improvement (CQI) program that supports you in responding to issues with provider network contracts, Medicare Part D requirements under federal law and mandates for CQI programs under state law.

Pharmacies, in order to be compliant with Centers for Medicare & Medicaid Services (CMS) regulations and network contract requirements, must have a quality improvement program. Most contracts ask you to implement and maintain a verifiable, documented pharmacy quality assurance program (the wording varies from contract to contract):

• a medication safe practices program
• a utilization management and quality assurance program
• establish an internal medication error identification program and a plan to reduce medication errors

Easily implemented into your pharmacy’s daily routine Pharmacy Quality Commitment (PQC) offers extensive toll free and online support to get your continuous quality improvement program started. Go to www.pqc.net to find out more about the program and get in compliance today!

Provider Exclusion Lists
Pharmacists are reminded that they should utilize Web sites provided by the Department of Health and Human Services, Office of Inspector General and General Services Administration to determine if an employee or contracted individual/entity is excluded from participating in any federally funded program, including Medicare, Medicaid and other programs that provide health benefits (other than the Federal Employees Health Benefits Plan). 

Visit the Drug Enforcement Administration (DEA) Web site.

• DEA- Combat Methamphetamine Act; Training and Certification
  Before selling products containing ephedrine, pseudoephedrine or phenylpropanolamine, pharmacies must be self certified and comply with all provisions of the CMEA relating to employee training, product placement, photo identification of customers, sales logbooks and other procedures listed in the law. The Drug Enforcement Administration has provided detailed training instructions for use in explaining the obligations at
  www.DEAdiversion.usdoj.gov. Self-certification must be done annually online. Only one certificate per retail store is required, and the date to recertify is determined by the date listed on the certificate.
  
  Pharmacies are also required to maintain a logbook, written or electronic, to record sales of products containing ephedrine, pseudoephedrine or phenylpropanolamine. The seller must enter into the logbook the name of the product and quantity sold. The patient must write or enter into the logbook their name, address, date and time of sale. The customer must also
  sign the logbook.
  

Visit the Federal Trade Commission Web site

• Red Flags Rule - Identity Theft
  Pharmacies have been exempt from the FTC's Red Flags Rule, as of Dec. 18, 2010. Click here for more information.
• Notice of Breach of Information

Visit the Food and Drug Administration (FDA) Web site.

• Medication Guides
• Risk Evaluation Mitigation Strategies (REMS)

HIPAA 5010 and D.0 Implementation
Effective Jan. 1, 2012, all health care providers must be compliant with the conversion to the new electronic Health Insurance Portability and Accountability Act (HIPAA) 5010 claims transaction standards. Providers should begin working with their software vendors to begin the testing process to ensure they are ready for the upcoming compliance date. CMS has made available a new MLN Matters Special Edition Article (#SE1106), titled “Important Reminders about HIPAA 5010 and D.0 Implementation.” This resource will provide updated information about Medicare’s implementation to the new Accredited Standards Committee (ASC) X12 Version 5010, as well as the National Council for Prescription Drug Programs (NCPDP) Version D.0 standards.

In addition, the Michigan Department of Community Health (MDCH) is creating companion guides to assist with the HIPAA 5010 transition. These guides are being posted on the MDCH Web site, as drafts and are subject to change. 
The companion guides are designed to be used in conjunction with the 5010 Technicial Report 3 documents (TR3s) to fully prepare for the HIPAA 5010 changes and how they relate to day to day billing with Medicaid.  As additional guides become available, they will be posted to the Web site www.michigan.gov/5010ICD10. Questions about the implementation can be e-mailed to MDCH-5010@michigan.gov.

Health Care Provider’s Guide to the HIPAA Privacy Rule

HHS Health Information Privacy Website

When does HIPAA Allow Disclosure to Law Enforcement

HIPAA Training Resources

CMS Clarifies Medicare Part D Fraud, Waste and Abuse Training Requirements
The Centers for Medicare & Medicaid Services (CMS) has provided additional information pertaining to the Fraud, Waste and Abuse training requirements required for all Medicare Part D providers due to multiple inquiries from Part D Sponsors and their first tier, downstream and related entities (including pharmacies and pharmacy staff).

The clarification by CMS identifies the following:

1. The Part D plan sponsor is responsible for providing appropriate fraud, waste and abuse training to all healthcare providers it has a contractual relationship with (including pharmacies).
2. The mandatory fraud, waste and abuse training requirement becomes effective January 1, 2009.
3. Training must be completed yearly and can be completed in the calendar year to meet the requirement (January 1 to December 31). Training completed prior to January 1 does not meet the requirement for the next calendar year.
4. All individuals employed by the pharmacy who have any interaction with a Part D beneficiary must receive the mandatory training (pharmacists, pharmacy technicians, cashiers, drivers etc..
5. A record of all fraud, waste and abuse training must be maintained for a minimum of 10 years.
6. First tier, downstream and related entities (including pharmacies) should NOT develp their own training. CMS has indicated that they are working with some organizations to provide a training program that will meet their requirements.

Providers can view additional guidance pertaining to CMS’s requirements for a comprehensive program to prevent and detect fraud, waste and abuse in the prescription drug program in Chapter 9 of the Medicare Prescription Drug Benefit Manual. 

Fraud, Waste and Abuse Training Programs

Medicare Trilogy: Effective Compliance Program; Fraud, Waste and Abuse Education; and Centers for Medicare and Medicaid Services (CMS) 2011 Surveillance Program - This recorded presentation is now available as a home study, valid for 1.0 hour of continuing education credit through Aug. 22, 2014. This program requires that you purchase a CE presentation DVD through MPA's online store and view, then complete the posttest and evaluation online. $5.

MPA Fraud, Waste and Abuse Program - This recorded, live presentation is available as a homestudy, valid for 1.3 hours of continuing education credit through Feb. 27, 2012. This program requires that you purchase a CE presentation DVD through MPA's online store and view, then complete the posttest and evaluation online. $5. (To receive continuing education credit, additional cost when completing posttest and evaluation is for pharmacists: Members, $15, Nonmembers, $25; for pharmacy technicians: Members, $10, Nonmembers, $20.)

Fraud, Waste & Abuse Policies & Procedures Manual - This includes MPA's Fraud, Waste and Abuse Program DVD and a FWA Manual on CD-ROM developed by the Pharmacists Society of the State of New York. Once the DVD presentation is viewed, information on earning continuing education credit for pharmacists and pharmacy
technicians is available online. Members, $200; Nonmembers, $400.

 

Alliance for Patient Medication Safety
The Alliance for Patient Medication Safety (APMS) strives to foster a culture of quality within the profession of pharmacy that promotes a continuous systems analysis to develop best practices that will reduce medication errors,
improve medication use and enhance patient care. To learn more go
to www.medicationsafety.org.

Safe Medication Disposal
Medicines play an important role in treating certain conditions and diseases, but they must be taken with care. Unused portions of these medicines must be disposed of properly to avoid harm. The Food and Drug Administration (FDA) offers a variety of resources for proper medication disposal on its Web site, as well as a list of medications that can be safely disposed of by patients at home, if they follow proper procedure.

In addition, there are a number of programs available in Michigan that allow pharmacies to get involved in medication disposal, including holding take-back events. Utilize the links below for more information on safe medication disposal initiatives in the state.

• Calhoun County Medicine Prevention Task Force
• Dispose My Meds
• Eaton County Resource Recovery Events
• Great Lakes Clean Water Organization: Yellow Jug Old Drugs
• Macomb County Public Health Medication Disposal Collection
• Michigan Department of Environmental Quality
• Muskegon Area Medication Disposal Program
• Pharmaceutical Take-Back Program, Washtenaw County
• State of Michigan Recycling and Household Hazardous Waste County Contacts
• West Michigan Take Back Meds

Institute for Patient Medication Safety and Pharmacist Peer Review
For some time, it has been recognized that there is a need for an alternative way to handle how minor medication errors are reported. Due to a fear of consequences for reporting any and all medication errors, there is a scarce amount of data on why these types of errors occur.

MPA, the Michigan Board of Pharmacy and the Michigan Bureau of Health Professions have worked together to design a system that encourages voluntary pharmacist reporting of medication errors and their causes so data can be accumulated and analyzed and information disseminated to practitioners to help prevent errors of a similar nature in the future; and, to provide the Board of Pharmacy with a way to move away from a punitive approach in dealing with pharmacists who make human errors.

MPA then created the Institute for Patient Medication Safety and Pharmacist Peer Review, an organization that collects information on medication errors, while protecting the pharmacists who report them. No information regarding the identity of the patient or the pharmacist is retained in Institute files after an error has been reported.

Although MPA provided the initial funding, the Institute has been established as a Michigan nonprofit corporation and is classified by the IRS as a 501(c)(3) tax-exempt organization. Its operation is overseen by a seven member Board of Directors. Each director is a pharmacist who brings expertise from a specific area of pharmacy practice (health-system, community, long-term care, etc.) Last month, MPA and the Institute sent a letter to all licensed pharmacists in the state providing them with an overview of the organization, as well as frequently asked questions and a medication error or accident reporting form. Additional copies of the form can be downloaded from the Institute Web site at MiInstitute.cphs.wayne.edu.

Visit the Michigan Board of Pharmacy Web site to learn more about its role, current members and meeting days and locations.

The Michigan Board of Pharmacy is composed of six pharmacists and five public members whose responsibility, noted in Section 17722 of the Public Health Code, is to “regulate, control, and inspect the character and standards of pharmacy practice and of drugs manufactured, distributed, prescribed, dispensed, and administered or issued in this State and procure samples, and limit or prevent the sale of drugs that do not comply with this section's provisions; prescribe minimum criteria for the use of professional and technical equipment in reference to the compounding and dispensing of drugs; grant pharmacy licenses for each separate place of practice of a dispensing prescriber who meets requirements for drug control licensing; and granting licenses to manufacturer/wholesaler distributors of prescription drugs. The Board also has the obligation to discipline licensees who have adversely affected the public's health, safety, and welfare.”

Verify a license here.

View the Michigan Public Health Code online.

Pay particular attention to the following sections:

• Article 7 – Controlled Substances
• Article 15 – Occupations; Part 177 – Pharmacy Practice and Drug Control

The National Precursor Log Exchange (NPLEx) is a real-time electronic logging system used by pharmacies, retailers and law enforcement to track sales of over-the-counter (OTC) cold and allergy medications containing precursors to the illegal drug methamphetamine.

Beginning Jan. 1, 2012, in compliance with Public Act 86 of 2011, pharmacies will be required to log pseudoephedrine (PSE) product sales in the NPLEx system. The provider of the NPLEx technology, Appriss, has shared several resources with MPA that will assist members in utilizing the system, including a deployment guide, a timeline of Michigan NPLEx milestones and a complete NPLEx overview.

Access these resources through the links provided, and be sure to begin using the new system by Dec. 1 (or sooner) to ensure compliance by Jan. 1, 2012. Appriss will also provide training sessions for all pharmacies and retailers located throughout the state during the launching of this project. If your pharmacy does not sell PSE products, or your pharmacy only administers PSE products by prescription, please notify Appriss by e-mail at MINPLEx@appriss.com. Be sure to include your pharmacy contact information and state license number.

Discrepancy Reporting Form
This form was developed as a tool for pharmacies to report third party payment discrepancies. MPA requests that the form be submitted to MPA, as well as the third party payor, so these discrepancies may be recorded.

Price Discrepancy Complaint Form
This form was developed for the purpose of filing a complaint about incorrect information on the Department of Community Health Drug Pricing Web site.

View the Michigan Administrative Rules.

View the Code of Federal Regulations.