Regulatory/Compliance

Utilize the resources and links below to be up to date on pharmacy regulations and maintain compliance with those rules. Click on the blue bars to view expanded content.

 

Audits

Utilize PAAS National for audit assistance needs.

Continuous Quality Improvement

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.

Federal Agencies and Compliance Issues

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

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

Medicare Part D Fraud, Waste and Abuse Compliance

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 responsibe 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

FWA DVDMPA 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.)

FWA ManualFraud, 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.


MPA Continuing Education Article – CMS
Requirements for a Part D Plan to Control Fraud, Waste and Abuse (one hour of CE credit, associated with a cost)

Michigan Board of Pharmacy

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.

Reimbursement/Pricing Issues

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.

State and Federal Rules/Regulations

 

Other Resources

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