PAAS National® continuously monitors legislative and regulatory changes that may impact your Fraud, Waste & Abuse and HIPAA Compliance Program. We keep a close eye on enforcement from the Department of Justice, Office of Inspector General, State Attorney Generals, and Office for Civil Rights to help ensure the program meets interpretative standards. Furthermore, PAAS works to keep pace with Pharmacy Benefit Managers as they continue to add credentialing requirements that can be extremely difficult, and a significant nuisance, to independent pharmacies.
The PAAS National® FWA/HIPAA Compliance Program has implemented changes to ensure pharmacies continue to have a robust program in place. PAAS FWA/HIPAA compliance members can login to the member portal to view the 2023 FWAC and HIPAA Updates.
Administrators should review all Compliance tasks (located in the left-hand navigation on the PAAS Member Portal) at least annually to keep the program up-to-date and in compliance. Section 2.6 Updates of Policies and Procedures of your manual contains information on maintaining open lines of communication and the distribution of changes.
If you’re not a member of PAAS’ FWA/HIPAA compliance program, contact us today at (608) 873-1342 or info@paasnational.com to add the program for a discounted rate.
“We have been with PAAS for many years and added the FWAC/HIPAA material to our membership and as a compliance officer, I’ve never been more pleased with the program. If you have already made the best choice to have PAAS in your corner, then continue with the best for your FWAC/HIPAA needs.” – Member since 2010 from North Carolina
“PAAS National® Fraud, Waste, Abuse and Compliance educational sessions are unsurpassed. The PAAS National® Policy and Procedure manual that you create for your pharmacy is a must for all pharmacies to have for their staff. All of this keeps your pharmacy up to date with current pharmacy procedures and operations and ensure proper pharmacy practices going forward.” – Member since 2021 from New York
“A pharmacy without the compliance program does not have their bases covered and required work finished. I can sleep at night knowing this program keeps me protected and on task.” – Member since 2009 from Iowa
Beware: Caremark is Monitoring High Quantity Utilization and Atypical Dispensing Habits
Beyond traditional desktop, on-site, investigational or invoice audits, Caremark performs various compliance reviews. These compliance reviews may include:
PAAS National® has recently reviewed a second round of these Rx Claim Review notices from members. While new for Caremark, PAAS has identified multiple versions of the letter primarily focusing on two areas of concern:
The brief, and poorly worded, letter states the pharmacy should evaluate the claims in question and consider whether the dispensing of these medications is appropriate. It concludes with “your cooperation is appreciated and will greatly assist us in our review”. Due to the ambiguous direction, pharmacies are unsure if they need to respond or provide any additional information or documentation to Caremark.
PAAS Tips:
Criminal HIPAA Charges Filed Against Compounding Pharmacy Sales Rep
Criminal HIPAA charges are not handed down frequently, but when an individual “knowingly” and inappropriately obtains and discloses a patient’s protected health information (PHI), they could face up to $50,000 in fines and up to one year in prison, according to 42 U.S.C. § 1320d-6. Additionally, if found guilty of obtaining or disclosing the information with the intent to sell, transfer, or use the PHI for commercial advantage, personal gain, or with malicious intent the penalties can increase up to $250,000 and 10 years in prison.
According to a October 20, 2022 Department of Justice press release, a former compounding pharmacy sales representative located in New Jersey is facing criminal HIPAA charges for obtaining unauthorized access to PHI with the intent to personally profit. The sales rep promoted compounded prescriptions and other medications which were subsequently filled by a Louisiana pharmacy. The sales rep and his co-conspirators knew which plans would reimburse significantly for certain compounded medications and the sales rep then recruited patients with that specific insurance. To do this, the sales rep gained access to a medical clinic where the doctor allowed him to have significant access to patient medical records. Since the sales representative was not an employee of the doctor’s office, he was not authorized to access the information without first obtaining proper release. The sales rep would then sift through medical records to identify patients with the sought-after insurance plan. The patient files would be tagged so the doctor could easily identify patients with the specific insurance plan so he knew whom he should prescribe the compounds. On occasion, the sales representative would even join the doctor and patient in the exam room as if he were employed by the medical office, which he was not.
Patients were targeted based on information illegally gained from within secure patient records, then they were prescribed and dispensed medically unnecessary compounded medications all as a result of this scheme.
Training staff to appropriately handle PHI, and discussing the consequences of mishandling PHI, is critical to preventing a breach and other unauthorized access to protected information—malicious or not. If you have not already taken advantage of the PAAS National® Fraud, Waste, and Abuse and HIPAA Compliance Program, now is a great time to reach out to a PAAS staff member to learn about the best program available to independent pharmacies. Ring in the New Year with confidence knowing that you have a method to provide your staff with comprehensive, community pharmacy focused HIPAA training.
Valid Prescriber/Patient Relationships and Marketing Concerns
With the U.S. Department of Health and Human Services Office of Inspector General’s (OIG) recent focus on telemedicine fraud, pharmacies may be wondering what their obligations are when determining a prescription’s authenticity – especially when it comes to whether a valid prescriber/patient relationship exists. Many PBMs, including Express Scripts, TRICARE, CVS Caremark, and OptumRx all have language in their provider manuals placing the responsibility on the pharmacy of ensuring a valid prescriber/patient relationship exists.
How can you determine if a prescriber/patient relationship is valid? Questions you may ask to verify this are:
Along with telemedicine, PBMs are also concerned about marketing practices of pharmacies. The provider manuals for Express Scripts, TRICARE, CVS Caremark, OptumRx, and Elixir all contain language surrounding what is not allowed and some, like Express Scripts, are known for using investigational audits to ensure compliance.
Prohibitions on certain marketing practices in these manuals include, but are not limited to:
Pharmacies must remain vigilant and always conduct marketing practices in a manner consistent with their state laws, federal laws, and Medicare regulations and guidelines.
PAAS Tips:
Top 10 PAAS National Articles of 2022
PAAS Audit Assistance members receive a monthly newsletter with new audit tactics and prevention tips. The printed newsletter, PAAS National® Newsline is only a fraction of the content that we put out each month as members have access to additional content online in the Member Portal, in addition to an archive of articles.
The top 10 Newsline articles for 2022 include:
Top eNewsline Exclusives: Articles that did NOT make print
PAAS Audit Assistance Admins can also keep their employees informed to increase engagement and lower audit results by adding employees to the Portal so that their whole staff has access to the eNewsline.
2023 Fraud, Waste & Abuse and HIPAA Compliance Program Updates
PAAS National® continuously monitors legislative and regulatory changes that may impact your Fraud, Waste & Abuse and HIPAA Compliance Program. We keep a close eye on enforcement from the Department of Justice, Office of Inspector General, State Attorney Generals, and Office for Civil Rights to help ensure the program meets interpretative standards. Furthermore, PAAS works to keep pace with Pharmacy Benefit Managers as they continue to add credentialing requirements that can be extremely difficult, and a significant nuisance, to independent pharmacies.
The PAAS National® FWA/HIPAA Compliance Program has implemented changes to ensure pharmacies continue to have a robust program in place. PAAS FWA/HIPAA compliance members can login to the member portal to view the 2023 FWAC and HIPAA Updates.
Administrators should review all Compliance tasks (located in the left-hand navigation on the PAAS Member Portal) at least annually to keep the program up-to-date and in compliance. Section 2.6 Updates of Policies and Procedures of your manual contains information on maintaining open lines of communication and the distribution of changes.
If you’re not a member of PAAS’ FWA/HIPAA compliance program, contact us today at (608) 873-1342 or info@paasnational.com to add the program for a discounted rate.
“We have been with PAAS for many years and added the FWAC/HIPAA material to our membership and as a compliance officer, I’ve never been more pleased with the program. If you have already made the best choice to have PAAS in your corner, then continue with the best for your FWAC/HIPAA needs.” – Member since 2010 from North Carolina
“PAAS National® Fraud, Waste, Abuse and Compliance educational sessions are unsurpassed. The PAAS National® Policy and Procedure manual that you create for your pharmacy is a must for all pharmacies to have for their staff. All of this keeps your pharmacy up to date with current pharmacy procedures and operations and ensure proper pharmacy practices going forward.” – Member since 2021 from New York
“A pharmacy without the compliance program does not have their bases covered and required work finished. I can sleep at night knowing this program keeps me protected and on task.” – Member since 2009 from Iowa
Natesto® Nasal Gel Pump – Bill It Right!
Pharmacies have begun to see more prescriptions for Natesto® (testosterone) nasal gel. Natesto® is indicated for primary hypogonadism and hypogonadotropic hypogonadism, whether those conditions were congenital or acquired. At this time, it is not approved for age-related hypogonadism or for male patient populations less than 18 years old.
Package Size
in Package
The recommended dose is 11 mg of testosterone (5.5 mg testosterone per nostril actuation) three times daily, preferably at the same time daily. Therefore, each package should be billed as a 10 days’ supply and a quantity of three packages would be dispensed for a 30 days’ supply, if prescribed as such. Despite needing to prime prior to initial use, no priming is necessary for the remainder of use and priming does not need to be factored in when computing the billed days’ supply.
PAAS Tips:
The Ballad of Snowbirds and Audits
The winter months have many pharmacies mailing prescriptions to their snowbird patients who leave their northern nests for more hospitable climates. Pharmacies want to keep these patients happy and coming back when the weather is nicer and may look to mailing maintenance medications to them when they have migrated out of state. Although these pharmacies may think they are doing the right thing for patient care, and their business, they may also be setting themselves up for audit failure.
Unfortunately, this does not just apply to northern states with snowbird patients. Many states now have laws that require nonresident pharmacies to obtain a license to ship, mail, deliver, or dispense prescription medications into their states. Auditors take advantage of these laws to recoup money from well-meaning pharmacies who may not even know that mailing a prescription out of state is a problem! For pharmacies situated close to the state border, delivering into a neighboring state carries the same risks. PAAS National® has seen these claims cited as law violations with limited appeal options.
PAAS Tips:
Start of New Year = Opioid Plan Rejects
PAAS National® analysts receive numerous calls at the start of the new year looking for guidance on opioid plan rejects. With the new year, many patients may be on a new Medicare Part D plan. Opioid prescriptions processed previously with no issues, may now reject at point-of-sale on the new plan.
With the opioid crisis on the rise, CMS acted in 2018 to closely monitor opioid use and safety of patients. Medicare Part D plans were required to implement opioid policies and work together with patients, prescribers, and pharmacies with this monitoring. These policies included real-time safety alerts at the pharmacy’s point-of-sale.
Here are the four Medicare Part D opioid safety alerts:
In August of 2022, CMS through the Medical Learning Network (MLN) published A Prescriber’s Guide to Medicare Prescription Drug (Part D) Opioid Policies. This guide offers guidance to both prescribers and pharmacies for patients using opioid medications. Pharmacies should note, alerts that cannot be resolved at point-of-sale may require providing patients with a copy of the CMS-10147 Medicare Prescription Drug Coverage and Your Rights form. This form provides instructions for patient to work with their prescriber and their Medicare plan to expedite coverage for their medication.
Pharmacies have an obligation to
PAAS Tips:
Update: Medicare Part D Mandatory E-Prescribing Requirements for Controlled Substances – Final Rule
In our December 2021 Newsline article, PAAS National® alerted pharmacies to the delay in enforcement of Electronic Prescribing for Controlled Substances (EPCS) for Medicare Part D until January 1, 2023. CMS has finalized policies in the Calendar Year (CY) 2021 Physician Fee Schedule (PFS) and CY 2022 PFS Final Rule for requirements on EPCS shown in section 2003 of the SUPPORT Act. Notably, in the CY 2022 PFS final rule, CMS finalized four proposals related to EPCS:
1. Compliance Action (Enforcement) Extension
2. Electronic Prescribing Controlled Substance Percentage
3. Finalized Proposals to the Classes of Exceptions (as outlined by section 2003 of the SUPPORT Act)
Note: there were no exemptions approved for prescribers issuing prescriptions to nursing facility patients (despite the delayed enforcement) nor hospice patients.
4. Limit compliance actions to sending a notice of non-compliance
The CY 2023 PFS Final Rule expands about this notice of non-compliance by clarifying two components. That CY 2023 compliance with EPCS requirements will be based on CY 2023 PDE data, that will not be evaluated until late CY 2024. Consequently, the non-compliance notice enforcement action has been extended through CY 2024. With CY 2025, CMS is planning more burdensome penalties that would apply to non-compliant prescribers.
PAAS Tips:
FDA’s Guidance on Compounding Commercially Available Products in Short Supply
For various reasons, including ingredient shortages or manufacturer back orders, a pharmacist may be required to compound a commercially available product. This is currently the case for Amoxicillin Oral Powder for Suspension, as evident from the FDA’s Drug Shortage List. As a result of this shortage, the FDA released Compounding Certain Beta-Lactam Products in Shortage Under Section 503A of the Federal Food, Drug, and Cosmetic (FD&C) Act which was put into effect immediately due to the urgency of the situation, stipulating their guidance as nonbinding recommendations (not legally enforceable), except in cases where there are regulatory requirements that pharmacies must meet.
Products compounded by pharmacies are not FDA-approved and must follow Section 503A of the FD&C Act. Under Section 503A, leeway is given to pharmacies in that they do not need to meet specific requirements stated in the FD&C Act, namely new drug approval or current good manufacturing practice requirements. However, pharmacies are only allowed to compound a commercially available product if
Although the FDA memo references beta-lactams only, being mindful of this guidance is helpful with any commercially available compounded product that a pharmacy makes, including oseltamivir (Tamiflu) suspension. Tamiflu suspension is not currently listed on the FDA’s Drug Shortage List, but pharmacies nationwide have been struggling to get the product from their wholesalers. So, what are pharmacies to do in order to be best protected in case of an audit?
PAAS has received numerous prescription validation requests, specifically from Caremark, for compounded Tamiflu prescriptions, looking for proper compounding and billing practices. For good measure, consider attaching a screenshot of your wholesaler(s)’ website showing proof the commercially available product was not available on or around the date of compounding, or a copy of your purchase order reflecting a product was unavailable to be shipped. Ensure the date, NDC, drug name, and inventory outage is visible. The longer you can prove that an ongoing shortage of a product exists, the better your situation becomes in the event an audit questions the continuous need to compound. We do not believe this is necessary for products listed on the FDA’s Drug Shortage List, but documentation to that effect on the prescription would be prudent regardless.
In addition, consider the following PAAS National® Tips when in the situation where compounding a commercially available product is necessary.
PAAS Tips: