Pharmacies are no stranger to the requirements of completing annual Medicare Fraud, Waste, and Abuse training, which is a very clear requirement created by Medicare Part D and MAPD statutes. Because CMS holds PDPs and MAPDs responsible, PBMs often ask for the pharmacy’s FWA training during onsite audits. On the contrary, cultural competency training isn’t something PBMs regularly ask for. In a world where pharmacy employees are already spread thin, is completing cultural competency training truly necessary?
As of April 2021, NCPDP required pharmacies to indicate if they train their staff on cultural competency and maintain evidence of such training, when going through the pharmacy’s annual NCPDP profile credentialing. Since adding this question, PBMs have decreased the number of direct attestations required of community pharmacies. However, indicating ‘no’ in NCPDP is not without potential repercussions as PBMs may exclude you from provider listings of culturally competent care, as this was required for Medicaid managed care plan directories. Additionally, there are federal requirements that have been in place for many decades.
Through many federal laws and regulations related to discrimination and cultural competence comes the requirement that all healthcare professionals, including pharmacies, must take “reasonable steps” to provide equal access to care across all patient populations. It cannot be expected that a pharmacy would be able to meet the standards if there is a lack of knowledge on what the legal requirements are or what is expected of your pharmacy staff to meet these federal regulations. For this reason alone, training your staff on cultural competency is a must.
In addition, there have been real world examples of pharmacies being subpoenaed and sanctions being placed on pharmacies due to the Department of Justice (DOJ) determining there was a lack of “reasonable steps” being taken to ensure equal access to care, one being Rite Aid. In November 2021, the Justice Department and the U.S. Attorney’s Office for the Middle District of Pennsylvania reached a settlement agreement with Rite Aid Corporation in the matter of people with disabilities having difficulty accessing information about the COVID-19 vaccinations and booking vaccination appointments online. Specifically, Rite Aid’s COVID-19 registration portal was not compatible with screen reader software used by some patients with disabilities. In addition, those who have issues using a mouse were unable to use the tab key in its place when filling out the consent form. Therefore, it was determined there was not equal access to care and Rite Aid had 30 days to correct their online COVID-19 vaccine content to industry guidelines that allows accessibility for users with disabilities. In addition, Rite Aid was ordered to regularly test and correct any issues with its COVID-19 Registration Portal for a 30-month duration.
PAAS National® understands that your time is valuable. Therefore, we condensed more than three hours of content into (less than) one hour of training, making it practical and tailored to the independent pharmacy setting. Our efficient training covers federal requirements, including linguistically appropriate services, and concludes with a certificate of completion.
PAAS Tips:
- Make sure your NCPDP profile is up to date! PBMs now utilize the pharmacy’s NCPDP profile to pull information in regard to cultural competency training instead of having pharmacies directly attest to each individual PBM.
- Humana still requires a direct attestation and additional training in select states
- Watch our On-Demand Webinar “Does My Pharmacy Really Need Cultural Competency Training?”
Why You Should Care About PBM Provider Manuals (and Where to Find Them)
Whether your pharmacy contracts directly with a PBM or the agreements are negotiated through a Pharmacy Services Administrative Organization (PSAO), the terms and conditions within the agreements are just the beginning of a pharmacy’s obligations. Additional expectations for the pharmacy are laid out in the PBM’s Provider Manual. Understanding and following the stipulations contained therein can help decrease your risk of audit recoupments and keep the pharmacy in good standing. However, these manuals vary significantly by PBM, often exceed 150 pages, and can get updated multiple times throughout the year – making it impossible for pharmacies to keep up with all the requirements. Making matters worse, PBMs do not accept a plea of ignorance and violating the provider manual can lead to claim recoupment, accusations of fraud, waste, or abuse, and even contract termination!
Through our Newsline and audit assistance, PAAS National® helps pharmacies stay abreast of these changing requirements as they relate to audits. To access the Provider Manuals directly, follow the links below:
PAAS Tips:
OptumRx Auditing for Medical Supplies Billed Under Medicare Part D
In March 2024, PAAS National® analyst assisted nearly 100 pharmacies with desk audits from OptumRx requesting documentation related to claims for medical supplies (primarily alcohol swabs) that were processed by OptumRx under the Medicare Part D benefit. OptumRx asked pharmacies to provide copies of insulin prescriptions as well as the associated fill histories, signature logs and explanation of payment for these insulin prescriptions dispensed between July 2019 and June 2023.
Most pharmacies report dispensing no insulin to the patients in question and explained that the alcohol swabs were being used in conjunction with diabetes testing supplies (test strips, lancets) that were also billed to OptumRx. Since OptumRx covered the cost for diabetes testing supplies, it would suggest that patients were enrolled in a Medicare Advantage (MAPD) plan and OptumRx incorrectly categorized the alcohol swab claims as “Part D” when they should have categorized as “Part B”. The OptumRx audits seem to stem directly from a nationwide CMS audit of Plan Sponsors initiated in December 2023. During this audit, CMS scrutinized Part D claims for medical supplies, such as alcohol swabs, in cases where patients lacked any claim history for insulin use.
The coverage of insulin and its related supplies may vary depending on the Medicare benefit type and the intended use of the item. Specifically, insulin vials and alcohol swabs could be eligible for coverage under either Medicare Part B or Part D.
Keep in mind that Medicare patients could have prescription and medical benefits that are separate or combined.
Here is a chart to help you identify the correct payer depending on the type of Medicare benefit and the item in question.
(Part B/DMEPOS)
(MAPD)
A few nuances to keep in mind:
PAAS Tips:
Philadelphia Pharmacy Employees Charged for Drug Diversion and Fraudulent Billing Practices
A years-long investigation of the top retail pharmacy purchasing oxycodone in Pennsylvania has come to resolution.
The pharmacy engaged in reckless controlled substance dispensing, ignoring signs of diversion (i.e., accepting blatantly forged prescriptions and sizable amounts of cash payments for drugs) and dispensing opioids in extreme doses or in combination with other “cocktail” drugs. In addition, the pharmacy took part in an extensive health care fraud scheme. The pharmacy would fraudulently bill for drugs that were not intended to be dispensed. A hallmark part of the scheme involves employees using the code “BBDF” or “Bill But Don’t Fill” in their computer system to communicate the prescriptions that were merely to be billed without dispensing medication to the patient as a means to further their profits.
The owner pled guilty and was sentenced to 42 months in prison for his role. He also plead guilty to having conspired with others to ultimately engage in this health care fraud scheme and illegally dispensing oxycodone. The owner and his business agreed to pay $4.1 million to resolve the company’s civil liability. In addition, the company will not be permitted to dispense any controlled substances in the future and will be unable to bill federally-funded programs for 22 years.
Two former employees of the pharmacy also plead guilty to charges alleging they knowingly dispensed oxycodone without a valid prescription, resulting in 3 months and 4 months in prison, respectively. In addition, they each agreed to pay the United States in order to resolve civil allegations and committed to never dispense any controlled substances going forward.
Although the pharmacy’s motives were blatant violations of the Controlled Substance Act and False Claims Act, that is not always the case. Ensure your pharmacy staff has a good grasp on proper billing habits and a policy manual for preventing, detecting and report Fraud, Waste and Abuse. See PAAS National®’s compliance program for more information or call us at 608-873-1342.
Does My Pharmacy Really Need Cultural Competency Training?
Pharmacies are no stranger to the requirements of completing annual Medicare Fraud, Waste, and Abuse training, which is a very clear requirement created by Medicare Part D and MAPD statutes. Because CMS holds PDPs and MAPDs responsible, PBMs often ask for the pharmacy’s FWA training during onsite audits. On the contrary, cultural competency training isn’t something PBMs regularly ask for. In a world where pharmacy employees are already spread thin, is completing cultural competency training truly necessary?
As of April 2021, NCPDP required pharmacies to indicate if they train their staff on cultural competency and maintain evidence of such training, when going through the pharmacy’s annual NCPDP profile credentialing. Since adding this question, PBMs have decreased the number of direct attestations required of community pharmacies. However, indicating ‘no’ in NCPDP is not without potential repercussions as PBMs may exclude you from provider listings of culturally competent care, as this was required for Medicaid managed care plan directories. Additionally, there are federal requirements that have been in place for many decades.
Through many federal laws and regulations related to discrimination and cultural competence comes the requirement that all healthcare professionals, including pharmacies, must take “reasonable steps” to provide equal access to care across all patient populations. It cannot be expected that a pharmacy would be able to meet the standards if there is a lack of knowledge on what the legal requirements are or what is expected of your pharmacy staff to meet these federal regulations. For this reason alone, training your staff on cultural competency is a must.
In addition, there have been real world examples of pharmacies being subpoenaed and sanctions being placed on pharmacies due to the Department of Justice (DOJ) determining there was a lack of “reasonable steps” being taken to ensure equal access to care, one being Rite Aid. In November 2021, the Justice Department and the U.S. Attorney’s Office for the Middle District of Pennsylvania reached a settlement agreement with Rite Aid Corporation in the matter of people with disabilities having difficulty accessing information about the COVID-19 vaccinations and booking vaccination appointments online. Specifically, Rite Aid’s COVID-19 registration portal was not compatible with screen reader software used by some patients with disabilities. In addition, those who have issues using a mouse were unable to use the tab key in its place when filling out the consent form. Therefore, it was determined there was not equal access to care and Rite Aid had 30 days to correct their online COVID-19 vaccine content to industry guidelines that allows accessibility for users with disabilities. In addition, Rite Aid was ordered to regularly test and correct any issues with its COVID-19 Registration Portal for a 30-month duration.
PAAS National® understands that your time is valuable. Therefore, we condensed more than three hours of content into (less than) one hour of training, making it practical and tailored to the independent pharmacy setting. Our efficient training covers federal requirements, including linguistically appropriate services, and concludes with a certificate of completion.
PAAS Tips:
OptumRx Targeting Medications Requiring Dispensing in Original Containers
Recent audit results coming into PAAS National® are showing OptumRx auditors have their sights set on several medications that are required to be dispensed in the original container.
PAAS has notified members of common medications (e.g., Creon® and Linzess®) being targeted for recoupment on audits when dispensed outside manufacturer guidelines. However, several new medications have been added to their target list …
Please visit the Member Portal for the most current Dispense in Original Container Chart, that is updated as information is available.
Without PBM hard stops in place at claim adjudication (which is complete malarky), the burden falls on the pharmacy to ensure FDA dispensing requirements are met. Don’t fall into the trap and face recoupment because you billed a claim that was not divisible by the package size (e.g., dispensing 28 tablets with a 30-count bottle size – only billed in multiples of 30).
Pharmacies that service long-term care and assisted living facilities, or provide special packaging for patients on a sync program, tend to be at the highest risk for billing these claims incorrectly. Often, the manufacturer has not provided any stability information that supports breaking the stock bottle, therefore this medication should not be dispensed using special packaging.
PAAS Tips:
2024 Self-Audit Series #3: Invoice Audits
The number of invoice audits continues to rise from Medicaid, and PBMs, across the board. This investigational audit is a way to potentially identify false or phantom claims. Auditors will reconcile the claims billed by a pharmacy during a certain timeframe, with the purchases made. This process ensures the pharmacy had inventory on hand to dispense for the claims they billed. Many PBMs, including OptumRx®, Elixir®, and Express Scripts® request pharmacies provide a full dispensing history for further reconciliation.
Some inventory audits are frequently combined with a desk audit. PBMs like Caremark request a high number of prescriptions, signature logs, and proof of copay collection. The amount of data a pharmacy is required to provide can be very overwhelming and time consuming. Performing internal, “mock audits” may help you be better prepared when receiving an invoice audit request.
Pharmacies must be diligent in following PBM requirements for purchasing. Audit recoupments can easily reach hundreds of thousands of dollars when invalid purchases are not accepted.
PAAS Tips:
2024 DMEPOS Series #3: Ostomy Supplies
Many pharmacies struggle with DMEPOS audits due to the complexity in medical billing and the onerous documentation requirements. Medicare Part B suppliers need to be able to produce all the required documentation if audited, and make sure all documentation meets Medicare Part B standards. This DMEPOS series is intended to help you understand these complexities and gather the needed documents.
In particular, you should be able to show the following if audited on ostomy supplies:
Other considerations include:
PAAS Tips:
Audit Preparedness in Long-Term Care Claims: Implementing Proactive Measures
The practice of LTC pharmacy is different – look no farther than the dichotomy between prescriptions and orders. While state laws may be vague or unclear, resulting in pharmacists using professional judgement, PBMs have their own requirements. Do PBM Provider Manuals (and auditors) view LTC differently? The answer may surprise you—not as much as one may think and following the “LTC is different” mindset may lead to a lot of extra work (or recoupments) if you find yourself with an audit. Insufficient documentation for Long-Term Care (LTC) prescription claims is a topic PAAS National® analysts cover frequently during audit preparation consultations with members operating combo shop pharmacies and/or closed door LTC pharmacies. Our analysts are experts in understanding the documentation requirements for both retail and LTC claims and want you to be comfortable and confident in your documentation as well. One reference tool the PAAS analyst will utilize when educating pharmacies …
Apart from the facility name and the small nuances with duration of therapy, the elements above should look very familiar as they are the same elements prescriptions for retail claims should have. Other similarities between retail and LTC requirements include:
While daily operations and workflow in a closed-door LTC pharmacy may be vastly different from that of a retail pharmacy, the pharmacy still has the same requirement to provide proof of a valid prescription, proof of dispensing, proof of copay collection, and proof of sufficient inventory. Failing to have sufficient documentation could mean claim recoupment, accusations of fraud, waste, or abuse, and (potentially) contract termination.
PAAS Tips:
V-Go® All-In-One Insulin Delivery Patch
The V-Go® all-in-one insulin delivery patch is a disposable device approved for use in patients with Type 2 diabetes. Because it is “disposable” and not “durable”, it is covered under Medicare Part D (rather than Part B). The device comes in three different strengths that deliver a basal dose of 20 units, 30 units, or 40 units of rapid acting U-100 insulin (such as Humalog® or Novolog®) per 24 hours. Additionally, each device can deliver up to 36 units of on-demand bolus insulin for mealtimes (in 2-unit increments). Prescribers will need to issue two separate prescriptions for patients – the prescription for #30 V-Go® devices to last one month and a prescription for the rapid acting U-100 insulin to put into the devices (typically 20-30 mL).
According to the instructions for patient use, patients must fill each device completely each day and each device holds slightly more than it can actually deliver. The amount of insulin each device can hold is referred to by the manufacturer as the Minimum System Daily Insulin Requirement and the amount of insulin each device can deliver is referred to as the Minimum Reservoir Dosing Capacity.
The table below summarizes each device and provides an estimated day supply to bill based on the number of vials of insulin and the amount of insulin used to fill each device.
PAAS Tips:
The Alarming Toll of HIPAA Breaches: Over 41 Million Individuals Affected in 2022
Each year, the Health and Human Services Office for Civil Rights (OCR) composes detailed reports on HIPAA compliance and breaches of unsecured Protected Health Information (PHI) and delivers them to Congress. The latest report is that of events from the 2022 calendar year. These reports can teach us about weaknesses in the HIPAA policies and procedures of other entities, the most common types of threats from malicious actors, and help educate staff on identifying vulnerabilities in the pharmacy’s safeguards during their next Risk Analysis.
Here are a few of the key takeaways from the 2022 Annual Report to Congress on HIPAA Privacy, Security, and Breach Notification Rule Compliance:
The 2022 Annual Report to Congress on Breaches of Unsecured Protected Health Information had several key takeaways as well:
According to OCR, “There is a continued need for regulated entities to improve compliance with HIPAA Rules. In particular, the Security Rule standards and implementation of specifications of risk analysis, risk management, information system activity review, audit controls, response and reporting, and person or entity authentication were areas identified as needing improvement in 2022 OCR breach investigations.”
If you are not sure where to start, contact PAAS National® (608) 873-1342 for more information on PAAS’ FWA/HIPAA Compliance Program that is easy to set-up, web-based and customized for your pharmacy.