OIG and GSA Exclusion Checking – Are You Compliant?

The United States Department of Justice recently released the outcome of an investigation of the False Claims Act. Two pharmacists and their management company in Pennsylvania agreed to pay $250,000 to resolve the potential liability.

Claims were brought forward under qui tam, known as the whistleblower provision of the False Claims Act statue. After an investigation by U.S. Department of Health and Human Services’ Office of Inspector General (OIG), the U.S. Office of Personnel Management’s Office of Inspector General, and the U.S. Attorney’s Office for the Eastern District of Pennsylvania, it was discovered the management group and pharmacies employed a pharmacist that had been excluded from participating in federal health care programs. This exclusion occurred due to a felony-controlled substance conviction.

The investigation also revealed that the pharmacist in question, although having a suspended pharmacist license due to his conviction, had been given administrative authority and was filling prescriptions when pharmacists-in-charge were not available.

Claims billed to Medicare, Medicaid or the Federal Employee Health Program by an excluded person are considered false or fraudulent. Penalties, claim recoveries and possible pharmacy exclusion can result from an excluded employee. Pharmacies must be diligent in monitoring the OIG and the General Services Administration (GSA) exclusion lists. Potential employees must be checked prior to hire.

PAAS National®’s Fraud, Waste and Abuse & HIPAA Compliance Program monitors the OIG and GSA lists for our members. The pharmacy is notified immediately if an excluded employee is found. The program also allows members to print monthly exclusion lists and stores them electronically. PBMs will often request proof of exclusion checks during an audit.

Contact PAAS National® at (608) 873-1342 or visit paasnational.com/fwac-hipaa for more information on our FWA/HIPAA Compliance Program. By becoming an Elite member of both programs you save $120; join today to avoid any gaps between checks and get daily OIG and GSA exclusion list checks!  

PAAS Tip:

Audit Risk: Ivermectin Used for Treating COVID-19 (September Update)

Ivermectin has been getting a lot of press as of late, from news outlets, national associations, and federal agencies, regarding the dangers of using it to treat or prevent COVID-19. While many of the reports discuss the concern about using veterinary products, there are also many reports of adverse effects when using high, and unauthorized or unapproved, doses of human products.

In March of 2021, the FDA published an article titled Why You Should Not Use Ivermectin to Treat or Prevent COVID-19 which lays out some of the reasons it is currently considered an ill-advised treatment, including not being an anti-viral drug, potential for serious patient harm when taken in large doses, and potential for patients to access via illegitimate sources and/or medications intended for animals. Subsequently, the CDC issued an official health advisory on August 26 to remind both clinicians and the public about the lack of evidence to support ivermectin use for COVID-19 and the potential dangers. Despite the FDA warning, the CDC advisory indicated a 24-fold increase in the number of outpatient prescriptions being prescribed, compared to the pre-pandemic baseline.

Consequently, PAAS is seeing more PBM audits on ivermectin prescriptions. Pharmacies should be prepared to

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have claims looked at for potential recoupment on the basis of “clinical appropriateness”. Pharmacists should give extra scrutiny to telemedicine prescribers who may not have a valid patient-provider relationship, be prescribing outside their scope of practice, or not licensed in the state in which the patient resides.

Due to the exponential increase in prescribing and dispensing, the AMA, APhA and ASHP issued a joint press release on September 1, 2021 calling for an immediate end to the prescribing, dispensing, and use of ivermectin for COVID-19 outside of clinical trials.

PAAS Tips:

  • See our July 2021 Article, Audit Risk: Ivermectin Used for Treating COVID-19
  • Prescriptions successfully processed at point-of-sale do not guarantee payment. PBMs, and payers, use pay and chase methods to recoup claims to avoid inhibiting potentially needed access to medications.
  • Prescriptions dispensed for cash may still carry risk (outside the scope of PAAS audit services).
    • While off-label prescribing is commonplace, what is atypical with ivermectin treatment for COVID is the FDA, CDC, NIH, and National Medical and Pharmacy Organizations recommending against its utility. Consequently, this seems to open the door for potential malpractice lawsuits to occur.
    • At face value, would a prescription be considered reasonable in the face of the aforementioned opposition, or does the pandemic environment and a pharmacist’s experience and professional judgement supersede?

Medicare Part D Audits: Top 11 Areas for Scrutiny

By Karen Blum, Published August 26, 2021 by Specialty Pharmacy Continuum

Medicare Part D pharmacy audits are on the rise, and pharmacists would be wise to adapt their business practices and know how to respond, an audit expert said at the virtual MHA 2021 Business Summit.

“Prior to COVID-19, we’ve seen a nearly 80% increase in audits that pharmacies experience,” said Trenton Thiede, PharmD, MBA, the president of PAAS National®, a pharmacy audit assistance company. These have primarily been from pharmacy benefit managers (PBMs) but also by plan sponsors and the Centers for Medicare & Medicaid Services, Dr. Thiede noted. The increase has occurred partly as a result of escalating health care costs and the opioid epidemic, as well as instances of fraud, waste and abuse, he said. There’s been a shift from on-site to more quick turnaround desk audits that try to validate quick outliers, such as high-dollar items or incorrect days’ supply. Nearly one-fourth of desk audits seen by his company now are for these prescription validation requests, he said.

Over the past year, due to COVID-19, many PBMs have conducted virtual audits. These take elements from both on-site and desk audits, Dr. Thiede said, asking compliance questions, requiring photos of the pharmacy area and copies of licenses, as well as requesting copies of prescriptions and signature logs.

Pharmacy owners who don’t perform well on audits face risking their reputation, license, fines and even imprisonment, he said. Financial recoveries are common, but his firm is seeing more and more network terminations due to poor compliance or bad actors.

Overall, pharmacies need the following items to perform well on audits: prescriptions that are legal and valid per state and federal laws, proof of filling and billing accurately, proof of dispensing, proof of copay collection, and documents to prove enough inventory was purchased from an appropriate source.

Common audit discrepancies can occur over items such as missing, invalid or altered prescriptions; unauthorized refills; refilling medication too soon; incorrect dispense-as-written (DAW) codes; missing or invalid signature logs; and issues delivering medication greater than 10 days after the date of fill, Dr. Thiede said.

Dr. Thiede presented the top 11 audit discrepancy areas noted by his firm, and advised how to prepare for them. >>Learn more

Humana Notice of Erroneous Billing under Medicare’s Limited Income Newly Eligible Transition Program (LINET)

Brace yourself, a Humana LINET recoupment could be in your future. LINET is a program that started January 1, 2010 under CMS, designed to simplify Part D prescription drug coverage for Medicare beneficiaries who are eligible for Medicaid (dual eligible) or the Medicare Low-Income Subsidy (LIS).

PAAS National® has received an exorbitant number of audits from Humana, the administrator for the LINET program, in the past two weeks. Pharmacies should be concerned about these supposed “overpayments” going back 6+ years and the potential industry implications that lie ahead. PAAS has researched the issue and wants to help your pharmacy respond to these egregious attacks on your business.

SPECIAL: Join PAAS for 1 year, instead of 2 years today to get assistance with this recoupment.

Call us at (608) 873-1342 or go to ‘Buy Now’ to join today!

PAAS’ insight and proactive guidance will help you build an audit wall around your pharmacy. We want to save you vast amounts of TIME and MONEY. See why more than 5,000 pharmacies across the US agree. As a member, you receive an unlimited amount of one-on-one audit assistance—as much as you need!

Pharmacies Facing More Payment Denials During Pandemic’s Virtual Audits

By Katie Adams. Published August 6, 2021 in Becker’s Hospital Review

Already marred from COVID-19 burnout and years of financial threats, independent pharmacies’ latest woe is pharmacy benefits managers’ shift to virtual audits during the pandemic. Independent pharmacies say the new process allows for significantly more claims to be denied and allege the practice is predatory, Kaiser Health News reported Aug. 6.

The number of pharmacy audits conducted in 2020 actually decreased by nearly 14 percent from the previous year, but the overall number of prescriptions reviewed increased by 40 percent, according to data from pharmacy audit assistance service PAAS National®. The data showed the number of prescriptions reviewed in September and October increased fourfold from what PAAS reported in previous years.

When PBMs conducted these reviews in-person, they sent an auditor who would perform the process and occasionally seek additional documentation from a pharmacist. The virtual process means pharmacies face an increased administrative burden and stand to lose much more money, a change imposed when they were scrambling to take care of patients during the pandemic.

Continue reading the full article here

Pharmacies Face Extra Audit Burdens That Threaten Their Existence

By Markian Hawryluk, Published August 6, 2021 by Kaiser Health News

The clock was about to strike midnight, and Scott Newman was desperately feeding pages into a scanner, trying to prevent thousands of dollars in prescription payments from turning into a pumpkin.

As the owner of Newman Family Pharmacy, an independent drugstore in Chesapeake, Virginia, he was responding to an audit ordered by a pharmacy benefit manager, an intermediary company that handles pharmacy payments for health insurance companies. The audit notice had come in January as he was scrambling to become certified to provide covid-19 vaccines, and it had slipped his mind. Then, a month later, a final notice reminded him he needed to get 120 pages of documents supporting some 30 prescription claims scanned and uploaded by the end of the day.

“I was sure I’d be missing pages,” he recalled. “So I was rescanning stuff for the damn file.”

Every page mattered. Pharmacy benefit managers, or PBMs, suspended in-person audits because of covid last year, shifting to virtual audits, much as in-person doctor visits shifted to telehealth. Amid added pandemic pressure, that means pharmacists such as Newman are bearing significantly more workload for the audits. It also has allowed benefit managers to review — and potentially deny — more pharmacy claims than ever before.

According to data from PAAS National, a pharmacy audit assistance service, while the number of pharmacy audits in 2020 declined nearly 14% from the year before, the overall number of prescriptions reviewed went up 40%. That meant pharmacies had to provide more documentation and stood to lose much more money if auditors could find any reason — even minor clerical errors — to deny payments.

The average audit in 2020 cost pharmacies $23,978, 35% more than the annual average over the previous five years, the PAAS data shows. And the number of prescriptions reviewed in September and October was fourfold over what PAAS members had seen in previous years.

Continue reading the complete article here

Announcing the new PAASNational.com

After many months of hard work and dedication from our team, we are pleased to announce that on June 22, 2021 we launched the new PAAS National® website paasnational.com.

The primary goal of the redesign was to create a valuable, mobile friendly resource for visitors to access information on PAAS Audit Assistance and Fraud, Waste & Abuse/HIPAA Compliance services and keep up-to-date on news and events. Visitors can also easily view the different membership offerings at https://paasnational.com/buy-now/.

PAAS members have access to the PAAS member portal by clicking the “Member Login” button in the upper right hand corner of the screen to unlock the resources available with their specific membership type, which may include: audit assistance, proactive tips, on-site credentialing tools, days’ supply charts, COVID-19 resources, recorded webinars, guidance on filling and billing prescriptions, policy and procedure manual, risk analysis, FWA/HIPAA training, OIG & GSA exclusion list checking and more.

The website also includes member testimonials and audit assistance results. We love hearing from our members at info@paasnational.com and we have made it easier to refer a friend: https://paasnational.com/refer-a-friend/

We hope you enjoy the new website! For any suggestions, questions or comments please contact us: https://paasnational.com/contact/

340B Contract Pharmacy Claims Identification and Submission Requirements

Major PBM Updates Network Provider Manual
For 2021, a major PBM updated their provider manual regarding their position on the 340B drug discount program. Previously stating the PBM encourages Network Providers to identify 340B claims, in 2021 that language was updated to state Providers must identify the claims. This update included a March 1, 2021 effective date for processing what is called N1 (information reporting) transactions. Read the full release.

The CVS Caremark and Aetna Deal

While it hasn’t gone through yet, some say the deal to merge CVS Caremark and Aetna will be bad for health care. “It’s going to face many hurdles,” said Adam Fein, president of Pembroke Consulting. Some House Democrats are calling for a hearing to examine the merger, which still faces the Federal Trade Commission. Some antitrust experts have stated that the deal could result in higher drug prices and less consumer choice. Aetna could simply drive their prescription business to CVS pharmacies, and charge more to patients who fill their drugs elsewhere.

The $69 billion merger could have major implications for patients. The deal would combine medical benefits and pharmacy benefits, and hopefully allow better treatment of those patients – a result yet to be seen after the 2015 merger of United Health Care and OptumRx, which resulted in a deal with the Walgreens 8,000 plus pharmacies to fill 90-day supply prescriptions at home delivery copay amounts, while independent and other community pharmacies saw copay clawbacks!

Larry Merlo, the CEO of CVS Health said, “While the traditional health care system could be overseeing people’s care, it isn’t,” and described the potential merger as, “an opportunity to meet a huge unmet need.” But some are asking if they wanted to change the health care landscape, why haven’t they done so already? Others say that the rumored interest of Amazon to enter the pharmaceutical supply industry is behind the potential merger.

According to the New York Times, “Some worry that the nation’s health care system will come to resemble a series of kingdoms, where consumers are locked into separate ecosystems of pharmacies, doctors and health care clinics depending on their insurance provider.” B. Douglas Hoey, CEO of the National Community Pharmacists Association said, “You may be bounced from kingdom to kingdom.” PAAS wonders if you could even be locked out of a (contract) kingdom? Aetna has over 22 million members that they can direct to CVS!

CVS Health and Aetna say that fewer people will fall through the cracks, getting high-quality and low-cost medical care at their corner drug store. Is CVS planning on ramping up their over 1,000 Minute Clinics for walkin medical care?

If the deal goes through, Aetna’s CEO is said to receive about $500 million in exit pay and stock options, so it’s a good deal for at least one person. Time will tell whether or not the deal is good for patients, and how it will affect independent pharmacies.