Fraud, Waste, & Abuse and HIPAA Compliance Updates for 2021

PAAS National® continuously keeps close tabs on legislative and regulatory changes that may impact our members’ Fraud, Waste & Abuse and HIPAA Compliance Program. Monitoring enforcement from the Department of Justice and the Office for Civil Rights (OCR) also allows us to be aware of interpretative standards as well.

Furthermore, Pharmacy Benefit Managers (PBMs) are continuously adding and changing requirements to their credentialing process. Pharmacies need to be certain they are ready for these changes. The PAAS National® FWA/HIPAA Compliance Program has implemented changes to ensure pharmacies with our program will continue to have robust policies in place.

Does your pharmacy have a policy for Timely Submission of Claims? PAAS has increasingly become aware of this credentialing requirement. Having written policies in place will assist you with credentialing responses. PAAS FWA/HIPAA compliance members can now find this in Section 4.1.8 of their Policy and Procedure  Manual.

It is also important for pharmacies to be aware of OCR’s stepped-up enforcement for Pharmacies who are not providing timely access to patient records – fines for violations have exceeded $200,000. PAAS FWA/HIPAA compliance members should review Section 10.5.1.1 of their Policy and Procedure Manual and review our January 2020 Newsline article First Two Settlements for HIPAA Right of Access Initiative by OCR.

PAAS FWA/HIPAA compliance members can login to the member portal to view the full memo of 2021 FWAC and HIPAA Updates.

With our 24/7 web-based Portal, extensive customization, and ease of use, it’s easy to see why most PAAS members use our FWA/HIPAA compliance program.

Are You Documenting DUR and Submission Clarification Codes?

PAAS National® is continuing to see Express Scripts (ESI) and Tricare flag claims for audit where clinical drug utilization review (DUR) or submission clarification codes (SCC), were submitted. Prime Therapeutics, now processed by ESI, has now joined in. Recoupments are happening due to “No DUR documentation” or “No SCC documentation.” Pharmacies that fail to show documentation of the support codes used on the prescription are facing recoupment.

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Dispensing pharmacists must use professional judgement when receiving a point-of-sale reject. If choosing to dispense a medication using an override code, it is imperative that supporting documentation be placed on the prescription to support its utilization. This documentation should contain detailed information with dates, names, titles, and discussions that took place if patients, or prescribers, were consulted. Lack of this documentation can lead to recoupment.

Most common SCCs subject to audit (as defined by NCPDP) are:

Please click here to view all 37 NCPDP Submission Clarification Codes and their corresponding definitions. There are additional codes found in the link that pertain to LTC billing, compounds and 340B. Drug utilization review codes can be found as follows: Reason for Service Code, Professional Service Code (NCPDP 440-E5) and Result of Service Code.

PAAS Tips:

  • Make sure all documentation is made on the original prescription or with an electronic note that can be retrieved upon audit request
  • Clinical notations should contain all four elements: date, name and title of person you spoke with, what was discussed and initials/name of pharmacy personnel that made the call
  • Be sure any notations made on previous prescriptions are carried forward to new prescriptions if you are using this as supporting information
  • Documentation should clearly support specific override code(s) submitted
  • Specific information to support vacation supplies and lost medication is recommended
    • For example: date of request, number of days patient will be gone, or amount of medication lost
  • Professional service code “M0” will require consultation with prescriber and appropriate documentation

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.

Webinar: 340B Contract Pharmacy Considerations for 2021

PAAS National® is hosting a webinar on Wednesday, March 3 from 2:00-2:45 p.m. CST

We look forward to you joining us as President of PAAS National®, Trenton Thiede, PharmD, MBA:

  • Reviews 340B audit risk
  • Looks at Medicaid considerations with 340B
  • Reviews the 340B claim identification and submission requirements
  • Discusses the two-tier (aka discriminatory) pricing model
  • Explores a recent PBM communication released on February 24, 2021

Bring your questions, we will do our best to allow some time for Q&A at the end of the webinar.

PAAS Audit Assistance members will have access to a recording on the member portal if you are unable to attend the live event.

Reminder first step to using your audit assistance with PAAS National® is when you receive an audit notice call PAAS 608.873.1342 to get a case set-up then email info@paasnational.com or fax 608.873.4009 in your audit notice.

Our all-inclusive audit assistance membership means there are no hidden fees or limits to the audit assistance you can receive. We are here to help you!

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FDA Requests Updated Product Labeling on Insulin Pens

Stop Breaking Insulin Pen Boxes

The pharmacy industry has long debated whether one box of insulin pens is considered “unbreakable”. The debate appeared to be settled January 22nd, 2019 when the U.S. Department of Justice issued a press release stating Walgreens agreed to a $209 million fraud settlement with the federal government regarding its billing and dispensing of insulin pens to Medicaid, Medicare Part D and TRICARE patients. Prior to the settlement, Walgreens’ policy was to not dispense any insulin pens in quantities less than one full box, forcing their staff to falsely understate the days’ supply on thousands of claims. They then enrolled many of these patients on its refill reminder program, causing patients to get early refills. The government labeled that billing activity as
widespread FRAUD and required Walgreens to enter into a Corporate Integrity Agreement with the Office of the Inspector General. Consequently, both Walgreens and CVS have been breaking insulin pen boxes when appropriate. Read the full urgent member alert here.

Caremark Manufacturer Coupon Policy

PAAS National® continues to see pharmacies suffer full recoupment on claims that are processed to coupons and copay cards in violation of Caremark’s policy found in section 3.03.03 of the 2020 Pharmacy Provider Manual. Violations are considered [by Caremark] to be an inappropriate waiver of patient pay amounts and could result in additional sanctions, including termination.

As defined in the current Provider Manual: “Pharmaceutical Manufacturer Coupon” means any item or mechanism, including but not limited to, paper coupons, copay cards, e-vouchers, mail-in rebates, and electronic coupon codes funded by a manufacturer, repackager, or supplier of pharmaceutical, chemical, or compounding products, that reduces the portion of the Patient Pay Amount that an Eligible Person is required to pay for a Covered Item.

Manufacturer coupons may be accepted if:

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  1. Pharmacy complies with all the terms and conditions specific to the coupon – including prohibitions on using for federally funded programs such as Medicare, Medicaid, and TRICARE
  2. The coupon is applied by your pharmacy location and not a hub
  3. The item is NOT a compound drug, 510(k) cleared medical device or Medical Food
  4. The item falls into one of the following categories:

a. Approved as a brand (NDA) or generic (ANDA) drug and published in the FDA Orange Book

b. Approved under a Biologics License Application (BLA) and published in the FDA Purple Book

c. Over-the-Counter (OTC) item marketed under an official final OTC monograph

d. Grandfathered drug marketed before 1938 or 1962, or is otherwise considered Generally Recognized as Safe and Effective (GRASE) by the FDA

PAAS Tips:

  • Pharmacies typically run afoul of Caremark with products sourced from secondary distributors identified as dietary supplements, medical foods or medical devices
    • These are typically products with large patient copays
  • Don’t assume that a product is “FDA approved” just because it has an NDC number
  • Use the following websites to determine FDA marketing status
    • FDA Orange Book
    • FDA Purple Book
    • DailyMed
  • If you are ever in doubt about a product, call PAAS at 608-873-1342 so that we can help you identify whether it will be a problem
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PBM Enforcement of Return to Stock Policies

PAAS National® wrote an article in our April 2020 Newsline regarding PBMs Enforcing Return to Stock Policies. A PBM will recoup a claim in full if a medication is picked up after their required return to stock timeframes listed in the respective provider manuals. The provider manual may reference these as “unclaimed prescriptions.” Pharmacies should have a policy and procedure in place to only allow medications to remain in the will call bins for the shortest outlined time – 10 days. If your pharmacy has PAAS National®’s Fraud, Waste & Abuse and HIPAA Compliance (FWAC) program, a return to stock policy is available to you, including a log to help you document and complete this task (see section 4.1.1 Unclaimed Prescriptions and Appendix B – Unclaimed Prescription Reversal Log).

Major PBM Return to Stock Timeframes:

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Calendar Business
10 days 13 days 14 days 10 days 15 days
MeridianRx
Serve You Rx
TRICARE		 Express
Scripts		 Aetna
Caremark
Elixir
MagellanRx
MedImpact
Navitus
OptumRx
Prime Therapeutics		 Southern
Scripts		 Humana

PAAS Tips:

  • Pharmacies should not leave prescriptions in the will call bins for more than 10 days to comply with the shortest return to stock timeline of 10 days per MeridianRx, Serve You Rx and TRICARE.
  • These return to stock timelines also apply to completions (aka “partial fills”) left in the will call bins
  • PBM return to stock policies are still required to be met during the COVID-19 pandemic
  • LTC prescriptions are not exempt from these return to stock policies
  • If you are a FWAC member and change your procedure for returning medications to stock, be sure to have your admin or compliance officer update section 4.1.1 of your Policy and Procedure manual
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Mid-Level Practitioners and Their Supervising Physicians– Documentation Required?

PAAS National® has seen a recent uptick in the number of prescriptions being found discrepant for missing the supervising physician when written by a mid-level practitioner (e.g. physician assistant or nurse practitioner). Laws pertaining to mid-level practitioners are specific to each state and may differ between physician assistants and nurse practitioners. Because these regulations may be found through the Board of Medicine or Board of Nursing, pharmacies are not always aware of the requirements to make a valid prescription. In particular, many states require the name of the supervising physician be present on the prescription hard copy.

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PAAS Tips:

  • Check your state’s laws regarding what is required for a valid prescription, including those through the Board of Pharmacy, Board of Medicine and Board of Nursing
    • Physician assistants and nurse practitioners may have separate requirements under the Boards of Medicine and Nursing
  • Check with your software vendor to see if the supervising physician is being transmitted by the doctor’s office but not pulling forward on an electronic prescription
    • There may be a “short” and “long” version of the electronic prescription that can be printed
  • If a supervising doctor is required on a prescription but not present, call the prescriber’s office to find out who the supervisor is and note the name on the prescription

PAAS National® is committed to serving your needs and helping you reduce audit risk.

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FDA Guidance on Insulin Pens Puzzling

On October 13, 2020, the U.S. Food and Drug Administration issued a statement looking to clarify the intent of the November 2019 label revisions for insulin pens. The updated labeling contained “Dispense in this sealed carton” on insulin pen boxes and Section 16.2 of the package inserts state: “Dispense in the original sealed carton with the enclosed Instructions for Use.” PAAS National® Members should be familiar with our February Urgent Email Alert and subsequent Newsline articles in March and April.

Looking to get further clarity into the rationale for the labeling change, PAAS had submitted a Freedom of Information Act request to the FDA. In response, PAAS learned

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that a Tracked Safety Issue was opened for insulin pens back in June of 2018. Congruently, the clarification from this October recognizes the following concerns when breaking insulin pen boxes: medication errors (including wrong drug/dose resulting in hyper/hypoglycemia), missed doses, complaints of possible tampering, and dispensing without the Instructions for Use.

The October letter goes on to the following:

  1. Insulin pens are approved to be dispensed in their original sealed cartons
  2. Insulin pens are not labeled for dispensing as individual units
  3. Sealed cartons of insulin pens are intended to be dispensed to a single patient
  4. Each carton is sealed, with the intent to alert health care professionals and patients when it has been opened, individual insulin pens within the cartons do not have their own sealed package. The carton labeling and sealed packaging are important for both health care professionals and patients.
  5. The cartons help health care professional and patients differentiate between the insulin pens

However, to the bewilderment of many, the FDA also stated the following:

  1. The FDA claims the November 2019 revisions stated that health care professionals should dispense the pens to a single patient in the original sealed carton (note should, not must)
  2. The FDA understands there are situations where health care professionals may choose to dispense individual pens (outside of the carton), not in accordance with FDA-approved labeling, based on their own professional judgement
  3. Health care professionals should consider the known risks of dispensing individual pens, and incorporate additional safety measures (e.g. adding tamper-indicator tape, providing the Instructions for Use, and labeling individual pens for individual patient use)

So, what does this all mean for community pharmacies? More of the status quo – don’t break the box. While the FDA may “understand” and permit dispensing of individual pens on an exception basis, payers (and PBMs) may not. PAAS often sees PBMs hold pharmacies accountable for FDA labeling requirements (e.g. dispense in the original container medications). Moreover, pharmacists could incur additional liability by choosing to go against FDA labeling requirements despite warnings from the FDA.

PAAS Tips:

  • Pharmacies should always try to first bill an accurate days’ supply based on the prescribed quantity– many insurers have accommodated days’ supply limits well in excess of 90 days
  • If plan limits are exceeded follow the guidance below:
    • Multiple cartons – reduce the # of cartons and corresponding days’ supply until the claim will adjudicate. Document Insurance Limits Quantity (e.g. ILQ = 30 days) on the hard copy.
    • Single carton (in order of preference):
      • Call the PBM help desk and request an override
      • If no override is available, adjust the days’ supply to the Plan Limit

Members can view our eNewsline in the member portal for additional PAAS Tips.

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COVID-19 Vaccine: Are You Prepared to Administer?

Healthcare providers will play a key role when a COVID-19 vaccine becomes available. CMS has issued a set of toolkits for providers, states and insurers to help in preparation of administering the vaccine when it becomes available. Medicare has provided these resources to help increase the number of providers that can administer the vaccine and ensure ample reimbursement for administration. They have also made it clear to Medicaid and private insurers their responsibility to cover the cost of the vaccine at no charge to the patient.

If you are not a Medicare enrolled provider then you need to enroll as a mass immunizer or other provider type to be able to bill for administering the vaccine. Please review the toolkits to see if your pharmacy needs to update your provider type. The toolkits explain how a pharmacy can enroll and discusses the Medicare coding structure and reimbursement strategy.

Medicare has established administration payment rates for the 2-dose series at $16.94 for the initial dose, and $28.39 for the final dose – incentivizing pharmacies and other providers to make sure the patient comes back for the second dose.

PAAS Tips: 

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  • Read the enrollment section of the toolkit to see if your pharmacy needs to take any current action
  • You can enroll as a mass immunizer over the phone – call your MAC-specific enrollment hotline
  • CMS will update the toolkits as new information becomes available
  • Make sure your pharmacy is prepared and educated on billing and administering the COVID-19 vaccine

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