On June 23, 2022 the Drug Enforcement Agency (DEA) created a Guidance Document about the use and posting of guidance documents by the DEA (yes, a guidance document about guidance documents). A historical view will help shed light on why the DEA felt it necessary to clarify this resource.
Prior to Executive Order 13891 (EO13891), Promoting the Rule of Law Through Improved Agency Guidance Documents, signed October 9, 2019, Federal Agencies, and the DEA, could communicate interpretative guidance through a variety of media, including “Dear Registrant” letters, Q&As, memorandums, and other guidance documents. PAAS National® has previously used these resources to help defend community pharmacies from overtly aggressive auditors trying to recoup on controlled substance prescriptions for what was often interpretated as missing prescription elements (e.g., can the pharmacy backtag be used to meet DEA prescription elements).
The EO13891 tried to standardize communication from Federal agencies and make communication more accessible to all. In doing so, the DEA created their own guidance document Portal, which can be found here. To be in compliance with EO13891, the DEA undertook a review of the documents available at that time and removed many of these informal documents from public view. It is suspected that the documents PAAS occasionally relied upon were swept up in this review.
On January 20, 2021, a new Executive Order 13992 was signed into effect. This order, rescinded EO 13891 (note: the timeframe traverses political regimes, likely playing a role in shifting policy). So, the question became, will the DEA re-publish some of the prior guidance that was removed?
Which brings us back to the most recent Guidance Document created June 23, 2022 where the DEA clarifies that, “These guidance documents [specifically prior to November 2019] will not be restored and should be considered rescinded or not valid”.
Beyond hearsay and anecdotal conversations with the DEA, NABP issued a memo dated August 22, 2022 to State Boards of Pharmacy. The memo states the following information was provided by the DEA:
In the past few months, DEA has received an increasing number of questions concerning pharmacists’ ability to add or modify information—like a patient’s address—on paper prescriptions. To address these questions, DEA has been reviewing the relevant regulations and working to draft new regulations to address this issue. As an interim measure, pharmacists are permitted to adhere to state regulations or policy regarding those changes that a pharmacist may make to a schedule II prescription after oral consultation with the prescriber.
So, what are pharmacies to do? Become an audit assistance member today to continue reading this article. As a member, you’ll have access to hundreds of articles and receive our monthly proactive newsletter!
Step 1: Don’t stress – while this guidance document was published recently, these policy changes likely went into effect with the signing of EO13891 (nearly 3 years ago). Just like science, healthcare, or pharmacy, we learn every day and make changes to our practice to stay in compliance with new ‘norms’.
Step 2: The memo from NABP to State Boards of Pharmacy is giving pharmacies some reprieve, with a couple caveats.
- NABP is highly regarded, and this memo should be effective at deterring rogue auditors/PBMs from denying pharmacist annotations to C-II prescriptions (pursuant to state law).
- The memo still lacks corroborating evidence. Who from the DEA provided this information, and to whom? Was this pursuant to a conversation or written correspondence?
- The overarching concern is Federal regulations cannot be superseded by a mere conversation. Perhaps the DEA will exercise “enforcement discretion”, but DEA registrants should demand to see something in writing from the DEA.
- The NABP memo states pharmacists are permitted to adhere to state regulations or policy regarding changes that a pharmacist may make to a schedule II prescription after oral consultation with the prescriber.
- Pharmacies that have relied on prescription backtags to fulfill missing elements of 21 CFR § 1306.05(a) should plan to verbally confirm those elements with the prescriber going forward (assuming state law permits the addition/change).
- For example, a missing patient address or DEA # will require a call to the prescriber to confirm the missing elements, documented with a clinical note.
Step 3: Consider proactively educating prescribers about the changing dynamics around controlled substance prescriptions and request to have all of the elements present on any prescriptions going forward.
All prescriptions for controlled substances shall be dated as of, and signed on, the day when issued and shall bear the full name and address of the patient, the drug name, strength, dosage form, quantity prescribed, directions for use, and the name, address and registration number of the practitioner.
Step 4: Understand the risk. While compliance with DEA requirements is critical, PAAS focuses on the audit risk – both theoretical (could present an audit problem in the future) and actual (pharmacies are currently getting recouped on).
- To date, we have not seen PBMs/Auditors looking to leverage these changes – quite possibly because much of the industry simply was unaware of the guidance changes pursuant to these Executive Orders. With the increased publicity, it is possible this change will no longer be under the radar, but the NABP memo may help support annotations being made.
- PAAS has not seen DEA enforcement of this change in guidance. While these rescinded communications were often effective at combating devious auditors, the documents never had the full force and effect of law and were not binding to pharmacies.
What if I receive a C-II prescription that is missing elements? While understanding the audit risk is important, DEA compliance is non-negotiable. If your state law affords pharmacists the opportunity to add/clarify DEA-required elements, and you are comfortable with NABP’s memo, call the prescriber and make a clinical annotation. In the absence of an applicable state law, reach out to the prescriber to educate and obtain an electronic order to replace the invalid prescription in hand. If the prescriber is unable to issue an eRx, consider obtaining an emergency C-II via phone as per 21 CFR § 1306.11(d). When the prescriber mails the hard copy backup, they can also send a new, compliant prescription for additional dispensing, if needed.
What about C-III through C-V prescriptions? The distinct advantage afforded to these schedules is the ability to obtain a verbal order. For example, if you receive a prescription for Alprazolam without a DEA # on it, PAAS would advise you to call the prescriber and convert the prescription to a telephone order.
PAAS Tips:
- Additional Federal elements (e.g., X DEA number and fill on/after dates for laddered prescriptions) should already be present on the prescription when presented to the pharmacy
- State requirements (e.g., alphanumeric quantity) should not be added/modified unless explicitly authorized to do so in the regulations
Are You Utilizing DAW Codes Correctly? Updated Tool Available!
In the September Newsline article, NCPDP Updates DAW Code Definitions to Encompass Interchangeable Biosimilars, you can find updated guidance for the utilization of Dispense As Written (DAW) codes with biologic drug products based on the August 2022 version of NCPDP Telecommunications Version D and Above Questions, Answers and Editorial Updates, set to go into effect October 15, 2023. Though the definitions were revised to include biologic drug products, the guidance holds true for all legend drugs. Now is the time to refamiliarize yourself with the best-practices for using DAW codes and to review DAW code audit pitfalls most seen by PAAS National® analysts. Additionally, the DAW Codes Explained tool has undergone a major overhaul to now include helpful tables, expanded DAW code definitions, PAAS tips, billing examples, and additional resources all in one place.
DAW Code Best PracticesJoin today!
- Single-source drug products (a brand or reference product with no available equivalent in the marketplace) should always be billed with DAW 0.
- Prescriptions written for a brand or reference product (which has a generic, authorized generic, interchangeable biosimilar, or “unbranded biologic” available in the marketplace) with Dispense as Written or Brand Necessary indicated in a manner compliant with state regulation should be billed with DAW 1.
- According to NCPDP guidance, when the prescriber allows for generic substitution, but the brand or reference product is billed for a multi-source drug, DAW 0 would be inappropriate. Most payers have historically accepted DAW 0, but it may have affected reimbursement rates. Instead, the brand or reference product would be more accurately billed utilizing DAW 2 through 9:
- DAW 2 if the patient prefers the brand or reference product.
- DAW 3 if the pharmacist believes the brand or reference product should be dispensed (this is rarely used).
- DAW 4 if the generic or interchangeable biosimilar is not stocked in the pharmacy.
- DAW 5 if the pharmacist is utilizing the brand or reference product as the generic or interchangeable biosimilar entity (e.g., using a brand name such as Amoxil® as your generic amoxicillin).
- DAW 6 if indicated by plan adjudication logic.
- DAW 7 if state law or regulation prohibits substitution of a brand or reference product despite an equivalent being available in the marketplace.
- DAW 8 when the generic or interchangeable biosimilar is not available in the marketplace.
- DAW 9 when the plan prefers the brand or reference product.
- Be sure substitutions are made between appropriate drug products. If you are unsure if two products are equivalent, utilize the FDA Orange Book (non-biologic drug products) or FDA Purple Book (biologic drug products) to verify.
- Check your state regulations or with your state Board of Pharmacy if you are unsure of the proper DAW 1 documentation requirements. Auditors will utilize state regulations to recoup when possible and law violations are difficult to appeal.
- Watch for electronic prescriptions submitted with erroneous DAW 1 codes. Billing a single-source product with a DAW other than zero is a red flag. It is best to avoid this pitfall because it could be just what the PBM needs to open an audit at your location. For more details, refer to the August 2022 Newsline, Erroneous DAW-1 Electronic Prescriptions.
- Prescriptions billed with a DAW 2 require documentation that the patient requested brand name. These notes should include the date of the request to meet certain PBM requirements.
- Be sure to keep documentation when DAW 6 is required per the plan.
- When billing DAW 8, keep proof that the generic, “unbranded biologic”, or interchangeable biosimilar was unavailable in the marketplace. This could be an invoice or a screen print of your wholesaler’s website. Additional guidance is in the January 2022 Newsline article, Be Proactive on DAW 8 Claims and Prevent Recoupments.
- Review the newly updated DAW Codes Explained tool found on the PAAS Member Portal
- Regularly perform a self-audit of any DAW code other than zero to check for appropriate documentation as per the guidance in the May 2021 Newsline article, Self-Audit Series #4: DAW Codes
- DAW codes 3, 4, 7, and 8 should be monitored specifically to watch for below cost reimbursement
- Consider transitioning claims for multisource drug products from DAW 0 to DAW 9 when the plan prefers brand name
DAW Code Audit Pitfalls to Avoid
PAAS Tips:
If you are billing the brand name or reference drug product when equivalent products are available in the marketplace, think about why you are doing so, utilize the correct DAW code, and ensure appropriate documentation exists to support the code utilized.
DMEPOS Mini-Series #6 – Therapeutic Shoes for Diabetes
According to the CDC, there are more than 130 million adults with diabetes or pre-diabetes in the United States. Every 17 seconds someone is diagnosed. Noridian, Jurisdiction D, has been conducting Targeted Probe and Educate reviews of HCPCS code A5500, which is for therapeutic shoes. The quarterly results based on dollars from April through June 2022 show an improper payment rate of 52%! Every other claim for therapeutic shoes is denied due to lack of medical necessity and/or technical reasons. CGS also shows a pre-pay review Quarterly Status report for the same date range with an error rate of 62%! Please review the guidance below for the required documentation to bill and dispense therapeutic shoes, and what the top denial reasons are for recoupment.Join today!
- Diabetic Condition
- Qualifying Foot Conditions – see link to Documentation Checklist under PAAS Tips
- Statement of Certifying Physician
- Supplier Evaluation
- Supplier Assessment of Fit
- Standard Written Order (SWO) – See our April 2021 Newsline for details
- Statement of Certifying Physician – Must be signed and dated by the MD or DO managing the beneficiary’s diabetes. (Exceptions to MD/DO as the certifying physician are listed in the Local Coverage Determination (LCD))
- Medical Records
- Patient must have an in-person visit within 6 months prior to delivery that documents the management of diabetes and at least one of the qualifying foot conditions
- The certifying statement by itself does NOT meet this requirement for the documentation in the medical record
- Supplier Evaluation
- Examination of the beneficiary’s feet describing any abnormalities that need to be accommodated by the shoes/inserts
- Measurements of the feet
- Impressions, casts, or images of the feet for custom molded shoes and inserts
- Supplier Assessment of Fit
- Must occur at the time of in-person delivery
- Supplier must conduct an objective assessment of the fit of the shoes and inserts while the beneficiary is wearing them and document the results
- For Example: no slippage of heals when walking, ample toe room, feet are supported by heel counter, inserts make contact with patient’s feet and fit inside the shoe properly
- A beneficiary’s subjective statement regarding the fit does not meet this criterion as they may have neuropathy which prevents them from feeling if there is any rubbing or pinching
- Proof of Delivery – Must include the address of the pharmacy, detailed description of item, quantity delivered, signature of beneficiary or representative and delivery date – billed date and delivery date must be the same
- See the LCD, checklists and other helpful forms under your DME MAC
- Jurisdiction B and C, CGS: LCD, Checklist
- Jurisdiction A and D, Noridian: LCD, Checklist
- CGS also has an activity timeline table that is helpful
- May use forms provided on the Comfort website to help meet Medicare requirements
Coverage Criteria (1 through 5) must be met, or claim will be denied.
Documentation needed upon an audit:
PAAS Tips:
Bill It Right – Diazepam Gel
Diazepam rectal gel continues to confuse prescribers and pharmacies alike when it comes to how a prescription is written and then ultimately filled and billed. According to FDA labeling, this medication “is intended for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient’s usual seizure pattern in patients with epilepsy 2 years of age and older.”
Diazepam gel comes in three strengths: 2.5 mg, 10 mg (5-7.5-10 mg), and 20 mg (12.5-15-17.5-20 mg). Each box contains two doses and is billed as “1 each.” The standard dosing for diazepam gel is one dose for appropriate seizure activity and repeat 4 to 12 hours later if prescribed. The FDA recommends that diazepam rectal gel be used to treat no more than five episodes per month and no more than one episode every five days, therefore one package should be considered a 5-day supply at minimum.
PAAS Tips:Join today!
- If a quantity is unclear, verify it with the prescriber and make a clinical note
- If a prescriber writes for a quantity of “2,” do they mean 2 doses (1 box) or 2 boxes (4 doses)?
- Most PBM audit enforcement of this medication revolves around quantity errors
- One box is 2 doses but billed as “1 each”
- Suggested days’ supply for one box is 5 based on FDA dosing recommendations
- Use caution and clinical common sense when filling refills
- Do not place this medication, or any emergency/rescue medication, on auto-refill
- Auditors track refill history which may open you up to audits if filling emergency/rescue medications at a higher rate than other pharmacies
- See September 2020 Newsline article, Suggested Days’ Supply for Emergency Medications for other frequent audit targets
2022 DEA Pharmacist’s Manual Updates – What’s Changed?
With the DEA and wholesalers cracking down on the dispensing of controlled substances and dangerous drug cocktails (see our July 2020 Newsline article Beware: DEA and Wholesalers are Cracking Down on Controlled Substance Dispensing for additional details), pharmacies might consider revising their controlled substance handling policy. In addition to resources provided by your State Board of Pharmacy or state pharmacy association, another valuable reference is the DEA Pharmacist’s Manual which was recently updated in 2020, and revised in 2022.
For those who have read the 2020 manual and are wondering what has changed, here is a summary of several major updates:
Being familiar with the guidance provided in the current version of the DEA Pharmacist’s Manual is recommend for any pharmacy that dispenses controlled substances and the manual would be a great resource to utilize if you are revising or developing policies and procedures for the handling of controlled substances.
Breaking Insulin Pen Boxes: Where Are We Now?
This month marks two years since the U.S. Food and Drug Administration (FDA) clarified their intentions behind revising insulin pen labeling, yet insulin pen boxes continue to present issues to pharmacies trying to establish best practices surrounding its dispensing and billing. Let’s review the historical context and recent NCPDP guidance that PAAS is starting to see Payors/PBMs implement.
For historical context, Walgreens settled with the Department of Justice (DOJ) in January 2019 for $209.2 million due to their pharmacies improperly billing insulin pen boxes. Patients’ insulin pen prescriptions were placed on automatic refill with inaccurate days’ supply, resulting in millions of dollars of waste. Six months later, the FDA contacted insulin pen manufacturers requesting the labeling found on insulin pen boxes and package inserts be updated. As a result, the new labeling “dispense in the original sealed carton” was approved and subsequently printed on insulin pen boxes. In February of 2020, the new label had made its way through the supply chain and PAAS had issued a member alert to stop breaking boxes due to PBM audit enforcement. However, eight months later, in October 2020, the FDA released “clarification” on their guidance of breaking insulin pen boxes, stating they acknowledge scenarios where breaking insulin pen boxes may be appropriate. In November 2020, PAAS wrote a Newsline article, reiterating our guidance that “while the FDA may understand and permit dispensing of individual pens on an exception basis, payors and PBMs may not” and therefore best practice would be to refrain from breaking insulin pen boxes.
As these updates were occurring, PAAS was an active participant in NCPDP Task Force Group meetings. In May 2021, NCPDP added an example scenario in Section 6.19 of their Telecommunication Version D and Above Questions. When a pharmacy is submitting a full insulin pen package and the calculated days’ supply exceeds the plan’s days’ supply limit, NCPDP’s guidance clearly states, “days’ supply restrictions should not hinder the pharmacy’s ability to dispense a full package” and subsequently states if “[the payer system requires some type of override action by the pharmacy], the recommendation is to use a Submission Clarification Code value 10 = Meets Plan Limitations. The pharmacy certifies that the transaction is in compliance with the program’s policies and rules that are specific to the particular product being billed.”
Recently, pharmacies have begun receiving adjudication rejects requesting the pharmacy to consider the use of SCC 10 when the days’ supply exceeds the plan limit. This presents potential audit risk and should be used as an opportunity to remind pharmacy employees of the importance of adjudication messaging. Billing the accurate, and larger, days’ supply (with an SCC=10 override), could put the pharmacy into an “extended days’ supply” (EDS) network. As such, it is possible that lower reimbursement and/or multiple member copays will occur. Pharmacies that ignore the messaging and reduced the days’ supply to the plan limit could face audits where PBMs argue pharmacies forewent using SCC 10 to avoid decreased reimbursement and failure to collect the appropriate copay amounts, causing the Payor’s costs to increase.
So, what is PAAS’ guidance given this new wrinkle? While audit risk related to breaking insulin pen boxes remains largely theoretical, pharmacies know PBMs cannot be trusted. PBMs enforce many other unbreakable packages (e.g., see PAAS Newsline article HIV Medications Cause Large Recoupments) and PAAS is aware of only one Payor who has formally stated it was “okay” to break insulin pen boxes. PBMs love the deregulated, opaque world they operate in, and failure to provide further guidance to pharmacies allows them to be judge, jury and executioner should they decide to enforce the FDA labeling restrictions. The SCC adjudication guidance adds another challenge for pharmacies trying to bill claims accurately.
PAAS Tips:Join today!
- Continue to bill for full boxes of insulin pens with an accurate days’ supply
- Review our updated Can You Bill It As 30 Days? document located in the PAAS Member Portal under ‘Tools & Aids’
- Obtain prescriber authorization when a larger quantity than what was originally prescribed is warranted, along with a corresponding clinical note
- Follow claim adjudication logic to lower audit risk – watch for SCC=10 guidance
- Review past Newsline articles related to insulin pens, including:
- March 2020 Stop Breaking Insulin Pen Boxes
- April 2020 Stop Breaking Insulin Pen Boxes – Your Questions Answered
- November 2020 FDA Guidance on Insulin Pens Puzzling
- Review our Dispense in Original Container chart, located in the PAAS Member Portal, for additional unbreakable packages
- Listen to PAAS’ On-Demand Webinar entitled “Thriving Against PBM Audits-Audit Trends and Tactics” to hear President Trent Thiede walk through the history of dispensing insulin pen boxes and examples of proper billing practices
Flu Shot Season Is Here – What Is Needed for Audit?
COVID-19 has forced a significant increase in the number of vaccinations pharmacies do daily. With this increase also comes additional audits. PAAS National® frequently sees PBMs audit for all vaccinations, including influenza. Now is the time to check that you have all documentation in place for this year’s flu shot season.
What you will need for an audit:Join today!
- Order
- A signed order from an authorized prescriber or
- A signed protocol that is up to date and includes specific vaccination(s) to be administered
- When using a protocol, create a placeholder prescription with all prescription elements
- Vaccination Information Statement (VIS)
- Required to be given to patient prior to each administration
- Be sure you have the most current VIS forms
- Vaccination Administration Record (VAR)
- Name of vaccine administered
- Lot and Expiration Date of vaccine given
- Site of administration (i.e. right arm)
- Signature or initials and title of person administering
- What VIS form was given
- Form can be used as proof of receipt on audit
- Check dates and vaccines on your protocols to ensure they are up-to-date
- Have current VIS forms printed for each vaccine you administer
- Have VAR forms printed and educate all staff on how to complete the forms
- All vaccines should be submitted using days’ supply of “1”
- All vaccines administered with protocol should be submitted with origin code of “5” (pharmacy created)
- Be sure correct quantity is billed, typically 0.5 mL, may need to consult with software vendor for guidance
- Keep vaccine documents stored in a system that makes access easy in case of an audit
VAR and VIS forms, and information regarding what the CDC requires for health care providers to record, can be found on the CDC website.
PAAS Tips:
Proposed Section 1557 Rule – How Could It Affect You?
The U.S. Department of Health and Human Services (HHS) has proposed to strengthen the interpretation of the Section 1557 of the Affordable Care Act (ACA) last modified in 2020 (“2020 Rule”). In the proposed version of the rule, HHS argues Section 1557 should apply more broadly than the 2020 Rule did, which includes extending the definition of “covered entity” to any health program or activity accepting “federal financial assistance”, including those who provide, administer or assist persons with health-related services or insurances, and/or providing pharmaceutical, clinical or medical care.
HHS names several proposed revisions, including but not limited to:
Currently, the Rule is in the Notice of Proposed Rulemaking (NPRM) stage and HHS is eliciting feedback until October 3, 2022. If you are interested in providing feedback, follow the link to the Federal Register. PAAS will be keeping abreast on what comes of the NPRM. In the meantime, it is becoming increasingly apparent that healthcare entities have a requirement to provide culturally competent care, free of discrimination. Consider investing in PAAS’ Cultural Competency Training, which has a section on LEP individuals and how to go about providing equal opportunities to healthcare recipients in your area.
Use and Posting of Guidance Documents by DEA – What’s Changed with Controlled Substance Annotations?
On June 23, 2022 the Drug Enforcement Agency (DEA) created a Guidance Document about the use and posting of guidance documents by the DEA (yes, a guidance document about guidance documents). A historical view will help shed light on why the DEA felt it necessary to clarify this resource.
Prior to Executive Order 13891 (EO13891), Promoting the Rule of Law Through Improved Agency Guidance Documents, signed October 9, 2019, Federal Agencies, and the DEA, could communicate interpretative guidance through a variety of media, including “Dear Registrant” letters, Q&As, memorandums, and other guidance documents. PAAS National® has previously used these resources to help defend community pharmacies from overtly aggressive auditors trying to recoup on controlled substance prescriptions for what was often interpretated as missing prescription elements (e.g., can the pharmacy backtag be used to meet DEA prescription elements).
The EO13891 tried to standardize communication from Federal agencies and make communication more accessible to all. In doing so, the DEA created their own guidance document Portal, which can be found here. To be in compliance with EO13891, the DEA undertook a review of the documents available at that time and removed many of these informal documents from public view. It is suspected that the documents PAAS occasionally relied upon were swept up in this review.
On January 20, 2021, a new Executive Order 13992 was signed into effect. This order, rescinded EO 13891 (note: the timeframe traverses political regimes, likely playing a role in shifting policy). So, the question became, will the DEA re-publish some of the prior guidance that was removed?
Which brings us back to the most recent Guidance Document created June 23, 2022 where the DEA clarifies that, “These guidance documents [specifically prior to November 2019] will not be restored and should be considered rescinded or not valid”.
Beyond hearsay and anecdotal conversations with the DEA, NABP issued a memo dated August 22, 2022 to State Boards of Pharmacy. The memo states the following information was provided by the DEA:
In the past few months, DEA has received an increasing number of questions concerning pharmacists’ ability to add or modify information—like a patient’s address—on paper prescriptions. To address these questions, DEA has been reviewing the relevant regulations and working to draft new regulations to address this issue. As an interim measure, pharmacists are permitted to adhere to state regulations or policy regarding those changes that a pharmacist may make to a schedule II prescription after oral consultation with the prescriber.
So, what are pharmacies to do?Join today!
- NABP is highly regarded, and this memo should be effective at deterring rogue auditors/PBMs from denying pharmacist annotations to C-II prescriptions (pursuant to state law).
- The memo still lacks corroborating evidence. Who from the DEA provided this information, and to whom? Was this pursuant to a conversation or written correspondence?
- The overarching concern is Federal regulations cannot be superseded by a mere conversation. Perhaps the DEA will exercise “enforcement discretion”, but DEA registrants should demand to see something in writing from the DEA.
- The NABP memo states pharmacists are permitted to adhere to state regulations or policy regarding changes that a pharmacist may make to a schedule II prescription after oral consultation with the prescriber.
- Pharmacies that have relied on prescription backtags to fulfill missing elements of 21 CFR § 1306.05(a) should plan to verbally confirm those elements with the prescriber going forward (assuming state law permits the addition/change).
- For example, a missing patient address or DEA # will require a call to the prescriber to confirm the missing elements, documented with a clinical note.
- To date, we have not seen PBMs/Auditors looking to leverage these changes – quite possibly because much of the industry simply was unaware of the guidance changes pursuant to these Executive Orders. With the increased publicity, it is possible this change will no longer be under the radar, but the NABP memo may help support annotations being made.
- PAAS has not seen DEA enforcement of this change in guidance. While these rescinded communications were often effective at combating devious auditors, the documents never had the full force and effect of law and were not binding to pharmacies.
- Additional Federal elements (e.g., X DEA number and fill on/after dates for laddered prescriptions) should already be present on the prescription when presented to the pharmacy
- State requirements (e.g., alphanumeric quantity) should not be added/modified unless explicitly authorized to do so in the regulations
Step 1: Don’t stress – while this guidance document was published recently, these policy changes likely went into effect with the signing of EO13891 (nearly 3 years ago). Just like science, healthcare, or pharmacy, we learn every day and make changes to our practice to stay in compliance with new ‘norms’.
Step 2: The memo from NABP to State Boards of Pharmacy is giving pharmacies some reprieve, with a couple caveats.
Step 3: Consider proactively educating prescribers about the changing dynamics around controlled substance prescriptions and request to have all of the elements present on any prescriptions going forward.
All prescriptions for controlled substances shall be dated as of, and signed on, the day when issued and shall bear the full name and address of the patient, the drug name, strength, dosage form, quantity prescribed, directions for use, and the name, address and registration number of the practitioner.
Step 4: Understand the risk. While compliance with DEA requirements is critical, PAAS focuses on the audit risk – both theoretical (could present an audit problem in the future) and actual (pharmacies are currently getting recouped on).
What if I receive a C-II prescription that is missing elements? While understanding the audit risk is important, DEA compliance is non-negotiable. If your state law affords pharmacists the opportunity to add/clarify DEA-required elements, and you are comfortable with NABP’s memo, call the prescriber and make a clinical annotation. In the absence of an applicable state law, reach out to the prescriber to educate and obtain an electronic order to replace the invalid prescription in hand. If the prescriber is unable to issue an eRx, consider obtaining an emergency C-II via phone as per 21 CFR § 1306.11(d). When the prescriber mails the hard copy backup, they can also send a new, compliant prescription for additional dispensing, if needed.
What about C-III through C-V prescriptions? The distinct advantage afforded to these schedules is the ability to obtain a verbal order. For example, if you receive a prescription for Alprazolam without a DEA # on it, PAAS would advise you to call the prescriber and convert the prescription to a telephone order.
PAAS Tips:
Prescription Quantity Changes Require Documentation
Anytime you dispense a quantity different from what was prescribed, you should note why. PAAS National®® has seen recoupments when quantities dispensed were decreased or increased from the original prescribed quantity.
Valid reasons for decreasing quantity include patient request, med sync program, “dispense in original container,” and plan limitations. In these situations, you should be documenting the reason on the prescription or within the pharmacy’s software. Many PBMs require this documentation, including OptumRx, Express Scripts, Elixir, CVS/Caremark, and MagellanRx, all of which have discrepancy codes related to “cut quantity.” The rationale behind these discrepancies is that the PBM believes the pharmacy is trying to acquire excessive dispensing fees and/or circumvent plan limitations. Having documentation stating otherwise is essential.Join today!
- If your state allows you to change a patient to a 90 days’ supply without consulting the prescriber, document accordingly (e.g., increased to 90 DS per state regulation xxx.xx) and ensure you do not go over the original total quantity and refills prescribed.
- If your state does not allow you to increase the quantity, you must contact the prescriber first and make a clinical note about the approval for a quantity increase.
- If the prescriber ordered a quantity less than the smallest package size, you still cannot go over the total quantity and refills prescribed without consulting with the prescriber
- For example, insulin pens written for a quantity of 3 mL with 2 refills. The total quantity prescribed is only 9 mL. You must clarify the quantity and refills with the prescriber to dispense a full box of 15 mL.
- Document the reason for any quantity change
- Insurance Limits Quantity (ILQ)
- Patient requests one-month supply
- Med sync program
- Must dispense in original container
- Do not cut the quantity to work around negative reimbursement or to acquire additional dispensing fees
- Do not cut the quantity to work around a plan limit rejection
- If the quantity written is less than the package size, and there are not enough refills to cover the actual quantity, verify the quantity and refills to dispense with the prescriber
- Clinical notes should contain four elements: date, name and title of who you spoke with, what was discussed, and your initials
Contractual obligations must also be taken into consideration when dispensing lesser quantities of a medication. If you are not already aware, PAAS has one of the largest troves of PBM contracts in the nation. PAAS has seen a prominent PBM recently insert language in their extended days’ supply agreements that require pharmacies to use “commercially reasonable efforts” to dispense an Extended Days’ Supply. Not only does the PBM frown upon cut quantities, but they also want pharmacies intervening to dispense more extended days’ supply prescriptions. Evidence to the contrary can result in required corrective action plans and decreased reimbursement on 30 days’ supply claims going forward (either at the point of sale, or through the reconciliation process). Indiscriminately changing patients to a 30 days’ supply resulting in increased reimbursement for the pharmacy can give the appearance of profiteering and be a slippery slope.
There are also some things to consider when increasing a quantity:
PAAS Tips:
Combivent® Respimat® Still Causing Confusion
In 2013, Combivent® Inhalation Aerosol inhalers made by Boehringer Ingelheim Pharmaceuticals were discontinued and phased out because they contained chlorofluorocarbons or CFCs (harmful substances that work to decrease the ozone layer above the Earth). The original Combivent® inhaler was then replaced by Combivent® Respimat®.
The new inhaler was not an exact replacement of the old one. The original Combivent® inhaler (14.7 g) had dosing of two inhalations four times a day with the total number of inhalations not to exceed 12 puffs in 24 hours. The updated Combivent® Respimat® (4 g) has a recommended dosage of only ONE puff four times a day with a total number of inhalations not to exceed 6 puffs in 24 hours.
This dosing change has caused problems for pharmacies over the years. Prescribers have been known to still send prescriptions to the pharmacy with the old directions. If the pharmacy fails to clarify the directions, patient safety could be a concern and the claim is sure to be flagged for audit.
Another problem PAAS National® has seen is related to billing the correct days’ supply on a claim. Combivent® Respimat® contains 120 metered doses. If a prescription is written for one puff four times a day, then the days’ supply is 30. If the prescription notes the patient may take up to 6 puffs per day, then the days’ supply is 20.
What happens if the plan will not allow a 20-day supply? The first instinct of many pharmacies is to rebill the claim as a 30-day supply, but this would be incorrect and would likely flag for an audit. The insurance company will see you originally tried to bill a 20-day supply and will want to know why it was changed. This may be interpreted as claims data manipulation and a circumvention of the plan limits. The proper thing to do in this case is follow any reject instructions, possibly obtaining a prior authorization for the correct dosing. See our January 2022 Newsline, Manipulating Quantity or Days’ Supply to Bypass Plan Limits Will Cost You, for further information.
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- Verify inappropriate directions with the prescriber and make a clinical note
- Always submit an accurate days’ supply based on the quantity prescribed and the maximum daily dose
- Do not workaround a plan limit to get a paid claim – follow the plan’s instructions in the reject message
- With a 20 day’s supply, some plans may require the pharmacy call for an override or obtain a prior authorization for that dosing interval
- Workarounds may save time and take care of a patient’s immediate need, but those short-term gains will invariably lead to long term pain with audit recoveries. PAAS has even seen network terminations for habitual offenders
- Review our April 2021 Newsline article, Self-Audit Series #3: Inhaler Prescriptions to help your pharmacy develop practical and efficient strategies to identify claims that may be at risk for audit recovery
- Review our Oral Inhalers chart found on the PAAS Member Portal under “Days Supply Charts”