2022 CVS Caremark Provider Manual Supplement for 2023

Caremark has released the 2022 CVS Caremark Provider Manual Supplement which is effective January 1, 2023. Pharmacies should have received a 23-page paper copy by mail and can also access it electronically on the CVS Caremark Pharmacy Portal at https://rxservices.cvscaremark.com/ (login required).

Unlike many PBMs that publish their Provider Manuals electronically on public websites, Caremark places theirs behind a password wall and chooses to mail 100-page plus paper manuals every even year (e.g., 2022) and shorter supplements during odd years (e.g., 2023).

The Provider Manual is an extension of the Provider Agreement (aka Contract) and pharmacies are “responsible for monitoring and complying” with these unilateral updates.

A few important 2023 CVS Caremark Provider Manual changes are as follows:

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Section 2.06 Change in Ownership

  • Buyers must satisfy any outstanding audit amounts associated with either the buyer or the seller prior to initiating change in ownership enrollment process

Section 3.03.03 Coupons and Other Programs

  • There are two additional coupon types that are specifically disallowed by Caremark (Alpha Scrip, SimpleSaveRx)

Section 5.06 Prior Authorization

  • Pharmacies may not “act on behalf of a Prescriber or member of Prescriber’s staff” as part of the prior authorization process

Section 8.05 Supply of Covered Items; Purchases Invoices (previously distributed May 2022)

  • Caremark outlines their “bulk purchase notification” requirements including the allowance to notify up to 21 days after the bulk purchase and to notify by email

Appendix C – Appeals Process Documentation Guidelines

  • Caremark has emphasized that documentation submitted should be relevant
  • Various changes to acceptable documentation descriptions, most of which simply provide more clarity
  • Copay (CPY) discrepancy spells out additional details with respect to cash copays
  • Drug invoice shortage (DIS) discrepancy spells out additional details with respect to proof of payment for inventory
  • No signature log (NSL) discrepancy spells out additional details for medications delivered by carrier other than a pharmacy employee

PAAS Tips:

  • Please contact PAAS National® (608) 873-1342 or info@paasnational.com, as soon as possible when you are notified of an audit – the sooner that we are part of your team, the more benefit we can bring

Essential Elements of Corrective Action Plans

PAAS National® analysts have recently seen an increased number of PBM audits with “significant” results, including a large number of unique issues, large dollar amounts (>$100,000) or both. Audits of this magnitude may trigger further consequences such as additional audits, payment suspension and/or threat of network termination. In these instances, pharmacies may need to perform a documented “deep dive” and uncover the root causes and implement corrective actions to convince the PBM that there is no Fraud, Waste or Abuse and that it is safe to retain the pharmacy as a network provider. This deep dive is often referred to as a Root Cause Analysis or Corrective Action Plan (CAP). These CAPs are intended to improve operations moving forward and generally do not resolve the audit discrepancies or reduce the recoupment amounts.

While there is no mandatory format for CAPs, there are a few essential elements that should be considered.

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Step 1 Identify and investigate each possible unique problem to find the root cause(s)

  • All possible errors should be considered until you can rule them out by process of elimination
  • Obtain an external point of view (e.g., PAAS) to eliminate confirmation bias

Step 2 Develop and implement a corrective action plan for each unique root cause identified in step 1

  • May include new/revised policy and procedure, new technology implementation or re-training on existing procedures
  • System solutions that remove the potential for human error, and prevent mistakes from recurring, are ideal
  • Designate a staff member to be the lead and develop a timeline for implementation
  • There may be one or more solutions for a given root cause – identify what works for your pharmacy based on available resources

Step 3 Train staff and implement corrective action plan

  • May include a staff memo, email, or meeting
  • May need formal training if new technology is implemented
  • All training should be documented and include when it occurred, who was involved and what was covered

Step 4 Perform internal scheduled audits to ensure that corrective actions are working

  • Document these audits both for your records and to prove to a PBM (if required) that you are following through on any promises made

In many audit situations, pharmacies go through these steps on a small scale without realizing it; however, when an audit is significant, it is worth your time to go through a formal/documented process.

The most common audit scenario that demands a CAP is an invoice shortage as PBMs often presume/assert fraud unless the pharmacy can prove otherwise. While each audit may uncover unique issues, here is a summarized CAP example.

Example audit situation: PBM invoice audit results show pharmacy has purchase shortages on 10 drugs over a 12-month period that total $150,000.

Summary example of 4-step Corrective Action Plan:

Step 1 – Pharmacy identifies the following issues

  • Root Cause #1 Purchased diabetic test strips from vendor that is not an authorized distributor
  • Root Cause #2 Wrong NDC billed
  • Root Cause #3 Purchases from another pharmacy without documentation
  • Root Cause #4 Missing wholesaler invoices
  • Root Cause #5 Bulk quantity on-hand prior to audit date range

Here is an example of Steps 2-4 for Root Cause #1 only, there would be similar details for all unique problems identified in each audit.

Root Cause #1: Purchased diabetic test strips from vendor that is not an authorized distributor

Step 2 Corrective Action Revise inventory purchase policy to verify that diabetic test strips are only purchased from supplier on manufacturer’s authorized distributor lists as explained in July 2021 and February 2022 PAAS Newsline articles.
Lead Staff Member Pharmacist-in-Charge
Timeline Immediate
Step 3 Training/Implementation Email sent to all staff on 12/20/2022 with copy of revised inventory purchase policy
Step 4 Follow-up Spot check purchase history for test strips in 30, 60, and 90 days.

  • If no problems, then stop monthly review
  • If continued problems with inventory source, revisit policy and provide additional training with purchasing staff and continue monthly review x 3

PAAS understands that developing a written CAP can feel daunting and may not always be necessary; however, should you need to implement a CAP, consider the steps discussed in this article and contact PAAS for support should the need arise.

PAAS Tips:

  • Internal CAPs may prove useful to reduce the likelihood of continued errors, lower future audit liabilities and potential stave off termination
  • A quality CAP that is well thought out, and documented, can benefit the pharmacy and address issues more effectively
    • CAPs that are poorly written, incoherent, or don’t effectively address the issues and resolution are often a waste of time and can do more harm than good
      • Do not just “check the boxes” if asked to produce a CAP
  • The Arkansas Office of the Medicaid Inspector General has a good discussion of Corrective Action Plans here

Medicare Extends Part B Coverage for Kidney Transplant Drugs

Patients with Medicare because of End-Stage Renal Disease (ESRD) currently lose coverage 36 months after a kidney transplant unless otherwise eligible for Medicare. A recently published final rule will extend coverage for patients who meet certain criteria to qualify for continuous Medicare-covered immunosuppressive drugs starting January 1, 2023. This new benefit is called Medicare Part B Immunosuppressive Drug (Part B-ID).

There are a few important limitations to be aware of including:

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  1. It only covers immunosuppressive drugs and no other items or services
  2. Patients who have other health coverage are not eligible to enroll
  3. Patients must provide notice to Social Security Administration within 60 days if they sign up for other coverage
  4. Patients will be responsible for annual Part B deductible and 20% coinsurance

PAAS Tips:

Beware of the New Problem with the Updated Online Santyl® Calculator

Santyl® ointment 250 units/gram is a topical medication indicated for debriding chronic dermal ulcers and severely burned areas. This medication is frequently targeted by auditors because correctly calculating the quantity needed and days’ supply requires knowledge about the wound size and treatment duration.

Prior to the recent update to the Santyl® online calculator, only the quantity needed for one wound could be calculated at a time and the total amount of ointment needed was rounded to the nearest 30 g or 90 g increment since these are the two commercially available package sizes. This led to an increased risk of overbilling and incorrect days’ supply calculations as previously discussed in the October 2021 Newsline article, Santyl® Dosing Calculator—Manufacturer’s Rounding May Lead to Recoupment.

Now, the calculator can determine the amount of ointment needed for more than one wound at a time and it provides the exact amount needed for the wound, or wounds, and specified treatment duration. However, what is not addressed with the online calculator is that once the pharmacy selects the total amount to dispense based on a 30 g or 90 g tube (or multiples thereof) the days’ supply may need to be recalculated to account for the extra dispensed which is necessary to accommodate the commercially available package sizes.

To determine the correct days’ supply, follow the example below:

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Prescription: Santyl® ointment qs 20 days with zero refills; sig: apply to affected area(s) once daily; wound #1 is 5 cm x 2 cm, wound #2 is 3 cm x 1 cm

Online Calculator: After inputting the wound length and width for each of the two wounds and the 20-day treatment duration, you will see that 45 g would be needed. However, the pharmacy can only choose from a 30 g tube or 90 g tube (or multiples thereof) when dispensing, therefore, the calculator states that two of the 30 g tubes, or 60 g total, would be needed.

Manual Days’ Supply Calculation: Since the pharmacy must dispense 60 g to provide the patient with enough ointment to finish their course of treatment, the pharmacy must calculate the true days’ supply for all 60 g dispensed. To do this, you must:

  1. Convert the total number of centimeters needed per wound per day, to grams. The online calculator provides the total number of centimeters of ointment needed for each application for each wound. Based on our example above, wound #1 requires 5.2 cm/application and wound #2 requires 1.6 cm/application for a total of 6.8 cm once daily.
  2. Using the cm-to-g conversion factor found in the calculator by clicking “How is this calculated?”, you will see 3.04 cm from a 30 g tube is approximately 1 g. Therefore 6.8 cm divided by 3.04 cm per 1 gm = 2.2 g per day.
  3. Determine the days’ supply for the 60 g dispensed by dividing 60 g by 2.2 g per day = 27 days.

PAAS Tips:

  • Every Santyl® ointment prescription requires the wound size (length and width in centimeters), the treatment duration, and the use of the online calculator
    • Wounds should be decreasing in size overtime, therefore, updated wound sizes are needed if refilling Santyl®
    • If you are calling the prescriber’s office to obtain wound information, be sure a full clinical note is documented including:
      • date of the call
      • name (and title) of the person you spoke with
      • the clarification
      • initials of who made the call
    • Maintain a copy of the calculator results with the Santyl® prescription in case of an audit
    • Manual days’ supply calculations are often still needed
    • The cm-to-g conversion factor is not the same for a 30 g tube and 90 g tube
      • From a 30 g tube, a length of 3.04 cm is equivalent to approximately 1 g
      • From a 90 g tube, a length of 1.78 cm is equivalent to approximately 1 g

 

Express Scripts Reminds Pharmacies of Copay Collection Obligations

Express Scripts sent a memo to network providers the middle of October, pertaining to copayment collection, to ensure requirements are being met in the appropriate manner. There is emphasis placed on network providers being adherent to Section 2.3 of the ESI Provider Manual stating “Network Providers agree that it shall collect the full Copayment from Members, and that the Copayment is not changed or waived unless required by law”. The memo also discusses what documentation is required in case of an audit, which includes credit card receipt, point of sale (POS) receipt which reflects cash payment, and/or copy of cancelled check.

As a reminder, Express Scripts, in addition to other PBMs, reserve the right to terminate your provider status if failure to collect copays is discovered.

PAAS Tips:

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  • Refer to the Provider Manuals of other PBMs regarding their copayment policies. The top PBMs and their corresponding Provider Manual sections are listed below:
    • Caremark: Section 3.03.04
    • Prime Therapeutics: Section 3: Claims Processing
    • OptumRx: V. Processing Claims, Section Q: Collection of Members Cost-Sharing Amount
    • Elixir: mentioned in sections pertaining to “suspensions and terminations”, and “reimbursement and cost share”
  • Review the following Newsline articles:
  • PAAS Fraud, Waste, and Abuse and HIPAA Compliance members can reference Section 4.1.5 within their Policy and Procedure Manual for a copay collection policy which corresponds to the response to question 12 on the policy and procedure manual questionnaire.

What Do Bowel Preps, EpiPen®, and Migraine Medications Have in Common?

Prescriptions for medications whose dosing is standardized in the industry often come with directions that simply state, “Use as directed.” These types of products typically have the standard dosing right on the package being dispensed to the patient like bowel preps for colonoscopy, EpiPen®, starter dose kits (e.g., Eliquis® 30-Day Starter Pack), and dose packs (e.g., Medrol® DosepakTM). Similarly, migraine rescue medications, insulin with a sliding scale, and topical medications tend to be generically written with directions that have no mathematical way to calculate the days’ supply.

Auditors require

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directions specific for the individual patient and those directions should be mathematically calculable to bill a proper days’ supply. Directions that come over as “Use as directed” should always be clarified with the prescriber as to whether or not the patient is to “use as directed per package instructions” in addition to updating the patient label directions accordingly. Medications that can be repeated after a certain amount of time (e.g., EpiPen®, migraine medications, Nitrostat®, and Diastat®) will need that information noted in the directions in order to include the additional dose(s) in the days’ supply calculation. Insulin with a sliding scale or topical medications should include maximum daily dose information in the directions and on the patient label.

PAAS Tips:

  • ALWAYS clarify “Use as directed” or “as needed” directions.
  • Clarify starter kits, dose packs, and bowel preps as “Use as directed per package” or with specific directions.
  • Migraine rescue medications should have the maximum number of tablets allowed per day, per week, or per month clarified with the prescriber. Check out the December 2021 Newsline article, Self-Audit Series #11 – Migraine Prescriptions to read more.
  • Topical medications should have mathematically calculable directions. See the November 2021 Newsline article, Calculating the Incalculable – Your Math Teacher Was Right (Show Your Math) for more.
  • Insulin with sliding scale directions should have maximum units per day listed.
  • Any clarification made to the directions needs to be documented with a clinical note AND be on the patient label directions.

DMEPOS Mini-Series #8 – The Six Medicare Auditing Entities and Their Purpose

The six Medicare auditing entities are responsible for auditing records, claims and payments. While they may use different methods to conduct audits, they all aim to detect, correct, and prevent improper payments to curb fraud, waste, and abuse and protect the Medicare Trust Fund. The Medicare Program Integrity Manual contains the policies and responsibilities for the entities tasked with medical and payment review.

What is the rationale for having these auditing entities? Taxpayers and future Medicare beneficiaries benefit when Medicare payments are returned to the Medicare Trust Fund. Subsequently, these audits lower the Medicare payment error rates. On occasion, pharmacies can benefit if there are any underpayments identified during an audit, in which case those dollars will be repaid to the pharmacy.

Listed below are six Medicare contractors that conduct audits and their main objectives:

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  1. MAC – Medicare Administrative Contractor
    1. Goal is to process claims for a defined jurisdiction
    2. Reviews claims on a pre-payment and post-payment basis
    3. Identify noncompliance with coverage, coding, payment, and billing policies through data analysis
    4. Take action to prevent and address improper payments
  2. UPIC – Unified Program Integrity Contractor
    1. Goal is to investigate cases of suspected FWA
    2. Take action to recoup inappropriate Medicare payments
    3. Ensure the integrity of claims under all lines of Medicare business
  3. SMRC – Supplemental Medical Review Contractor
    1. Goal is to lower the improper payment rates by conducting nationwide medical reviews with documentation requests
  4. CERT – Comprehensive Error Rate Testing Contractor
    1. Goal is to collect documentation and perform reviews on random samples of Medicare FFS claims post-payment
    2. Determine whether claims were paid appropriately based on Medicare coverage, coding, and billing rules in place
    3. Produces the improper payment rates to the MACs who can repay underpayments and recoup overpayments
  5. RAC – Recovery Audit Contractor
    1. Goal is to identify overpayments and underpayments by conducting automated and complex reviews on a post-payment basis
      1. Automated – no medical records needed
      2. Complex – medical records required
    2. OIG – Office of Inspector General
      1. Goal is to lead efforts to fight FWA
      2. Develop and distribute resources to help the health industry comply with FWA laws
      3. Education the public about fraudulent schemes
      4. Responsible for reporting to both the Secretary of Health and Human Services (HHS) and Congress and to provide recommendations to correct FWA

PAAS Tips:

  • Be prepared with FWA policies and procedures, should you not have a compliance program in place, learn more about PAAS’ Fraud, Waste & Abuse and HIPAA Compliance program or contact our office at 608-873-1342
  • Reminder: Send your Medicare Part B audits to PAAS! info@paasnational.com or fax (608) 873-4009 and we can advise what documentation is being requested and help navigate the Medicare Part B requirements and responses to audits.

Navigating PBM Audits

Working collaboratively can be key to either avoiding a PBM audit altogether or making the process as painless as possible.

Read more

Be on the Lookout for OptumRx Unannounced Onsite Audits

Receiving a PBM onsite audit notice can be intimidating but the pharmacy typically has some time to prepare before the auditor arrives. However, are you aware that pharmacies can receive unannounced onsite visits from PBMs, FDA inspectors, DEA agents or Board of Pharmacy inspectors? Being prepared for an unannounced audit is crucial and PAAS National® wants to make sure you have the tools to be successful. PAAS has become aware that OptumRx is again performing their unannounced onsite audits, see the tips below to help you be prepared should you get an unexpected visit.

PAAS Tips:

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  • Utilize our Onsite Credentialing Guidelines resource
    • Provides a list of frequently asked questions from the PBM auditors
    • Includes references to the PAAS National® Policy and Procedure Manual for our Fraud, Waste & Abuse and HIPAA Compliance members
  • These audits typically focus on credentialing requirements and not prescription review
  • Auditors may check licenses, on-hand stock of certain medications and may ask permission to take a few photos – If you are a PAAS Vault member and have uploaded licenses to the portal, those licenses are available at your fingertips
  • Two auditors may be present, and the visit is usually about 30 minutes
  • See the OptumRx Provider Manual for more information regarding an onsite audit.
    • “Administrator or its designee shall have the right, with or without notice, at reasonable times, to access, inspect, and review on-site the facilities, licenses and credentialing documents/records of Network Pharmacy Providers and pharmacy locations applying to participate in any of Administrator’s Benefit Plans, as well as make copies of the licenses credentialing documents/records etc. maintained by pharmacy. Pharmacy agrees to cooperate with Administrator or its designee with the on-site visit and acknowledges non-cooperation with an on-site visit may result in denial or termination of network participation.”
  • See the July 2022 Newsline, Is Your Pharmacy Ready for an Unannounced Audit?

Don’t have an FWA/HIPAA Compliance Program? Contact PAAS and receive a $126 discount when you combine services with your audit assistance. Get started today? info@paasnational.com or (608) 873-1342.

Fraud, Waste, and Abuse Compliance Programs Are Not Optional

PAAS National® analysts continue to see audits requesting documentation of compliance policies and procedures. FWA Training and OIG/GSA exclusion checks are not enough to be compliant as they do not constitute a compliance program. Since 2009, PAAS’ Fraud, Waste & Abuse and HIPAA Compliance program has been designed to meet CMS’ seven core elements required to adopt and implement an effective compliance program, which include:

  1. Written Policies, Procedures and Standards of Conduct
  2. Compliance Officer, Compliance Committee and High-Level Oversight
  3. Effective Training and Education
  4. Effective Lines of Communication
  5. Well Publicized Disciplinary Standards
  6. Effective System for Routine Monitoring and Identification of Compliance Risk
  7. Procedures and System for Prompt Response to Compliance Issues

PBM Provider Agreements require pharmacies to have a compliance program that meets CMS standards, and they reserve the right to request documentation of your compliance policies and procedures.

Consider the following:

  • OptumRx Section VIII Compliance; Fraud, Waste and Abuse (FWA); General Training; Audits – “A Network Pharmacy Provider involved in providing services for Medicare Part D/Medicaid Members is responsible for implementing a program to control FWA and to facilitate compliance in the delivery of Covered Prescription Services through the Medicare/Medicaid benefits.”
  • Humana’s 2022 Notice of Program Requirements – Humana’s Compliance Policy for Contracted Healthcare Providers explicitly states pharmacies must have a compliance program that meets the seven elements outlined by CMS, including written policies, procedures and standards of conduct.
  • PerformRx Pharmacy Compliance Attestation 2022/2023 – PerformRx requires attestations to the following: The pharmacy has implemented and maintains a compliance program that is consistent, at minimum, with applicable federal and state requirements, including, but not limited to the standards set forth in 42 CFR §423.504(b)(4)(vi) and other Centers for Medicare & Medicaid Services (CMS) guidance set forth in the Medicare Part D Prescription Drug Benefit Manual.
  • While not public, Express Scripts and Caremark also have explicit language to require a compliance program. See Caremark’s 2022 Provider Manual, Section 10.01.06 FWA program and Express Scripts 2022 Provider Manual with regards to maintaining a compliance program in accordance with CMS requirements.

Ensure you have all your compliance bases met so you can provide proof when requested for credentialing or audit. Don’t have an FWA/HIPAA Compliance Program? Contact PAAS, info@paasnational.com or (608) 873-1342 and get started today!