Medicare Part D Long-Term Institutionalized (LTI) Resident Report

PAAS National® recently assisted numerous pharmacies that received an email communication from Express Scripts stating the pharmacy had inappropriately billed Part D claims while patients were in a qualified Part A stay. The communication cited CMS’s LTI Resident Report as the reason for the conclusion of erroneous payments.

Many pharmacies reported that the data did not seem to add up as prescriptions were dispensed to either retail patients or patients that were residing in nursing homes while on “private pay” and not on a Part A stay. PAAS helped pharmacies get in touch with the appropriate CMS regional office, Part D Plan Sponsor, and an Express Scripts audit manager to challenge the findings. Within a few days Express Scripts sent additional emails to affected pharmacies notifying them that the first email was sent in error.

Background on CMS LTI Resident Report

Every calendar quarter CMS provides a list of Medicare patients that have been enrolled in a Part A skilled nursing facility stay to Part D Sponsors. This list identifies the skilled nursing facilities where the beneficiaries resided, so that Sponsors (and their PBMs) can ensure network pharmacies are available to serve these beneficiaries.

Part D Sponsors can also use this list to prevent inappropriate Part D payment of drugs covered by Medicare Part A. Sponsors, and their PBMs, can implement prospective edits to reject Part D claims at point of sale when a beneficiary is enrolled in a Part A stay, and these can be used for retrospective reviews of paid claims to identify prescriptions that should have been billed under Part A.

PAAS Tips:

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!

  • Review your procedures to communicate with skilled nursing facilities when patients are admitted, discharged, or moved to/from Part A to “Private Pay” status, to guarantee that pharmacies are billing the correct party.
  • Develop agreements to bill skilled nursing facilities when claims “should have been” billed to Part A but were incorrectly billed to Part D. Payment errors are bound to happen eventually, and if pharmacies and facilities have not discussed how to handle in advance, it could be more difficult to reconcile payments later.

Automatic Mailing for Part D Patients

As a follow up to the August 2022 Newsline article, Medication Synchronization: Possible Concerns we want to remind pharmacies of some specific requirements when automatically mailing refills to Medicare Part D patients. CMS first outlined requirements for auto-shipping refills in the 2014 Call Letter and most recently made revisions in the 2020 Call Letter – these requirements were implemented in response to beneficiary complaints of receiving medications that they did not order or want and to reduce waste and unnecessary cost to both patients and taxpayers.

Here are the important points from the 2020 Call Letter:

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!

  1. Automatic shipping of refills must be voluntary
  2. Affirmative consent is NOT required prior to shipping each refill if the pharmacy provides the following protections
    1. Enrollment in auto-shipping is done on a drug-by-drug basis after an initial fill
    2. Patients may opt-out at any time
    3. Pharmacy provides a minimum of two shipping reminders before each fill
      1. Reminders should include the name of the medication, approximate ship date, information to determine the cost-share amount and how to cancel
    4. Pharmacy must provide a refund for any unwanted fills
      1. This must occur even if the patient does not return the medication to the pharmacy

PAAS Tips:

  • The Call Letter requirements only apply to Medicare Part D prescriptions that are automatically shipped and do not apply to med sync prescriptions that are picked up at the pharmacy
  • Caremark and Express Scripts Provider Manuals mirror the 2020 Call Letter guidance for Medicare Part D

Navigating Rights & Responsibilities in a Post-Roe v. Wade World

With the overturning of Roe v. Wade, the U.S. Supreme Court ruling on an individual’s rights surrounding abortion, pharmacies may be left wondering how to proceed. Being aware of legislation that exists is a pertinent first step in guiding your pharmacy practice.

The U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) issued a statement which first acknowledges pharmacies’ importance to the healthcare system, in part due to the accessibility to patients. As such, the statement attempts to reinform retail pharmacies of their obligation to ensure patient access to comprehensive reproductive health care without discrimination, which includes potential, current, or past pregnancy, or medical conditions related to pregnancy or childbirth. The guidance reminds pharmacies that under Section 1557 of the Affordable Care Act and Section 504 of the Rehabilitation Act of 1973, entities that accept federal funding cannot discriminate when dispensing medications, determining medication appropriateness, and/or advising patients about medication usage. In addition to the guidance given, HHS OCR also brings attention to the high, yet preventable, maternal mortality rate in the United States and reaffirmed their dedication to improving maternal health via “vigorous enforcement of our civil right laws”.

Frustratingly, this guidance puts pharmacists between states that have moved to limit abortions and the federal government – who seems committed to protecting access, despite the Supreme Court ruling.

In tandem with the above-mentioned civil rights that patients possess, healthcare entity employees also possess civil rights that OCR enforces. The Church Amendments (42 U.S.C. §300a-7) protects health care employees’ personal beliefs from being a point of discrimination in relation to employment. For example, actions taken by a health care employee cannot be discriminated against if due to their “religious beliefs or moral convictions”. That said, OCR reserves the right to assess and apply the Church Amendments on a case-by-case basis. To learn more, reference HHS’s Guidance on Nondiscrimination Protections under the Church Amendment.

PAAS Tips:

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!

  • Be knowledgeable on what state laws are in effect considering Roe v. Wade being overturned
  • Obtain an understanding on exceptions to state regulations
  • Many of the medications being called into question have various indications. As such, consider proper documentation of indication for use to mitigate risk
  • Consider PAAS’ Cultural Competency Training to better serve your patient population

Be Prepared for Audits on Pharmacist-Prescribed Paxlovid

The FDA released a statement on July 6, 2022, which expanded the Emergency Use Authorization (EUA) of PaxlovidTM (nirmatrelvir and ritonavir) “to authorize state-licensed pharmacists to prescribe PaxlovidTM to eligible patients, with certain limitations to ensure appropriate patient assessment and prescribing of PaxlovidTM.” As pharmacies across the country are gaining access to this anti-viral COVID-19 therapeutic agent, it is important to understand the specifications of the EUA and verify your pharmacy has a process in place to capture and maintain documentation supporting the validity of the claim, in the event these claims are audited. Think to yourself, would an auditor have irrefutable evidence that this patient qualified for treatment and that the pharmacist-prescribed PaxlovidTM was provided pursuant to EUA guidelines?

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!

Patient Qualifications EUA Limitations for Pharmacists to Prescribe PaxlovidTM Additional Documentation to Maintain
Must meet ALL:
·         ≥ 12 years old
·         ≥ 88 pounds (40 kg)
·         Positive SARS-CoV-2 viral testing
·         Symptom onset was within ≤ 5 days
·         Mild-to-moderate coronavirus disease
·         At high risk for progression to severe COVID-19, including hospitalization or death
Must meet ALL:
·         Sufficient medical records < 12 months old or consultation with health care provider to assess renal (kidney) function
·         Sufficient medical records < 12 months old or consultation with health care provider to assess hepatic (liver) function
·         Sufficient information is available (via access to health records, patient reporting of medical history, or consultation with health care provider) to obtain a medication list to check for potential drug interactions
PAAS National® analysts suggest ALL of the following:
·         Patient-specific placeholder hardcopy referencing the pharmacist’s authority to prescribe (e.g., EUA and PREP Act, standing order, or collaborative agreement, etc.) and details of the prescription
·         Proof patient met all qualifications
·         Proof pharmacist verified kidney function, liver function, and had sufficient information to assess potential drug interactions
·         Vaccine administration record
·         Date/version of the Fact Sheet for Patients, Parents, and Caregivers EUA of PaxlovidTM for COVID-19 that was given

PAAS Tips:

  • Limitations on authorized use of PaxlovidTM:
    • Not authorized for the treatment of patients requiring hospitalization due to severe COVID-19
    • Not authorized for pre-exposure or post-exposure prophylaxis to prevent COVID-19
    • Not authorized for use longer than five consecutive days
  • Kidney and liver function, as well as the patient’s current list of medications, must be assessed to determine if PaxlovidTM is an appropriate therapy for the patient and if the dose needs to be reduced
  • For additional details refer to the:
    • July 6, 2022, Emergency Use Authorization for Paxlovid
    • Fact Sheet for Healthcare Providers: EUA for PaxlovidTM
    • Fact Sheet for Patients, Parents, and Caregivers: EUA of PAXLOVIDTM for COVID-19
    • List of medical conditions and factors associated with increased risk for progression to severe COVID-19 as per the CDC

Be Audit Ready! Clinical Notes and Annotations: What Documentation is Essential for Audit?

Many pharmacies receive hundreds of prescriptions every day, and inevitably, some of those prescriptions will contain errors, omissions, or just be confusing enough to require clarification with the prescriber’s office. When these situations occur, make sure you have good documentation of the conversation with the prescriber’s office to successfully pass an audit that may occur years later.

Documentation that should be included in any clinical note are as follows:

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!

  • Date (and preferably time)
  • Name and title of who you spoke with (some PBMs do not accept “per MD” or “per nurse”)
  • The details of the clarification/conversation
  • Your name or initials

This documentation should either be noted directly on the prescription or within your dispensing software. For clinical notes on controlled substance prescriptions received electronically, the clinical note must be made and retained electronically per 21 CFR 1311.200(f). Any notations made must be visible to the auditor at the time of audit.

Clarifications to a prescription should be made prior to dispensing. PAAS National® has seen clinical notes invalidated when the pharmacy prints an image of a prescription for audit that shows the printed date, then proceeds to hand-write a clinical note on the prescription with a date prior to the printed date of that prescription. The auditor assumes the pharmacy “made up” the clinical note after the audit notice was issued and will expect the pharmacy to prove the clinical note was valid on appeal.

PAAS Tips:

  • Remember to always document the When, Who You Spoke With, What Was Discussed, and Who Documented elements of a clinical note
    • A custom ink stamp containing these elements may be made to help ensure pharmacy staff documentation is complete
  • Documentation should be included on the original prescription or electronically
  • Documentation should be visible to the auditor at the time of audit
  • Any notations made on previous prescriptions that are still valid should be carried forward to the new prescription
  • Submission clarification codes and Drug Utilization Reviews must be clearly documented with details to support the override given
  • Professional service code “M0” requires consultation with the prescriber and documentation to support the conversation
  • If the patient directions are clarified, ensure the patient label is updated prior to dispensing to reflect the new directions
  • Verbal clarifications do not change the origin code of the prescription
  • See our March 2021 Newsline article, Are You Documenting DUR and Submission Clarification Codes?
  • See our October 2021 Newsline article, Prescriber Statements Requested to Validate Incomplete Clinical Notes

A Day in the Life of a PAAS National Analyst – Audits, Billing Questions and FWA/HIPAA support

With over 200 years of combined pharmacy experience and over 50 years of dedicated audit assistance experience, this PAAS National® analyst team is the best in the industry.

The PAAS Analyst team is made up of five pharmacists and three certified pharmacy technicians. Their job day in and day out is to be a member’s resource in:

Answering filling and billing questions

PAAS provides proactive education – a guiding light steering community pharmacies from trouble. Keep in mind the prescription claims you submit today may be the subject of an audit conducted a year or two from now. Audit-proof your pharmacy today, bill it correctly, and avoid future recoupments. PAAS can provide information on new wrinkles and requirements to safely bill a prescription.

FWA/HIPAA compliance guidance

PAAS Fraud, Waste & Abuse and HIPAA Compliance program members can get guidance to help avoid being caught off guard. Having a HIPAA expert on your side to navigate through the turbulent waters of a data breach or internal fraud investigation can help ensure that all appropriate steps are taken, and deadlines are not missed.

Preparing you for on-site and virtual audits

If you receive notification, your first step is to get the audit notice to PAAS. Your all-inclusive membership means there are no hidden fees or limits to the number of audits we provide assistance on. After receiving your notice, a PAAS Analyst will reach out to you within 1-2 business days for a customized, pre-audit consultation to guide you on next steps. PAAS is here to support you! Make PAAS part of your audit process, every time.

Review your prescriptions for desk audits

When reviewing prescriptions in preparation for an audit, it is helpful to reference the self-audit tool. Every prescription has required information that needs to appear on the original hard copy. Ask a PAAS analyst for assistance with your next audit to confirm you have the required information. If you receive an audit notification, your first step is to get the audit notice to PAAS.

Work with you on your audit appeals

Our team members are highly trained experts, here to help you! Even though it is best to involve PAAS from the very beginning with audits big or small, we provide guidance regardless, and will guide you through an appeal to help give you the best chance at favorable results.

Could You Be Giving Vaginal Creams Away for Free?

PAAS National® analysts continue to see claims for Premarin® and Estrace® creams being audited and recouped. Pharmacies not calculating the accurate days’ supply are in jeopardy of refilling too soon. These early refills will be taken back during audit which means the pharmacy is basically handing the medication out for free.

Since these vaginal creams only come in one package size, instructions rarely support the days’ supply to be 30. This makes your claims easy targets if you are consistently defaulting the days’ supply. Software default fields, plan limits, or data entry errors should all be reviewed to ensure you have safeguards in place to prevent losing these claims.

Product Package Size Applicator Measurements
Estrace® (estradiol) 0.01% vaginal cream 42.5 gram 1 to 4 grams
Premarin® (conjugated estrogens) vaginal cream 30 gram 0.5 to 2 grams

PAAS Tips:

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!

  • PBMs look for calculable instructions (e.g., grams per application or max grams per week/month)
  • Instructions for “pea-sized amount” or “X number of inches” are not sufficient for audit purposes
    • For a pea-sized amount, work with prescribers to clarify if 0.25 grams would be appropriate (half of a finger-tip unit)
  • Clarify any instructions that do not provide enough information to accurately calculate days’ supply
  • See our June 2021 Newsline article, Self-Audit Series #5: Topical Prescriptions
  • Always submit an accurate days’ supply first, as many plans now have overrides for exceeding plan limits
  • Refer to our Can You Bill It As 30 Days? in our Tools & Aids section if plan limits are exceeded
  • Self-audit your vaginal creams for accurate days’ supply and appropriate instructions
  • Vaginal creams are not recommended to be part of a patient’s med sync program – refill upon request only

Medication Synchronization: Possible Concerns

Medication synchronization programs have many benefits for community pharmacies (and your patients) – improved workflow of your team, leaner “just in time’ inventory replenishment and fewer patient trips to the pharmacy.

Unfortunately, medication synchronization also poses a threat of waste or abuse if it goes off the rails. PAAS National® analysts have noticed PBMs auditing for refills of high-cost maintenance medications that seem to be filled especially early every month (e.g., every 23 days on a 30 days’ supply) – remember that PBM audit algorithms are looking for FWA conducted by bad actors and will use data analysis as a reason to audit your pharmacy if the claims look suspicious.

Most independent pharmacies can tell numerous stories about patients bringing in large quantities of unwanted or unused medications that they received from a PBM mail-order pharmacy because the refills just kept coming. In fact, Express Scripts was named in a recently unsealed False Claims Act lawsuit from 2019 due to automatic refills of medications for TRICARE beneficiaries. The complaint states that Express Scripts set up 90-day supply medications for refill on day 60 (of 90) which represented only 67% utilization. Over time these early refills accumulated such that over a one-year period patients would have received nearly 500 days’ worth of medication. Surely, these extra fills benefitted the dispensing pharmacy, but at an inappropriate cost to patients and plan sponsors.

See the tips below to ensure that your medication synchronization program will stand up to PBM scrutiny and keep you out of harm’s way.

PAAS Tips:

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!

  • Be aware, State pharmacy regulations may prohibit, or require additional documentation for, automatic refill programs
  • Payer restrictions may also apply (e.g., Medicare B/D and Medicaid)
  • Automatic mailing and delivery of prescriptions often have additional requirements
  • Best Practices for Med Sync include:
    • Having patients opt in for med sync (preferably with a retrievable signature to support enrollment documentation)
      • Consider annual reverification
    • Cycling prescriptions at ≥ 90% utilization
    • Avoid putting bulk items like inhalers, insulin, eye drops or topicals on med sync
    • Do not put “as needed” (aka PRN) or controlled substance medications on med sync

DMEPOS Mini-Series #4 – Urological Supplies: Intermittent Catheters

If you are a Medicare Part B supplier, then you are aware that billing Medicare B is quite different than billing other payors, and consequently, can be incredibly challenging for pharmacies. Being able to produce all the required documentation upon an audit, and making sure that the documentation meets Medicare Part B requirements, is a daunting task.

Medicare performs post-payment medical reviews on intermittent catheters due to having a high, sustained error rate. The top errors are:

  • invalid orders or missing documentation to support the item is reasonable and necessary
  • no clinical documentation received
  • invalid proof of delivery
  • NPI on claim is not the ordering physician

Follow the tips below to be prepared in case of an intermittent urinary catheter audit.

PAAS Tips:

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!

  • Required Documentation for all DMEPOS items – See our April 2021 Newsline for more details
    • Standard Written Order
    • Proof of refill request
    • Proof of delivery
    • Medical Records
  • Coverage Criteria for Intermittent Catheterization
    • Beneficiary must have permanent urinary incontinence or retention
    • “Permanent” is defined as a long and indefinite duration of at least three months
    • The impairment is not expected to be surgically or medically corrected within three months
    • The beneficiary or caregiver can perform the procedure
    • For each episode, Medicare will cover:
      • One catheter: A4351 (straight tip catheter) or A4352 (coude or curved tip catheter) and an individual pack of sterile lubricant A4332 OR
      • One sterile intermittent catheter kit: A4353
        • Must meet one of the following:
          • Nursing facility resident
          • Immunosuppressed
          • Radiologically documented reflux
          • Pregnant female with spinal cord injury with neurogenic bladder (for duration of pregnancy only)
          • Had at least 2 urinary tract infections (UTIs) within 12 months while on sterile intermittent catheterization using A4351/A4352 and sterile lubricant A4332
        • Maximum quantity of intermittent catheterization supplies per month is two hundred for codes A4332, A4351, A4352 and A4353
        • Medical necessity of coude (curved-tip) catheters must be supported by documentation in the medical record – use of a coude tip catheter in female beneficiaries is rarely reasonable and necessary
        • Urological supplies are an exception to requiring proof of continued need. Once the initial medical need is established, ongoing need for urological supplies is assumed due the permanent condition
      • Please reference the following helpful links when billing intermittent catheters
        • Urological Supplies LCD and Policy Article
        • Documentation Checklist for Urological Supplies: Intermittent Catheters

Metformin ER – Can I Substitute?

Many pharmacies struggle with identifying which metformin ER product they can dispense or substitute. There are three different strengths and three different extended-release mechanisms. The FDA uses Therapeutic Equivalency (TE) codes to show which generic products can be substituted for a specific brand name. When there are multiple branded versions of an identical active drug ingredient, form, and route of administration, then the FDA must assign each brand an additional identifier such as AB, AB1, AB2 and AB3. The brand names below are different due to their extended-release mechanisms. Generic versions may only be substituted for the brand with the same TE code.

Brand Name Strengths (mg) FDA Orange Book

TE Codes

Extended-Release Format
Glucophage XR® 500, 750 AB, AB1 Dual hydrophilic polymer system
Fortamet® 500, 1000 AB2 Single-Composition Osmotic Technology (SCOT)
Glumetza® 500, 1000 AB3 Gastric Retention Technology

For example, if you receive a prescription for Fortamet® 1000 mg, you may dispense with the brand name product or a generic formulation with a TE code of AB2

PAAS Tips:

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!

  • PAAS has seen countless PBM audits for metformin ER products due to the substantial price differences
    • Fortamet®, Glumetza® and their TE generics are higher risk for audit due to their higher cost
  • It may be appropriate to switch patients for clinical reasons, including side effects – for audit purposes, consider documenting the rationale on the hard copy
  • Be aware that a PBM may require clarification from the prescriber when dispensing the higher cost metformin ER products
  • Use the FDA orange book and/or your wholesaler database to identify the TE codes of various manufacturers
  • If a prescription is written for generic metformin ER, the pharmacy should clarify which “version”
    the patient has been on or which “version” the prescriber prefers and notate on the prescription
  • If you need to substitute between formulations that have different TE codes (e.g., AB1 and AB2), the pharmacy will need to obtain prescriber approval and document a clinical note on the prescription