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:

  • Discrimination against Limited English Proficiency (LEP) individuals: the Section 1557 Notice of Proposed Rulemaking (NPRM) includes “requiring entities to give staff training on the provision of language assistance services for individuals with limited English proficiency (LEP), and effective communication and reasonable modifications to policies and procedures for people with disabilities.” Additionally, the proposed rule looks to reinstate a previous requirement from the 2016 version of the Final Rule that obligates covered entities from notifying patients of their ability to provide language assistance services.
  • Disability Discrimination: Barriers were observed when patients requiring screen reader software or those who require modifications to the usual “point-and-click” mouse attempted to sign-up for COVID-19 vaccinations and tests online. Therefore, the proposed rule calls for covered entities to make “reasonable modifications” to allow these individuals to access telehealth services in a nondiscriminatory manner and requires those entities to alert their patients of auxiliary aids and services available.
  • Section 1557 Policies & Procedures Program: Covered entities would be required to develop and implement a Section 1557 Policy, complete with a written Policy & Procedure manual. As part of the program, a covered entity is to have a nondiscrimination policy, procedures in place to mitigate any grievances that would arise, what language accommodations are available to individuals, etc. In addition, covered entities that employ a minimum of 15 employees would designate a “Section 1557 Coordinator” who will ensure entities are adhering to the goals set forth by Section 1557.
  • Section 1557 Training: Despite the 2016 and 2020 Rule not having a training requirement, HHS proposes that training should be done to best mitigate any potential Section 1557 violation. Although who does the training, the content, and the timing of the training is left up to the covered entity to determine, HHS proposed “relevant employees” complete training over the covered entity’s Section 1557 Policies and Procedures at a minimum. Training should be completed “within a reasonable period of time” after being hired and “within a reasonable time after a material change has been made”.

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?

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.

  1. 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).
    1. 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?
    2. 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.
  2. 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.
    1. 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).
    2. 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).

  1. 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.
  2. 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

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.

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!

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:

  • 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.

PAAS Tips:

  • 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

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.

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!

  • 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”

DMEPOS Mini-Series #5 – Surgical Dressings

Per CMS, for the 2020 reporting period, the improper payment rate for surgical dressings was 67.3% representing $194.9 million. CMS indicated 82.4% of improper payments were due to insufficient documentation. Additional errors were no documentation (1.9%), medical necessity (1.7%), incorrect coding (1.9%) and other (12.2%). Pharmacies need to ensure that the clinical information in the patient’s records proves the dressings are reasonable and necessary as well as what type and quantity of dressing(s) they qualified for. Use the helpful tips and links below to be prepared in case of an audit on surgical dressings.

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 (SWO)
    • Proof of refill request
    • Proof of delivery
    • Medical Records
  • Coverage Criteria for Surgical Dressings
    • Medical records must support the surgical dressings are required for one of the following:
      • Treatment of a wound caused by, or treated by, a surgical procedure, OR used after debridement of a wound
      • Initial wound evaluation must include:
        • Type, location, number, and size of qualifying wounds (L x W and depth)
        • Amount of drainage
        • Frequency of dressing change
      • Ongoing wound evaluation (weekly or monthly)
      • Specific dressing coverage criteria (in addition to meeting the criteria for qualifying wound)
      • A new order is needed at least every 3 months for each qualified dressing dispensed, OR sooner if quantity required increases
      • Modifiers (A1-A9) to indicate the number of wounds on which the dressing is being applied
        • If using A9, must also submit actual number of wounds being treated in narrative on electronic claim
      • Please reference the following helpful links for more detail when billing for surgical dressings:

Trudhesa™ Nasal Spray for the Treatment of Migraines

Migraine relief medications are frequently monitored and flagged for audit due to high cost, quantities submitted, days’ supply and/or frequency of refills. Trudhesa™ 4 mg/mL nasal spray was FDA approved on September 3, 2021. It is indicated for the acute treatment of migraine with or without aura in adults. While Migranal® and Trudhesa™ are both nasal sprays containing dihydroergotamine, Trudhesa™ is the newer form made to reach the bloodstream more quickly by being absorbed better through the nose. Pharmacies often struggle on billing Trudhesa™, due to some specific dosing and administration guidelines. Please see below for guidance on how to properly bill for this migraine relief medication.

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!

  • Trudhesa™ is for nasal administration only
  • Supplied as a package of four single-dose units (NDC# 77530-0725-04)
    • Each single-dose unit contains a 1 mL vial and an intranasal delivery device
  • Each device must be assembled and primed with exactly four sprays prior to use
    • The purpose of priming is to bring the medicine to the tip of the spray nozzle. You may or may not see liquid or spray come out of the nozzle during each priming pump
    • Each 1 mL vial contains 2 sprays (one dose) after the four priming sprays
    • NCPDP billing unit is mL – one package containing the four units is billed as 4 mL
    • There are a total of 4 doses or 8 sprays in each 4 x 1 mL package
    • A complete dose is 2 sprays, 1 spray in each nostril
    • If prescribed, the dose can be repeated at least one hour after the first dose
    • If an additional dose is needed, a new unit must be opened and prepared
  • Use or discard within 8 hours after vial has been opened or product has been assembled
  • Do not use more than two doses of Trudhesa™ within 24 hours or three doses within 7 days
  • If written for more than one package of 4 mL, it is best to have a notation from the physician as to the number of headaches the patient has per week or month to support billing multiple packages
  • See our updated Nasal Spray Chart on the PAAS Member portal for additional guidance on billing
  • See the December 2021 Newsline article, Self-Audit Series #11 – Migraine Prescriptions for further reference
  • Call PAAS (608) 873-1342 with questions on how to bill Trudhesa™

NCPDP Updates DAW Code Definitions to Encompass Interchangeable Biosimilars

In the August 2022 version of the National Council for Prescription Drug Programs (NCPDP) Telecommunication Version D and Above Questions, Answers and Editorial Updates, there is new guidance in section 3.1.3 regarding interchangeable biosimilar products and Dispense As Written (DAW)/Product Selection Code (408-D8) field in anticipation of the DAW code definition updates which should go into effect October 15, 2023. With more interchangeable biosimilar products set to hit the market later this year, it is important to understand how to appropriately use these DAW codes to prevent future audit issues.

Section 3.1.3 of the NCPDP document starts by outlining the FDA definitions of a biosimilar product, interchangeable product, and reference product. It goes on to state that when a prescriber indicates DAW 1 on a prescription, substitution of the product as written is not appropriate and when the prescriber does not indicate DAW 1 on a script, DAW 0 or DAW 2-9 could be appropriate. The chart below was included in the NCPDP document to aid pharmacies in determining appropriate DAW codes to bill.

Prescribed Drug Substitution Allowed

Substitution Not Allowed

Dispensed/Billed Drug DAW Code (408-D8)
Reference Product Allowed Interchangeable Biosimilar 0
Reference Product Not Allowed Reference Product 1
Reference Product Allowed Reference Product 2-9
Interchangeable Biosimilar Allowed Interchangeable Biosimilar 0
Interchangeable Biosimilar Not Allowed Interchangeable Biosimilar 1
Interchangeable Biosimilar Allowed Reference Product 2-9

While this chart is useful, you may be asking yourself – What does this all mean?! Let us go through several examples.

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!

Example #1 – The pharmacy receives a script for Lantus Solostar® (DAW 1) from the prescriber.

Since the script was flagged “Dispense as written” by the prescriber, the pharmacy must dispense the prescribed reference product, Lantus Solostar® and should utilized DAW 1 in field 408-D8 on the claim.

Example #2 – The pharmacy received a script for Lantus Solostar® (DAW 0) from the prescriber.

Since Lantus Solostar® has an authorized interchangeable biologic (Semglee®), and both Lantus Solostar® and Semglee® have interchangeable unbranded biologics there are some additional considerations that must be made before determining the proper item to bill:

(1) State regulations regarding the substitution of interchangeable biologic agents. Many states require the least expensive biologic agent to be dispensed. To find a link to your applicable state regulation, you may reference the Cardinal Health website. This may mean looking at your inventory to see what you have in stock and trying to bill the least expensive product first, then following the PBM claim messaging if the claim rejects.

a. If the interchangeable biosimilar is dispensed instead of the reference product, DAW 0 is appropriate.

b. If the reference product is dispensed, due to a formulary preference, DAW 9 would be appropriate.

(2) Patient Preference. Though the prescriber allows for substitution, the patient may prefer to stay with the reference product prescribed, in this case that would be Lantus Solostar®. DAW 2 would be appropriate for this claim.

Example #3 – The pharmacy received a script for Semglee®, the interchangeable biosimilar for Lantus Solostar®, (DAW 1) from the prescriber.

Since the script was flagged “Dispense as Written” by the prescriber, the pharmacy must bill Semglee® as prescribed and a DAW 1 would be appropriate on this claim.

Example #4 – The pharmacy received a script for Semglee®, the interchangeable biosimilar for Lantus Solostar®, (DAW 0) from the prescriber.

If the claim is billed for Semglee®, DAW 0 would be appropriate. If instead the patient wishes to be on (or stay on) Lantus Solostar®, then DAW 2 should be used on the claim for Lantus Solostar®. If Semglee® is not available from your supplier and Lantus Solostar® is available, DAW 8 could be utilized when billing the claim for Lantus Solostar® to signify that the interchangeable biosimilar was unavailable from your wholesaler—for this scenario, be sure to keep record to prove Semglee® was unavailable in the event the claim is audited. This could be a copy of an invoice showing Semglee® was out of stock, or a screen shot of your wholesaler’s website showing it was unavailable.

Example #5 – The pharmacy received a script for insulin glargine 100 units/mL (DAW 0) from the prescriber.

Insulin glargine encompasses several different insulin products, include reference products Lantus Solostar® and its unbranded equivalent, Semglee® and its unbranded equivalent, Basaglar®, and RezvoglarTM. Pharmacy staff should consider clinical context, patient history, formulary preference, and cost of the medication when determining the correct product to bill and may need to contact the prescriber’s office for additional clarification. If Lantus Solostar® (the reference product) is billed due to formulary preference, a DAW 9 would be appropriate and if Lantus Solostar® was billed due to the patient requesting brand, DAW 2 would be appropriate. If an interchangeable biosimilar was billed, DAW 0 would be appropriate.

PAAS Tips: 

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