Inventory Purchase Reminders for Successful Audits

With a 29% increase in PBM audits in 2023, PAAS National® wants to help you avoid PBM scrutiny, especially when it comes to drug procurement.

PBMs conduct invoice audits to confirm pharmacies have purchased enough medication to support the claims they have billed for. This is the primary method PBMs can identify false/phantom claims, where a pharmacy is billing for medications that never get dispensed. The auditor will reconcile claims billed with invoices provided, over a certain timeframe. After the reconciliation is complete, any inventory shortages must be explained or resolved by the pharmacy, or it could result in recoupment of claims and even termination of contract if there are substantial issues.

PAAS analysts have assisted with countless invoice audits and are eager to provide helpful tips for success.

PAAS Tips:

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  • Take the proper steps to vet any wholesaler you intend to purchase from
    • Confirm they are licensed in your state
    • Check the NABP website for Accredited Drug Distributors (formerly “VAWD”)
    • Verify you have a direct contact to request invoices on a timely manner
    • Be sure wholesaler can provide Drug Supply Chain Security Act (DSCSA) information if requested
  • Diabetic test strips have unique requirements
    • OptumRx requires OTCs dispensed via prescription to be bought from a licensed wholesaler accredited by NABP
    • Caremark and Express Scripts require Authorized Distributors of the manufacturer
      • If the pricing is substantially better, they’re likely not authorized – even if they’re affiliated with one that is (i.e. McKesson-authorized; River City Pharma & Masters-not authorized)
    • Authorized Distributors can be verified at the links below
      • Abbott https://www.diabetescare.abbott/support/distributors.html
      • Ascensia https://www.ascensiadiabetes.com/ (click on “distributors” at the bottom of the page)
      • LifeScan genuineonetouch.com
      • Roche https://rxvp.accu-chek.com/welcome/adr_list
      • Trividia Health https://www.trividiahealth.com/where-to-buy/
    • Limit pharmacy to pharmacy purchases to a minimum
    • Be sure the NDC billed is the NDC dispensed, this includes package size
      • Bar code scanning is highly recommended during the filling process
    • Remember Caremark requires pharmacies to notify them of any bulk purchases
    • Verify your pharmacy is appropriately reversing claims that are not dispensed

Need assistance with an invoice audit? Engage PAAS early for information and guidance for the best possible outcome. Call (608) 873-1342 or email to info@paasnational.com

Addressing “Weird” Days’ Supply

Days’ supply errors are one of the easiest audit triggers a PBM can pursue. Algorithms can be set for any days’ supply that does not correspond with typical dispensing of a medication and have an audit sent almost as soon as the claim adjudicates. We know that days’ supply should be billed based on the mathematically calculable directions, but what happens when the days’ supply does not fall in the easily calculable 30- or 90-day spectrum? What if it is “weird?”

The answer is …

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that you should still attempt to bill your claim for the correct days’ supply! Many plans have built-in overrides in place for medications that are known to be greater than 90-day supply, like Prolia®. This medication is typically administered once every six months and should be billed for a 180-day supply. Do NOT assume that the claim will not go through. PAAS National® has seen many claims adjudicate correctly at this days’ supply. A patient may end up with a higher copay, but that is because they are receiving six months’ worth of medication.

Other “weird” days’ supply medications to be aware of:

  • Vaginal Creams: Typical directions vary, but a majority of the time they are only used a couple of times a week making a tube last much longer than 30 days, sometimes as much as 210 days.
  • Annovera® should be billed as 1 each for a 364-day supply (thirteen 28-day cycles).
  • Dexcom receiver should be billed as 1 each for a 365-day supply.
  • Tobramycin inhalation solution is typically used as one single-dose ampule twice daily for 28 days, then stop for 28 days, and should be billed as 280 mL (56 vials) for a 56-day supply.
  • Bowel preps: 1- or 2-day supply based on whether or not the patient is doing a “split” prep.
  • Vaccines: NCPDP billing guidance states all vaccines should be billed as a 1-day supply.

PAAS Tips:

  • Always attempt to bill the actual days’ supply calculated first. If the correct days’ supply does not go through, call the plan help desk and ask for a days’ supply override.
  • If the plan cannot (or will not) issue a days’ supply override, bill for the plan maximum, and note the plan limit on the hard copy (ILQ=90 or ILQ=30).
  • Review our Can You Bill It As 30 Days? document under Proactive Tips on our website.
  • Be careful with auto-fill or med sync programs – do not run for a 30-day supply when the actual days’ supply is 130.
  • Utilize separate fields for “billed” and “actual” days’ supply if needed and if your pharmacy system supports them.
  • Note the actual days’ supply on the patient label to help flag pharmacy employees not to refill early.
  • Days’ supply should be billed for the length of therapy needed (e.g., birth control with 3 weeks on and one week off is a 28-day supply, not a 21-day supply).
  • Products billed weekly should not be billed as a 30-day or 90-day supply. They should be billed as a 28-day supply (4 weeks) or an 84-day supply (12 weeks) respectively.

Caremark Bulk Purchase Notification

PAAS National® analysts continue to see a large volume of Caremark invoice audits. Remember that Caremark will only review aggregate purchases over the selected date range plus the 30 days prior to. If pharmacies want Caremark to consider purchases made prior to the selected date range, then there must be a “bulk purchase notification” on file in accordance with Section 8.05 of the Caremark Provider Manual. Since future audit date ranges cannot be known in advance, it is in your best interest to report any purchase that is subjectively “large” based on your normal purchase patterns – consider quarter or year-end bulk purchase if you are trying to meet wholesaler rebate thresholds or inventory that you are purchasing with intention to last greater than one month.

If your pharmacy plans to make any large purchases, be sure to …

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notify Caremark by mail or email within 21 days after the purchase and provide the following information:

  1. Pharmacy NCPDP
  2. Contact email address
  3. Drug name
  4. NDC
  5. Total quantity purchased
  6. Name of wholesaler used

Pharmacies should submit notifications to the addresses provided below.

Email:   PharmacyAudit@CVSHealth.com

Mail:     CVS Caremark

Attn: Bulk Purchase Notification, MC 020

9501 E. Shea Boulevard

Scottsdale, AZ 85260

Pharmacies do not need to include cost information when submitting. Some pharmacies have received a notification back stating that their purchase was routine in nature and would not be considered a bulk purchase. This is laughable, since Caremark doesn’t clearly define what constitutes ‘bulk’. This response can actually be used in the pharmacy’s defense and should not deter pharmacies from reporting. PAAS recommends continuing to inundate CVS with notifications for ‘bulk’ purchases.

During Caremark invoice audits, it is typical that Caremark will only consider purchases for the selected date range upon initial review. During the audit appeal, Caremark will factor in purchases made during the 30-day period prior to the selected date range as well as any bulk purchase products that were on hand more than 30 days in advance.

PAAS Tips:

Adapting to Change: Levemir® Phase Out and Its Implications for Pharmacies

In November 2023, Novo Nordisk® announced that it would be phasing out the company’s long-acting insulin, Levemir®, in the United States. The company cited “global manufacturing constraints, formulary losses impacting patient access, and the availability of alternative options” as the reasons for discontinuing this medication.

The Novo Nordisk® website shows that supply disruptions of Levemir® FlexPen® would start mid-January with discontinuation complete on April 1, 2024. The Levemir® vial would be discontinued by December 31, 2024. Product will only be available while supplies last. There has been no indication that Novo’s other long-acting insulin, Tresiba®, is being discontinued.

PAAS National® has already seen some audit implications with this phase out of Levemir® products.

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The company switch from the Levemir® FlexTouch® to the Levemir® FlexPen® has caused confusion due to the slight differences in product and similar name. See the March 2023 Newsline article, Levemir® FlexPen® is Replacing the Levemir® FlexTouch®, for more on the previous switch.

We do expect PBMs to audit Levemir® through discontinuation of the product. As supply dwindles, and patients are switched to another product, the best thing you can do to protect yourself from audits is to have a conversation with the patient and prescriber and obtain a new prescription for an alternative product before supply gets constrained.

PAAS Tips:

  • If receiving a prescription for a patient new to Levemir®, contact the prescriber and have a conversation about alternative medications – the last thing a patient wants is to be introduced to a medication just as it is being discontinued.
  • Obtain a new prescription for the alternative product instead of making clinical notes on the original to avoid audit issues.
  • Make sure patients and prescribers are aware of any supply chain disruptions to temper expectations.
  • Send all audits to PAAS right away for your best chance of success:

Best Practices for DAW Billing in Pharmacies

In what should be a fairly straightforward process, proper DAW billing practices can be convoluted. Despite NCPDP guidance to standardize adjudication practices, PBMs do not always adopted these standards, leaving the pharmacy in a gray area of what proper DAW billing should look like.

Due to the variability between each PBM’s (and even individual Plan Sponsor) expectations for DAW billing, pharmacies need to have a multi-pronged approach that includes understanding biologic terminology (PAAS Audit Assistance members can see this month’s article, Insulin Substitution Review: Understanding Purple Book Terminology), a list of core “DAW billing guidelines” to follow, and additional considerations to guide your pharmacy in the scenarios where billing may not be straightforward.

Every claim adjudication comes with its own unique set of circumstances, making it difficult to establish a process that can be applied universally. Furthermore, audit tactics continue to morph and industry dynamics, such as the 2024 elimination of retroactive DIR fees, make the pharmacy’s reimbursement more transparent at point-of-sale, potentially driving DAW considerations. As such, having a grasp on the suggested DAW best practices is necessary.

PAAS Tip 1:

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When using a DAW, be sure to have supporting documentation

Pharmacies must ensure documentation exists on the hardcopy anytime they are billing a DAW (other than DAW 0). If the PBM audits a claim with a particular DAW, documentation on the hardcopy needs to support the DAW billed or the pharmacy will risk potential recoupment. Passive DAW 1 indicators on electronic scripts (e.g., a simple DAW checkbox) have been known to be challenged by PBMs, requiring further documentation. Additionally, pharmacies need to be mindful of their state laws and Medicaid requirements on DAW 1. Some state Medicaid programs require an explicit handwritten or electronic note stating “Brand Medically Necessary” in order for a DAW 1 to be billed appropriately.

PAAS Tip 2: Where applicable, bill the generic/interchangeable biosimilar of the medication utilizing a DAW 0 first, unless the prescriber or patient has indicated a preference for the product dispensed (DAW 1, DAW 2, respectively). Make note of any rejected messages received and follow adjudication logic.

Let’s walk through an example of billing a Lantus® prescription, including the suggested corresponding DAW, for a patient who has never been on this medication before. Claim adjudication would typically begin with Semglee®, an interchangeable biosimilar product to Lantus®, utilizing a DAW 0, similar to choosing an A or AB-rated generic medication to bill first in place of a brand medication.

In instances where there is only an unbranded biologic or an authorized generic on the market, such as the case with Humalog®, pharmacies can attempt to bill the unbranded biologic (insulin lispro) first. Recall that an authorized generic or unbranded biologic is considered the same product as the brand name/reference product since they have the same NDA/BLA number, per the Orange Book and #11 in the Purple Book FAQ Resource. Therefore, both the reference product (Humalog®) and the unbranded biologic (insulin lispo) can be billed as a DAW 0.

Subsequent steps should be guided by the reject message received. For example, if a patient’s plan requires a different reference product be dispensed, such as Basaglar®, the prescriber must be contacted to approve as this is not considered to be a product that can be freely substituted. In addition, documentation of the conversation should be included in a clinical note that includes the date, title, and name of the person spoke with, a recap of the conversation, and pharmacy staff initials.

If the claim for Semglee® returns the reject message “Lantus required by plan”, Lantus® should be billed with a DAW 9 – plan requires brand – along with a notation on the hardcopy. Should the plan require an unbranded biologic equivalent (e.g., insulin glargine-yfgn), PAAS would recommend billing that as a DAW 0.

Unfortunately, adjudication rejections are not always explanatory – not surprising with opaque PBMs, but frustrating for pharmacies and technicians. Their lack of communication can be intentional, leading to underpaid claims or forcing pharmacies to play a guessing game of how to bill the claim correctly based on formularies. If there are predominate plans/payors in your market, having access to their formulary may help save you team a lot of headaches.

PAAS Tip 3: Do not use DAW 9 unless adjudication logic or plan formulary explicitly shows the plan requires brand.

This is a newer piece of guidance. In the absence of an adjudication reject that states, “Drug X not on Formulary, bill Drug Y as DAW 9” (or something analogous), PBMs have questioned why a DAW 9 was used when in fact the plan formulary does not show the drug product billed is plan-preferred. The better question is why didn’t the PBM reject the claim if it wasn’t not covered? Protect yourself by being able to substantiate why the pharmacy is billing a brand or reference product as DAW 9 (as stated in PAAS Tip #1). Looking at the plan’s formulary may help guide your decision on whether a DAW 9 is appropriate or not. Express Scripts and Humana put out communications that list products they expect to be billed as DAW 9, but be mindful that some Plans may not accept DAW 9 on any claims and formularies can change at any time. Technicians need to watch adjudication messaging closely – even for paid claims. If a PBM rejects a DAW 9 stating the Plan Benefit design doesn’t allow the use, a DAW 0 may be the pharmacy’s only choice.

PAAS Tip 4: In instances where adjudication rejections are unclear, take an all-encompassing approach to determine what medication and DAW to bill.

One of the more common DAW questions we get at PAAS encompasses the situation where both the brand and generic (or reference product and interchangeable biosimilar), result in a paid claim with DAW 0, one with a positive margin and the other in a negative margin. What options does the pharmacy have without increasing their risk of recoupment?

One consideration is cost of the product to the patient. State laws commonly have language obligating the pharmacy to dispense the most cost-effective medication to the patient. Therefore, the copay of the brand vs. generic needs to be taken into consideration when determining if the pharmacy can bill for the product that results in a positive margin. In cases where the copays are the same and the patient truly prefers the brand, billing DAW 2 may be appropriate in that scenario (and consider researching the Plan Formulary for a DAW 9 indication). If the copays are not the same, review the adjudication messaging results for any clues and consult the plan’s formulary. PBMs have been known to prefer a Brand and, instead of rejecting the generic, significantly underpaying on the generic. With so many claims underwater, it’s hard to know the difference, so diligence may be prudent. In instances where a product’s unbranded biologic/authorized generic results in a lower cost to the patient, a DAW 0 can be used. Ultimately, determining which product to bill should not be based solely on pharmacy reimbursement.

PAAS Tip 5: Watch claim adjudication messaging carefully – even on paid claims. Rechallenge DAW 9 when new prescriptions are issued and be careful at the beginning of Plan years (particularly the New Year).  

Pharmacies can fall into the habit of billing a DAW 9 solely based on history. Plan formularies change often and sporadically with new medications being introduced to the market, and products having generic/interchangeable biologics available that previously were not. Therefore, ensuring the DAW historically used is still warranted is a great preventative step.

PAAS Tips:

Tip to Federal Agents Leads to Jail Time for Pharmacy Owner

The Department of Justice announced a Nebraska pharmacist, and owner of two pharmacies, was sentenced to two months of imprisonment, three years of supervised release, and ordered to pay restitution in the amount of $573,000.

The pharmacist was found guilty of making a false, fictitious, and fraudulent statement related to health care services. The investigation began in 2020 based on a tip to Federal Agents, and included pharmacy staff interviews, patient interviews and an inventory audit. The inventory audit reconciled claims billed to both Medicare and Medicaid with invoice purchases made by the pharmacy.

Upon completion of the investigation, the inventory audit identified significant shortages. Investigators discovered the pharmacist was billing for brand name drugs but ordering and dispensing the generics. Additionally, the pharmacist in question was submitting claims that were never dispensed to the patient.

PAAS Tips:

 Contact PAAS National®®  today and start your robust Fraud, Waste and Abuse and HIPAA Compliance Program, ensuring your pharmacy employees are informed and trained against fraudulent activities.

DMEPOS Updated Refill Request and Affirmative Response Requirements

Medicare Part B/DMEPOS billing and documentation rules are VERY different from most of your pharmacy claims. If you don’t have a strong grasp of these differences, or a process for handling the documentation, then you are sure to experience significant problems during an audit. PAAS Audit Assistance members can download PAAS’ Basic DMEPOS Documentation Guidance resource for a helpful checklist when processing these claims.

This Newsline article focuses on the refill record request and affirmative response requirement that was updated January 1, 2024. Suppliers can find all the revisions in CMS Final Rule 1780-F. DMEPOS items and supplies that are provided on a recurring basis must be based on prospective, not retrospective, use. Medicare requires documentation to ensure the item(s) remain reasonable and necessary, existing supplies are expected to end, and to confirm if there are any changes to the order. If your pharmacy currently has a process for documenting a proof of refill request, PAAS National® would recommend you review and update your form if necessary to meet Medicare’s requirements.

The refill record request, at a minimum, must include:

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  1. Requestor’s name (beneficiary or authorized representative)
  2. A description of each item being requested
  3. Documentation of an affirmative response indicating a need for the refill
    • Includes confirmation that the beneficiary is still using the item
    • No changes have been made to the order
    • A refill is needed
  4. Date of the request

PAAS Tips:

  • For an item that the beneficiary obtains in-person at your pharmacy, the signed delivery slip or copy of an itemized sales receipt is sufficient documentation for a refill request and affirmative response
  • For an item that is delivered to the beneficiary, there must be documentation recorded from the beneficiary, or their authorized representative, affirming the need for a refill
    • The refill request must occur, and be documented, before shipment or delivery
  • Contact with the beneficiary, or authorized representative, must take place no sooner than 30 calendar days before the expected end of the current supply
  • Medicare states suppliers are permitted to use any mode of communication if the beneficiary affirmation is received, documented and can be produced upon request
    • This affirmation can occur through a phone call, an email, a text message, or in-person
  • The supplier must provide the DMEPOS product no sooner than 10 calendar days before the expected end of the current supply – regardless of whether the refill is picked up in the pharmacy or delivered
  • Medicare believes the new requirements take the burden off both suppliers and beneficiaries by:
    • Extending the time frame for the supplier to contact the beneficiary with an affirmative response (went from 14 to 30 calendar days)
    • No longer requiring beneficiaries to “count” their remaining on-hand supplies
    • Changing the terminology of “pending exhaustion” to “expected end of the current supply”
  • Download PAAS’ Proof of Refill Request and Affirmative Response form on the Member Portal where you can document the required information from the beneficiary or their caregiver

Don’t Cut Corners: Notations on Prescriptions

Not only are new medications frequently released to market, but also new strengths and formulations of existing medications. For example, consider Humulin® R U-100 insulin which was developed in the early 1980s. In the mid-1990s, Humulin® R U-500 vials became available in the market. That meant prescribers and pharmacists alike needed to be mindful of indicating which formulation of Humulin® R insulin the patient was to receive.

Not only are there new strengths of existing medications, but also new formulations. In 2016, Humulin® R U-500 insulin became available with a dedicated device used for the delivery of insulin – the KwikPen® – after previously only being available by vial. Yet again, this meant pharmacists needed to be explicit in what the patient was to receive, not only for the sake of the patient but also for accurate billing and dispensing.

For medications that come in one strength or dosage form, PBMs have proven to be more lenient with prescription hard copies that do not contain that information. However, medications that come in different strengths or dosage forms must include that information on the hard copy for it to be accepted by PBMs. Instead of trying to remember whether a medication comes in multiple forms, get all pharmacy staff into the practice of including strength and formulation for prescriptions, especially on telephone and transferred prescriptions. Below are the more common types of medications that could be recouped with missing information:

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  • Missing Strength
    • Topicals
    • Insulin
    • Inhalers
  • Missing Formulations
    • Topicals: cream, ointment, gel or solution
    • Buprenorphine and Naloxone: film or tablet
    • Insulin: vial, pen or refill cartridge
    • Injections: auto-injector/pen, prefilled syringe or vial
    • Vyvanse®: capsules or chew tablets

PAAS Tips:

  • Utilize PAAS’ Self-Audit Mindset to ensure prescription hardcopies include all necessary components
  • If you need to clarify strength or formulation on a hardcopy, include a complete clinical note with the date, name and title of the person you spoke with, what was clarified, and your initials
  • Coach staff members who are able to take telephone prescriptions, transferred prescriptions, or voicemail messages of including all hardcopy components
  • Consider ordering telephone and transfer prescription pads which include all necessary components to meet PBM and state requirements

FDA Issues Updates to iPLEDGE® REMS Program

Isotretinoin capsules are FDA approved for the treatment of severe recalcitrant nodular acne in non-pregnant patients 12 years of age and older with multiple inflammatory nodules with a diameter of 5 mm or greater. Due to the risk of severe life-threatening birth defects and risk of embryo-fetal toxicity, isotretinoin is only available under the iPLEDGE® Risk Evaluation and Mitigation Strategy (REMS) program.

On November 30, 2023, the FDA posted an update to the iPLEDGE® program“…to minimize burden on patients, pharmacies, and prescribers while maintaining the safe use of isotretinoin”. Several changes include:

  • Pregnancy test is no longer required to be performed in a Clinical Laboratory Improvement Amendments (CLIA) certified lab
  • Home pregnancy tests can be utilized during and after isotretinoin treatment
    • The burden is on the prescriber to ensure strategies are in place to decrease the likelihood of patients falsifying results
    • Pre-treatment pregnancy tests must still be performed in a medical setting such as an office or lab

Patients who cannot become pregnant and pharmacies dispensing isotretinoin products will see no changes to the iPLEDGE® program requirements. Pharmacies will still need to:

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  1. Assign a responsible site pharmacist
  2. Enroll online in the iPLEDGE® REMS program by completing the pharmacy activation and annual reactivation
  3. Have the dispensing pharmacist obtain a Risk Management Authorization (RMA) before filling and dispensing the prescription
  4. Obtain and document the “Do Not Dispense To Patient After” date
  5. Follow all other applicable program requirements

PAAS Tips:

  • For the full list of modifications to the iPLEDGE® REMS program, visit ipledgeprogram.com
  • Pharmacies dispensing isotretinoin products can refamiliarize themselves with the iPLEDGE® program requirements for pharmacies by reading the iPLEDGE® Pharmacist Guide
  • Consider promoting over-the-counter (OTC) pregnancy tests to a person who can become pregnant at the time of dispensing an isotretinoin prescription to facilitate patient adherence to the iPLEDGE® guidelines

Law Enforcement Access to Protected Health Information – What’s Your Policy?

Understanding and adhering to the HIPAA Privacy Rule is required for covered entities who handle protected health information (PHI), but because the Privacy Rule was designed to be flexible, implementation of policies and procedures to meet the Privacy Rules can vary from covered entity to covered entity. Look no further than the December 12, 2023 letter from the United States Senate Committee on Finance (herein, “The Committee”) for evidence of this variation and how it can seriously impact the privacy of sensitive patient data.

In the December letter drafted to Xavier Becerra, Secretary of the U.S. Department of Health & Human Services, The Committee outlined the results of their oversight inquiry into the seven largest pharmacy chains (CVS Health, Walgreens Boots Alliance, Cigna, Optum Rx, Walmart Stores, Inc., The Kroger Company, and Rite Aid Corporation), and Amazon Pharmacy. The inquiry focused on obtaining briefings from the major pharmacy chains about their policies and procedures for releasing PHI to law enforcement agencies. Below is a general overview of the findings:

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  • Five pharmacy corporations had policies that would require a law enforcement agency’s demand for PHI to be reviewed by legal professionals before responding
  • The remaining three pharmacy corporations had policies that put “extreme pressure” on the pharmacy staff to respond to the inquiries immediately and stated their pharmacy staff “are trained to respond to such requests and can contact the legal department if they have questions
  • None of the pharmacy corporations required warrants to share information with law enforcement agencies, unless required by state law
  • Pharmacies would turn over PHI to a law enforcement agency when presented with a subpoena (“which often do not have to be reviewed or signed by a judge prior to being issued”)
  • Only CVS Health published annual transparency reports on the records requests from law enforcement
  • Patients already have the right to know who is accessing their health information through the HIPAA Accounting of Disclosure process, but the obligation is on the patient or their authorized representative to request the appropriate information from the covered entity; since this patient right is not well known in the general patient population it leads to a very small number of disclosure requests annually

The Committee urged the Secretary to strengthen HIPAA Privacy regulations to better protect PHI, and referenced a 2010 decision from the Federal Court of Appeals which protected the privacy of emails and would require a warrant before providers such as Google, Yahoo, and Microsoft could release customer data.

What does this mean for independent pharmacies? As stated in The Committee’s letter, “These findings underscore that not only are there real differences in how pharmacies approach patient privacy at the pharmacy counter, but these differences are not visible to the American people.” Also, “Proactively notifying customers about any patient record disclosures to law enforcement that impact their medical records, except where prohibited by a non-disclosure or “gag” order issued by a judge, would be a major step forward in patient transparency.”

PAAS Tips:

  • PAAS Fraud, Waste, and Abuse and HIPAA Compliance members can refer to section 10.5.2.5 for more information about disclosures related to the law and public health activities
    • Utilize the Accounting of Disclosures Report form in Appendix B to document disclosures required by law or otherwise permitted without the patient’s authorization (not related to permitted disclosures for treatment, payment, or other healthcare operations)
  • Ensure your pharmacy has a written policy and procedure detailing the actions to take if presented with a demand for PHI from a law enforcement agency
  • All documentation related to HIPAA practices must be maintained for a minimum of six years after the last effective date