USP <800> is not subject to any pending appeals and will become official December 1st, 2019. Many facets of USP <800> are intertwined with compounding (<795>/<797>), so the General Chapter will be considered informational and not compendially applicable at this time.
With rare exception, all pharmacies will be responsible for meeting USP standards in General Chapter <800> Hazardous Drugs – Handling in the Healthcare Settings. If your pharmacy plans to prepare compounded prescriptions with Hazardous Drugs (HDs), then you must comply with all elements of the standard, including the extensive containment requirements. If your pharmacy does not plan to compound with HDs but has HDs in inventory (as all traditional pharmacies do), then your responsibilities are greatly reduced, but there are still aspects of USP <800> you must comply with.
USP developed General Chapter <800> to address a public health need to protect healthcare personnel from HDs. Both acute and chronic health issues can arise from improper handling or exposure to HDs. HD handling is not new. The National Institute of Occupational Safety and Health (NIOSH) first published a list of HDs in 2004 and the Occupational Safety and Health Administration (OSHA) first published guidelines for HD handling in 1986 (originally only cytotoxic [antineoplastic] drugs).
Various states have adopted USP <800> into law as they feel it’s the best practice to prevent employee, and public, harm. However, regardless of whether a state has specifically enacted USP <800>, all pharmacies should have robust policies and procedures to handle HDs. OSHA was established to ensure safe and healthful working conditions by setting and enforcing standards and by providing training, outreach, education and assistance.
The following statement was taken from OSHA’s website regarding HDs:
“Institutions should have formal written programs to manage hazards. Such programs should include training, exposure assessment, emergency procedures for spills, policies for managing staff with reproductive concerns, and most importantly, ways to ensure that the institution is adhering to critical national standards.
Although OSHA has no explicit standard, USP 800 focuses explicitly on protecting workers from exposures to hazardous drugs. It, and USP 797, represent professionally expected requirements in healthcare that incorporate national consensus standards on infrastructure maintenance (ASTM).”
OSHA also makes available guidance on Controlling Occupational Exposure to Hazardous Drugs. They have the authority, and resources, to enforce USP <800> for the welfare and safety of pharmacy employees.
PAAS Tips:
- Where to start (not all inclusive):
- Review Applicable USP Chapters
- Download NIOSH HD list
- Establish a qualified/trained individual to be responsible for developing and implementing appropriate standard operating procedures
- Complete an Assessment of Risk for all HDs that are dispensed in the pharmacy. NCPA has made a template available for consideration.
- Obtain Safety Data Sheets for all Hazardous Chemicals
- If you have HDs from the NIOSH list in your inventory that in are in final dosage forms and do not require further manipulation (other than counting or repackaging – unless specified by manufacturer) you may not need to follow all the containment requirements of USP <800>, but should consider the following
- Tablets and capsules may not pose a significant risk of direct occupational exposure; however, dust from tablets/capsules may present a risk of exposure by skin contact or inhalation
- If you do not perform an assessment of risk, all HDs must be handled with containment strategies defined in USP <800>
- Counting or repackaging of HDs must be done carefully. Clean equipment (e.g. counting trays and spatulas) should be dedicated for use with HDs and should be decontaminated after every use.
- Tablet and capsule forms of antineoplastic HDs must not be placed in automated counting or packaging machines, which subject them to stress and may create powdered contaminants.
- Splitting HD tablets (e.g. Warfarin 1 mg) is considered manipulation and should only be done if a pharmacy is in full compliance with USP <800>
- If you plan to compound under USP <795> or <797> using HDs, you must fully comply with USP <800>.
Stop Breaking Insulin Pen Boxes– Your Questions Answered
On February 18, 2020, PAAS National® sent an email to all members discussing our revised recommendation: STOP breaking insulin pen boxes. This recommendation came as a result of the FDA-approved product labeling change for insulin pens; effective November 15, 2019.
If you did not receive our email, please see the Stop Breaking Insulin Pen Boxes article from our March 2020 Newsline for more details.
Since that time, we have received many questions from pharmacies regarding this important change. Here are the most common questions:Join today!
- Pharmacy Provider must request an override through the pharmacy help desk when rejected for plan limits and dispensing in the smallest commercially available package size (typically 15 mL per carton).
- If an override is not available and the days’ supply is altered, pharmacies must ensure the refill interval is based on the actual days’ supply, not the submitted days’ supply (or risk audit recoupments).
Claim Processing
1. Will PBMs allow claims with a days’ supply greater than 90?
Many pharmacies report that claims will successfully process for greater than 90 days. Pharmacies should always start by submitting an accurate days’ supply for a full box and follow plan messaging, See Can You Bill It As 30 Days? for additional guidance.
2. Why is my reimbursement going down?
We suspect that pharmacies are processing more insulin pen claims for extended day’s supply (> 30 days). PBM contracts have more aggressive rates for extended days’ supply dispensing. Pharmacies may consider contacting their PSAO or the PBM to try to opt out of these networks. Submitting a false days’ supply (e.g. 30 days) when the product should really last 90 days, and the plan allows 90 days, is a contractual violation and would probably be considered fraudulent.
LTC Pharmacy
3. Does this apply to LTC practice?
Yes, FDA-approved labeling applies to all practice settings and pay types.
Audits
4. Will PBMs issue written guidance such as fax memos or update Provider Manuals?
There was no explicit guidance issued subsequent to the Walgreens’ DOJ decision, but most PBMs were quick to audit claims and enforce. We continue to encourage various audit departments to provide clear expectations on audit policies. On March 20, OptumRx sent a one-page memo entitled “Accurate Billing for Insulin Pens” confirming the FDA labeling update and reminding Network Pharmacies how to correctly submit claims. In particular, Optum states:
PAAS is not aware of additional PBM guidance; and much like MAC pricing, the more vague and opaque policies are, the more broadly they can be applied to benefit the PBM.
Additional questions answered on the eNewsline:
PBMs Require “Cut Quantity” Documentation
Whenever a pharmacy dispenses a quantity less than what the prescriber ordered, there should be a reason documented for the “cut quantity”. PBMs want to know why the pharmacy is dispensing less than what was prescribed. There are many reasons why this could happen, but the three most common are:
PAAS has seen a few PBMs try to recoup on cut quantities if the pharmacy did not have the reason documented. PAAS Audit Assistance members can view chart of audit discrepancy codes on eNewsline.
PAAS Tips:
COVID-19 Resources
PAAS National® was proud to support you during the PHE for COVID-19 and we want to thank you for your endurance, perseverance, and service to our communities. Due to the PHE ending, resources on this page have changed. Please contact PAAS for the most up-to-date information.
COVID-19 Vaccine Self Attestation
First released 9/27/2021, last updated 8/3/2023
COVID-19 PBM Concessions
First released 5/2020, last updated 5/9/2023
COVID-19 Audit Considerations
First released 4/2020
Medicare and Commercially Insured Patient Request and Attestation for OTC COVID-19 Test Billing
Last updated 4/4/2022
Medicare and Commercially-Insured OTC COVID-19 Tests Frequently Asked Questions (FAQ)
First released 2/2/2022, last updated 4/4/2022
Webinar: PBM FWA Trends and COVID-19 Vaccine Audit Risks
Recorded: 11/18/22
We want to help you stay informed of PBM requirements to help keep your staff, patients, and business safe. The above resources were sent to our members upon the initial release, and members are the first to know any updates, as we are in a consistent evolving state and receiving daily updates from PBMs. Become a PAAS Member Today – call 608-873-1342 or online at PAASNational.com
PBMs will continue to use any technical discrepancy to deny claims on an audit, and these temporary waivers only increase the likelihood that pharmacies will face recoupments. PBMs will be auditing this time period, specifically looking to recoup high dollar claims without supporting documentation – in FULL.
GoodRx Shares Consumer Data
GoodRx, the website and app that has a seemingly endless TV marketing budget, has been sharing their consumer data with Facebook, Google, and others according to a recent article by Consumer Reports. During testing, Consumer Reports found that, “a company could infer highly intimate details about GoodRx users suffering from serious chronic conditions and make educated guesses about their sexual orientation.”
One company that GoodRx has shared consumer information with is Braze, a marketing firm, which claims that the data they collect is only used to target GoodRx users with information and not shared broadly with other advertising companies. GoodRx states Braze is used to send email or text reminders when a consumer is running low on their medication. Another company, Branch, claims it uses GoodRx data to make sure links work correctly in the mobile app.
According to Consumer Reports, both Facebook and Google have denied that they use prescription information to target consumers with ads, especially based on sensitive information like a person’s personal health information. However, Consumer Report’s Digital Lab observed sensitive information being passed to these companies and believes the app and website could be redesigned to prevent it from happening.
The big questions are: Is this legal? Doesn’t HIPAA apply?
Because GoodRx is a private company with no doctors or hospitals involved, it does not have to protect the health data a consumer gives it. Many consumers would be surprised to hear about this, although it is good to remember that if a service is free, the real product is the consumer and his or her data, and how a company shares consumer data is usually located in the fine print.
Shortly after the Consumer Report’s article came out, GoodRx posted a statement apologizing for the Facebook advertising in particular and vowing to “do better.” They also stated they would appoint a new VP of Data Privacy, make it possible for consumers to opt-out from cookies and tracking, and allow consumers to delete their data.
Auditors Targeting Ladder Schedule II Prescriptions
PAAS has been seeing an increase in audits for ‘laddered’ controlled substance prescriptions. A ladder prescription is a Schedule II controlled substance written as multiple prescriptions issued on the same date. This allows for fewer prescriber office visits where refills are not allowed by DEA regulations. They are commonly written for routine ADHD and pain medications.
The DEA has specific regulations for the issuance of multiple prescriptions for Schedule 2 controlled substances in 21 CFR §1306.12. The requirements include:
PAAS Tips:Join today!
- Make sure that multiple prescriptions do not exceed a 90-day supply
- Most common is 3 x 30-day supply prescriptions
- 6 x 15-day supply may be allowed
- Cannot do 4 x 30-day supply or 3 x 31-day supply
- Ensure that all prescriptions have the same issue or written date
- This must be the date that the prescriber signed or issued the prescriptions
- Written date must be accurately entered into the prescription claim
- Do not use the ‘Fill on’ date as the written date
- Entering the wrong date can lead to Wrong Hard Copy or Invalid Written Date discrepancies. It may also result in a claim being filled past the normal expiration date
- Ensure that at least the 2nd and 3rd prescriptions have the ‘Fill on’ or dispense date clearly indicated
- Must be an actual date
- ‘Fill 30 days after xx/xx/xx’ is NOT accepted
- Ensure that all DEA required elements are present on the front face of the prescription
- Patient name and address
- Prescriber name, address, and DEA
- Follow all state requirements for dispensing Schedule 2 controlled substances:
- Prescription expiration after written
- Varies from 7-90 days after written date
- Supervising physician information for mid-level practitioners
- May require supervisor’s name, address, phone, NPI, and/or DEA
- What can be changed or clarified on a Schedule 2 prescription
- DEA no longer allows changes to a Schedule 2 prescription unless specifically allowed by state regulations
- Verify with your State Board of Pharmacy
Stop Breaking Insulin Pen Boxes
PAAS National® sent out an URGENT Email Alert February 18, 2020 regarding the FDA’s involvement in the breaking of insulin pen boxes. The pharmacy industry has long debated whether one box of insulin pens is considered “unbreakable”. The debate appeared to be settled January 22nd, 2019 when the U.S. Department of Justice issued a press release stating Walgreens agreed to a $209 million fraud settlement with the federal government regarding its billing and dispensing of insulin pens to Medicaid, Medicare Part D and TRICARE patients. Prior to the settlement, Walgreens’ policy was to not dispense any insulin pens in quantities less than one full box, forcing their staff to falsely understate the days’ supply on thousands of claims. They then enrolled many of these patients on its refill reminder program, causing patients to get early refills. The government labeled that billing activity as widespread FRAUD and required Walgreens to enter into a Corporate Integrity Agreement with the Office of the Inspector General. Consequently, both Walgreens and CVS have been breaking insulin pen boxes when appropriate.
Since that time, PAAS has seen OptumRx, Express Scripts, Humana, Prime Therapeutics, and EnvisionRx dramatically increase their audit recoupments on insulin pens being dispensed that exceed plan limits.
To complicate the matter, the FDA got involved June 20th, 2019 when it sent a “Safety-Related Supplement Request” to Eli Lilly, Sanofi, and Novo Nordisk requesting:
“…updates to the Prescribing Information (PI) and carton labeling to specify that pens be dispensed in the original sealed carton…”
Regardless, it is important to note that PBMs are aware and will likely enforce the revised standard during audits (i.e. do not break insulin pen boxes). PAAS just received audit results where the PBM expected insulin pen boxes to have been broken between 1/22/2019-11/15/2019, and post-11/15/2019 they are expecting full insulin pen boxes to be dispensed. The absurdity is not lost on PAAS, but PBMs will use anything they can to deny paying claims – especially high dollar insulin claims.
Updated Section 16.2 of the package insert, and the exterior carton, will now state to dispense in the original sealed carton. Your supply chain and inventory management will dictate when you start seeing the revised product labeling, if you haven’t already.
16.2 Storage
Dispense in the original sealed carton with the enclosed Instructions for Use.
PAAS Tips:
PAAS Audit Assistance members can visit our Tools & Aids to find updated versions of our popular tip sheets:
Auditors Scrutinize Printed Electronic Prescriptions!
PAAS has observed audit results from Humana where electronic prescriptions are marked as invalid (INVP) due to missing electronic elements. Humana results have stated “Hard copy provided does not contain an electronic physician’s signature, SPI number, Transaction Number, or Message ID.” Software systems often have multiple ways to print an electronic prescription. When a pharmacy prints an electronic prescription for audit purposes, be aware of the electronic prescription requirements and ensure they are present.
PAAS Tips:
OptumRx/SCIO Targeting Part B Drugs & Supplies
In the most recent round of OptumRx/SCIO desk audits, PAAS is seeing audits for test strips, insulin used in a pump, nebulizer solutions, immunosuppressants, chemotherapy medications, and vaccines. If the patient is Medicare-eligible and meets Medicare requirements, these claims should be billed to Medicare Part B. If the pharmacy is processing under a Medicare Advantage plan (Part C), they are required to cover everything that is covered by Part A, B and sometimes D. Some plans require that all drugs and supplies be billed to the prescription benefit and they will process them under either B or D as appropriate. Other plans may require that you bill Part B drugs and supplies to the medical benefit and only Part D to the prescription benefit.
Why do these potential Medicare B claims go through the Part D plan at the point of sale?
PAAS Tips:
Caremark Strictly Enforces Coupon Policy
Caremark Strictly Enforces Coupon Policy
CVS Caremark first updated their policy on the use of manufacturer coupons in May of 2017 and again in September of 2018. Pharmacies continue to suffer full recoupment of claims that were processed to coupons and copay cards in violation of Caremark’s policy. Caremark considers violations to be inappropriate waivers of patient pay amounts, and could result in additional sanctions, including termination.
As defined in the current Provider Manual: “Pharmaceutical Manufacturer Coupon” means any item or mechanism, including but not limited to, paper coupons, copay cards, e-vouchers, mail-in rebates, and electronic coupon codes funded by a manufacturer, repackager, or supplier of pharmaceutical, chemical, or compounding products, that reduces the portion of the Patient Pay Amount that an Eligible Person is required to pay for a Covered Item.
Caremark prohibits the use of any coupon for:
Note: First DataBank (FDB) recently updated their database to list dietary supplements differently than approved drug products.
With USP <795> and <797> on Hiatus, Time to Focus on USP <800>
On September 23rd, USP announced they were postponing the official dates of the revised General Chapters <795> and <797> (and <825> – radiopharmaceuticals). Stakeholders submitted appeals and have now requested further review by an appointed panel. In question are Beyond Use Dating requirements and Alternate Technology Provisions. According to the USP Bylaws, the panel will meet within 90 days. If the standard is upheld, the date for conformance will be reestablished with at least a six-month notice.
USP <800> is not subject to any pending appeals and will become official December 1st, 2019. Many facets of USP <800> are intertwined with compounding (<795>/<797>), so the General Chapter will be considered informational and not compendially applicable at this time.
With rare exception, all pharmacies will be responsible for meeting USP standards in General Chapter <800> Hazardous Drugs – Handling in the Healthcare Settings. If your pharmacy plans to prepare compounded prescriptions with Hazardous Drugs (HDs), then you must comply with all elements of the standard, including the extensive containment requirements. If your pharmacy does not plan to compound with HDs but has HDs in inventory (as all traditional pharmacies do), then your responsibilities are greatly reduced, but there are still aspects of USP <800> you must comply with.
USP developed General Chapter <800> to address a public health need to protect healthcare personnel from HDs. Both acute and chronic health issues can arise from improper handling or exposure to HDs. HD handling is not new. The National Institute of Occupational Safety and Health (NIOSH) first published a list of HDs in 2004 and the Occupational Safety and Health Administration (OSHA) first published guidelines for HD handling in 1986 (originally only cytotoxic [antineoplastic] drugs).
Various states have adopted USP <800> into law as they feel it’s the best practice to prevent employee, and public, harm. However, regardless of whether a state has specifically enacted USP <800>, all pharmacies should have robust policies and procedures to handle HDs. OSHA was established to ensure safe and healthful working conditions by setting and enforcing standards and by providing training, outreach, education and assistance.
The following statement was taken from OSHA’s website regarding HDs:
“Institutions should have formal written programs to manage hazards. Such programs should include training, exposure assessment, emergency procedures for spills, policies for managing staff with reproductive concerns, and most importantly, ways to ensure that the institution is adhering to critical national standards.
Although OSHA has no explicit standard, USP 800 focuses explicitly on protecting workers from exposures to hazardous drugs. It, and USP 797, represent professionally expected requirements in healthcare that incorporate national consensus standards on infrastructure maintenance (ASTM).”
OSHA also makes available guidance on Controlling Occupational Exposure to Hazardous Drugs. They have the authority, and resources, to enforce USP <800> for the welfare and safety of pharmacy employees.
PAAS Tips: