The newest segment to the Pharmacy Podcast Network is a partnership with RJ Hedges & Associates bringing our listeners the Pharmacy Compliance Guide.  R.J. Hedges & Associates has a dedicated team, devoted to providing complete turnkey healthcare compliance programs for our clients. We offer easy-to-use Policy and Procedure Manuals and Programs that contain all requirements for the U.S. Department of Health and Human Services (HHS), Medicare Quality Standards; HIPAA Compliance with HITECH requirements; Compounding; Fraud, Waste & Abuse Prevention; OSHA Bloodborne Pathogen requirements; Human Resource Management, Immunization requirements, and business consulting services. About the co-host: Jeffrey Hedges Jeff Hedges -- President & CEO of R. J. Hedges & Associates of New Florence, PA.  After serving in the United States Air Force for 27 years, Jeff transitioned into the private sector, developing software to help independent pharmacies understand and become compliant with HIPAA.  Later, Jeff founded R. J. Hedges & Associates to support healthcare providers with compliance services and software solutions.   Today his company offers comprehensive customized healthcare compliance and consulting services for independent pharmacies, home health care facilities, medical supply companies, physicians and other small practices throughout the United States.  Jeff is a sought-after speaker at numerous seminars and national conferences, educating his audiences on healthcare compliance, especially relating to the pharmacy and Durable Medical Equipment (DME) communities.   Jeff is a board-certified DME Specialist (CDME) and serves on the Board of Directors for the Board of Certification/Accreditation (BOC); BOC is the only accreditation organization that was founded by an independent pharmacist.   In 2014, the Better Business Bureau awarded R. J. Hedges & Associates a Torch Award for Marketplace Ethics.  In 2015, O&P News named Jeff one of the Top 175 Innovators in Orthotics and Prosthetics.

R.J. Hedges Podcast

The Pharmacy Compliance Guide

The R.J. Hedges Team delivers another "heads up" discussion on the Suspension of Competitive Bid and what this means to your pharmacy business.  Listen to Becky & Jeff on the latest

Suspension of Competitive Bid What's this mean to me

In order to stay competitive, many businesses are turning to offshore companies as a way to cut costs while still providing tech support, customer service, billing processes, and more. Consider your contracted companies with which you have signed a business associate agreement (BAA); could any of them be utilizing offshore workforces? In the case of any breaches, the United States government won't have any legal recourse.  Plus NCPDP and many PBM's are already asking for attestations stating your BAA's are not using an offshore workforce. We'll help you understand the concern so you can prepare before issues arise.  For example; Draft a document that mirrors the contract PBMs ask your pharmacy to sign and have any business associates complete, sign and send back. Once this is completed, your pharmacy can adequately answer any questions from the NCPDP and PBMs pertaining to your BAA's offshore practices. This podcast episode discusses the impacts offshore businesses will have and helps pharmacies take action as soon as possible. Remember that business associate agreements are contracts; if you are signing a vendor's BAA, make sure you read it, understand it, and agree with it, because once it’s signed you are stuck with it. Draft a document that mirrors the contract PBMs, ask your pharmacy to sign and have any business associates check one of the two boxes prior to returning it. Once this is completed, your pharmacy can adequately answer any questions from the NCPDP and PBMs

Protecting Your Patient's Data HIPAA Off Shore Threat

Today's Pharmacy Compliance Guide is the second part of our series on preparing for USP <800> Hazardous Drugs (HD). In our last podcast, titled: “How will USP <800> Impact My Retail and LTC Pharmacy?” we addressed what each pharmacy must do to prepare for implementation of these guidelines. We covered these topics: How to identify hazardous drugs through the NIOSH List Segregating hazardous drugs from regular stock Proper handling of hazardous drugs When pill scanners and robots are permitted to be used Special handing of hazardous drugs that require alterations Determining Personal Protective Equipment by using Safety Data Sheets Which agencies will enforce these guidelines? 

Today's Pharmacy Compliance Guide is the second part of our series on preparing for USP Hazardous Drugs (HD). In our last podcast, titled: “How will USP Impact My Retail and LTC Pharmacy?” we addressed what each pharmacy must do to prepare for implementation of these guidelines. We covered these topics: How to identify hazardous drugs through the NIOSH List Segregating hazardous drugs from regular stock Proper handling of hazardous drugs When pill scanners and robots are permitted to be used Special handing of hazardous drugs that require alterations Determining Personal Protective Equipment by using Safety Data Sheets Which agencies will enforce these guidelines? 

Preparing the Hazardous Drugs Assessment of Risk

Can every pharmacist give immunizations? What are the restrictions and license requirements? How do you bill for immunizations? Who can administer vaccines in the pharmacy? How can I improve my pharmacy business by doing immunizations? Why should I do travel vaccines? Jeff Hedges, our in-house compliance expert and CEO of R.J. Hedges and Associates, answers all these questions and more 

Pharmacy Immunizations – It’s Far More than Flu Shots

Quality control, its something everyone in the pharmacy must be involved in. Quantity control helps to reduce mistakes, and improve Patient Safety. Errors do happen and it is imperative pharmacies are aware of how to protect themselves as well as their patients. The Fit Pharmacist partner and Pharmacy Podcast Network co-host Dr. Christina Tarantola joins Jeff Hedges, President of R.J. Hedges & Associates and Pharmacy Compliance Guide podcast host with Tara Modisett, Executive Director of Alliance for Patient Medication Safety in a podcast on Patient Safety Organizations recorded live at the NCPA 2017.

Patient Safety Organizations - Pharmacy Compliance Guide

 Participating means that you are accepting the Medicare reimbursement or allowable for each product you bill for. Non-Participating means that you are not accepting the Medicare reimbursement. So participating means accepting Assignment? Yes, you are accepting the Medicare allowable or Assignment. You also agree to charge the patient no more than 20% of the allowable at the time of dispensing. Medicare sends the supplier the reimbursement of 80%, less the 2% sequestration fee. If you know the patient has a secondary insurance carrier, the copay should only be the balance after the secondary payment. This can be collected at the time of dispensing which is preferred or after all payments are received. I guess this means if I’m non-participating, I’m not accepting Assignment Correct, you are not accepting the Medicare assignment. Is the pharmacy penalize in any way? No, there is no penalty to the supplier, except if the supplier is a competitive bid awardee supplier who must be a participating supplier. The major difference is the supplies is not accepting assignment. Which means the Medicare reimbursement will be sent to the patient. The supplier collects the full amount from the patient at the time of dispensing. This fee can be your Usual & Customary (U&C) down to the Medicare allowable. It is the supplier’s choice for each dispensing action. Yes, you can accept assignment on a specific item or a specific patient if you so choose OK, we now understand this, there must be a reason why you want to talk about this subject now. It doesn’t sound very important or fun? Well it is definitely not fun! However it is very important. Medicare reimbursement are continuing to be slashed and every supplier should look at this option every year, but especially this year. There is only a short time period where a supplier can change their status from Participating to Non-Participating and it’s coming in November. The official time frame is from November 15 to December 31, but we strongly encourage not to go past December 15th. NSC states the letter must be post marked by December 31st, but if there is a glitch, the supplier has to wait a year. It doesn’t matter whose fault it is, you must wait until next November 15th. The requirement states, “if you are currently a participant, write to each carrier to which you submit claims, advising of your termination effective the first day of the next calendar year. This written notice must be postmarked prior to the end of the current calendar year.” In plain English, the supplier writes a letter on their letterhead to the National Supplier Clearinghouse for CMS 855S products or to the Part B Contractor for CMS 855B products advising the contractor you are terminating you participating status. The letter must contain your Legal Business Names as reported to the IRS, Address on your CMS 855, PTAN, NPI and the “Authorized Persons” signature. CMS doesn’t tell you that. We are writing a blog on this subject and it will be posted on our public website, www.RJHedges.com and we will have a sample letter there for you to download. Our clients will find the sample letter on the Compliance Portal® in the Message Center. OK, we know what this means and how do to it, but what are the reasons to make the choice?

Participating or Non-Participating, That is the Question

A lot of people ask me about Medicare. There is a lot of confusion about who needs what number. Immunizations Really easy process to get a number. The pharmacy would complete the 855 B application. Applications have a fast turnaround-usually a month YOU DO NOT NEED to be ACCREDITED Medicare Number –This division (NSC) takes about 3 months to issue a number. This application requires you to carry a surety bond and have a certificate of liability with NSC as the certificate holder as well as your AO (if you have one). New applications, as well as re-validations, will require owners and authorized officials to be fingerprinted. Two ways to complete For non-accredited drugs only o   Benefits For DMEPOS accredited items o   Benefits o   Accreditation o   Exemption o   Revalidation Revalidation happens every 3 – 5 years What that means You  “update” your Medicare application and pay Medicare $$. Every year they change the Medicare application fee. For 2018 it is $569 per application.

Medicare Applications by the Numbers Pharmacy Compliance Guide

We know that no employer likes to terminate an employee; from the business standpoint- there’s an open position that we must re-hire and re-train, it can be taxing on the rest of the staff and difficult for managers to try to work in interviews and screening processes into their already jam packed schedules.  And then there’s the additional emotional tie as well- these folks maybe leaving unexpectedly or under strained situations, and there’s personal friendships have been forged and they’re now kind of dicey, so it can be very difficult. With so many regulations, PHI, and privacy concerns how in the world do you prepare for an employee termination way before it even becomes a necessary discussion?  What should the Employee Handbook include?  What documents do parting employees need to complete?  Are there entities that need notified when employees leave?

Keeping in Compliance when Terminating Employees

USP-800 was designed to address the proper handling of hazardous drugs (HDs) in a pharmacy setting. Its guidelines are plainly aimed at promoting patient and worker safety in and around non-sterile and sterile compounding. The first section clearly covers compounding in its purest form. However, when you move into section two, you quickly realize the dispensing of pills, capsules, liquids and manufactured packaged items are also covered by USP-800 Different types of terms are being used to describe types of hazardous drugs, such as antineoplastic, non-antineoplastic, reproductive risk only; dosage form, risk of exposure, packaging, and manipulation. This may sound like a whole lot of mumbo jumbo, but it is the new language of hazardous drugs.

How will USP 800 Impact My Retail and LTC Pharmacy

What is a breach? In simple words, the loss of patient protected health information, either printed or electronic. How common is breached within pharmacies? There are two types of pharmacies and pharmacy owners, The first are the ones who know they have had a breach The latter are the ones who have had a breach and don’t know about it How can I have a breach and not know about it? Simple, has your pharmacy clerk ever given a patient another patient’s medication? That is a breach Can you give me examples of breaches? Pharmacy is robbed and the will-call bin is stolen Pharmacy is robbed and the server is stolen Staff pharmacist has a laptop stolen The delivery driver has their vehicle is stolen which is full of prescriptions to be delivered Billing manager has a jump drive with patient files for billing to work at home and loses it on the bus What do I do when a breach occurs? First, don’t panic Get the facts Complete a Potential Breach Evaluation and a Risk Assessment Determine whether the breach is reportable or non-reportable to HHS/OCR Document everything What is OCR Desk Audits Tested in 2016 Launched on January 1, 2017 Notification via U.S. Mail and Email Also conducting no notice on-site inspections What is the OCR asking for? Notice of Privacy Practices (date must be after 07/01/2013) Risk Analysis Risk Management Plan Disaster Recovery Plan/Contingency Plan Annual Privacy and Security Assessments Random Policies and Procedures On-Site Inspections Same as above, but in person The first question is to the person at your counter, normally your clerk Can I have a copy of your Notice of Privacy Practice? They have to know the answer and provide the NOPP Penalties for Non-compliance Fines up to 1.5 Million Dollars Is there help available to pharmacies? Yes, but you get what you pay for You can buy a set of policies and procedures, but if you have breached, especially a reportable breach: Will the consultant stay with you when you need them the most? Will they charge you extra? Will they provide the correct advice? How do you know how to pick a consultant? Ask your peers Ask hard questions about how they have handled client breaches and inspections Do you get detailed answers from the consultant? Do you referrals from multiple people? 

HIPAA Breaches & Desk Audits - Pharmacy Compliance Guide

PHARMACY COMPLIANCE GUIDE (5) Diabetic Shoes – Do It Right the First Time  Why would I ever consider doing Diabetic Shoes, Audits, insurance companies, and stinky feet? Is it not worth the hassle? Diabetic shoes are the only preventive medicine Medicare and Medicaid pay for. If done correctly, the process is just that, a process. Just like filling any other prescription. But it takes so much time Yes, it does take time. But whose time does it take? This is not a requirement for the pharmacist to accomplish. Depending on the type of shoe and the state, a manufacturer-trained individual may see and fit a patient for their shoes and inserts. Then there are always the audits Yes, there is a lot of fraud with shoes. But understanding the audit documentation process and the details the auditors are looking for before you see the patient makes all the difference. OK, you make it sound simple. Then why are folks dropping diabetic shoes? It all in the documentation, that is why you must do it right the first time. Then let’s start at the beginning by asking, who is eligible? We are talking about Medicare patients billing through their Part B coverage because this is the most restrictive and most audited process. The patient must be diabetic The patient must have at least one of the following conditions documented by their physician History of partial or complete amputation of the foot History of previous foot ulceration Peripheral Neuropathy with evidence of callus formation Foot deformity Poor circulation Who can sign the prescription for diabetic shoes and inserts? The patient must see a MD, DO, PA, CNPT or Podiatrist for a face-2-face visit and receive a prescription for diabetic shoes and inserts. Once the prescription is received from the patient, a Detailed Written Order is completed and faxed to the individual writing the prescription requesting their signature and their clinical notes. If the prescription was signed by a PA, CNPT or Podiatrist, then the patient must be seen by an MD or DO for another face-2-face visit and a Physician Certification of Therapeutic Footwear is needed along with their clinical notes. If the initial visit was with an MD or a DO, then the Physician Certification of Therapeutic Footwear can be faxed with the Detailed Written Order. You mention clinical notes, pharmacists normally don’t deal with physician’s clinical notes. Why is importation for shoes? Clinical notes are a Medicare Part B, DMEPOS requirement. Almost all audits are lost on the clinical notes. The pharmacist, fitter or billing clerk do not need to be a medical expert to identify what is needed or the problem in the notes. The notes must state: The patient is diabetic Has an approved medical condition that requires the need for diabetic shoes The patient must have at least one of the following conditions documented by their physician History of partial or complete amputation of the foot History of previous foot ulceration Peripheral Neuropathy with evidence of callus formation Foot deformity Poor circulation Prescription was written for both shoes and inserts. You mentioned fitter, can all pharmacists fit diabetic shoes and insert? The fitter is designated by state law, licensure and CMS rules. In every state except Illinois, a Pharmacist Scope of Practice covers the dispensing of a medical device with a legal prescription. All that is needed is the manufacturer’s training and a training certificate. Pharmacy technicians and other staff also require a manufacturer’s training and can fit diabetic shoes under the supervision of the trained pharmacist. DME facilities must follow state licensure requirements when applicable and an in most instances will only dispense heat-moldable inserts. When can the initial fitting occur? The initial fitting can occur at any time after receipt of the initial prescription. The initial fitting is an assessment of the patient to ensure the patient meets the requirements for diabetic...

Diabetic Shoes – Do It Right the First Time

In early 2017, we saw DEA changing its focus on pharmacy compliance. DEA increased its enforcement from the verification of the Combat Methamphetamine Certificate to a more formal on-site inspection. Now with the emphasis on the opioid epidemic, DEA is under increasing pressure to look for abuses of the system. Naturally, the first place any inspector will start is the pharmacy. We have been spending more time updating our clients on this trend and providing as much information as we can find. Then I attended a conference last September and one of the presentations was on “Maintaining Your Pharmacy in DEA Compliance”. Carlos Aquino is the President of PharmaDiversion and he is based out of Philadelphia. Carlos is a retired DEA diversion investigator and a great supporter of independent pharmacies. If you ever have an issue with the DEA, Carlos is the first person you should call. CSOS user names and passwords Power of Attorneys for DEA forms 222 and Electronic Orders Receiving C-II orders from the wholesaler and completing the DEA documentation First, every person who uses the CSOS system must have their own user name and password. No person may share another person’s user name. Having a single user name for a pharmacy only works if the user never takes a day off, ever; and we know that won’t happen to occur so you are opening yourself for criticism with the DEA as soon as they start asking questions. Setting up additional user names is not hard, you work with your wholesaler software system to establish a new user name. Each system has its own variation and perimeters, so if you have questions, go to their IT department. When the drug order is received: a. CSOS is accessed by an authorized individual with a Power of Attorney for DEA Forms 222 and Electronic Orders with an individual user name and password that is not shared with another person b. The order of Controlled Substances is checked against the packing slip/invoice c. DEA 222 is completed through CSOS d. Print the DEA 222. Most systems will state on the document, “This is not a DEA issued Form 222. This form is available for convenience.”  If this document does not print, check your Pop-up Blocker  The Pop-up Blocker may also prevent a completed DEA 222 from being printed (Carlos picks up) • This document acts as the DEA 222 for DEA on-site inspection purposes • In most cases, this document prints with the fields empty. Manually complete this document by entering the following information: o Packages Received o Date Received o DEA requires the persons' initials:  Remember this person must have a Power of Attorney  Recommend a signature over an initial e. Attach the packing slip/invoice to the acting DEA 222 f. Keep on file for two (2) years: • DEA requires the pharmacy to produce the completed DEA 222 and invoice upon demand o DEA regulations require you to have this record to be “readily retrievable” and separate from other records o Reference: DEA Pharmacist’s Manual, Section VI – Record-Keeping o You cannot print and complete the document when a DEA inspector is on-site. Carlos, I have been working with other organizations on the opioid crisis, this process is straight forward, but as Jeff stated at the beginning, DEA is enforcing the documentation requirements. Can you give us specific examples of pharmacy who have recently received DEA fines or you are aware of the DEA fines? Example 1: CSOS user names and passwords Example 2: Power of Attorneys for DEA forms 222 and Electronic Orders Example 3: Receiving C-II orders from the wholesaler and completing the DEA documentation If time permits, one more example 

DEA Documentation Requirements

A Certified Durable Medical Equipment Specialist or a CDME is a certification created by the BOC or the Board of Certification / Accreditation Int’l BOC saw a need to highlight the skills and qualifications of the highly skilled yet unknown individuals who are key to the dispensing of DME products. The CDME certification demonstrates the broad knowledge of the Durable Medical Equipment (DME) industry.  What does a Certified DME Specialist do? The CDME basically does every aspect within the DME realm.  They are the people who meet the patients, do the documentation, fit the patients, determine what product the patient is eligible for and bills Medicare, Medicaid, and the insurance companies for DME products.  They also help with basic repairs, troubleshooting, and home inspections for DME products like oxygen, transfer systems, enteral supplies, and wound care.   A trained and certified DME specialists are highly valued in the DME industry as an assurance to patients and referral sources of professionalism and quality care. The BOC CDME Scope of Practice provides greater detail regarding the role of a BOC Certified DME Specialist.

Certified Durable Medical Equipment Specialist

Every fall we hear the PBMs sending out requests for Attestations for Fraud, Waste and Abuse, and HIPAA Compliance. Why do they all keep asking for the same information? When Medicare Part D came into play, the Pharmacy Benefit Managers were given the regulatory authority to manage the Medicare Part D program. Part of this program was ensuring pharmacies were properly training their staff. It initially started with annual: Fraud, Waste & Abuse Training, OIG Exclusion Verification, and HIPAA Compliance Training Then each fall, everyone had to attest they accomplished these requirements for Medicare Part D. Unfortunately, a lot of pharmacies and organizations signed off of the attestations and really didn’t do it. The attestation is a legal statement where the individual, the pharmacy owner and/or the pharmacist-in-charge were legally attesting they were accomplishing the training and had no documentation to support their claim. Legally this was a false claim under Medicare Part D and the PBM can and did recoup all Part D reimbursements from the pharmacy, which was devastating. The PBMs then added to their requirements over the years making them a sticker and more overbearing. Most especially is the OIG Exclusion verification requirement. Only pharmacy in all of the healthcare must accomplish this task every month. It started with just one database, the Office of Inspector General, then was added to the General Services Administration (GSA) and the Systems for Award Management (SAM). The GSA and SAM have publicly merged into one, but as of today, we are still receiving a database from each of them. In addition, individual states are developing their own exclusion lists that must be checked. There is no standard for the lists. Some are managed by the health departments, others by the Attorney General or the Treasury Department.

Attestations & Certifications Pharmacy Compliance Guide

Catch up on the latest pharmacy compliance news, as well as tips and advice on pharmacy management and compliance strategies.

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R.J. Hedges Podcast

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