Pharmacy Compliance Guide

Ransomware is a major threat to any and all computer networks. All companies large, small, healthcare, nonhealthcare can be impacted by it. Ransomware is a cyber-attack where the user cannot obtain access to their system. They are criminal acts that much be treated as one, swift action must be taken to protect your system and your patients PHI.  Join Jeff Hedges from the Pharmacy Compliance Guide and Becky Templeton from R.J. Hedges & Associates, as they discuss Ransomware, how to determine a HIPAA breach, what to do if you are a victim of Ransomware, how to report cyber-attacks, how to report a breach due to ransomware attack, how cyber insurance may help, what kind of fines may be associated with a cyber-attack, and the real steps to prepare for an OCR inspection. Learn more about how to protect your pharmacy from Ransomware threats: https://www.rjhedges.com/blog/topic/podcasts Learn more about your ad choices. Visit megaphone.fm/adchoices

Ransomware; being held hostage from your own information and your own data. It's in the news every day, generally large businesses, and banks, but it happens to every type and size of business every day. With complex schemes, malicious deception, various access points, complex research, and impersonation- ransomware is a worldwide threat that often funds nefarious dealings like terrorism, oppressive government and even the development of more ransomware. Today Jeff Hedges, the Pharmacy Compliance Guide and owner of R.J. Hedges & Associates and Nick Dorazio, Present of LVTech and technology expert are going to talk about what ransomware is and how it happens, put some context around the shear cost of this type of event happening to your business, we'll go over some terminology and solutions for your business and even how you can prevent this from happening to your system.  https://www.rjhedges.com/ Learn more about your ad choices. Visit megaphone.fm/adchoices

Whether you’ve worked your whole career building your business, inherited or purchased from family, or more recently acquired the business, at some point all owners start to think about the next chapters of their life and selling their business.  The world of pharmacy isn’t much different from other businesses in this sense, and it can be hard for an entrepreneur, visionary, and owner to start forecasting life without the business they’ve given so much of their time, energy, focus, and money. To say there is an emotional attachment may be an understatement.  While some owners can’t wait to dump their business, I’d be willing to bet the majority of pharmacy owners truly love their business, employees, and patients.  Being so engrained in the community, it’s hard for owners not to worry about their patients.  Owners worry about the level of care, or access to care, their patients may, or may not, have should they sell their location.  In some instances that worry for their staff and their community leaves owners holding onto the business much longer than maybe they initially wanted. Lear more:  https://www.rjhedges.com/blog/3-roads-to-sell-your-pharmacy  See omnystudio.com/listener for privacy information.

Today's guest on the Pharmacy Compliance Guide is Greg Wozniak. Greg is the President of Healthcare Group at Excellis Health Solutions from New Hope, PA. Excellis Health Solutionsprovide end-to-end consulting and project management services for a wide range of organizations — from established Fortune 500 companies to start-ups. In each case, we help them create value at every stage of their supply chain and ensure their business is fully compliant with new and changing legislation. Becky Templeton, CDME, ABI Director of Business Development Office:  724-357-8380   Website:  www.rjhedges.com See omnystudio.com/listener for privacy information.

Feeling overwhelmed by changing rules and regulations?  Are audits, attestations and credentialing driving you crazy?  Not sure how to keep up? We realize every facility is unique and has different compliance needs.   If you are struggling in today's healthcare market, we can help with the following compliance programs: Pharmacy (Part D Compliance) Compounding (non-Sterile including USP ) HIPAA Diabetic Shoes DMEPOS (Medicare) FWA Prevention (including OIG/SAM verification) Immunizations (including Travel Vaccines and 30+ Standing Orders) USP for Retail/LTC locations DEA and Pseudoephedrine Custom Solutions- Such as Cultural Awareness to satisfy CVS/Caremark and Humana See omnystudio.com/listener for privacy information.

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? CONTACT:  https://www.rjhedges.com/contact  See omnystudio.com/listener for privacy information.

How will USP 800 Impact My Retail and LTC Pharmacy? 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. Email us: sales@rjhedges.com Call Us: 724-357-8380  See omnystudio.com/listener for privacy information.

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:  Pharmacy Compliance Guide, part of the Pharmacy Podcast Network.  CONTACT:   Becky Templeton, CDME, ABI Director of Business Development R.J. Hedges & Associates Office:  724-357-8380     Website:  www.rjhedges.com  See omnystudio.com/listener for privacy information.

Becky Templeton and Jeff Hedges review the sensitve employer's issue and topic about Terminating Employees.    Despite all of your efforts, you still may not see the type or quality of improvement needed, and the only option left is to sever the relationship. However, by now, you should have clearly documented what you did to help the under-performing employee improve. Performance-based terminations should never come as a surprise to your employees. Prior to terminating your employee, be sure to review all associated documentation. Also, contact your legal counsel or HR representative to ensure your case is supported, justified and sound. Confirm that you’re following all state-specific wage and hour regulations. And if you use employment contracts or non-compete/non-solicitation agreements, you should ask your legal counsel to provide you with validity and enforcement guidance. Contact the R.J. Hedges Team today:  Becky Templeton, CDME, ABI Director of Business Development R.J. Hedges & Associates Office:  724-357-8380   www.rjhedges.com See omnystudio.com/listener for privacy information.

Becky Templeton Director of Business Development at R.J.Hedges & Associates talks with Jeff Hedges about With the increasing need for businesses to save on costs, many companies are utilizing offshore companies to help with customer service, tech support, billing processes, etc.  Is it possible one of your contracted companies whom you have a Business Associate Agreement, is utilizing an offshore workforce?  Not only should you be concerned with this because of possible breaches which the US government won’t have any legal recourse, but PBM’s and NCPDP will be asking for attestations in the future.  The time to prepare is now.  Our latest episode with the Pharmacy Compliance Guide will discuss the impacts of Offshore businesses accessing PHI, why PBM’s are concerned,  and what pharmacies should do now.   The covered entity is solely responsible for issuing the Business Associate Agreement, so if you sign someone else’s agreement, you are stuck with it.  The Business Associate Agreement is a contract.  Remember that!   Develop a document similar to the one the PBMs are asking you to sign and ask Business Associate to check a box with one of the two options and send it back to you.  Now you can truthfully answer the questions posed to you by the PBMs and NCPDP.   To ensure we are in compliance with these federal mandates, please check the appropriate box below and return this signed attestation to us.  Your failure to provide this attestation, as specified herein, constitutes a material breach of your agreement with us.  An inaccurate response may constitute a violation of federal law for which penalties may apply.   Choose the appropriate statement by checking one of the boxes below:   As your HIPAA Business Associate, our organization and our downstream and related entities DO NOT utilize Off-Shore subcontractors to perform activities that involve receiving, processing, transferring, handling, and storing or accessing PHI at an Off-Shore location(s).   As your HIPAA Business Associate, our organization and our downstream and related entities DO utilize Off-Shore subcontractors to perform activities that involve receiving, processing, transferring, handling, and storing or accessing PHI at an Off-Shore location.   CONTACT:   Becky Templeton, CDME, ABI Director of Business Development R.J. Hedges & Associates Office:  724-357-8380    Website:  www.rjhedges.com Follow us on Facebook!  Learn more on our Blog See omnystudio.com/listener for privacy information.

The NEW Segment part of the 'Pharmacy Compliance Guide' is hosted by Jenny Schell, CDME Sr. Compliance Strategist with R. J. Hedges & Associates.  Podcast on Medicare Applications by the Numbers   A lot of people ask me about Medicare. There is a lot of confusion on 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 ACCREDIATED   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. Contact Jenny: Website:  www.rjhedges.com  See omnystudio.com/listener for privacy information.

DEA Documentation Requirements  Special Guest: Carlos Aquino from PharmaDiversion LLC™ In early 2017, we saw DEA changing their focus on pharmacy compliance. DEA increased their 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 increase pressure to look for abusers 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 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 their 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 Jeffrey Hedges, CDME President & CEO P.O. Box H, New Florence, PA 15944 Direct:  724-357-8380    Fax:  814-446-6336    Website:  www.rjhedges.com See omnystudio.com/listener for privacy information.

Certified Durable Medical Equipment Specialist What is a Certified Durable Medical Equipment Specialist? 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.  The 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. Jeff, I really haven’t heard about this before, so what advantage does a pharmacy or DME supplier gain by having a CDME on staff? This is simple.  We live in a very competitive market.  We need to ensure the pharmacy has unique qualities and products outside the normal pharmacy prescription filling process.  Those days have come and gone.  We have talked about immunizations and diabetic shoes in previous podcasts.  We will talk about other opportunities in future podcasts.  Pharmacists are experts in pharmacy operations.  When it comes to Medicare Part B and DMEPOS products, the rules are completely different.  For example, a physician writes a prescription or eScript and the pharmacist fills the script, the patient picks the medication up and pays their co-pay.  The insurance company and secondary adjudicate the claim and reimburse you for it.  Hopefully there is a low dollar DIR fee so the PBM claw back isn’t too severe next month. However, when it comes to Medicare Part B, everything changes when the physician writes a prescription.  The pharmacy language stops working.  So you look for someone who can do this work.  What do most pharmacies do? You grab a tech and throw them into this world and let them try to figure it out.  The tech starts reading reading Medicare Supplier Manuals, DME MACs and then learns about Detailed Written Orders and Local Coverage Determination and this doesn’t make sense.  Again the language has changed and there really is only limited training out there for dispensing or billing these products.  This is why the CDME certification was created.  It certifies individuals who have the basic skills for dispensing, setup and billing Medicare Part B and DMEPOS products. That makes sense.  I have heard about all the audits from Medicare and all the paperwork that is needed.  Jeff, you and I talked about the Diabetic Shoes April 2017 on an earlier podcast last year about the importance of the documentation and following the process.  So this certification helps the pharmacy? Absolutely.  When you are confused about something or you are losing money and audits, you stop dispensing that item.  This is what has happen with DME products.  Over 40% of DME facilities have gone out of business in the last six years due to competitive bidding.  Pharmacies have dropped DME products because of the bad taste of audits and not understanding the process. Now imagine having staff properly trained and certified who know what they are doing when it comes to Medicare Part B and DMEPOS products.  They can advise the pharmacist not to fill a prescription of albuterol because it needs a “Detailed Written Order Prior to Delivery” signed by the physician.  Who knew?  Your CDME did.  That saves your reimbursement. Whoa, is it that simple? Yes.  Now you are ready to market your pharmacy.  Your pharmacy may be accredited or exempt.  Your pharmacists are licensed.  Are you doing something out of the ordinary to make you stand out?  Your DME department has “board certified” specialists.  Who else in town has this? Here are some other advantages. Differentiation in the market; Management of risk; Criteria for evaluating potential employees; Limiting of fraud, waste, and abuse; Increase in customer satisfaction; Assurance for referral sources; and Medicare human resources management standards require that technical personnel be knowledgeable, competent, and trained in order to deliver products. A CDME will provide additional assurance of compliance.  How do you get certified? First here is the criteria for the certification: The candidate needs 500 hours of experience (3 months) A high school diploma (or equivalent) Registers to take an exam with BOC The exam is at a H&R Block testing facility Another way is through BOC live trainings and then a paper exam following a day long training When are these trainings scheduled? There are always two scheduled at Medtrade Spring in Las Vegas and Medtrade Fall in Atlanta.  There are normally two and sometime more classes throughout the year.  BOC’s prep courses are sponsored by MedGroup and are typically $150.00 for the class and $50.00 for the exam.  The paper exam is one to two days after the prep course. If you have 20 or more people who want to go through the course, a class can always be added to the schedule. What about the exam? The exam is a 100 question, 2 hour exam.  To pass the candidate needs to score 70% or higher grade.  It’s not a walk in the park exam.  You need to study for it and taking the prep course or one of the other on-line course before taking the exam.  Currently the passage for the exams following the BOC prep course is 94% with the last class passing 100% and the previous two only having one person falling short by one question. How do you find out about them? BOC sends out notices about these courses and so do we through our monthly newsletters. How are these courses related to you, Jeff? Well I’m the current BOC Prep course instructor.  When I was on the Board of Directors for BOC, I helped develop a number of projects for BOC and the CDME certification was one of them.  I believe in this certification and I always walk the walk.  Most of my staff also carries this certification. So you truly believe this will give the pharmacy a competitive edge? Yes.  Look at your local healthcare providers.  Everyone is boasting about their “board certified” specialists.  Pharmacists are always listed as the most trusted healthcare professionals.  But pharmacy is a lot more than dispensing pills.  Pharmacies have diversified into a multitude of areas.  So here is a way to promote your DME department.  How’s this, come into the Hedges Pharmacy for all of your prescription needs, immunizations and see our board certified DME specialists.  Bet you never heard that one before.  Add this to your Face Book ads.  Show off your staff and let them be part of the revenue stream.  DME is not very sexy, but if you run a tight ship and are careful on what you dispense, document correctly, it will add profit to your pharmacy.  Add diabetic shoes and the profit margin jumps.    Notes: CDME Prep Courses CFS Allied Health Education "BOC Certified DME Specialist Exam Prep Course": The objective of this 24-hour, self-paced online course is to provide new and existing DME employees a review of the competencies required to perform tasks in the DME environment. It is an excellent tool to use in preparation for the BOC Certified Durable Medical Equipment Specialist (CDME) certification exam. MED Group "CDME Specialist Course": This complete course is a compilation of three CDME Specialist courses. In the courses, you will gain an understanding of: how to create a safe and comfortable environment for your customer, how to conduct yourself as a CDME Specialist, and how to properly fulfill and bill an order. The three courses total approximately 8 self-paced hours of on-line content and instruction and account for 7.25 Business BOC CEUs and 1 Scientific BOC CEU. Please visit this link for pricing information.  O&P Education "CDME-DME Specialist Course": This course is written to ensure a basic understanding of many aspects of the DMEPOS business and provides guidance for those who wish to endeavor in the proper procedures for a successful business. This course will help to prepare those who anticipate testing for BOC's Certified DME Specialist examination. Completing this course requires the completion of all 13 sub-courses. Contact RJ Hedges & Associates today for more information:  Phone: (724) 357-8380   Email: sales@rjhedges.com See omnystudio.com/listener for privacy information.

Pharmacy Compliance Guide Attestations & Certifications  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 requirement 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 was 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 sticker and more over bearing. Most especially is the OIG Exclusion verification requirement. Only pharmacy in all of health care must accomplish this task every month. It started with just one database, the Office of Inspector General, then were added 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.   Jeff, let’s break these requirements down. What is involved with the Fraud, Waste and Abuse requirement besides the OIG Exclusion? Fraud, Waste and Abuse really is not hard to comply with. It is having established policies and procedures and training. However, when someone gets in trouble with the government with stealing money through claims or misleading patients, the Fraud, Waste and Abuse processes is where all of the federal penalties come from. There are ten (10) basic policies and procedures from Fraud Waste and Abuse Prevention, Anti-Kickback, Conflict of Interest, False Claims, Whistleblower Protection and General Compliance. When you look at these policies and procedures, they are mostly common sense. Bill for what you dispense and treat patients like they are your family. There are several methods of training. CMS has training modules and like all things created by the government and their lawyers it is complicated. To use these training modules, each employee logs into the CMS system, establishes a user name and password, then embarks on a one-hour on-line training session, with on-tests along the way. When the employee has the completed the training, he or she will have a CMS training certificate for Fraud, Waste and Abuse with General Compliance. There are several problems with this training: Who has the time and the computers to have each employee to spend one hour going through the training program? In the statute Title 42 C.F.R. 422.504(B)(4)(vi) and the Medicare Prescription Drug Benefit Manual, Chapter 9, you are to train on the pharmacy’s policies and procedures, which the CMS Module does not do meet There is no requirement for a test We covered the OIG/GSA/SAM verification above, however, most people have the opinion the OIG check is only for employees. This is not correct. The statutes specifically states: “Any individual or entity that has been convicted…”   Jeff, I never heard this before, so what is an entity? The best definition I have been able to define is: a HIPAA Business Associate and any vendor you purchase a product from that you then dispense to a Medicare or Medicaid patient. It also includes: 1099 employees, part-time employees and contractors. So the question is are you verifying these entities? CVS/Caremark is checking this on their on-site inspections.   So what is the HIPAA requirement? HIPAA has been around since 2003. We had a podcast earlier this year on HIPAA breaches and desk audits. If you haven’t listen to it. It is quite important. HIPAA requires all health care providers and Business Associates to have a HIPAA Privacy and Security policies and procedures. Annual training on these policies occurs on how HIPAA relates to your operations. Our listeners will primary need privacy training on interactions with their patients and their requests, handling Protected Health Information and most importantly what to do when a breach occurs. Jeff, I remember the podcast on HIPAA Breaches. That was one of the most informative podcasts we have had and if you don’t do anything when they occur will lead to millions in finds.  So I understand there was a new requirement added this year to attestations. Yes, Cultural Awareness Training. This was originally part of the Affordable Care Act but it was struck down by the federal courts in November 2016. But Humana and CVS/Caremark brought it back to life. This is a training to ensure the pharmacy and the staff understand the culture of your patients and the language skills if they can’t speak English. My biggest concern with this added requirement for community independent pharmacies is we all live in our communities. We know our communities. If there are a second or third language in the neighborhood, we hire staff who speak these languages. We understand the local customs and cultures. Why would anyone offend your patients, who would then go to your competitor? That might make sense inside the Washington Beltway or an insurance company board room, but not in an independent pharmacy.   Now let’s talk about Credentialing. What is it and why do we have to deal with it. Credentialing is simply the validation of the attestations. These normally start in late January. The PBMs want to see proof. These are mostly completed on-line or via fax. However, CVS/Caremark and OptumRx are doing follow-up on-side inspections. Each PBM has their own list of items to send in or provide the on-site auditor: Fraud, Waste and Abuse training certificate or Log I recommend only sending the Pharmacist in charge, not the entire staff HIPAA training certificate or log I recommend only sending the Pharmacist in charge, not the entire staff Specific pharmacy operational policies and procedures Pharmacy licenses Pharmacist-In-Charge License Other miscellaneous requests All in the effort to validate the attestation that was submitted in the fall were correct   Does anyone look at these documents? Good question. There are 26,000 plus independent pharmacies submitting documentation. Just the volume of documents is huge. The server size to store the data year after year will be in the terabytes. But I do know they do a random checks.   Are there any penalties? Yes, if you falsify an attestation, the pharmacy is in jeopardy of losing all Part D reimbursements for the period or year in question. Plus the pharmacy is in breach of contract and will be drop from the contract. It really can’t get much worse than that.   OK, what was this NCPDP credentialing about in August? This has been on my radar. I met with NCPDP in 2016 about this project and then again at the NCPA convention in Orlando this year. NCPDP developed a platform to help pharmacies report one time, rather than multiple times each year. The concept is good. But there are challenges and concerns. First, the development was with chain pharmacies with no independent involvement. The reason was NCPDP had a massive test pool with the same organizations. It’s logical, but there are more independents than chain pharmacies. This program works with the PBMs but not with the PSAOs who still are requesting the same information. So it does reduce the amount of reporting. Now my major concern is NCPDP is sharing the information they are collecting with different organizations. They are updating your NPI information. OK, that is good. But they are also sending it to the National Supplier Clearinghouse. Here is the concern. If the data submitted to NCPDP differs from the CMS 855S Medicare Enrollment Application, NSC’s process is to deactivate the PTAN. If you catch it right away, the pharmacy can re-activate the PTAN with no issue. However, if the pharmacy does not catch it because they are not reconciling their reimbursements on a weekly basis and PTAN is deactivated for a period of time, the pharmacy must reactivate their PTAN from scratch. If the pharmacy had “Exempt” status, depending on the length of time, the pharmacy loses the exemption and they must start over with accreditation to continue to dispense DMEPOS products. I have seen this done already. It is as simple as changing your hours of operation, updating the NCPDP credentialing website and not updating your Medicare 855S and your PTAN is deactivated. This is a very costly error that no one thought about.   Jeff, how can you prevent that from happening? Don’t let just anyone complete these attestations and credentialing documents. Complete them all the same way, every time. Keep copies so you are consistent. Always know what your CMS 855S Medicare Enrollment Application states. When a change is made on the NCPDP website, make the same change on the CMS 855S application.   Is there anything else the pharmacies need to be aware of for Credentialing? Yes, one very important item. Continuous Quality Improvement Certificates are required for Medicare Part D. Every pharmacy is required to have a Continuous Quality Improvement (CQI) program. The CQI certificate is generated by an organization certifying the pharmacy has an active CQI program. This is normally through a Patient Safety Organization. We talked about a PSO on our last podcast with the Alliance for Patient Medication Safety. We can see the PBMs looking at the CQI certificates more closely in 2018. For my clients, make sure you continue with the PQC+ entries so you can pull the CQI certificates when these requests start in January and February. If you are not sure if you have a CQI program or how to get your CQI certificate, the process is not a week or two quick fix program. There are a number of items that are required to be completed. Check out our last podcast on Patent Safety. There are not a lot of organizations talking about these subjects, especially the CQI programs and certificates. I keep my podcast factually based, but on the Continuous Quality Improvement program, certificates and enrollment with a patient safety organization, this is part of our standard pharmacy compliance program that we offer. To my knowledge, no other consulting firm offers these services.   Jeff, so wrapping up, on our conversation today, you always bring items to us that no one is talking about. See omnystudio.com/listener for privacy information.

The Fit Pharmacist partner & Pharmacy Podcast Network co-host Dr. Christina Tarantola joins Jeff Hedges president of RJ Hedges & Associates & Pharmacy Compliance Guide podcast host with Tara Modisett, Executive Director of Alliance for Patient Medication Safety - recorded live at the NCPA Annual Conference 2017 in Orlando FL.  To help improve Patient Safety and reduce mistakes, everyone in the pharmacy must be involved in quality control; helping to identify mis-steps and errors, being aware of sound-alike/look-a-like drug fills are ways to ensure you are taking proactive measures. Errors found behind the counter are quality control, errors going out the door are medication errors. Errors do happen and it is important to understand what you need to protect yourself, as well as your patients. The Patient Safety and Quality Improvement Act1 requires a Continuous Quality Improvement (CQI) Program be implemented. A CQI program is designed for detecting, documenting, analyzing and preventing quality-related events (QREs) with the intent of preventing medication errors and improving patient safety. A Continuous Quality Improvement (CQI) program creates an environment that makes quality the top priority and allows pharmacy staff to learn from past mistakes, while focusing on improving patient safety by decreasing errors and increasing quality. Pharmacy staff must be willing and open when discussing all failures of quality. Reporting errors should not lead to blame or punishment but instead needs to be seen as an opportunity to learn and improve. When an error occurs your first question should be “what in our system allowed this error to occur?” A PSO will most likely assist you in designing your Patient Safety Evaluation System (PSES), which is a system of procedures and policies for collecting, managing, and analyzing information for reporting to the PSO. A PSO provides the framework for safety data to be protected as Patient Safety Work Product (PSWP). PSWP is defined as any quality data and analysis and/or oral statement, assembled or developed by a provider, for reporting to a PSO which constitutes the deliberation or analysis of a Patient Safety Evaluation System (PSES). PSWP is not subject to subpoena, discovery or admission into evidence. According to the Patient Safety and Quality Improvement Act1 , federal privilege preempts state tort law, but not state reporting laws. However, federal privilege does not preempt state laws that are more stringent. The collected and reported quality and patient safety data that you report to a PSO are shielded by federal confidentiality and privilege protections. The protected information can include event reports, Root Cause/Systems Analyses, minutes of quality/safety meetings, related graphs, spreadsheets, reports, communications to/from the PSO, and related information listed in the Act. In order to maximize the legal protections afforded by the Act, pharmacies must enter into an agreement to join a PSO, develop and maintain a PSES, conduct all quality and safety activities within the PSES, maintain PSWP as confidential and protect PSWP from disclosure outside the PSES. In turn, the PSO must remain in good standing with the Agency for Health Research and Quality and must meet operational and security requirements set forth by the Patient Safety Act Regulations. Special Guest:  Tara Modisett Executive Director Alliance for Patient Medication Safety™ PSO 2530 Professional Road  Richmond VA 23235 Phone (866) 365-7472   www.medicationsafety.org     See omnystudio.com/listener for privacy information.

Pharmacy Compliance Guide Podcast Session 7 Participating or Non-Participating, That is the Question Participating vs non-participating, what does this mean? 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? Simple. Profit margin. At some point every pharmacist and healthcare provider must stop being a healthcare provider and start being a business owner.   There is a big difference and this might sound harsh, but it’s true. If you take care of the patient at all costs, you will be out of business and you and your staff will be out of a job. You must keep a keen eye on your profit margin. Everyone knows a lot of pharmacy owners who have gone out of business. They were great pharmacists, took care of the patients, but maybe not the best business people. You must look at your competition, your patients, and your staff and make an informed decision whether moving to a non-participation status will work for you. The first thing you need to do if you move to non-participating and not accepting assignment, is educate your patients. Let them know that starting January 1st, you will be collecting the full fee of Medicare Part B products and Medicare and their secondary will send them their reimbursement checks. They also must understand about the sequestration 2% and copays and the difference between the Medicare allowable and your Usual and Customary fee. I have had clients who have transition to non-assignment with no problems and other who have had a disaster. It’s all about education I’m still concerned about repercussions from the patients. How do I answer questions like? Why are you making me pay now and wait for Medicare pay me? Changes in Medicare are happening to you as well as me. It is getting harder for us to stay in business so we can take care of you and everyone else in the community. This is one way we are trying to see if it will work. We are not happy either but we have to make adjustments so we can be here to take care of you. You are supposed to be helping me, how does this help me, I don’t have all the money right now? OK, let’s sit down together and see if we can work out a plan together that works for you. You just personalized the conversation Answers need to be straight forward to the patient. These are tough questions and depending on your individual market, you may say I don’t want to do this and that is OK. Every business must look at their options every year and this is one of them. There are no simple answers. For example: If the patient is dual eligible the individual state Medicaid program may have very specific restrictions that prohibit this. In this case you can accept assignment for the individual product for the individual patient at the time of billing. Your competitor may have all dropped DMEPOS products and when your patients ask why, you can explain the cut in reimbursements and the wait in payments. Jeff, so wrapping up, on our conversation today, At the end of the day, it comes down to a business decision that each pharmacist owner needs to make. And we are strongly recommending that every pharmacy owner look at this option this year. We are not telling you to do it, but to review your books, your patients and your competition. Be prepared to act or not act on November 15th. If you decide to move to non-participation you now know you can still accept assignment on certain products at any time.         See omnystudio.com/listener for privacy information.

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 is 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 is 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 a 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 a 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 manufacturer’s training and a training certificate. Pharmacy technician and other staff also require 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 shoes and can be safely fitted. The assessment includes the entire foot and every aspect is document. Once the assessment is completed, the fitter and patient pick the best style of shoe and complete the order forms. Where can the fitting occur? At your pharmacy, DME facility, assisted living facility, senior center or the patient’s residence. You are not limited to stay within your facility. This is a wonderful way to get into your community. When is the final assessment / fitting completed? This is a scheduled appointment. When you have received the diabetic shoes from the manufacturer and have received all of correct documentation: Detailed Written Order Physician Certification of Therapeutic Footwear Clinical notes from all healthcare providers indicating Face-2-Face visits Needs for Diabetic Shoes Orders for Diabetic shoes and type of inserts One of the conditions that authorize diabetic shoes What happens if you don’t or can’t get the documentation? You use your biggest resource, contact the patient and ask for assistance. Explain what you need from the specific physician or licensed practitioner and ask if they can call. If it is a document that needs completed, you can give the patient the document and ask them to take it to the physician for signatures. The patients are motivated to get their shoes so they are motivated to their paperwork. There seems to be a lot of diabetic shoe manufactures and they all have their own documentation and they are all different. Which documents should be used? Shoe manufacturers are experts in manufacturering diabetic shoes and inserts. They market shoes to suppliers and provide a quality product to be dispensed to the patient. They provide documentation from what they feel is appropriate that meets the CMS guidelines but how up to date is it? There are a lot of regulations that must be followed for all Medicare Part B dispensing. If the claim is rejected, the manufacturer really doesn’t have any skin in the game. They have already been paid. It is always the responsibility of the supplier to follow all of the LCD requirements and CMS regulations. Jeff, you sound very confident on these processes. Why? Over the years, I have worked with the shoe manufacturers, CMS, DME MAC auditors, inspectors, accreditation organizations and many other groups. We have developed a deep understanding of what is required to dispense diabetic shoes and more importantly how to win audits. It is always about the documentation. If you know what everyone wants before you start, it is easy to meet the requirements. The problem is all the requirements are not written down. You have to talk to all the people involved. Once you do and the process developed, our process done the right way the first time never has an issue with DME MAC or insurance audits. So does R.J. Hedges have a solution? Yes, we actually have several solutions. First, if the pharmacy is exempt, you can still add diabetic shoes to you CMS 855S application. All you need is manufacturer training and an amended CMS 855S application. There is NO fee Second, we have a Diabetic Shoe program that focus’ just on the dispensing of diabetic shoes. It comes with all of the documentation, DWOs, Physician Certification of Therapeutic Footwear, Assessments, delivery receipts and compliance training. The cost is $500.00 for the first year and $100.00 for every year thereafter. Our final option for DMEPOS products is a full DMEPOS compliance program that comes fully customized for the facility. Our sales team will work with the facility to set up the best solution for the program and then one of our Project Managers will be assigned and will create the program and become the facility’s Go To Person or what I like to say, your Assistance Compliance Officer. See omnystudio.com/listener for privacy information.

Pharmacy Immunizations – It’s Far More than Flu Shots Jeff Hedges, co-host of the Pharmacy Compliance Guide brings us new insights into the Business of Pharmacy & keeping your Community Pharmacy Compliant. This week we focus on Pharmacy Immunizations.  Can every pharmacists give immunizations? Absolutely, flu is the most recognized but most states will permit pharmacist to provide most immunizations to patients Are there any restrictions? Yes, each state sets its own requirements for what a pharmacist can administer For example: there are age limits for certain vaccine some vaccine are prohibited by pharmacists to dispense Location of vaccines to be administer Is there any license requirements? Yes, each states sets its requirements Most states require a separate immunization license Some states have the immunizations within the state issued pharmacist license and scope of practice Who can administer vaccines in the pharmacy? Licensed pharmacists Registered nurses Licensed interns under the supervision of a pharmacist when permitted by state law Are there any training requirements? The normal requirements are Complete an American Pharmacist Association approved Immunization course Complete and maintain an American Red Cross or American Heart Association CPR course and certification Maintain state licensure if required What is needed for Medicare immunizations? I prefer a CMS 855B application for the pharmacy This give the pharmacy the PTAN rather than the pharmacist Submitted through the regional CMS administrator Application fee Separate PTAN is issued How do you bill for immunizations? It depends on the patients insurance Medicare Using a billing company, such as Change Health or OmniSys  Medicare & Medicaid and Third Party Payor A more robust billing company like TransactRx, Allegiant Billing, Electronic Billing Service Medicare Part C Advantage Plans Bin numbers through the pharmacy software Private payors Bin numbers through the pharmacy software What other types of immunizations can a pharmacist do? Think outside your box! Contact local businesses Contact local schools and universities Contact local churches and places of worship who are going on mission trips Think different types of immunizations Travel Vaccines International travel requires vaccines Who provides travel vaccines Physicians – No County Department of Health – No Most pharmacies – No You – Absolutely Advantages You can go to churches and other places of worship You can go to businesses who travel internationally Colleges and Universities travel extensively throughout the globe All of these vaccines are CASH! Who sets the price – YOU! Disadvantages You are letting someone else do these immunizations What type of order is needed to administer a vaccine? Written prescriptions Legal order to administer the vaccine Standing Orders Developed by the CDC and IAC Signed by a physician Should be renewed annually Except in CA and ID where the Pharmacist is now permitted to sign standing orders Emergency Protocols Emergency treatment procedures when a patient has an adverse reaction Signed by a physician Except in CA and ID where the Pharmacist is now permitted to sign standing orders However, I personally recommend that a physician still sign this order to protect the pharmacist Am I required to have Policies and Procedures? By federal statute, No Strongly recommended by APhA Required to be submitted to the liability carrier when an adverse reaction occurs Check your insurance policy for your compliance requirements Where do I turn for help and guidance? Well that is where my company comes in We work with the IAC and CDC in developing policies and procedures, standing orders and many other documents All are contained within our Pharmacy Immunization Compliance Program which is maintain as changes occur from the CDC and IAC CONTACT RJ HEDGES TODAY:  R.J. Hedges & Associates 163 9th Street PO Box H   New Florence, PA 15944   Phone: (724) 357-8380   Email: sales@rjhedges.com See omnystudio.com/listener for privacy information.

HIPAA Breaches & Desk Audits What is a breach? In simple words, the loss of patient protected health information, either printed or electronic. How common are breaches within pharmacies? There are two types of pharmacies and pharmacy owners, The first are the ones who know they have had a breach The later 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 Delivery driver has their vehicle 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 are 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 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 breach, 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? CONTACT: Office:  724-357-8380  Website:  www.rjhedges.com See omnystudio.com/listener for privacy information.

Jeff Hedges, the Pharmacy Compliance Guide is back discussing the IMPACT repealing the Affordable Care Act (ACA) will have on the Pharmacy Industry.  Question: Now that the Republicans have control of both houses and the White House, they are going to Repeal and Replace the Affordable Care Act (ACA) or Obamacare. What does this mean? Answer: The current system is broken, mainly because the government and the insurance companies worked together to write this law to control health care payments to health care practitioners. Patient care and the health care practitioners were not factored into the law. Question: Will the new healthcare law contain the popular portions of the ACA? Answer: Before the ACA was created, both the Republicans and Democrats agreed that pre-existing conditions, children staying on their parent’s health insurance until the age of 26 as well as many small portions of health care that benefit patients and providers. In fact, 80% of the ACA had been mutually agreed upon by everyone before the law was enacted. However, over the last eight years, this fact has been forgotten. Question: So why is the ACA considered to be so bad? Answer: ACA eliminated competition and fixed pricing for practitioners. Then turned over the management of health plans to the insurance carriers with no oversight on premiums. This eliminated competition by the mergers of insurance companies. Now there are only six national insurance carriers who set their premiums and control the market.  Question: What can we expect with the new changes to health care?      Answer: 2017 insurance policies have already been written, so there will be no changes for current policies. However, depending on what changes are made in the first half of 2017, 2018 may have a completely different look for health insurance. Question: What can we expect the first changes to be made in our healthcare? Answer: Interstate competition. Enabling insurance companies to compete across state lines will have a dramatic effect on insurance premiums. Health care practitioners will be involved in the development of the new regulations so the focus is on health care to the patient and the patient / doctor relationship. This concept alone will redefine the entire health care program in the United States. The simple concept of patient driven care rather than cost driven care will be the most radical change. Question: We hear about practitioners, especially pharmacies, who are being reimbursed below their acquisition prices, is this true and if so, how are healthcare facilities able to stay in business? Answer: Yes, as insurance premiums continue to climb, reimbursement to providers are being cut. Especially in the pharmacy industry. 75% of generic drugs are reimbursed at or below acquisition price. The insurance companies have also imposed a Direct / Indirect Remunerations (DIR) fee that is clawed back 60 days after the reimbursement is made. This can be a flat fee or a percentage and it fluctuates, this makes it difficult to plan your cash flow. This fee has forced thousands of pharmacies out of business. What key points need to be addressed as the Affordable Care Act is repealed and replaced- points to keep if speaking to members of Congress Before the ACA was created, both the Republicans and Democrats agreed that pre-existing conditions, children staying on their parent’s health insurance until the age of 26 as well as many small portions of health care that benefit patients and providers. In fact, 80% of the ACA had been mutually agreed upon by everyone before the law was enacted. However, over the last eight years, this fact has been forgotten. Critical points that are hurting pharmacies and patients Pharmacy Benefit Managers have: Established a regulatory empire with no over-sight Established reimbursement rates for pharmacies with no input on acquisition prices Worked in collusion with insurance companies Set price fixing with other PBMs Have no transparency, even with mandatory state laws requiring transparency Direct / Indirect Remunerations (DIR) fees Were initially established under the ACA as a quality payment to pharmacies for providing quality patient services Let health insurance attorneys working with HHS the ability to change definitions within the ACA, to change the quality payments to a DIR fee. The DIR Fee is an after service fee (insurance tax) deducted or clawed back normally 60 days after the reimbursement. This is either a percentage or flat fee that also changes from carrier to carrier and throughout the year. This has the most detrimental effect on pharmacies’ cash flow and consequently forces them out of business. Mandatory Mail Order Insurance carriers increasingly force patients into the insurance company’s mail order pharmacy. Prescriptions are auto-filled/auto-shipped without patient consent Patients become overwhelmed with excess medications and DME products Medicare/Medicaid/Tri-Care are the payors who are the end losers who pay for extra fees for services not needed. Orthotic Products moved to Off-the-Shelf This single move has caused rampant fraud throughout the country The current practice allows the mail order companies to advertise in all forms of media. A patient contacts the supplier who matches them with a physician over the phone. Physician writes prescription and sends to the mail order medical supply company who then ships the product to patient. No medical necessity is required. Thousands of new fraud cases are occurring every month. Competitive Bidding has: Drastically reduced patient access to DMEPOS products Reduced reimbursements for DMEPOS products leads to cheaper products being dispensed therefore, affecting the quality of care  Conclusion -It’s a great time to be in pharmacy and a better time to be looking into accreditation to be able to add the most amount of services and reimbursements to your bottom line.  Connect with Jeff today:  R.J. Hedges & Associates 163 9th Street PO Box H  New Florence, PA 15944   Phone: (724) 357-8380 See omnystudio.com/listener for privacy information.

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. CONTACT  R.J. Hedges & Associates 978 Pumphouse Road   PO Box H  New Florence, PA 15944   Phone: (724) 357-8380   Email: sales@rjhedges.com     See omnystudio.com/listener for privacy information.