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NEW YORK CITY PHARMACISTS SOCIETY How To Survive A VOLUME 29, ISSUE 9 PSSNY HELPLINE 1-800-632-8822 DECEMBER 2020 - YEAR END DEA Inspection Series: The Voice of Pharmacy in the Big Apple www.NYCPS.org $15,080 Per Civil Fine© President’s Message Well, here it is as we I want to wish pharmacists, get recognized as an approach 2021 and everyone a Happy essential healthcare partner in the we wish you, your and a Healthy New community setting. family, and your staff Year!!! We also had a very big win late lots of health, happi- Instead of recapping last year with the Supreme Court’s ness, and wealth in 2020 I want to talk unanimous decision overturning 2021! We also wish your pharmacy about what we can the Eighth Circuit’s decision that a checkbook, lots of health! anticipate this coming year. There 2015 law banning pharmacy benefit My article is about your pharmacy are so many things to look forward managers from swindling local and your inventory of controlled sub- to like Covid-19 testing that pharma- pharmacies defying the Employee stances. If you do not want to keep a cies already started, COVID-19 vac- Retirement Income Security Act perpetual inventory of your controlled cines that we will be providing and (ERISA). If you remember that the substances because you trust your a lot more opportunities that will be Governor Cuomo’s veto was partly pharmacists and staff, I can sell you coming our way as we, community based on the ERISA ruling and now continued on page 20 continued on page 20 ATTENTION PHARMACISTS: IF YOU ARE A PHARMACIST AND HAVE BEEN IN CONTACT WITH A COVID-19 PATIENT, YOU CAN OBTAIN PRIORITY TESTING BY CALLING THE NYS DEPARTMENT OF HEALTH COVID-19 HOTLINE AT 888-364-3065 AND TELL THEM YOU ARE A PHARMACIST - AND SINCE YOU ARE A HEALTH CARE WORKER WHO HAS BEEN EXPOSED TO AN ACTIVE COVID-19 PATIENT, YOU WILL BE GIVEN A CALL BACK FOR PRIORITY TESTING WITHIN 24-48 HOURS. Modern Compounding PSSNY An Open Letter to Perspectives President’s Message Gov. Andrew Cuomo

P a g e 3 P a g e 7 P a g e 1 9

OFFICERS PSSNY/NYCPS. NEED YOU AND YOU NEED WE DUES, YOUR OF CARE Ilana Aminov, President 212-737-8800 IN THIS ISSUE TAKE AND 8822 632 800 AT PSSNY CONTACT PLEASE NAME. YOUR ABOVE

Bill Scheer, Treasurer 917-805-4207 President’s Message...... 1 Jim Schiffer, Secretary 212-616-7069 RIGHT SO, STATING MESSAGE A SEE WILL YOU DELINQUENT ARE YOU IF Mohammed Taher, President Elect 718-827-7528 How To Survive A DEA BOARD OF DIRECTORS Inspection Series...... 1 Aneidi Etuk, Chairwoman 212-222-3652 Danny Dang 212-246-8169 Modern Compounding Imran Kazmi 917-449-0086 Vinnie Mazzamuto 718-543-3116 Perspectives...... 3 Joseph P. Navarra 516-249-7436 Treasurer’s Corner...... 4 Roger J. Paganelli 718-364-6100 Marina Plotkin 212-313-5409 A Message & Greetings from Rathna Veeramachanani 201-780-7210 PSSNY Executive Director...... 4 PAST PRESIDENT BOARD MEMBERS Mike Agovino 718-543-3116 PSSNY President’s Message...... 7 Charles Catalano 718-358-1300 Ron DelGaudio 718-230-3535 Reminder on Medicaid Managed Care Jim DeTura 718-292-1856 Patients Conversion Back to Medicaid Russell Gellis 212-877-3480 Ray Macioci 914-439-2781 Fee for Service Billing...... 7 Boris Mantell 347-276-5566 Secretary’s Report...... 8 John Navarra 516-650-1870 Alex Perchuk 718-835-2000 Chairwoman’s Report

Parthiv Shah 718-292-4244

News from Around the World...... 12 PSSNY REGIONAL REPS Yes, I Got the Vaccine!...... 15 REQUESTED SERVICE ADDRESS Danny Dang Bronx Imran Kazmi Manhattan NCPA Message...... 17

Rathna Veeramachanani Brooklyn, Staten Island Ilana Aminov Queens ISMP...... 18 10006 NY York, New 2002, Suite Broadway, 111

RECORDING SECRETARY CPESN...... 18 Joseph P. Navarra 516-249-7436 An Open Letter to Society Pharmacists City York New The NEWSLETTER Jim Schiffer, Senior Editor 212-616-7069 Governor Andrew Cuomo...... 19 Designed, Printed & Mailed by: GBV Printing Services 631-231-7300 PAAS...... 21 PAGE 2 DECEMBER 2020 YEAR END EDITON NYCPS NEWSLETTER

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© 2019 Cardinal Health. All Rights Reserved. KINRAY and the Kinray LOGO are trademarks of Cardinal Health and may be registered in the US and/or in other countries. (2/19) NYCPS NEWSLETTER DECEMBER 2020 YEAR END EDITON PAGE 3 Modern Compounding Perspectives: Assuring the Compliance of Your Compounding Operation – Temperatures and Drug Storage - Items to Consider Assuring Regulatory Compliance. As the pandemic continues to spread, we finally with the requirements and guidance of the USP/NF for have some good news--- several vaccine candidates the materials in your possession. In New York State, this have obtained emergency use authorizations from FDAi. begins with the regulations of the Board of Pharmacy. Pharmacists continue to work as an integral part of the Since most of this regulation deals only with refrigerated healthcare team, we are looking forward to being a large storage (2 to 8 degrees C or 36 to 48 degrees F) you part of the distribution mechanism for these promising must look to National compendia for clear standards in vaccines. No doubt pharmacists will be in the thick of the other areas that are part of your pharmacy operations. the vaccination and distribution efforts to turn the tide of pandemic. As the vaccine stocks begin to be distributed, HOW DO I PUT THIS INTO DAILY PRACTICE? we can do well to focus on what we can control, especially As you access your entire pharmacy operation, you in terms of our service to our patients. need to remember to include all areas where drugs Much has been written about the “cold chain” (both prescription and non-prescription medications) requirements of the Pfizer vaccine candidateii and the are stored. Where the pharmacy department extends to Moderna candidate although less complicated, has the selling floor in retail operations, having the general its own transport and storage challenges as welliii. For ability to monitor this temperature is essential to assure any healthcare professional directly involved in the that you have control over this inventory. If you are using procurement, distribution, and administration of these a storeroom or basement area away from the retail or vaccine you should be thoroughly familiar with all of these general pharmacy areas to hold over-stock or inventory, requirements and processes to protect the drug and the you must be able to monitor those areas. It is ideal for you patients we all serve. to create a standard method to monitor these all these With all that has been published recently on the areas daily and have a way to record these temperatures handling if these vital drug candidates, many health to document the control of this drug inventory. facilities began to review and access their capabilities A small investment in a basic continuous monitoring for the storage of medications in general. This is a system for all these areas (not just the refrigerators prime opportunity for all of us to review our drug storage & freezers) in your pharmacy will make this daily task conditions, processes and the documentation we use simpler. Please remember that the Centers for Medicare to be able to assure that all the active pharmaceutical & Medicaid Services (CMS)iv require that all vaccines ingredients (API), medications (both prescription and be monitored, and those temperatures recorded twice non-prescription) as well as other legend supplies in our daily. These temperature monitoring devices can be charge are appropriate. wired, wireless, or have Blue-tooth™ conductivity. The What follows is an overview of the methods, regulation, equipment you choose will depend upon the number of and general practices to assist you in assessing your areas or devices (i.e., refrigerators) you need to monitor, current situation and to assist you in improving your your budget, as well as the level of for reporting which methods where possible. the accompanying software can deliver. Please refrain The pandemic and the resulting interruptions of our from buying and installing “home-type” systems which normal supply channels have served to underline how are easily found on the web, as these systems are not fragile our pharmaceutical supply pathways can be, so intended for medical or pharmacy applications, and even why not do all you can do to protect and preserve these if they can be “calibrated” they cannot be calibrated to vital materials? the standards of the National Institute of Standards and Technology (NIST)v which is a required annual activity for SO, WHERE SHOULD I BEGIN? any measuring devices in your Pharmacy. It is the responsibility under both Slate and Federal So, what are my targets for temperature monitoring law to assure that all the drugs, components (both active to be compliant to the many overlapping regulations that & inactive) and other medications be of the highest must be satisfied for the storage of my medications and quality and conform to the storage conditions consistent supplies? The USP/NF in General Chapter <659> lays continued on page 25 PAGE 4 DECEMBER 2020 YEAR END EDITON NYCPS NEWSLETTER Our healthcare cost for the United States is $3.5 trillion Treasurer’s a year, increasing each year almost 5%, and consuming 17% of our Gross Domestic Product (GDP). These Corner numbers highlight the reason Haven Health struggled to make any headway on our bloated spend for health care. There are many interested parties to whom change is an anathema. Even Warren Buffett and Jeff Bezos with HAVEN HEALTH FADES AWAY all their business acumen seemed to be stumped by this Haven Health, an innovative approach to “fixing” complex system. health care by three prominent companies Amazon, Amazon seems to be taking a different track, sort of Berkshire Hathaway and J P Morgan Chase is to be no “ if you cannot beat them join them” approach. The push more. The company will cease operations in February. It into the PBM marketplace with Amazon Pharmacy and seems that it accomplished few changes or savings to their new Halo health tracking device have shown that the workforce of the three companies. The answers to their takeaway is that there is money to be made and a growing health care costs seem to be more complex than new market to dominate for Amazon. So, the secrecy and these three leading companies imagined. deceptive practices continue, not even three of the richest Of the three entities who formed this joint project, men in the world seem to be able to change this business. is seems that Amazon has made the most inroads into A sad situation for America, I spoke about the Australian containing its employee health care costs. Amazon system a couple months back, they and most of the world launched a virtual primary care clinic for its employees can control their costs while managing good health care, called Amazon Care. Then Amazon purchased Pill Pack but we one of the richest nations in the world have failed to and dubbed it under the name, Amazon Pharmacy, hoping even implement modest improvements to our health care. to get into the Pharmacy Benefit Manager marketplace. - Bill Scheer, R.Ph. ©2020 Bill Scheer All Rights Reserved

post all updates in eblasts and the Escript. For detailed A MESSAGE & GREETINGS information on NYC’s plan and priority populations to be FROM PSSNY vaccinated, visit this DOHMH link: https://www1.nyc.gov/ EXECUTIVE DIRECTOR site/doh/covid/covid-19-providers-vaccines.page Roughly a quarter of the 443,000 vaccines have been MID-WINTER WAS AMAZING! administered in New York City, which have been received from the federal government as of Monday, January 4th Hello and Happy New Year to all of you. I hope you according to the latest data, though Mayor de Blasio said and your families had a peaceful holiday season and you the remaining supplies may only last through January 11th. are healthy and looking toward progress and possibility in In the briefing, de Blasio and Dr. Chokshi, the NYC Health 2021. I know so much of our professional and personal Commissioner, mentioned independent pharmacies and lives have been COVID-19 focused and today is no the inextricable role they play health access and equity. exception. I just watched the Governor’s daily press Mayor de Blasio said “Independent pharmacies, mom- briefing and he stated that over the last three weeks, and-pop pharmacies in communities that in many ways 300,000 vaccinations have been given to New Yorkers depend on them even more than communities that have in priority group 1. There were questions from reporters a lot more healthcare options available. A lot of places, about distribution delays, supply chain, bureaucracy, the only place to turn to is that independent pharmacy priority classifications, and vaccine hesitancy. and they’ve been there for their neighborhoods year after The PSSNY office has received many calls over the year, generation after generation in some cases. I want to past few weeks as well. Most members and non-member thank all the independent pharmacists, all the folks that pharmacists want to know where and when pharmacists work in independent pharmacies, we’ve needed you [a] and pharmacy staff can receive the vaccine, and when long time for things like flu shots and everyday health, pharmacies will have access to vaccine supply. We are and now we’re going to need you to play a crucial role in working to get concrete information from the state and the fight against COVID going forward.” continued on page 21 NYCPS NEWSLETTER DECEMBER 2020 YEAR END EDITON PAGE 5 PAGE 6 DECEMBER 2020 YEAR END EDITON NYCPS NEWSLETTER

NYCPS NEWSLETTER DECEMBER 2020 YEAR END EDITON PAGE 7 PSSNY President’s Message Thomas D’Angelo is PSSNY’s 131st president. He is a graduate of St John’s University class of 1989 and has practiced pharmacy on Long Island his whole career. Thomas specializes in home infusion, retail and compounding. He is a licensed captain and spend many hours on the water, and as such, his theme for this presidency is Charting the Course.

Happy New Year !!! handle everything including Covid testing and vaccination As the year 2020 comes to an end and we begin 2021 procedure. I’ll let you all know that with every conversation we I would like to reflect on the past year, this past ten months have, the issue with PBM abuse is brought up. Time after time in particular has been very difficult for sure. In the middle of it is mentioned that unless we get PBM relief, the pharmacies battling PBMs and struggling to make ends meet we get side in this state will not survive. We are being heard and have a swiped by a pandemic. Rather than close our pharmacies, very very good chance of getting much of what we’ve been instead we remained open. Rather than hiding at home we asking for this year. We are continuing to push extremely hard continue to operate our pharmacies. We all realized the for PBM registration, regulation and controls. chances that we have been taking and we stayed open to I personally want all of our members to rest assured that support our communities. In many cases we were the only I along with the entire PSSNY staff and leadership will not place left open for many people to get any form of healthcare stop until we finally have some form of PBM legislation or any cleaning products any first aid supplies and yes any regulation. In addition, we are continuing to push for more toilet paper! Pharmacists stayed strong and some paid for responsibilities in the health care spectrum. We continue to it by getting ill and some unfortunately succumbed to the push for CLIA waved testing, increases in our vaccination virus, as they did not survive. My heartfelt condolences go responsibilities and all other increases in our scope of practice. out to all of the families that lost a loved one. We should all As terrible as this pandemic has been, it has also pushed be proud of the role we played in this unfortunate year. pharmacy into the spotlight. We have finally been recognized As the saying goes never let a tragedy go to waste and for all we do and all we can do. Sometimes it takes something although early on, we did not realize what was going to terrible to effect a change. This is about as terrible as it can get. happen we soon found out that pharmacy on a whole was in Please spread the word about our upcoming Mid the spotlight. We were being recognized as a vital healthcare Winter convention January 30 and 31. It would be really provider. Many were touting the fact that we are the go-to nice to have a great turnout it is after all a virtual event, people right now. All other resources were being shifted to no worries about travel, hotel costs etc. Please check the Covid-19 only, that left pharmacy for everything else. This PSSNY website for information and registration. Please recognition is not going to waste. We at PSSNY along with continue to check the website for information regarding the FixRX team have been tirelessly making sure that we guidance on vaccinations and testing. READ your weely are being placed in the press and the news as much as E-Scripts as it is packed with useful information. possible. We’ve been prominently recognized in newspapers Let me wish you all a Very Happy New Year! We have throughout the state as well as on every major news network. much to look forward to this year. Stay tuned and stay What does this mean for us? It means we are being recognized well. As always members can always reach me if they and it shows. We have been in constant communication with have any questions. the elected officials including the governor’s office. We are ~ Thomas D’Angelo being approached for our opinion and suggestion on how to PSSNY President REMINDER ON MEDICAID MANAGED CARE PATIENTS CONVERSION BACK TO MEDICAID FEE FOR SERVICE BILLING Beginning April 1, 2021 patients who are enrolled in too smart and let that Medicare Part B Surety Bond lapse various New York State Medicaid Managed Care plans will and then the cascade of problems begins. Medicare Part be converted back to using their New York State Medicaid B discovers the bond lapses, you get a notice by fax, you Benefit Card for prescription drug coverage. ignore the fax, you get dropped from Medicare Part B for at In order for pharmacists to be able to service those least one year. NY Medicaid learns you are dropped from patients, the pharmacy must have an active Medicaid Fee Medicare and then Medicaid Fee for Service drops you till for Service account actively in effect. you reactivate Medicare Part B. Welcome to the confusing As a pre-requisite for having a Medicaid Fee for Service world of pharmacy!! You need to stay active in Medicare active account, you must maintain an active Medicare Part Part B and maintain that surety bond. Remember that B supplier number (which means you have to bill and get Medicare Part B supplier account will be helpful when paid for at least one claim per year). Billing is not sufficient pharmacies are eventually allowed to vaccinate for COVID you must be successful in that claim submission. 19 because that will be the paying entity for Medicare Make sure you maintain the Medicare Part B Surety patients. Stay tuned and stay involved. Bond as an ongoing pharmacy policy as some folks are not ~ Jim Schiffer PAGE 8 DECEMBER 2020 YEAR END EDITON NYCPS NEWSLETTER victimized by the antics of their PBM teams as a result of Secretary’s spread pricing activities.

December/ In order to stay in the Medicaid Fee for Service Year End Program your pharmacy must maintain active status Report 2020 with Medicare Part B (as per the federal requirements included in the Affordable Care Act). Being enrolled in Medicare Part B in itself has certain minimum statutory This has been a year to remember, or shall we say requirements. You must maintain your Medicare Part B a year to forget. It has been a difficult one for everyone, Surety bond (renewed each year for a fee of about $300- and we have to be thankful that we made it to celebrate $400) and you must successfully bill one Medicare Part and welcome in 2021. B claim each and every year. Failure to maintain the Looking back on the past twelve months is not an surety bond or failure to successfully bill one claim per easy task. I remember leaving the PSSNY annual Mid- year results in Medicare Part B termination for one or Winter meeting in Albany as I was driving home on more years, depending upon the penalty imposed by the Sunday January 26, 2020, when news flashed across the National Medicare Clearing House. If New York Medicaid radio waves that a helicopter which was carrying Kobe tracks down your termination from Part B, you will be Bryant, his daughter and family friends had crashed into a given a 90-day warning to get re-activated in Part B and I mountain range in southern California. That was just the suggest you move fast and do not ignore the request from beginning of a tragic year. Then a few short weeks later, NY Medicaid, they have terminated pharmacy providers the COVID-19 pandemic then hit our nation like a rocket. for ignoring their requests. Back in late February we did not realize that COVID 19 had Friends, the New York City Department of Health already infiltrated our country probably sometime in late and Mental Hygiene continues to do unannounced walk- December 2019 but most likely those that had the virus in inspections, in order to confirm that your pharmacy is back in December 2019 wrote it off as a bad dose of the flu. complying with the local ordinances regarding COVID-19 By mid-March we were learning of the seriousness of regulations, such as social distancing inside of the this pandemic while President Trump was publicly telling pharmacies; documented daily temperate checks of everyone not to worry about this virus, yet in private, the your staff; as well as enforcing use of facial masks for was telling Washington Post write Bob Woodward how all of your staff and your walk-in patients. I heard of s terrible this virus really was. We then went through a very supermarket in downtown Brooklyn that was fined $1,000 difficult few months as pharmacists working “the bench” for allowing staff and customers not to wear masks while and being considered as an essential worker meaning in the premises. there was no government efforts to shut down the retail As we enter the 2021 New Year, we hope that the pharmacies during any government mandated shutdown. vaccines used to protect against COVID-19 will become We struggled through the springtime and I vividly recall readily available to all of us, since pharmacists are President Trump asking all Americans to go back to work officially recognized as essential workers/individuals in and starting on Easter Sunday that we should try and health care we will have access to this life saving vaccine resume our normal lives. Back in the spring, he also shortly. As you will read elsewhere in this newsletter emphatically said that the virus was going to disappear many of our pharmacist members are now managing like magic. Now we are waiting for someone else to COVID-19 patient testing with services provided through disappear. CPESN and the New York State Health Department. Key pharmacy related things to remember as we Follow the weekly PSSNY E-Scripts each Friday morning enter into 2021. New York Medicaid is taking back the for important weekly updates. Our annual PSSNY Mid- prescription benefit starting on April 1, 2021 from the Winter Meeting will be held virtually on Saturday January various Medicaid Managed Care programs. Finally, 30th and Sunday January 31st. Sign up either on the Governor Cuomo realizes that when NYS Department PSSNY website (pssn.org) or email: [email protected] or of Health shifted the Medicaid prescription benefit to the calling weekdays during business hours at 518-869-6595. various managed care plan cannibal operators in October Remember stay in touch, stay involved and stay well. 2011, that move cost New York State millions of extra Happy and Healthy 2021 to all. dollars in drug costs. Since the fall of 2011 the various - Jim Schiffer, Managed Care Plans had free reign to create their own Secretary NYCPS formularies, their own fee structures and were most likely ©2020 James R. Schiffer All Rights Reserved NYCPS NEWSLETTER DECEMBER 2020 YEAR END EDITON PAGE 9

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A Network Of Independently Owned Pharmacies 800-965-EPIC (3742) | epicrx.com [email protected] NYCPS NEWSLETTER DECEMBER 2020 YEAR END EDITON PAGE 11 COVID vaccine. I salute your courage and taking the Chairwoman’s challenge with stride. Thank you. Friends we have a lot of work ahead of us and we Report need each and everyone of you and your expertise. DECEMBER 2020 PSSNY our parent organization is having our mid winter virtual conference January 30th and 31st. I encourage you all to sign up as we have a whole lot more information OUR FALLEN HEROES to share with you. As a reminder fee for service returns in Hello my friends, colleagues and business owners, I April as patients get moved from Medicaid managed care. write in hope you are looking forward to the end of a year that We look forward to putting forward our pbm bills again has tested all of us in ways we could never have imagined. in hope that recent court rulings might set precedence It has left empty chairs in our dining rooms, empty spots in our request. Are you interested in joining our board where our colleagues or co-workers would typically stand, or representing us at PSSNY meetings let us know as or work and phone numbers we can no longer dial or call. we will have a regional meeting during our mid winter to The list is endless and the despair on our faces covered up choose two reps for Brooklyn and Queens. in a mask is still very obvious. Our prayers and hope is that May the festival of lights of Hanukkah, the hope of the impressions they all left with us will bring some comfort. Christmas and the seven principles of Kwanzaa fill our My personal thoughts is being sent to the Orlando family hearts and homes. I wish you and your loved ones a of town drugs and Willilam Mantel of Vitality and to those happy new year. other families thatI did not get a chance to meet. Thank you for all of your support and I look forward to I write with great joy celebrating our fellow pharmacists a new year filled with joy, good heath and prosperity. Till on the front lines in retail and hospital settings who are I write or see you over zoom stay safe, wash hands and working tirelessly to take care of our sick patients and practice social distancing. fighting hard to be recognized for the work we do. Signing ~ Aniedi Etuk, RPh up to do COVID testing and eventually administer the NYCPS Chairwoman Guidance and resources to plan for the road ahead. At MassMutual Metro New York, we’re affiliated with MassMutual — a solid company with a long-running history of financial strength and stability. And with access to MassMutual’s broad product line, services and tools, we can help you reach the financial goals that matter most.

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Insurance Representative of Massachusetts Mutual Life Insurance Company (MassMutual), Springfield, MA 01111-0001, and its affiliated US Insurance companies. Local firms are sales offices of MassMutual, and are not subsidiaries of MassMutual or its affiliated companies. Insurance products issued by Massachusetts Mutual Life Insurance Company (MassMutual), Springfield, MA 01111, and its affiliated US insurance companies. 1Disability income insurance policies have exclusions and limitations. 2Securities and investment advisory services offered through MML Investors Services, LLC, Member SIPC® and a MassMutual subsidiary. Supervisory Office: 250 West 34th Street, One Penn Plaza, Suite 2035, New York, NY 10119-0002. 212-736-2001. 3Performed in conjunction with your attorney and/or other advisors. 4Trust services provided by the MassMutual Trust Company, FSB, a wholly-owned subsidiary of MassMutual. CRN202212-275576 PAGE 12 DECEMBER 2020 YEAR END EDITON NYCPS NEWSLETTER

Jim Schiffer Reporting... R END 0 • YEA - 202 ER News from Around MB CE DE The Pharmacy World

DECEMBER 2020 YEAR END EDITION 2020 WRAP UP along, we see some very unpresidential actions, pardons This issue of our newsletter spilled over to January 2021, to his cohorts (some real sleezy folks), medals of freedom and I am finishing this column on Wednesday January 6th, to reward loyalists to the President, and raging complaints a day which will be remembered as the day Washington on the false claims of illegal mail ballots and complaints that DC almost fell to a mob attack. And yes, I am taking an the Centers for Disease Control has deliberately inflated the unusual posture of sounding off in this column on the end of number of COVID-19 deaths in this country. This four year the Trump Presidency. If you disagree, I accept your right of President Trump will be remembering in history books in to disagree, but as I am a nearly 70-year-old individual, I the future as a strange and disorganized period of time in need to sound off and I will take the liberty to exercise my our country with the looming question, what does Vladimir own individual and personal thinking in this section of the Putin have on this man? We hope and pray for decency and News from Around the World column. The year has been honor being restored to the White House in the presence of one strange and scary year, the Pandemic snuck into the President Elect Joe Biden. United States in late December 2019 or early January 2020 and took a grip on the folks in the United States like nobody PHARMACY WIN IN US SUPREME COURT OVER ever expected. President Trump in his own strange way of PCMA (PBM TRADE ASSOCIATION) management tried to play down the seriousness of this killer FINAL RULING - - PHARMACY 8 - PCMA 0 virus for month after month. Then in mid-September 2020 The Supreme Court of the United States issued its as Bob Woodward published his second book on President landmark ruling in Rutledge v. Pharmaceutical Care Trump, Rage, the country learned that Trump knew all Management Association (PCMA), determining whether along about the potency of the COVID-19 Virus but decided community pharmacies are protected from abusive payment not to alarm the country because he did not want to scare practices of the PBM’s. For decades the PBMs have hidden anyone. Woodward shared tape recordings of his multiple behind a confusing federal law known as federal Employee conversations with Trump which confirmed Trump knew that Retirement Income Security Act of 1974 (“ERISA”). ERISA is the COVID-19 virus was easily transmitted and that facial a section of law that pre-empts all state and local regulations mask wearing (although not 100% protective) would help that deals with employer sponsored health plans and prevent the virus transmitting from one person to another. benefits. At the heart of the issue was the extent to which Instead of straight talk to our citizens, Trump tried to hid the (ERISA), which regulates private employee benefit under the proverbial “blanket” as he kept saying the virus plans, preempts the states from regulating the amount was going to disappear like magic. Well nearly a year later that PBMs pay pharmacies to dispense prescription drugs we have over 350,000 dead (and more dying every day) that are covered by an employer-sponsored health plan. It from COVID-19, our economy is in tatters and millions of has taken decades for the Supreme Court to finally rule on people (especially in the food and entertainment industries) an ERISA case dealing directly with state PBM oversight. are out of work. Then when the voters of this country Other states besides Arkansas have attempted to reign decided one term was enough, Trump in his typical style in PBM issues but each time before this, the local federal claims his election victory was stolen. Friends I try to avoid courts or the respective appellate court would strike down getting too political, out of respect to our diverse political regulations that seemed to interfere with ERISA exemptions. views, however the circumstances surrounding the past The state of Maine back in 2003, tried and came close to four years show a disdain to honesty, ethics and just plain PBM regulations some years back which I reported in this decency. As the final days of the Trump Presidency move column. The district court magistrate judge, MARGARET continued on page 13 NYCPS NEWSLETTER DECEMBER 2020 YEAR END EDITON PAGE 13 Around the Pharmacy pharmacists, and pharmacies,” legislative activity in Congress in the From page 12 said Rebecca Snead, RPh, NASPA coming congressional session. As executive vice president and CEO. I have mentioned many times in the J. KRAVCHUK, held that the PBM “Now, it’s time to get to work to make past, I have been a supporter and industry creates a “layer of fog”, sure states have appropriate PBM member of NCPA (I joined when it was specifically Judge Kravchuk wrote, “In regulations in place, and continue to known as the National Association of other words, although PBMs afford a work with our members of Congress to Retail Druggists) since 1974, shortly valuable bundle of services to benefits do the same for the federal programs.” after I received my pharmacist license. providers, they also introduce a layer of “Today, Arkansas pharmacists join fog to the market that prevents benefits their colleagues across the country SURPRISING RETAIL CHAIN IS providers from fully understanding how to celebrate a triumphant victory SAVED FROM BANKRUPTCY best to minimize their net prescription years in the making,” said Arkansas Covid-19 has wrecked many retail drug costs.” Although Judge Kravchuk Pharmacists Association CEO John outlets, big and small, and malls are found this statute was legal, the 1st Vinson. “The Supreme Court’s ruling hurting all over this country and the Circuit of the Federal Court held that means that states can finally protect our world. Yet, JC Penny has emerged the statue violated ERISA. However, in patients who receive their pharmacy from bankruptcy. You may not know the Arkansas statute, Arkansas fought benefits through their employers. that JC Penny was the parent of their appellate court loss right up to the This win should increase drug pricing several regional pharmacy chains over United States Supreme Court (in the transparency, increase pharmacy the 20th century. The surprising move 8th Circuit Federal Appeals Court in St. access for patients, improve freedom out of bankruptcy happened when two Louis). It took nearly two years for the of choice, and improve the healthcare competing mall owners got together in Supreme Court to render a decision in for our citizens both during and after an effort to keep the JC Penny chain part due to COVID-19 and a jammed the pandemic.” alive as the malls fight to stay afloat. packed Supreme Court calendar. NCPA will continue to monitor the Two large commercial landlords, In the words of NCPA’s CEO, Doug Arkansas statue and share updates with keen interest in mall survivals, Hoey, this unanimous (8 to 0) decision as the law is now enforced. There Simon Property Group and Brookfield ruled in favor of the interests of patients are other important pharmacy related Property Partners have finalized a and community pharmacies, who have cases working their way through the deal worth about $800 million to save been fighting for years to regulate courts, and there will be lots more the JC Penny department store chain pharmacy benefit managers (PBMs), continued on page 14 the controversial middlemen that manage prescription drug benefits for health insurers, Medicare Part D drug plans, and large employers. With this ruling, states will have greater authority to protect their local businesses and their patients from PBM overreach. Other pharmacy associations chimed in as well. This is a great day for pharmacists and their patients,” said Scott J. Knoer, executive vice president and CEO of the American Pharmacists Association. “For years, PBMs have threatened the sacrosanct relationship between pharmacists and they been forced to answer to any authority for their actions. This opinion redresses that imbalance and returns the power to protect the interests of patients to the states and other local authorities, where it belongs.” “We’re excited to see a unanimous decision from the Court on this case – it’s truly a best-case scenario for patients, PAGE 14 DECEMBER 2020 YEAR END EDITON NYCPS NEWSLETTER Around the Pharmacy chain’s 17 locations in Charleston. federal Controlled Substance Act. In order to satisfy the FTC concerns, Many times, the DEA lawsuits force From page 13 JC Penney divested 164 stores in the the defendant pharmacy or supplier or from certain and terminal bankruptcy. Carolinas. The divested stores were big box operator or common carrier to This interesting joint venture of two purchased by an investment group settle with a large civil fine instead of mall operating companies, avoided a led by former Thrift Drug executives fighting things out in court. In a recent total liquidation of Penny as well as who left JC Penney after the Eckerd Wall Street Journal editorial, the WSJ saving about 70,000 jobs and 650 transaction. These stores were editors took aim at the unfair attacks stores in the process. It seems to renamed the Kerr Drug chain, using of pharmacies, chains locations and be a total win for all parties, the mall the name of another former Carolinas other DEA registrants at the vague set operators, (who desperately need chain acquired by JC Penney in 1995. of enforcement rules and regulations to keep the “anchor stores” alive to After JC Penny acquired Eckerd, in as drawn up by the DEA. Also keep the malls viable); the JC Penny 1997 JC Penney merged Thrift Drug mentioned the famous DEA Red Flag current employees; and the various and all other pharmacy chains into rules have no true connection to any suppliers that would have been left the larger Eckerd chain (now split up precise regulation or statue. Related in the lurch had JC Penny shut down between CVS Pharmacy and Rite Aid. to that issue is the concept of rejecting for good. Years ago, JC Penny JC Penny used to have New York City prescribers that order “Holy Trinity” owned the Thrift Drug Chain which as their headquarters and several drug cocktails as the DEA claims was a regional pharmacy chain. years back they decided to relocate has no therapeutic value. This case Thrift Drug was a U.S. pharmacy to a suburb of Dallas, Plano Texas. will be interesting. Back in 2013, the chain founded in 1935 and originally JC Penny headquarters were in New DEA threatened to sue United Parcel based in Pittsburgh, Pennsylvania. York City from 1914 until the move to Service and FedEx for negligence in The company was purchased by JC Plano in 1988. While bankruptcy was their shipping “suspicious” deliveries Penney in 1968, and Penny greatly filed in May of 2020 leading to the of controlled and or illicit drugs to expanded this drug chain, having closure of hundreds of J.C. Penney people’s homes or businesses. The Thrift serve as the flagship chain of stores, the company used to be at the UPS leadership folded like a manilla JC Penney’s pharmacy group. The top of the retail game, with the move envelope and forked over $40 million chain did not hide its affiliation with to Texas playing a big part in its early settlement. FedEx took a different JC Penney, as it had JC Penney success as Texas does not maintain approach, they fought the DEA in catalog “pickup centers” locate inside corporate or individual income taxes federal court in California, guess many of the Thrift Drug locations, as and the real estate taxes are a fraction who won? It was not DEA, FedEx well internal promotions advertising of what they are in New York. won. It seems FedEx attempted to “JC Penney Catalog Center”. Stores Moving onto other chains, both CVS work with the DEA on suspicious also accepted the JC Penney credit and Walgreens have been doing a bit order addresses and the DEA refused card for purchases. better as the pandemic has focused on to work with FedEx, claiming their Continuing the growth of Thrift, in access to vaccines and Covid-19 testing policy is not to share information on 1996, JC Penney purchased Eckerd, at these pharmacy chains. Even Rite Aid alleged illegal activity. Well Kudos to another pharmacy chain. The Federal who is a mere shell of what it was before FedEx for holding their ground as the Trade Commission (FTC) initially they tried to be married to Walgreens is judge spanked Dea for their arrogant objected to the purchase on antitrust doing better and their stock price even behavior. Let’s see how Wal-Mart grounds, stating that ownership of perked up to over $21 per share in late handles this 900-pound gorilla. Eckerd would give JC Penney a December. What will happen in 2021? dominant position in the drug store The vaccine administration should help CLOSING business in the states of North the bottom line for all of the pharmacy Folks time to wrap up this issue Carolina and South Carolina through chains. Let us see if 2021 turns out to be of our year end newsletter. 2020 was its ownership of Thrift Drug, Rite Aids a better year for independent pharmacies truly a historic, and sad year We were in the Carolinas, and Eckerd. The FTC as well. hoping for a Happy and Healthy New ultimately approved the transaction, Year but so far 2021 has not been but as a condition of approval, in 1997 DEA VS WAL-MART much better (except for the hopes of JC Penney and Thrift were required to You may have heard that Wal- a successful Covid-19 vaccine rollout, divest 14 Thrift drug stores in Charlotte Mart had sued the Justice Department and oh yes, best of luck to our new and 20 Thrift stores in Raleigh-Durham, as an attempt to fight back against President, Joseph Biden. as well as all 110 Rite Aid locations in the Drug Enforcement Administration ~ Jim Schiffer the state of North Carolina and that (“DEA”) before the DEA sued Wal- ©2020 James R. Schiffer Mart for various violations of the All rights reserved NYCPS NEWSLETTER DECEMBER 2020 YEAR END EDITON PAGE 15 Yes, I Got the Vaccine!

As a pharmacist and a resident of New Jersey I was when I had operated my pharmacy, some local medical able to register for the Moderna COVID-19 vaccine. doctors in Brooklyn that would save their left-over flu Bright and early on Wednesday January 6th, I was given vaccines and use them for the next flu season, isn’t that the first of the two doses of this important and potentially ethical??? How will your software system handle billing life-saving medication (my second dose is scheduled for for the various health plans who cover your patients? February 5, 2021). Except for a little soreness in my arm, Time will be needed to access contracts from the various I am feeling fine. Over the past few weeks, I have fielded health plans and Will a phone app (like the one used for many pharmacists calls and emails from our NYCPS COVID-19 testing) which simplifies the registration and pharmacist members who want access to the COVID-19 administration process. My message here is please be vaccine for: (i) to be administered to themselves for patient, please stay involved ad aware of the process, I their own protection and (ii) to have access to adequate have been assured by my contacts at the NYS Senate quantities of COVID-19 vaccine to provide to their patients and Assembly that Governor Cuomo and NYS Health who seek this important vaccine. (see the open letter Commissioner Howard Zucker values our involvement. to Governor Cuomo by our NYCPS and PSSNY past We are an important part of the health care delivery team president Boris Mantell). Conversations on how to set and are now recognized by the public more than every of up our members access to these important vaccines are our importance to the public. ongoing between NYCPS leadership, PSSNY leadership ~Jim Schiffer and elected officials serving us in New York City and Albany. I have been informed by various elected officials in the NYS Assembly and Senate that it is planned that independent pharmacist immunizers will be granted access to the COVID-19 vaccines, hopefully by early March. There are several issues which need to be worked out before these life saving vaccines are delivered to the pharmacies. Just think about this process. Consider, the logistics of delivery to your pharmacy, your ability to maintain the freezer temperatures needed for safe and proper storage. Then move onto issues of patient distribution, will your pharmacy have the sufficient number of interested vaccine recipients or will your supply of vaccine turn bad before you can provide all to your patients have you ever get stuck with flu vaccines? (We have already seen some examples of such waste in hospitals scattered throughout the country). I remember from the days PAGE 16 DECEMBER 2020 YEAR END EDITON NYCPS NEWSLETTER

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Dear Colleague, Medicare has established its payment rates which are: As we prepared for the holiday season, the U.S. also First dose: $16.94 anxiously awaited what could be the most important gift it Second dose: $28.39 has received in decades — a vaccine to protect against For a one-dose vaccine, the payment will be $28.39. the anxiety and the threat of COVID-19. Community Each dose is slated to come with its own PPE kit. pharmacies are going to be in the middle of the action Commercial payers are free to set their own and pharmacy practice will never be the same again. vaccination payment rates, but NCPA is hopeful those Thousands of pharmacies have signed agreements rates will be at least comparable to the Medicare rates so to access the vaccines through their PSAO or CPESN®, that the pharmacy network is as robust as possible. Early and thousands more will be working through their reports to NCPA have reflected a mixed bag. NCPA also respective department of health to access vaccines. We strongly supports that the immunization be billed through know that the CDC has encouraged states to use CVS the medical benefit rather than the PBM. and Walgreens to service long-term care facilities — a The opportunity to be a solution to a public health crisis decision that surprised NCPA and our members since the is enormous. The business opportunity is also sizable. As LTC population has unique needs that require nuanced a point of comparison, LAST year 48.4 percent of people and intricate care that’s nearly impossible to produce over the age of 18 got a flu shot. en masse. For the sake of patients, everyone hopes Last year, CVS administered 9 million flu shots. This for a successful roll out of the vaccine, and community year they report being on track to double that number. Rite pharmacists are ramping up to help wherever it is needed Aid and Walgreens report a 50 percent increase in the and whenever we are allowed. number of flu vaccinations this year. We have also heard NCPA has told the CDC that the roll out of the vaccines from our members similar reports about a surge in their flu will not be successful unless community pharmacists are vaccination practice. Pharmacists providing vaccinations involved. is no longer a ‘nice to do.’ It is a core competency for Dr. Robert Redfield, director of the CDC, said this to the profession. Just as counseling, checking for drug me in a Nov. 10 letter: interactions, and facilitating medication adherence “Community pharmacists, including those represented are core competencies, so now must vaccinations by by the National Community Pharmacists Association pharmacists join the list. (NCPA), have a unique ability to amplify COVID-19 I mention the flu vax to say that even with widespread vaccine administration efforts using existing infrastructure vaccine hesitancy, there is a good chance that at least to reach a significant portion of the population. Engaging the same number of people who got their flu shot in a with community pharmacists will be an important part pharmacy this year will also get their COVID-19 vaccine. of our pharmacy partnership strategy as we recognize Whatever number that is, double it, since right now, most the value these providers play in their communities, of the vaccines require two shots. Then do the math and particularly rural and underserved communities.” decide if the opportunity makes business sense. If your NCPA has been preparing our members for the Phase calculation is close, I say round up because brick-and- 2 rollout, which is anticipated to include not only the Pfizer mortar community pharmacies have a rare opportunity to and Moderna vaccines, but other vaccine candidates as redefine themselves now and forever as a public health well. There are tons of step-by-step resources on the solution that includes and goes beyond the dispensing of NCPA website to help motivated members, including a prescriptions. recent webinar to answer questions and to go over what we know so far about distribution, contracting, and billing. Best, Speaking of billing, remember that the vaccines are Douglas Hoey, Pharmacist, MBA “free” in that they are paid for by taxpayers. But while the NCPA CEO vaccine may be free, the vaccination is not. PAGE 18 DECEMBER 2020 YEAR END EDITON NYCPS NEWSLETTER MEDICATION SAFETY • PREVENTING ERRORS By the Institute for Safe Medication Practices “Have you experienced a medication error or close call? Report such incidents in confidence to the ISMP National Medication Errors Reporting Program (ISMP MERP) at 1-800-FAIL-SAF(E) or online at www.ismp.org to activate an alert system that reaches manufactur- ers, the medical community, and FDA. ISMP guarantees confidentiality of information received and respects reporters’ wishes as to the level of detail included in publications.”

Wrong resident errors. Wrong patient errors do not only or illegible, pharmacy staff should contact the LTC facility happen at the point-of-sale in pharmacies or only impact retail to collect and verify the information. Pharmacies may also customers. The Institute for Safe Medication Practices (ISMP) consider employing alerts to warn staff about possible name regularly receives reports of wrong long-term care (LTC) resident confusion when residents have the same or similar last names, errors that occur when pharmacy staff enter a medication order particularly if residing in the same LTC facility. into the wrong resident’s profile. This erroneous order entry Educate fluorouracil home infusion patients about subsequently appears on the wrong resident’s pharmacy- accidental overinfusion. We received a call from the family prepared medication administration record (MAR) increasing of a patient with cancer who was to receive a 7-day infu- the risk that the error will reach the resident. Similar or the sion of fluorouracil at home via an ambulatory elastomeric same last names of residents are at the root of many of these infusion pump. For an unknown reason, the entire infusion errors. The risk can be compounded if the resident’s name is ran in over 4 days. The patient was very sleepy for the next not clearly printed on the order. 2 days and had “terrible diarrhea.” Even though the infu- In one event, the pharmacy received an order for warfarin sion was empty, they waited until the patient’s scheduled 4 mg for a resident, but the order was entered into the profile appointment 4 days later to report the mishap. The doctor of another resident with the same last name. Although the drug hospitalized and treated the patient. The patient was dis- appeared on the wrong resident’s MAR, the error was caught charged after 7 days of hospitalization. by a nurse before warfarin was given. ISMP has also received reports in which medications for This incident points to the need to educate patients with a resident in one LTC facility were accidentally entered into ambulatory infusion pumps about specific details in regards to the pharmacy computer for a resident in another LTC facility. how the pump works, what to expect over the course of the For example, a buprenorphine (BUTRANS) patch (7.5 mcg/hr) treatment, infusion rates, how long the infusion should last, how intended for an opioid-tolerant resident with chronic pain was much should be left in the container each day, and the need dispensed to an opioid-naïve resident with the same last name to immediately report any incident to their care team should in a different facility. Fortunately, a nurse noticed the error the container empty sooner than anticipated. Dangerous before the patch was applied. delays have been known to occur because patients are Unlike traditional community pharmacy practice, those often asymptomatic in the first few hours and days. But rapid who provide medications to LTC residents cannot engage identification of an overdose allows prompt treatment with the residents to help in the identification process. Pharmacies the antidote to minimize serious side effects and the risk of a must rely on the information they receive from the facility. Use harmful or fatal outcome. Patients need to be educated about at least two resident identifiers (i.e., full name and date of birth) rapidly reporting events so an antidote can be administered. to verify resident identity. If these identifiers are not available

• CPESN NY has contracted with 7 different payers, including Healthfirst, on payment for pharmacy services • CPESN NY has an exclusive contract with USA Update Prescryptive and the State of New York to provide COVID-19 testing at your pharmacy • CPESN NY has members-only pricing discounts from WHAT A YEAR IT HAS BEEN! Cardinal Health/Kinray on COVID-19 supplies As we say goodbye to 2020 and look ahead to the If you are looking to re-energize your pharmacy promise of better days in 2021, we’d like to thank all of business in 2021. It is now time to consider joining the the pharmacy-industry leaders, pharmacy owners, and CPESN movement taking place in the State of New York partners for the success CPESN NY has experienced, and NYC. Don’t put it off any longer! IF YOU AR NOT despite the challenges the year gave businesses ALREADY A CPESN MEMBER NOW IS THE TIME TO everywhere. JOIN!!! For more information on CPESN pharmacies, CPESN NYC has experienced an explosive year and visit cpesn.com/pharmacies, or you can contact either is poised for even more successes in the year ahead. of the New York City CPESN Luminaries, Roger Paganelli Consider: at: [email protected], by phone 917 417 0240, or • CPESN NY has grown to over 250 participating Vinnie Mazzamauto at [email protected] or by phone at pharmacies, including over 150 in the five boroughs 845 406 0547. Happy and Healthy New Year 2021!! NYCPS NEWSLETTER DECEMBER 2020 YEAR END EDITON PAGE 19 Governor Cuomo…We Are Here to Help… Why Not Let Us Do It Now!!! An Open Letter to Governor Andrew Cuomo Dear Governor Cuomo: Why are you holding up the vaccinations of New Yorkers? New York State pharmacists are in the best position of helping immunize their communities. And I mean pharmacists in all community pharmacies, not just the big chain pharmacies. Most of the pharmacists in New York State are certified pharmacist immunizers. We have been immunizing New Yorkers for years. We are fully qualified and most accessible health care providers available. You are dragging your feet. Since Modena vaccine has become available, every independent pharmacist immunizers as well as chain pharmacists in New York State are ready to do the job. In New York City , we pharmacists are standing by able and willing to contribute in the fight against Covid 19. We have not abandoned any of our patients when this pandemic hit New York back in March 2020. Please wake up and smell the coffee. Your delay is deadly. Since the Moderna vaccine was made available we could have immunized probably over 1 million New Yorkers. Other states have been very happy utilizing their independent pharmacists/ immunizers in contributing big time in this vaccine. Arkansas Governor Asa Hutchinson said on “Face the Nation” in the January 3rd show pointed out how the independent pharmacists immunizers made a huge positive difference in his state. We are waiting for you to make this move. Let’s go, Governor Cuomo we are here to help save New Yorkers lives. Sincerely Boris Mantell, RPh New York City

PAGE 20 DECEMBER 2020 YEAR END EDITON NYCPS NEWSLETTER DEA and accurate perpetual inventory. How you ask? Here is my suggestion. If you have one supplier, the perpetual From page 1 inventory can be done for all controlled substances. You the Brooklyn Bridge for a simple $1.00 and I’m sure you need to contact your prescription software provider who know what I’m saying. Last year, Attorney Jim Schiffer can provide you the service. In most cases, your software and I covered more employee theft than any other year. update will cause you no additional expense. Yes! It is Who were the thieves? Family members, husbands, free! wives, their children, pharmacists, pharmacy technicians, Now, let us talk money! Like we said $15,080 per re- cashiers, etc. You get the point? cord-keeping violation and $64,640 per prescription vio- We are not writing this to scare you, but to tell you lation. If you have the unfortunate moment to have DEA that you need to maintain a perpetual inventory for all come into your pharmacy, you need to understand that controlled substances. All opioids should be accounted they are not there to help you, but to look for violations of for whether on paper or electronic. Now you say that the federal laws and regulations with regards to the handling DEA regulations says that “Schedule II must be exact of your controlled substances. Their number one goal is while Schedules III to V can be estimated provided that to determine diversion. the containers hold no more than 1,000 dosage units”. So To determine that controlled substances have not true! The DEA regulations under Title 21, Code of Fed- been diverted into the illicit black market, DEA person- eral Regulations Section 1304 says, “A registrant must nel will do an audit of your controlled substances. Lately, maintain a complete and accurate inventory of their con- they have been auditing Schedules III to V controlled sub- trolled substances”. The DEA civil settlements also say stances such as APAP with Codeine, Clonazepam, Lora- that, “the registrant failed to maintain a complete and ac- zepam, Tramadol, etc. If you have such audit, you need curate inventory of their controlled substances to prevent to immediately call your corporate counsel or attorney. the diversion of such controlled substances into the illicit My question to you as the owner of your pharmacy, market”. The DEA Diversion Offices in the State of New do you have so much money that you want to give it to the York are competing for the greatest civil fine in a case. government? Look, I know you care, but your constant saying that “you ~ Carlos M. Aquino have no time to keep a complete and accurate perpetual Compliance Consultant & Founder inventory” should never be a vocabulary coming out of PharmaDiversion LLC™ your mouth. ©2020 Carlos M. Aquino So, you want to know what to do? Maintain a complete All rights reserved

NYCPS President’s Message state the important roll we play in We will be providing and updating From page 1 our communities as well as have you with relevant information as we a service that you provide and get it. we have Supreme Court’s decision get reimbursed for it without PBM With a great relief I bid farewell to warrant PBM reform in New York involvement. My pharmacy is part to Year 2020 and welcome Year State. We need Governor Cuomo to of CPESN NYC network and with 2021, full of new beginnings and recognize this important decision. their leadership I was able to set opportunities. By now every pharmacy up a testing site in my pharmacy Please register for the upcoming should be registered with a federal and provide a much needed service PSSNY Mid Winter Meeting January partner to provide vaccinations to my community. I would strongly 30-31, which will be another virtual to our communities. If you have encourage you to look in to obtaining event. To register: not registered yet there is still an a CLIA waver and joining CPESN to • go to pssny.org and select meetings opportunity, please reach out to us at help you set up for COVID testing. • email: [email protected] [email protected]. We now have a new Facebook • or call 518-869-6595 As you all know last year page for NYCPS members only. I Wishing everyone a prosperous Governor Cuomo had allowed encourage you to use this link to join year. Till next time. pharmacies to test for COVID-19 the group: in New York State. We have a https://www.facebook.com/ ~ Ilana Aminov great opportunity to show the groups/249383519910587 NYCPS President NYCPS NEWSLETTER DECEMBER 2020 YEAR END EDITON PAGE 21 BILLING AND DISPENSING VAGINAL CREAMS – TIPS TO AVOID RECOUPMENT

Vaginal creams are targeted during many audits due o PBMs know there is a wide dosing range and limited to the high probability of insufficient directions for use, high package size and may allow claims that exceed 100- cost, unbreakable package and plan limits that prevent the day supply; do not assume the plan will limit the claim pharmacy from billing the true days’ supply. When a PBM to a 30 or even a 90-day max auditor sees a claim for Premarin® or Estrace® vaginal o If the claim is rejected due to a days’ supply limit, call cream, they see dollar signs and often 100% recoupment. the pharmacy help desk to obtain an override—if no To reduce the risk of an audit recoupment, please review override exists, document that date of the call and the following table. who you talked with on the hardcopy, then bill the Vaginal Cream Package Applicator Applica- largest days’ supply allowable (OptumRx® outlines Size Calibrations tor Max this process in their provider manual1 under heading Premarin® (conjugated 30 g 0.5 g 2 g V, section P) estrogens) 0.625 mg/g increments • Write the true days’ supply in the sig field so the patient Estrace® (estradiol) 0.01% 42.5 g 1, 2, 3, or 4 g 4 g can see how long the tube should last and to serve as an alert to the individual billing the claim PAAS Tips: • Preventing early refills is necessary to avoid recoupment • Obtain calculable directions that include the number of • Periodically perform a self-audit of recent vaginal cream grams per application and frequency of use claims to ensure your hardcopies are complete • One-half applicatorful for Premarin® is 1 g, but for PAAS National® is committed to serving community Estrace® it is 2 g pharmacies and helping keep hard-earned money • When the cream is also being used externally, be where it belongs. Contact us today at (608) 873-1342 or sure there is a defined amount of cream indicated in [email protected] to see why membership might the directions (e.g., “pea-sized amount” is typically be right for you. interpretated to be 0.25 g) ~ By Trenton Thiede, PharmD, MBA, ® • Always bill the true days’ supply first President at PAAS National , expert third party audit advice and FWA/HIPAA compliance. PSSNY Executive Director Mid-Year Meeting is January 30th provided scholarships for SPSSNY From page 4 and 31st. A dynamic Keynote students to attend the meetings. Presentation from Antonio Ciaccia Students register here: https://www. This is exactly the reason and Scott Knoer from APhA will pssny.org/events/EventDetails. pharmacists need to be vaccinated open the event. Please join your aspx?id=1458151&group= asap. colleagues for a lively and timely two- Remember to stay connected Another update involving the New day event. Register today at: https:// through eblasts, Escript, social York City DOHMH is a new partnership www.pssny.org/events/EventDetails. media and SHARE the benefits of with PSSNY to offer funding to aspx?id=1361263&group= membership with your colleagues NYC independents for COVID-19 As you know, pharmacy students who are not yet PSSNY members. related needs. The announcement are an integral part of PSSNY’s *Pharmacists who join PSSNY as came in an eblast from PSSNY and Mid-Year Meeting and this year a new member before the Mid-Year through the PHERN system with a we have a full slate of student Meeting can attend the event free- link to a Needs Assessment. The programming that includes a virtual of-charge. https://www.pssny.org/ submission deadline is January 7th Poster Presentation. We encourage general/register_member_type.asp and once results are scored the top all PSSNY members to attend the Stay safe and stay involved in 50 applications will be eligible for presentation at the conclusion of your pharmacy organization. Thanks funding of up to $10,000. Access the Saturday’s agenda. If you are a for all you do. opportunity and Needs Assessment preceptor, encourage your student ~ Deanna Ennello-Butler, link here: https://conta.cc/2KK4psu to attend the event. PSSNY affiliates Executive Director A reminder that PSSNY’s virtual including NYCPS and IPS have PAGE 22 DECEMBER 2020 YEAR END EDITON NYCPS NEWSLETTER

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All products may not be available in all states and territories. NYCPS NEWSLETTER DECEMBER 2020 YEAR END EDITON PAGE 25 Modern Compounding cies, hospitals, and warehouses, bears an appropriate instruction to and during shipping are allowed. protect the article from freezing. From page 3 Provided the mean kinetic tem- Protection from light: Where out all the conditions which appear on perature does not exceed 25°, tran- light subjects an article to loss of all the labelling of compendial legend sient spikes up to 40° are permitted strength or potency, or to destruc- drugs, goods, and supplies: as long as they do not exceed 24 tive alteration of its characteristics, h. Spikes above 40° may be per- STORAGE CONDITIONSvi the container label bears an appro- mitted only if the manufacturer so Specific directions are stated in priate instruction to protect the arti- instructs. Articles may be labeled some monographs with respect to cle from light. for storage at “controlled room tem- storage conditions, e.g., the temperature” or at “up to 25°,” or other perature or humidity at which an wording based on the same mean WHAT SHOULD I LOOK AT NEXT? article must be stored and shipped. kinetic temperature. An article for Utilizing the “storage conditions” Such directions apply, except which storage at Controlled room provided above you should review where the label on the article has temperature is directed may, alter- your physical space(s), assure that different storage conditions that are natively, be stored and shipped in you have the correct monitoring based on stability studies. Where a cool place or refrigerated, unless devices in all areas necessary no specific storage conditions are otherwise specified in the individual (including your compounding spaces) provided in the individual mono- monograph or on the label. as well as a clear document pathway graph, but the label of an article to prove that all these areas are fully states storage conditions based on Warm: Any temperature between under your control. stability studies, such labeled stor- 30° and 40° (86° and 104 °F). Remembering that if you age directions apply. Excessive heat: Any temperature compound (either sterile or non- Freezer: A place in which the tem- above 40° (104 °F). sterile preparations) additional perature is maintained between Dry place: The term “dry place” de- guidance as to specifics of storage −25° and −10° (−13° and 14 °F). notes a place that does not exceed of components and finished preparations will be contained within Refrigerator: A cold place in which 40% average relative humidity at the corresponding compounding the temperature is maintained be- 20° (68 °F) or the equivalent water general chapter (<795>, <797>, or tween 2° and 8° (36° and 46 °F). vapor pressure at other temperatures. The determination may be <800>) as applicable. Cold: Any temperature not exceed- made by direct measurement at the ing 8° (46 °F). place or may be based on reported CLOSING THE LOOPS IN YOUR Cool: Any temperature between 8° climatic conditions. Determination DOCUMENTATION – and 15° (46° and 59 °F). [NOTE— is based on NLT 12 equally spaced Pulling together a formal An article for which storage in a cool measurements that encompass monitoring process (to assure the place is directed may, alternatively, either a season, a year, or, where daily data collected is correct and be stored and shipped as refriger- recorded data demonstrate, the all out of specification conditions ated, unless otherwise specified by storage period of the article. There are remedied timely), the annual the individual monograph.] may be values of up to 45% relative calibration and maintenance of all of your temperature and other sensors is Room temperature: The tempera- humidity provided that the average consistent will assure that you have a ture prevailing in a work area. value does not exceed 40% relative humidity. Storage in a container proper compliance program. Finally, Controlled room temperature: validated to protect the article from making sure you have a screening & The temperature maintained ther- moisture vapor, including storage in audit tool for all these processes, and mostatically that encompasses at bulk, is considered a dry place. it is in-use by the pharmacy will close the usual and customary working the needed documentation loop. environment of 20°–25° (68°–77 Protection from freezing: Where, Controlled Substances - If your °F). The following conditions also in addition to the risk of breakage of routine compounding includes apply. Mean kinetic temperature the container, freezing subjects an controlled substances, please be not to exceed 25°. Excursions be- article to loss of strength or poten- sure all your reporting, invoicing, tween 15° and 30° (59° and 86 °F) cy, or to destructive alteration of its and other documents are up-to-date, that are experienced in pharma- characteristics, the container label continued on page 26 PAGE 26 DECEMBER 2020 YEAR END EDITON NYCPS NEWSLETTER Modern Compounding CLOSING THOUGHTS lectures, writes, and consults on these topics; A complete and thorough of your Lou lends his expertise to many State Boards From page 25 of Pharmacy and is a nationally recognized current pharmacy operation and the subject matter expert on compounding, quality neat and that your CDS inventory is associated temperature monitoring management, & medication safety. During the completed and within easy reach. equipment will assure that you are 2020 Pandemic LDT has been appointed a Pharmacy Monitor of the temporary Veterinary compounding - If your providing the safest and highest quality prescriptions and custom Field Hospital Operations by the NJ Board practice includes the compounding of Pharmacy, overseeing the medication of medications for animals (that are medicines to your patients. distribution and automation & robotics use for not food-producing animals) you the Governor’s project. must assure that the storage of Lou Diorio, RPh, FAPhA- Is a principal ©2020 Louis Diorio, RPh, LDT Health these materials is consist with their of LDT Health Solutions, Inc. (LDT) a Solutions Inc. all rights reserved. labelling. medication safety & quality management consulting company with over 70 years of i https://www.fda.gov/emergency-preparedness-and-response/ [Although this list is not intended to combined pharmacy expertise serving clients mcm-legal-regulatory-and-policy-framework/emergency-use- authorization nationwide. Lou is a graduate of Long Island be complete, it should assist you in ii https://www.pfizer.com/news/hot-topics/covid_19_vaccine_u_s_ getting started. Your analysis must University’s Schwartz College of Pharmacy, distribution_fact_sheet and an adjunct Professor of Pharmacy iii https://www.fda.gov/media/144638/download be specific to your pharmacy, it must iv Practice for the college. Lou is an active https://www.cms.gov/ v be specific to the types of items member of the College’s Alumni Executive https://www.nist.gov/ vi Excerpt from USP General Chapter <659> you stock, dispense and utilize to Board. Lou has extensive experience in IV © US Pharmacopeial Convention [www.USP.org] compound regularly] and extemporaneous compounding, and

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