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NEW YORK CITY PHARMACISTS SOCIETY PRESIDENTS MESSAGE VOLUME 26, ISSUE 1 PSSNY HELPLINE 1-800-632-8822 JANUARY/FEBRUARY 2017 The Voice of Pharmacy in the Big Apple www.NYCPS.org I hope Everyone is well. I want to thank all attendees, sponsors, and exhibitors of the Midwinter Convention! Steve Moore and his convention commit- tee killed it. It was truly an unforget- table event. Stephanie Alvarez did an outstanding job with the student programming. I believe we may have had close to 300 people at our Con- vention. Lots of credit goes to Kathy Fabrio our Executive Director, Claire, Terry, Jamie, Barbara, and student volunteers. Our Conventions keep getting bigger and better each year. We are selling out of sponsor and exhibitors. We have several vendors on waiting list to be able to present to our organizations. Hats off to Russell, Roger, Ray and Dhiren of the RX PAC committee. The Rx PAC was able to raise well over $41,000 in less than 30 minutes. I love the fact that we don’t need to nag folks for money. People get what we are trying to do. Now for the first time, many folks are giving to us with open arms. I thank everyone for this new awareness of PSSNY. Thank you for staying in touch and be- ing involved. My next topic is very near and dear to my Heart and Wallet. March 7th is our annual NY Pharmacist and Pharmacy Owner Lobby Day. Each Year we have close to 200 motivated and forward thinking Pharmacist and Owner converge on the steps of the New York State Capital and Legislative continued on page 17 OFFICERS Parthiv Shah, President 718-292-4244 Aniedi Etuk, President Elect 212-222-3652 Bill Scheer, Treasurer 917-805-4207 Jim Schiffer, Secretary 212-616-7069 BOARD OF DIRECTORS Ron DelGaudio, Chairman 718-230-3535 Stephanie Alvarez 347-860-1390 Ilana Aminov 212-929-7527 Charles Catalano 718-358-1300 Mike Agovino 718-543-3116 Charlie Ciaccio 718-452-3261 Vito Columbo 718-418-9700 Jim DeTura 718-292-1856 Aneidi Etuk 212-222-3652 Russell Gellis 212-877-3480 Carol Georgiadis 718-762-7111 Roy Greif 718-363-3300 Robert Hopkins 516-852-1405 Ray Macioci 718-823-1085 Boris Mantell 347-276-5566 John Navarra 212-213-5570 Joseph Navarra 212-213-5570 Boris Natenzon 718-720-3710 Roger J. Pagenelli 718-364-6100 Dhiren Patel 212-281-0488 Alex Perchuk 718-835-2000 Richard Schirripa 646-590-1154 Mohammed Taher 718-827-7528 PSSNY REGIONAL REPS Parthiv Shah Bronx Dhiren Patel Manhattan Boris Natenzon Brooklyn, Staten Island Robert Hopkins Queens RECORDING SECRETARY Ilana Aminov 212-929-7527 NEWSLETTER Jim Schiffer, Senior Editor 212-616-7069 Designed, Printed & Mailed by: GBV Printing Services 631-231-7300 IN THIS ISSUE President’s Message ...................... 1 How to Survive a DEA Inspection Series ....................... 1 PSSNY Albany Lobbyist’s Report ..... 3 Treasurer’s Report .......................... 4 A Message & Greetings from PSSNY Executive Director ............... 4 A Message from PSSNY President Russell Gellis .................. 6 Secretary’s Report.......................... 8 Important Information Regarding Compounds and CVS Caremark ...... 8 NPCA .......................................... 10 ISMP ........................................... 11 PAAS........................................... 11 News from Around the Pharmacy World........................... 12 PSSNY Pharmacy Practice Coordinator ................................. 19 Important Information ................... 21 IF THERE IS A “D” OR “VD” ON YOUR LABEL... YOU’RE DELIQUENT OR VERY DELIQUENT. PLEASE REMIT. FOR FURTHER INFORMATION CALL 1-800-632-8822 The New York City Pharmacists Society 111 Broadway, Suite 2002, New York, NY 10006 ADDRESS SERVICE REQUESTED After so many years of doing CE presentations by Attorney James R. Schiffer and myself on issues relating to the handling of controlled substances by a retail pharmacy, we always are asked the difference between “Corresponding Responsibilities” and the “Due Diligence Policy” of a pharmacy. The corresponding responsibil- ities can be found in federal regu- lations specifically Title 21, Code of Federal Regulations Section 1306.04 that states the following. “(a) A prescription for a controlled CHAIRMANS REPORT P AGE 3 PSSNY EXECUTIVE DIRECTOR P AGE 4 PSSNY PRESIDENTS MESSAGE P AGE 6 continued on page 23 How To Survive A DEA Inspection Series: Understanding The Difference Between Corresponding Responsibilities Of A Pharmacist And The Due Diligence Placed On A Pharmacy Registrant

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Page 1: NEW YORK CITY PHARMACISTS SOCIETY How To Survive A › › resource › resmgr › NYCP… · NEW YORK CITY PHARMACISTS SOCIETY President’s Message VOLUME 26, ISSUE 1 PSSNY hELPLINE

N E W Y O R K C I T Y P H A R M A C I S T S S O C I E T Y

President’s Message

VOLUME 26, ISSUE 1 PSSNY hELPLINE 1-800-632-8822 JANUARY/FEBRUARY 2017The Voice of Pharmacy in the Big Apple www.NYCPS.org

I hope Everyone is well. I want to thank all attendees, sponsors, and exhibitors of the Midwinter Convention! Steve Moore and his convention commit-

tee killed it. It was truly an unforget-table event. Stephanie Alvarez did an outstanding job with the student programming. I believe we may have had close to 300 people at our Con-vention. Lots of credit goes to Kathy Fabrio our Executive Director, Claire, Terry, Jamie, Barbara, and student volunteers. Our Conventions keep getting bigger and better each year. We are selling out of sponsor and exhibitors. We have several vendors on waiting list to be able to present to

our organizations. Hats off to Russell, Roger, Ray and Dhiren of the RX PAC committee. The Rx PAC was able to raise well over $41,000 in less than 30 minutes. I love the fact that we don’t need to nag folks for money. People get what we are trying to do. Now for the first time, many folks are giving to us with open arms. I thank everyone for this new awareness of PSSNY. Thank you for staying in touch and be-ing involved. My next topic is very near and dear to my Heart and Wallet. March 7th is our annual NY Pharmacist and Pharmacy Owner Lobby Day. Each Year we have close to 200 motivated and forward thinking Pharmacist and Owner converge on the steps of the New York State Capital and Legislative

continued on page 17

OFFICERSParthiv Shah, President 718-292-4244Aniedi Etuk, President Elect 212-222-3652Bill Scheer, Treasurer 917-805-4207Jim Schiffer, Secretary 212-616-7069

BOARD OF DIRECTORSRon DelGaudio, Chairman 718-230-3535Stephanie Alvarez 347-860-1390 Ilana Aminov 212-929-7527Charles Catalano 718-358-1300Mike Agovino 718-543-3116Charlie Ciaccio 718-452-3261Vito Columbo 718-418-9700Jim DeTura 718-292-1856Aneidi Etuk 212-222-3652Russell Gellis 212-877-3480Carol Georgiadis 718-762-7111Roy Greif 718-363-3300Robert hopkins 516-852-1405Ray Macioci 718-823-1085Boris Mantell 347-276-5566John Navarra 212-213-5570Joseph Navarra 212-213-5570Boris Natenzon 718-720-3710Roger J. Pagenelli 718-364-6100Dhiren Patel 212-281-0488Alex Perchuk 718-835-2000Richard Schirripa 646-590-1154Mohammed Taher 718-827-7528

PSSNY REGIONAL REPSParthiv Shah BronxDhiren Patel ManhattanBoris Natenzon Brooklyn, Staten IslandRobert hopkins Queens

RECORDING SECRETARYIlana Aminov 212-929-7527

NEWSLETTERJim Schiffer, Senior Editor 212-616-7069Designed, Printed & Mailed by: GBV Printing Services 631-231-7300

IN THIS ISSUEPresident’s Message ......................1

How to Survive a DEA Inspection Series .......................1

PSSNY Albany Lobbyist’s Report .....3

Treasurer’s Report ..........................4

A Message & Greetings from PSSNY Executive Director ...............4

A Message from PSSNY President Russell Gellis ..................6

Secretary’s Report ..........................8

Important Information Regarding Compounds and CVS Caremark ......8

NPCA ..........................................10

ISMP ...........................................11

PAAS...........................................11

News from Around the Pharmacy World ...........................12

PSSNY Pharmacy Practice Coordinator .................................19

Important Information ...................21

If there Is a “d” or “Vd” on your label... you’re delIquent or Very delIquent. please remIt.

for further InformatIon call 1-800-632-8822

The New York City Pharmacists Society111 Broadway, Suite 2002, New York, NY 10006

ADDRESS SERVICE REQUESTED

After so many years of doing CE presentations by Attorney James R. Schiffer and myself on issues relating to the handling of controlled substances by a retail pharmacy, we always are asked the difference between “Corresponding Responsibilities” and the “Due Diligence Policy” of a pharmacy. The corresponding responsibil-ities can be found in federal regu-lations specifically Title 21, Code of Federal Regulations Section 1306.04 that states the following.“(a) A prescription for a controlled

Chairman’s reportP a g e 3

pssnY exeCutive DireCtor

P a g e 4

pssnY presiDent’s message

P a g e 6

continued on page 23

How To Survive A DeA Inspection Series:

Understanding The Difference Between Corresponding

Responsibilities Of A Pharmacist And The Due Diligence Placed

On A Pharmacy Registrant

Page 2: NEW YORK CITY PHARMACISTS SOCIETY How To Survive A › › resource › resmgr › NYCP… · NEW YORK CITY PHARMACISTS SOCIETY President’s Message VOLUME 26, ISSUE 1 PSSNY hELPLINE

PAGE 2 JANUARY/FEBRUARY 2017 NYCPS NEWSLETTER

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NYCPS NEWSLETTER JANUARY/FEBRUARY 2017 PAGE 3

New York State Budget News Testimony presented February 16th by PSSNY President Russell Gellis and Executive Director Kathy Febraio at the NYS Legislature’s Joint Budget Hearing on Health and Medicaid was very well received. If enacted, the Governor’s Budget Proposal would:• Change the reimbursement formula in FFS Medicaid

to Actual Acquisition Cost (NADAC) for brands plus a $10 professional fee, sharply reduce Medicaid covered OTCs, pay the $10 fee for OTC’s and change co-pays to $2.50 across the board for brands and to $1 for OTC’s and generics. (NADAC = WAC-3.3%) Also: for non-NADAC brands WAC-3.3%; for generics lower of WAC-17.5%, FUL or SMAC. Medicaid will continue to pay at Usual & Customary if lower than any of these. You may ask what is NADAC? It is a pricing scheme based on National Average Drug Acquisition, and therefore the acronym (NADAC). Such pricing is calculated by the review of the voluntary cooperation of pharmacies that are sampled for their drug costs from their suppliers and the NADAC pricing was established several years ago by the Centers for Medicare and Medicaid Services.

• Regulate and license PBMs through the Department of Financial Services.

• Establish a state benchmark price for high cost drugs then require manufacturers to pay a supplemental Medicaid rebate equal to the difference between the benchmark and the manufacturer’s price or, in non-Medicaid, apply a 60% surcharge on the difference.

• Authorize Comprehensive Medication Management so that community pharmacists can collaborate with a primary care MD to manage non-adherent patients with common chronic diseases.

Highlights of PSSNY’s testimony:Medicaid Budget Proposals: More Smoke and Mirrors The CMS Covered Outpatient Drug Final Rule requires that as of April first this year pharmacies will be

paid at an Actual Acquisition Cost (AAC) methodology for drugs plus a new professional dispensing fee. The Rule includes the additional stipulation that pharmacy reimbursement as a whole should be fair: payments are to be consistent with efficiency, quality of care and assure access. Nothing in the CMS requirement suggests that realigning the reimbursement formula means the reduction in per prescription payment levels. Use of NADAC is concerning.• For some independents, (NADAC) payment at a national

average cost will be below their dead net cost.• NADAC costs will never be current due to price increases.• NADAC represents a deep cut in payment to pharmacies

for prescription drugs. Proposed $10 fee is unreasonable, inadequate and unsustainable• By any reasonable standard, the fee in New York should

be higher than the fee paid in other states to take into account New York’s high taxes and business costs as well as the new mandatory minimum wage.

• We are very concerned about the viability of independent community pharmacies and the patients they serve having access to high priced brand name medications that do not have generic equivalents (i.e. HIV, Hepatitis C, transplants, MS, diabetes, cancer and epilepsy ).

• It is important to reiterate that the Department of Health did not conduct a recent up-to-date cost of dispensing survey. They relied on the flawed 2012 survey that was rejected by the legislature.

• CMS requires that the state either does its own current updated cost of dispensing survey or uses the data from recently approved cost of dispensing surveys done in another state adjusted for the cost of doing business in New York. The Department of Health has done neither. This proposal represents a steep cut in reimbursement to pharmacies and is unacceptable.

PSSNY strongly supports PBM registration and licensing• PBMs raise drug prices by extracting rebates from

pharmaceutical manufacturers for formulary positioning. As a result manufacturers are forced to increase drug prices to offset rebates they anticipate paying to pharmacy benefit managers.

• PBMs often keep a significant portion of manufacturer rebates that is not always transparent to their clients who are the payers, i.e. health plans, insurers and large employers.

PSSNY Albany Lobbyist’s Report

This is an update on several key issues, which affect the practice of pharmacy here in New York State. You should already be familiar with the terms relating to these proposed pieces of legislation.

continued on page 19

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PAGE 4 JANUARY/FEBRUARY 2017 NYCPS NEWSLETTER

This year there is a unique opportunity for pharmacists to have an item on our wish list answered. This year the governor has added into his budget a proposal to register PBM’s in New York State, and to put them under the control of the Department of Financial Services. The PBM industry has been neither fish or fowl; neither a fiduciary agent, responsible for the cost to its clients, nor a simple intermediary facilitating prescription transactions for both pharmacies and payers. This apparent lack of definition has been a constant source of frustration for our industry, as we attempted to shed some light on the deceptive and predatory practices the PBMs use to manipulate their profit margins. The governor has decided that these agents have been the causative factor in escalating prescription expenses for this state through the Medicaid program. He is asking for the PBMs to be registered and under the control of the Department of Financial Services, which will set up standards of practice for the PBM industry. This department will have the authority to suspend or revoke said licenses for deceptive, unfair or abusive business practices. So we have the chance to see many of the complaints we have noted and shouted about come under the scrutiny of a government agency for the first time. Not content with going after the PBMs, the governor is also going after the Pharmaceutical Manufacturers for the

exorbitant drug price increases we have seen occurring over the past few years. He has recognized the effect it is having on our customers, and included a plan to limit price increases in New York, innovative, and definitely a shot across the bow for the runaway drug manufacturer industry.This is why it is more important than any time in the past few years that we have your presence at our Lobby Day, Tuesday March 7th in Albany to make sure that in the budget negotiations our assemblypersons and Senators know the importance to our industry of these budget proposals, that they must be kept in the budget and enacted as law. We are usually on the other side from the governor, his object to cut costs, ours to keep our businesses viable and profitable. This time the stars have aligned and we have a common issue that can and will benefit both the state and pharmacy. I do not remember having that luxury for the focus of our lobby day before, usually it being the uphill battle to have the legislature work with us to correct a budget attack. Again our nemeses will be there trying to deflect the issue and change the proposed budget . This is not a difficult to explain this issue. It doesn’t involve WAC or AWP, things that seem to make most legislators eyes glaze over. It is simply the regulation of an industry that being unregulated effects not just us but every one of their constituents. Its the best we could have hoped for , that the PBMs a would be regulated in this state and held responsible for deceptive ,predatory and non transparent business practices. Show up in Albany on March 7th and help bring this about for pharmacy.

- Bill Scheer, R.Ph. © 2017, Bill Scheer

Treasurer’s CornerPERFECT STORM

The PSSNY Mid-Winter Meeting was an amazing success! I hope you were there and enjoyed the camaraderie, professional development, and networking opportunities.For those of you who were not able to be there, here’s what you missed

The Students We had a record turnout of students, thanks in part to NYCPS’ generous contribution to the Student Sponsorship Program. This program sponsors the registration and hotel accommodations for ten students from each school—70 students. In addition, another 39 students registered at their own expense.

The students were an impressive group—engaging with the exhibitors, networking with fellow students from across the State, and fulfilling their volunteer requirements in exchange for the sponsorship. The Student Business Plan competition pitted four teams against one another in a due diligence analysis of a hypothetical pharmacy that is available for purchase. The teams evaluated the financials, product offerings, staffing and store layout to determine a fair market value for the store. All of the teams did a phenomenal job!Congratulations to the winning team: Laura Bielecki, Olivia Dioguardi, Stacy Fredrick, Cassandra Nickola from University of Buffalo School of Pharmacy. The Student Poster competition was another great example of the work happening on New York’s campuses and the preparation the next generation of pharmacists are experiencing. Topics included the impact of patient counseling on patient outcomes and the patient/pharmacist relationship, prevalence of medication synchronization in community pharmacy and PBMs as

A MessAge & greetings FroM PssnY

executive DirectorMiD-Winter WAs AMAZing!

continued on page 21

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NYCPS NEWSLETTER JANUARY/FEBRUARY 2017 PAGE 5

Page 6: NEW YORK CITY PHARMACISTS SOCIETY How To Survive A › › resource › resmgr › NYCP… · NEW YORK CITY PHARMACISTS SOCIETY President’s Message VOLUME 26, ISSUE 1 PSSNY hELPLINE

PAGE 6 JANUARY/FEBRUARY 2017 NYCPS NEWSLETTER

chAnce oF A liFetiMe Pharmacy issues are taking a very prominent position in the Governor’s proposed 2017-2018 State budget, offering us an opportunity to have more influence on our patients’ outcomes than ever before. This, combined with PSSNY’s Legislative Agenda: The Pharmacy Patient’s Right to Care http://c.ymcdn.com/sites/www.pssny.org/resource/resmgr/Legislative/PSSNY_Legislative_Agenda_201.pdf puts us in the right place, at the right time. Within the budget, the Governor is taking on the high cost of prescription drugs through a multi-pronged approach and one of his most exciting proposals is one we have all been waiting for: the regulations of PBMs.

• The Department of Financial Services (DFS) would be authorized to regulate the pharmacy benefit managers (PBMs), initially as registered entities and eventually, as licensed entities. DFS would be given broad authority to require PBMs to report financial incentives for promoting

certain drugs, as well as other financial arrangements deemed reportable by DFS. Regulations would establish standards to eliminate deceptive practices, conflicts of interest, anti-competitive practices, and unfair claims practices. PBMs would be subject to investigations, examinations and held accountable for reporting, upon penalty of perjury, fines, and/or revocation of registration or licensure. This is an opportunity to have a conversation with our elected representatives and inform them of the egregious practices of the PBMs and their impact on the patients we serve. Any proposal such as this, will have incredible pushback from the PBM lobby group, the PCMA; however, we are not their biggest foe, the Governor of the State of New York is.

• The Health Department would be empowered to identify a drug that seems excessively expensive, demand detailed disclosures from its manufacturer about costs and pricing, refer that information to a Drug Utilization Review Board, and establish a maximum “benchmark price” for the product. If a manufacturer exceeds the benchmark, the excess would be rebated to the state and for sales to the private sector, a 60% surcharge would be assessed on the price difference. These funds would be held for the purpose of reducing health insurance premiums. The details are vague and there will be significant pushback from the manufacturers, but we need to assure that the pharmacy and our partner wholesalers are not swept into these surcharges and fees.

Medicaid Covered Outpatient Drug Rule As I have been reporting, CMS announced last year that by April 1, 2017, every state must pay pharmacies on the basis of actual acquisition cost and establish a reasonable professional dispensing fee for patients in the Medicaid Fee for Service program. The Governor’s budget includes the NYS Department of Health’s proposal which includes a proposed $10 professional dispensing fee and ingredient costs as:

• Brands: the lower of NADAC or Usual & Customary (U&C)• Brands with no NADAC value: lower of WAC-3.3% or U&C• Generics: Lower of NADAC or U&C• Generics with no NADAC value: l ower of WAC, FUL, SMAC or U&C

NY Medicaid officials have met monthly with PSSNY leaders since February to discuss this proposal. We reiterated that ingredient cost and professional dispensing fees should meet this standard: total reimbursement to pharmacies must be consistent with quality of care and must assure patient access. It is amazing that New York State has a dispensing fee lower than North Dakota and Missouri when clearly we have

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Page 7: NEW YORK CITY PHARMACISTS SOCIETY How To Survive A › › resource › resmgr › NYCP… · NEW YORK CITY PHARMACISTS SOCIETY President’s Message VOLUME 26, ISSUE 1 PSSNY hELPLINE

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Page 8: NEW YORK CITY PHARMACISTS SOCIETY How To Survive A › › resource › resmgr › NYCP… · NEW YORK CITY PHARMACISTS SOCIETY President’s Message VOLUME 26, ISSUE 1 PSSNY hELPLINE

PAGE 8 JANUARY/FEBRUARY 2017 NYCPS NEWSLETTER

We have just returned from one of the most successful and informative PSSNY Mid-Winter Meeting in Albany New York at the end of January. There were in excessive of 250 attendees which included our government officials, and government agency leaders. PSSNY put together a very impressive mid-winter event. As I have been preaching for years, you don’t know what you are missing by not attending these events. Show me where you can direct a face to face question with the Executive Secretary of the State Board of Pharmacy, or a member of the Bureau of Narcotic Enforcement on important issues affecting your profession? Assemblyman John McDonald, a pharmacist, pharmacy owner and member of the NYS Assembly addressed the group at the PSSNY general membership session. PSSNY leadership addressed many items brought to the state legislature by Governor Cuomo in his proposed April 1, 2017 budget. Did you know that Governor Cuomo has proposed regulating Pharmacy Benefit Managers in his budget bill (meaning he places a priority on that issue)? Did you know that NYS Medicaid (fee for service) is proposing a huge change in reimbursement to conform to federal guidelines which will mean closer cost rates but a dispensing fee of $10 per dispensing (including OTC covered items)? But with the other hand Governor Cuomo is proposing to eliminate many OTC products from the NY Medicaid formulary. I just gave a short synopsis of some of the issues discussed at the PSSNY Mid-Winter meeting. I am giving you advance notice of the PSSNY Annual Independent Pharmacist Lobby Day which will be held on Tuesday March 7th in Albany at the State Capital, The Egg. Join your colleagues to advocate for the best interests of community pharmacy to your state senator

and state assemblyperson. In Governor Cuomo’s proposed NY State Budget there are two key two issues for community pharmacy, they are the new Medicaid Fee for Service reimbursement methodologies and Governor Cuomo’s bold proposal to regulate Pharmacy Benefit Managers. Show me an independent pharmacy owner that has not had a problem with these PBMs. Restrictive networks, intentional underpayments, outrageous audit techniques, reduced reimbursement, DIR fees, mandatory mail order plans, need I go on? Looking further into the future, our PSSNY Summer Convention will be held in Rye Brook New York during June 23rd to June 25th a three-day marathon packed event which I urge all to attend. Folks there is plenty going on in New York and the country, especially with a new president, President Trump running the country. Every day is an interesting day with daily events affecting our lives taking place. What will become of state Medicaid programs under President Trump? What is really going to happen to the Affordable Care Act? Will be build a wall on our southern border? Will we really see new jobs in our country? Will we see tax reform? Many questions, but what will really happen? I urge you all to attend the March 7th Independent Owners Day at Albany as well as sign up for the PSSNY Summer Convention. I suggest you read this newsletter cover to cover as many important issues are in this issue. Make sure you are following the rules of your PBM contracts on your purchases and dispensings. If you don’t it may cost you that PBM contract. Terminations are common and the minimum time of such termination is 12 months (some other are lifetime bans while others are up to 5 years) but it takes on average an additional 3 months after that 12 month period to get your pharmacy approved for readmission to that PBM! Stay in touch, stay well and informed.

- Jim Schiffer, Secretary NYCPS

se C r e T a r y’sreporT January/february

2017

a higher cost of doing business and new minimum wage requirements to implement. PSSNY will begin its fight against this proposal at the Joint Legislative Budget Hearing on Health and Medicaid, February 16 where I will testify and explain to the Senate and Assembly Health Committees PSSNY’s position on the State budget proposals.

Comprehensive Medication Management The Department of Health, as a result of recommendations of the Deliv-

ery System Reform Incentive Payment (DSRIP) Program, have included a Comprehensive Medication Manage-ment program in the budget, recogniz-ing the importance of clinical services a pharmacist brings to the healthcare team that improve patient outcomes and how these activities can decrease costs in the healthcare system. It is defined as a “program that ensures a patient’s medications, whether pre-scription or non-prescription, are in-dividually assessed to determine that each medication is appropriate for the patient, effective for the medical condi-tion, safe given comorbidities and other medications being taken, and able to be taken by the patient as intended.” It is

implemented pursuant a “comprehen-sive medication management protocol” which is a written document entered into voluntarily by a physician or a nurse practitioner and a qualified pharmacist. A “qualified pharmacist” is a pharmacist with a current unrestricted license who has completed one or more programs accredited by ACPE.

Lobby Day The March 7 Lobby Day will be critical to making our voice heard on all of these issues in pharmacy. Please join us. It is the Chance of a Lifetime!

Russell Gellis, RPhPSSNY President

PSSNY PresidentFrom page 6

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NYCPS NEWSLETTER JANUARY/FEBRUARY 2017 PAGE 9

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PAGE 10 JANUARY/FEBRUARY 2017 NYCPS NEWSLETTER

If you are the type of person who doesn’t care for politics, then 2016 was a rough year for you. On the other hand, if you are a political junkie, then you must be loving 2017! The news cycle for the first two weeks has been dominated by speculation about positions President-elect Trump, his administration, the Republican Congress, and the Democrats will be taking. If you are a cable news talking head, business is booming right now! Policy positions on health care have been dominated by the Affordable Care Act (ACA), but a couple of days ago the President-elect forcefully articulated this position on drug pricing: “We have to get our drug industry coming back. Our drug industry has been disastrous. They’re leaving left and right. They supply our drugs but they don’t make them here, to a large extent. And the other thing we have to do is create new bidding procedures for the drug industry, because they’re getting away with murder.”

--President-elect Donald Trump, January 10, 2017 Candidate Trump had expressed his concerns about drug pricing while campaigning, but it certainly wasn’t as dominant a theme as it was for candidate Clinton. In fact, despite the sector losing an estimated $24.6 billion in market cap after Trump’s comments this week, overall the sector is still up nearly 9% since the election, according to Fortune magazine. We think that the way prescription drug costs are currently managed in the U.S. is backward. Pharmacists, the only providers who are experts on the way medications work and how much they cost, largely have their hands tied to help lower costs. And, PBMs, which are hired to keep drug costs down, make money when drug prices go up. It’s backward! NCPA said as much in correspondence to President-elect Trump this week. Our letter asked the Administration to first take out the waste in the system and that new models that can lower prescription drug costs: “. . . we believe there are simpler, more transparent, and more economical ways to administer the important prescription benefit Americans need to get and stay healthy.” NCPA also sent a letter to key members of Congress as they consider ACA replacement package ideas to warn them of possible unintended

consequences if/when the ACA is repealed and also to suggest solutions. For example, you may recall several years ago that NCPA and NACDS won a temporary restraining order that stopped the Centers for Medicare & Medicaid Services from moving forward with the way it was implementing average manufacturer’s price (AMP) in the Medicaid program. Without that court order, thousands of pharmacies would likely have closed their doors. We then worked with Congress to refine Medicaid reimbursement using AMP, which was passed as part of the massive ACA. That improved AMP approach could be in jeopardy if ACA is repealed without precision. Pharmacists have much to offer to help make sure our country is getting the most bang for its buck from prescription drugs and to lower overall health care costs. We wound down our letter to the President-elect with these words: “Our interests are to help citizens get the best value from their hard-earned dollars and allowing pharmacy small businesses to better serve the people in their communities. Independent community pharmacists can help solve drug problems, ensure appropriate medication use, and stretch prescription dollars farther.”

- B. Douglas Hoey, RPh, MBANational Community Pharmacists Association CEO

rx Drugs cAtch truMP’s eYe

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NYCPS NEWSLETTER JANUARY/FEBRUARY 2017 PAGE 11

Securing the cap on Quillivant XR. A toddler was admitted to the hospital with a QUILLIVANT XR (methylphenidate) overdose. The medication, used to treat attention deficit hyperactivity disorder (ADHD), had been prescribed to his sibling. Quillivant XR is available as a powder, which after reconstitution, forms an extended-release oral suspension. After reconstitution and prior to dispensing, the pharmacist is to insert the manufacturer supplied bottle adapter into the neck of the Quillivant XR bottle. It is critical that the adapter be properly inserted so the child-resistant cap can properly engage the bottle. The manufacturer also supplies an oral syringe which should be provided to the patient. In the case above, the adapter was not inserted into the bottle by the pharmacy. Instead, the parent inserted the adapter and screwed on the cap. However, the adapter was not seated correctly and therefore the child-resistant cap did not engage. When the toddler found the bottle he was able to remove the

cap and drink the contents of the bottle. The young boy was admitted to the hospital and required several days of supportive therapy. Thankfully, he recovered. To reduce the risk of accidental ingestion of this medication, pharmacists should insert the bottle adapter and confirm that the child-resistant cap properly engages the bottle prior to dispensing. Consider adding a note to the pharmacy receipt to remind the pharmacist to insert the adapter after reconstitution. Pharmacists should teach and verify, using a teach-back method, that parents or caregivers can accurately prepare a dose of the medication using the oral syringe and adapter and securely close the bottle. It is also important to educate parents and caregivers to store this product, and other medications, up and away and out of the sight and reach of children at all times. Advise parents and caregivers to call the Poison Help Line (1-800-222-1222) immediately if they suspect a child has ingested a medicine. For more strategies to

MeDICATION SAfeTY • PReveNTINg eRRORSBy 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.”

continued on page 25

Many pharmacies have questions about how to fill and bill prescriptions for brand products when a generic is approved. Recent generic approvals of the blockbuster branded products Crestor® and Nexium® have caused significant confusion. While in general, most states require substitution to an AB-rated generic product when available, the confusion commonly arises due to insurance “preferences” during the initial 6-12 months of generic availability. During this period there may be only a smaller number of generic products and the discount off the brand is small. As a result of this modest discount many insurance plans will still prefer brand name – this is due to rebate arrangements with manufacturers that likely cause the brand product to be less expensive overall. Pharmacies often struggle with determining if they should dispense brand or generic and what DAW code (if any) to submit. Here are some tips from the PAAS team.

1. All prescriptions should initially be transmitted with a DAW-0 (brand or generic NDC) unless the prescriber or patient have requested otherwise

2. If the brand is preferred, submit the brand NDC with DAW-0 or DAW-9 as directed by the plan

3. Some tricky PBMs that prefer generic, including CVS Health, may actually pay for a claim submitted for brand product (DAW-0) but reimburse BELOW cost

4. If the prescriber issued the brand prescription BEFORE generic approval and now generic is available, then you should follow state substitution laws and payer, patient and prescriber preferences. You generally will not need a new prescription to substitute an equivalent generic.

We caution pharmacies to avoid submitting erroneous DAW codes as this is a substantial audit risk. If the plan does not cover generic or brand when submitting DAW-0 or DAW-9 we suggest you contact the PBM helpdesk for advice when processing the claim.

hoW Do i Bill BrAnD ProDuct When generic is APProveD?

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Jim Schiffer reporting...News from Around

The Pharmacy World

jANUARY/feBRUARY 2017 eDITIONOur New President We elected Donald J. Trump as president of the United States back in November. President Trump was sworn in to office on January 20th at noon in Washington D.C. Things in Washington D.C. have not quite been the same since that day and most of the concerns raised by many folks have to do with several of President Trump’s impulsive and candid styles. Many people have such personality traits but then again, most people are not elected to President of the Unit-ed States. Our concern as a profession affected by federal decisions rests with several key areas, Medicare Part B re-imbursement, Medicare Part B efforts to have pharmacists recognized as PROVIDERS and not just suppliers, Medi-care Part D concerns on a multiple set of levels, preferred pharmacy copay variations, specialty reimbursement and charges related to DIR fees, access to health insurance prescription plans as federal guidelines permit “closed net-works”, status of Medicaid reimbursement, in both the fee for service open network Medicaid and Medicaid Managed Care (limited networks). Some of the picks President Trump has made for cabinet positions has us scratching our heads. Dr. Ben Carson who is a well-respected neurosurgeon is now changing fields to run the federal Department of Hous-ing and Urban Development (once lead by our own Andrew Cuomo for President Bill Clinton.) Then there is the very controversial secretary is the selection for the federal De-partment of Health and Human Services (HHS) Secretary, Tom Price. He was confirmed by the United States Senate in a party-line vote of 52-47. Democratic senators were con-cerned that this conservative congressman from Georgia wants to drastically cut down government health programs. Democrats were also very troubled by lingering ethics ques-tions over Price’s financial investments in health care related companies while he would then introduce legislation which would directly help these companies.

Secretary Price, is a retired orthopedic surgeon from suburban Atlanta, and he had served as chairman of the House Budget Committee. Secretary Price has the responsibility to implement the repeal and replacement of Obamacare, or the Affordable Care Act, which his re-publican colleagues in Congress have been working on this year. This repeal of Obamacare is very controversial as many citizens are now protesting the possible loss of Obamacare as a safety net for their health care concerns. Secretary Price will oversee HHS which has a budget of $1 trillion, and the largest budget of any Cabinet secretary. In addition to Obamacare, HHS administers the Medicare and Medicaid programs and oversees the National Insti-tutes of Health, among other programs and agencies. Secretary Price will have oversight on our pharmacy profession. Secretary Price has a reputation as being a budget hawk who over the past few years he has pro-posed replacing the Affordable Care Act subsidies that are tied to income, with tax credits to purchase insur-ance. Tax credits are not determined by an individual’s income level. It will be interesting to see what really comes of Obamacare in this session of Congress. Just like our proposed wall on the southern border, will it be built? Who knows?

Health Insurance Mergers The pending mergers of mega health insurance com-panies specifically Aetna’s efforts to purchase Humana as well as the Anthem attempted buy out of Cigna have been both rejected by their respective federal judges. Thus, there are breakup fees normally awarded to the smaller party that was rejected at the alter by the big-ger company. Courts refer to these fees as anti-breakup strategies to prevent the original parent insurance com-panies from changing their minds. Aetna has thrown in

continued on page 13

january/february - 2017

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NYCPS NEWSLETTER JANUARY/FEBRUARY 2017 PAGE 13

continued on page 14

the towel on the acquisition that they tried to make with Humana after the Judge’s ruling against the $34 billion deal. Since Aetna gave up any ap-peal rights, Aetna will fork over $1 Bil-lion to Humana which was what the contract called for in the event of a termination of their agreement. Ad-ditionally, Aetna will also have to pay a breakup fee to Molina Healthcare since Aetna was anticipating selling off some of the Medicare Advantage Part C plans as part of a divestiture to get the government to go along with the purchase of Humana. The reason that the federal judge rejected the Aetna/Humana merger because after the trial was conducted the judge concluded that the merger wasn’t in the best interest of consumers, which was what the U.S. Justice Department had alleged all along claiming that the combined company would have too much control over the Medicare Ad-vantage market which would be anti-competitive. Regarding the Anthem attempt-ed takeover of Cigna, that deal also went south, with a ruling by a different federal judge. This health care mega merger was valued at $54 billion and the interesting thing about this merg-er trial was that the two parties (Cig-na and Anthem) acted more like arch enemies during the trial then they did act like bride and groom. Cigna man-agement seemed to be happy that the judge ruled against this merger, while Anthem was still acting like a wounded puppy dog. While Cigna would have been happy to continue life alone, Anthem scored a slight moral victory on Friday February 17th as federal appeals court agreed to rapidly review the Anthem appeal of

a trial judge’s ruling earlier this month that blocked the health insurer from acquiring rival Cigna. The US Court of Appeals for the District of Colum-bia Circuit said it will hear oral argu-ments in Anthem’s appeal on March 24. The US Court of Appeals for the DC Circuit could have let this drag on or could have rejected the request for an appeal. That would have made Cigna happy, but we shall see what comes of this review. In the mean-time, I suspect all such huge deals in healthcare will now be getting a clos-er look by the Trump administration than the public had expected.

Chain Pharmacy News The pending merger of Rite Aid into the Walgreens family has been delayed yet once again. This time the delay is costing Rite Aid millions of dollars in a reduced offering price. This pending deal, previously valued at $17.2 billion, including debt, is now valued at between $14 billion and $14.6 billion, depending upon the fi-nal purchase price which is open to a range of $6.50 to $7.00 share down from the prior offer of $9 per share. It seems that the Federal Trade Com-mission was not satisfied with the proposal which was on the table late in December with Fred Supermarkets and Pharmacies, buying 865 Rite Aid overlapping pharmacies which are located near existing Walgreens or Duane Reade locations. The price of this proposed sale is a fire sale price of $950 million. This proposed pur-chase by Fred’s Supermarket of 865 stores and certain assets related to store operations located across the eastern and western United States is still on the table for Rite Aid and Walgreens to grab if the merger deal goes through. Upon this proposed sale, Fred’s will operate the former

Rite Aid acquired stores and will re-tain the Rite Aid banner through a 24-month transition. Fred’s Pharma-cy expects that the acquired stores would be accretive to earnings and generate substantial cash flow. In the meantime, CVS Health has started their recovery in their stock price after the recent drop in value related to the loss of certain preferred networks in the Medicare Part D are-na, and the joint venture being estab-lished by Walgreens and Prime Ther-apeutics (a Midwestern based Blue Cross PBM venture with a strong presence in Medicare contracts). CVS Health continues to maintain a huge presence in the New York metropolitan marketplace. In other areas of the country, CVS Health - - although strong - - is not as powerful as they are in the metropolitan New York market.

Tightening the distribution of oxycodone The Drug Enforcement Admin-istration has reduced the output au-thorizations for pharmaceutical man-ufactures to product opioid drugs in 2017. The cuts in production is dras-tic, as the DEA has announced that in 2017, the DEA has reduced the number of opioids that can be man-ufactured in the US this 2017 calen-dar year. Production of the class of medications known as opioids, which are a class of pain medication, will be cut by at least 25 percent in 2017 due to less demand and growing concern around the abuse of these prescrip-tion painkillers. For some time, the DEA has set manufacturing quotas on the total amount of a controlled drug that can be produced each year. The 2017 change affects drugs in-cluding morphine, hydromorphone, oxycodone, hydrocodone, and fen-

Around the PharmacyFrom page 12

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PAGE 14 JANUARY/FEBRUARY 2017 NYCPS NEWSLETTER

tanyl. Production of some drugs will be reduced by more than a quarter. The amount of hydrocodone, for ex-ample, will be cut by 34 percent. As a result, the nation’s wholesalers will need to curb the amount of opioid sales that are permitted to their phar-macy constitutents. You may find your wholesaler is cutting back the amount of opioids you can purchase on an ongoing basis. Governor Chris Christie has signed a new law limiting prescribing of opioid medications to a five-day supply per prescription to new pa-tients. Exceptions will be made for those suffering from terminal condi-

tions, but for the average new patient for opioid medication it will be a limit of a five-day supply. For the longest time pharmacists, have been on the firing squad by the DEA when prescriptions which were questionable were filled at the Rx counter. Now at least in New Jer-sey a limit of a five-day supply will be mandated. A few months back Gov-ernor Cuomo initiated a similar limit of a seven-day supply for new patients being placed on opioid medications. These two initiatives are steps in the correct direction. Patients and Prescribers alike need to be reedu-cated in the use of morphine deriva-tives for use only when severe pain is diagnosed and being treated.

Pharmaceutical Pricing Issues Ever since Martin Shkreli was exposed for jacking up the price for their anti HIV drug, we have been working with national pharmacy organizations to help shed light on the outrageous pricing issues. There appears to be a new patient group known as Patients for Afford-able Drugs who is mounting a cam-paign for transparency in drug pric-ing. Between Daraprim pricing and Epi Pen Pricing the drug industry is under scrutiny. Interestingly New York’s Governor Andrew Cuomo is now looking to regulate the PBM industry as he included language in the pending New York State Budget. It would be nice to finally

have such operators final-ly get regulated. New York State may set the pace for such, although other states have made some inroads in such regulation. Remem-ber New York State started the trend toward prohibiting smoking in restaurants. It caught on nationally. I cannot wait for the spring NCPA Legislative meeting in Washington. I have been attending these annual events for years. This year’s meeting should prove to be a very inter-esting event with our new President Trump running the Executive Branch. Check out www.ncpanet.org and see meetings for the details. Speak to everyone in March, we may escape without any real winter. Global warming anyone? ~ Jim Schiffer

©2017 James R. Schiffer

Around the PharmacyFrom page 13

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NYCPS NEWSLETTER JANUARY/FEBRUARY 2017 PAGE 17

As a business owner you’re under-standably concerned with the rising incidence of stolen card-holder account data. The thefts cause businesses and financial institutions fraud losses and unanticipated operational expens-es, and inconvenience consumers significantly. The major credit card companies (Visa, MasterCard, American Express, and Discover) have established stringent requirements for collecting and storing customers’ payment card data. These Payment Card Industry (PCI) Data Security Standard Requirements protect your business, your customers (cardholders) and the payment system’s integrity. You may store the following cardholder data (but must still protect this data at all times):• Account number• Cardholder name• Expiration date Cardholder data you should never store:• Full magnetic strip or chip information• The card verification codes or values (three digit code on the signature panel or code embedded within the magnetic stripe)• The cardholder’s PIN You should always destroy or purge all media containing obsolete transaction data with cardholder information.

According to the PCI requirements, your business has to comply with security audits and you may be asked for a system’s scan or self-assessment. If your business has a security breach and is found not in compliance with the payment card security rules, there are severe penalties, including barring your business from accepting payment cards. When you follow the payment card security requirements you protect your customers’ sensitive data, and put your business at a competitive advantage with others that are not in compliance. Contact the bank or company that manages your payment card processing for details or visit www.pcisecuritystandards.org for more details on the PCI Data Security Standards Requirements. If you haven’t considered joining the Retail Council’s processing program, why not allow us to do a free, no-obligation savings analysis? We’re typically able to save businesses money on this expense. Your Retail Council membership is a great complement to the continuing education and other services you receive through NYCPS and PSSNY. In addition to our competitive credit card processing service, the Council also has a great workers’ compensation program,* which can save pharmacies significantly on this mandatory insurance. You can learn more about the Retail Council and its programs by visiting www.retailcouncilnys.com or by contacting us at (800) 442-3589 or [email protected].*Must be a dues paying member to participate in the workers’ comp program.

WhAt cArDholDer DAtA You cAn AnD cAnnot store

Security rules your business must follow

Office Building. This Year there will be no different. We are for the first time going to aid Governor Cuomo’s budget proposal. Governor wants to register the PBMs. You heard me correctly, REGISTER the PBMs. NY will be one of the first states to require the PBM to register with the state. Pharmacist and Owners from all 50 states are watching how we do in NY. Its up to us, New Yorkers to handle these PBMs. Most of you will not register and will not attend lobby day. Im warning you all. Guess who will be making the trip to Albany to wage a war against us, It will be our arch enemy the PBMs &

their association, Pharmaceutical Care Management Association, aka PCMA. Yes, these PBMS have already started to work hard to make us look bad in front of the legislatures. Wouldn’t it be nice to have some type of oversight over the PBMS. The PSSNY Leadership, as well as the PSSNY Lobbyists, and the members of the PSSNY Legislative committee have worked very hard to get to this final game. We all need to show up and be ready for our Pharmacy Super Bowl March 7th. All the groundwork has been done. We need to dig deep and execute. We can not leave one stone unturned. Our Industry, Our professional ancestors, our businesses depend on this single day of success. I get it.

No one wants to pay for coverage. No wants wants to come back to a mess at the pharmacy when the temporary help messed things up the previous day. I want to remind you what it is costing us to get to our LOBBY DAY each year; approximately $200,000 in lobbyist cost and possibly $100,000 in the Rx PAC distributions. Take what I just said and multiply by the number of years and meetings it took for the Governor to get our level of understanding of the PBM. Let us not miss this delicious opportunity!!! Register for Lobby Day today at PSSNY.org.. Thank you.

~ Parthiv ShahNYCPS President

President’s MessageFrom page 1

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PAGE 18 JANUARY/FEBRUARY 2017 NYCPS NEWSLETTER

In a business that is as fast changing as Independent Pharmacy do you really think signing a multi-year Prime Vendor Agreement makes sense?

At RDC we understand your business and your need for a flexible partnership! And we never charge for deliveries.

BEFORE YOU SIGN, CALL US!

800.333.0538 | www.rdcdrug.com

DON’T GET CUFFEDBY PRIME VENDOR AGREEMENTS!

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NYCPS NEWSLETTER JANUARY/FEBRUARY 2017 PAGE 19

• The budget proposal requires PBMs to report on an annual basis financial arrangements and other benefit for promoting certain drugs to the department of Financial Services, under penalty of perjury. These disclosures will begin to unveil the hidden costs and profit center of the PBMs that ultimately increase the cost of prescription drugs to consumers, health plans and the State of New York.

PSSNY supports efforts to control high drug costs• Manufacturers control drug

prices. Additional rebates and surcharges on should apply only to manufacturers. Wholesalers and pharmacies operate on razor thin margins and must be held harmless.

PSSNY supports Comprehensive Medication Management (CMM) • CMM is a recommendation from the Health Department to improve

adherence by patients with common chronic diseases. CMM authorizes primary care providers to refer selected patients to a local pharmacist for medication management services that are specified in a written protocol. The proposal requires that the pharmacist has access to the patient’s medical record.

Respectfully submitted,Elizabeth M. Lasky

Capital Public Affairs

PSSNY Lobbyist’s ReportFrom page 3

Yes, today’s pharmacy students do want to be involved in what is transpiring within their chosen profession, and we, as pharmacists and vested members of that same profession, must welcome them. Over my tenure at PSSNY, I have had the pleasure and opportunity to speak with hundreds of students from each college of pharmacy within our state, and will attest to their enthusiasm in working with us to promote and protect this great profession. The students are not sitting idly by, waiting for us to do all of the work, they are preparing for the battles, engaging their faculty, engaging their legislators, and proposing new programs, all while still in the process of learning and preparing to become licensed. Over the last few years we have seen a tremendous increase in student membership and student involvement. In fact, I believe that the student group is the largest single group in our society. Each pharmacy college campus has an active SPSSNY group, promoting PSSNY opportunities and benefits, setting up informational sessions regarding pending legislative actions, and creating interest in the upcoming legislative days: owner’s day 3/7/2017 and pharmacy day 4/25/2017. They are forming alliances between all of the colleges of pharmacy in the state, helping to promote existing programs and offering

new ideas. The student attendance at the mid-winter conference has more than quadrupled over the last 3 years, they are coming and getting involved.

What must we do? We need to exhibit the same enthusiasm and participation that the students are doing; engaging our legislators, attending meetings, imploring our colleagues to join the society and to get involved, and we need to show to our future colleagues, partners, and employees that we care about them.

How? We started a mentor program last year (Under My Wing). This is a very nice program, intended to give students that are interested in owning a pharmacy, the basic knowledge of what is needed to be successful in that endeavor. If you are a pharmacist/owner, please visit our website to find out how you can become involved. When you go to an affiliate meeting, invite a few students to attend with you, so that they can enhance their experiences. Do you employ any student interns? If so, take some time out of your busy day to discuss pharmacy issues with those students, ask your employee pharmacists to do the same. Are you a preceptor for a college of pharmacy? If not and you would like to have students, contact the college and discover the values of being a preceptor. Do you attend our conferences? Why not bring a student along? Finally, work a little harder in trying to get more members. It is so very important that we develop a stronger, more cohesive group, indicating to the students that we are a united and powerful unit that everyone in pharmacy should belong to.

Thanks for listening,~ Terry Towers, PSSNY Pharmacy Practice Coordinator

A message from PSSNY Pharmacy Practice Coordinator, Terry Towers. Feel free to contact him for your pharmacy concerns at the PSSNY office at [email protected].

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PAGE 20 JANUARY/FEBRUARY 2017 NYCPS NEWSLETTER

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NYCPS NEWSLETTER JANUARY/FEBRUARY 2017 PAGE 21

barriers to medication access.Congratulations to Dorcas Adjaloko and Elizabeth Riegle from D’Youville College School of Pharmacy who had the winning poster.

The Exhibits The exhibit hall was full with many new exhibitors and many long-time supporters. If you missed out, check out who was there: http://www.pssny.org/resource/resmgr/2017_mid_winter/2017_MW_exhibitors.pdfMany thanks to our major sponsors: Epic, Anda, Appriss Health, Kinray, Amerisource Bergen, Cardinal Health and HD Smith.

Legislative There was a significant amount of conversation on the 2017-18 State Budget proposal where Cuomo addresses the high cost of prescription drugs. One of his key initiatives is regulating the PBMs—a fantastic opportunity for pharmacy. Joining us for Lobby Day is more important than ever. We need to let our legislators know how PBM practices impact pharmacies and their patients. We also reviewed the Medicaid Covered Outpatient Drug Rule proposal in the budget. Please see Russell Gellis’ column for more detail. The Board of Directors also unveiled PSSNY’s 2017 Legislative Agenda: The Pharmacy Patient’s Right to Care—PSSNY’s proactive legislative agenda focused on patient

outcomes. You can see the agenda here: http://c.ymcdn.com/sites/www.pssny.org/resource/resmgr/Legislative/PSSNY_Legislative_Agenda_201.pdf. This was the result of an incredible amount of work from many people. We are excited that we have a proactive agenda to push after the State budget has been negotiated. I hope you recognize the great event that PSSNY put together. It could not be done without the help of my staff, the convention committee and the Board of Directors. I hope to see you at the Annual Convention, June 23-25 in Westchester. Registration will open March 1, 2017.Thank you. - Kathy Febraio

CAE Executive Director

Executive DirectorFrom page 4

IMPORTANT INfORMATION REgARDINg TEST STRIPS, COMPOUNDS AND CVS CAREMARk

The sale of blood glucose strips and related supplies has taken on new importance at the PBM level. It is important that you bill precisely for the brand of products you are dispensing. There are some lancets and alcohol swabs that have very expensive AWP prices while the dead net prices are in line with other generic products in the marketplace. Warning don’t get greedy. Remember that you are required to include a usual and customary retail price for all pharmaceuticals and supplies you dispense on the various insurance plans. If a stranger walked in and purchased a box of 100 generic alcohol swabs and a box of 100 lancets, would you charge the patient $50 for these two items if they cost you $4 or $5 dollars? You also need to insert a real retail price for all such products billed to the various pharmacy benefit managers. Additionally the PBMs have now determined that purchases of blood glucose strips must be made from a primary wholesaler and not the secondary suppliers. There is a list of acceptable suppliers that CVS Caremark may share with you as a provider. Otherwise ask Abbott for their list of acceptable suppliers. Remember the rule of thumb, you must bill for the product exactly with the NDC and or UPC code on the package being dispensed. Moving to compounds, please also note that CVS Caremark has created a new definition for compounds and it is a definition of what is being phased in as a prohibition in their pharmacy contracts. The concept CVS Caremark is spelling out what is not permitted in their basic retail pharmacy provider contract. The issue is the result of a huge increase in compound rx billings for therapy which have questionable value as compared to other prepared pharmaceutical

preparations. Sometimes PBMs react to issues which can be considered the result of pharmacy providers killing the “Goose that laid the golden egg”. Pharmacists have fought long and hard to have the right to create individual formulas to suit specific patient needs. However, a true reflection on the compounding activity of the pharmacy profession over the past few years shows a huge increase in costs to insurance providers for what may be limited therapeutic enhancements to patients. I am not attempting to discredit those pharmacists that truly offer value in their compounding skills by creating specific pharmaceutical mixtures to serve patients’ needs. I hope you understand the difference. Read on for the new terms of CVS Caremark provider contracts which is being phased in as your contract is up for review.

CVS Caremark is now defining when a compounded prescription considered “Complex” in nature….A “complex compound” is defined as a compound that meets any one of the following three (3) elements:(I) a mixture of chemicals that involve bulk chemicals (API),

aliquots, or dissolutions of tablets and/or capsules; or(2) the route of administration does not remain in

accordance with FDA-approved labeling/indications for each ingredient contained within the compound; or

(3) requires specialized equipment (such as: unguator, ointment mill, etc.), training, or gowning or requires special environmental conditions to protect pharmacy staff and the public.

- Jim Schiffer, Senior Editor NYCPS Newsletter

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PAGE 22 JANUARY/FEBRUARY 2017 NYCPS NEWSLETTER

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NYCPS NEWSLETTER JANUARY/FEBRUARY 2017 PAGE 23

substance to be effective must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice. The responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner, but a corresponding responsibility rests with the pharmacist who fills the prescription. An order purporting to be a prescription issued not in the usual course of professional treatment or in legitimate and authorized research is not a prescription within the meaning and intent of section 309 of the Act (21 U.S.C. 829) and the person knowingly filling such a purported prescription, as well as the person issuing it, shall be subject to the penalties provided for violations of the provisions of law relating to controlled substances.” As the supervising pharmacist or a staff pharmacist, you are responsible to determine that there is a legitimate medical purpose for the prescription and that the prescriber is acting under their course of their professional practice. A classic example is a OB/GYN prescriber writing an Oxycodone 30mg

prescription for a 40-year-old male. DEA will look at these prescriptions as being filled by a pharmacist who dispensed the medication with willful blindness and deliberate ignorance of that pharmacist’s corresponding responsibility to confirm the legitimacy of the prescription order. As an owner of a retail pharmacy, you are responsible to know that controlled substance prescriptions filled by your staff pharmacists are for legitimate medical purpose. The real question is how often are you reviewing your prescriptions. We get request from pharmacy owners to evaluate their 90-day dispensing report to determine if there are issues that may place the pharmacy in the cross-hairs of a DEA investigation. Most of the times, we found prescribers were writing prescriptions outside of their professional practice. For examples, a cardiologist writing for 240 Oxycodone 30mg tablets as part of a pain management strategy or a family practice practitioner writing the same amount of Oxycodone 30mg or Hydromorphone 8mg for the last three years for a patient. Many times, the report is an eye-opener for the pharmacy owner and in other cases the monetary gain overshadowed and took precedence over their responsibilities as noted in federal laws and regulations. DEA in their revocations of DEA registrations for retail pharmacies is very clear that as an owner and registrant of a retail pharmacy, you are required to have in place a Due Diligence Program to prevent the diversion of controlled substance prescriptions into the illicit market. Where do you find this information? First start by going to the DEA Diversion website (www.deadiversion.usdoj.gov) and downloading the DEA Pharmacist’s Manual of 2010. In the manual, you need to look for Appendix D which reads “Pharmacist’s Guide to Prescription Fraud”. My recommendation is to print a copy and share it with each of your pharmacy employees including staff pharmacists, and pharmacy technicians. You need to make it clear that DEA has placed all responsibilities for controlled substances on you as the owner and also on your supervising pharmacist. The most important recommendation is for you as a pharmacy owner to understand the corresponding responsibilities of your pharmacists and to have in place a stringent Due Diligence Policy to prevent being the target of a DEA investigation. Best wishes for a safe and Happy New Year.

~ Carlos Aquino©2017 Carlos Aquino

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NYCPS NEWSLETTER JANUARY/FEBRUARY 2017 PAGE 25

NAME DATE OF BIRTH

HOME ADDRESS

HOME PHONE E-MAIL

HOME CITY HOME STATE

BUSINESS NAME BUS. PHONE ( )

BUSINESS ADDRESS BUS. FAX ( )

BUSINESS CITY BUSINESS STATE

FAX NUMBER ( ) PHARMACY SCHOOL Do you want your correspondence sent to: ______ HOME ______ BUSINESSCHECK ONE: ACTIVE OWNER MEMBER (MUST HAVE A DEGREE IN PHARMACY) ....................$400.00 ACTIVE NON-OWNER MEMBER (MUST HAVE A DEGREE IN PHARMACY) .............$325.00 ASSOCIATE MEMBER (NON-PHARMACIST) .....................................$275.00 RETIREES ......................................................................................................$250.00 STUDENT — EXPECTED DATE OF GRADUATION _______ ............ $10.00 DUES I WOULD LIKE TO ADD______ (at least $50.00) TO THE POLITICAL ACTION COMMITTEE P.A.C. (VOLUNTARY) I WOULD LIKE TO ADD______ (sugg. $100.00) TO THE LEGAL WAR CHEST FUND L.W.C (voluntary) ______________ TOTAL

MAKE CHECKS PAYABLE TO NYCPS/PSSNY And Mail to: 111 Broadway, Suite 2002, New York, NY 10006DUES AUTOMATICALLY INCLUDES MEMBERSHIP IN THE PHARMACISTS SOCIETY OF THE STATE OF NEW YORK

MEMBERSHIP APPLICATION—NEW YORK CITY PHARMACISTS SOCIETY

111 Broadway, Suite 2002, New York, NY 10006

neWMeMberSjOInnOW fOr12 MOnTH

MeMberSHIP

This newsletter is published by the NYC Pharmacists Society as an exclusive service to its membership. The annual newsletter subscription rate is $100.00. Unless specifically indicated as such, the views expressed in this publication do not necessarily constitute official positions

of the New York City Pharmacists Society, nor do they necessarily represent the views of all the NYC Pharmacists members. © Copyright 2017 New York City Pharmacists Society. Under license from our collective authors. All rights reserved.

protect children from unintentional medication overdoses, visit the Up and Away and Out of Sight educational campaign at: www.upandaway.org. greater than and less than symbols discouraged. The “greater than (>)” and “less than (<)” symbols are often used incorrectly or misunderstood. For example, an order to “hold warfarin if INR < 2.5” was actually intended as “INR greater than 2.5.” These symbols can be misinterpreted in other ways as well. In a recent example, the “greater than” symbol was misread

as a 7, which allowed an order to “continue warfarin until INR > 2” to be interpreted initially as “continue warfarin until INR 72.” Using the words “greater than” or “less than” can prevent these kinds of errors. A point about levothyroxine. After reviewing transfer orders from a hospital, a nursing care facility physician ordered levothyroxine 0.25 mg for a patient. The long-term care pharmacy confused mg and mcg and dispensed levothyroxine 25 mcg—a 10-fold underdose. This is not the first time we have heard about errors confusing mg and mcg with these products. In May 2003 we reported that errors had become so common with levothyroxine

that one pharmacist told us that he had set up his computers to signal an alert whenever a 0.25 mg dose was entered. When the warning appeared, the correct dose almost always was 0.025 mg or 25 mcg. Alert clinicians to the risks associated with dosing this product and have pharmacists or nurses at community or long-term care sites provide feedback directly to prescribers if a dosing error, especially an overdose, is suspected. To avoid decimal points and dose conversions, healthcare practitioners should express the dose of levothyroxine in the same way most manufacturers express the dose—in mcg, not mg.

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