volume 24, issue 1 - New York City Pharmacists Society
Transcription
volume 24, issue 1 - New York City Pharmacists Society
NEW YORK CITY PHARMACISTS SOCIETY VOLUME 24, ISSUE 1 PSSNY helpline 1-800-632-8822 The Voice of Pharmacy in the Big Apple JANUARY/FEBRUARY 2015 www.NYCPS.org President’s Message President’s Message and fast, Governor Cuomo’s budget contains reimbursement language that can have a harsh effect on each of our businesses. It includes changes in Fee or Service Medicaid reimbursement on brands to WAC minus 9% (~ AWP minus 24%). Do the math yourself, this would be devastating for community pharmacy. How could it be fair for us and our businesses to lose money by filling prescriptions for Medicaid? The answer is, it’s not. We are members of this profession because we care about the health of our community As most of you remember in January 2012, NYCPS and PSSNY held a “Town Hall Meeting” of pharmacists to release, discuss and, hopefully, agree on steps to be taken to combat the Department of Health’s intended use of their interpretation of the survey results about “cost-of-dispensing” and “costof-goods sold” surveys conducted by DOH during the previous year or so. The survey started just as Hurricane Sandy devastated the metropolitan area in the fall of 2012. You may recall that DOH insisted on proceeding with the audit in spite of the severe problems so many continued on page 19 continued on page 20 PSSNY President Elect An Update on One Pharmacist’s Fight for DOH Disclosure S e e A b ov e IN THIS ISSUE President’s Message.......................1 Page 3 Page 1 An Update on One Pharmacist Fight for DOH Disclosure.................1 A Message from PSSNY President Elect Roger Paganelli........3 Treasurer’s Report...........................4 A Message & Greetings from PSSNY Executive Director................6 Secretary’s Report...........................8 NPCA...........................................10 ISMP............................................11 ADDRESS SERVICE REQUESTED News from Around the Pharmacy World............................12 The New York City Pharmacists Society 111 Broadway, Suite 2002, New York, NY 10006 OFFICERS Ron DelGaudio, President 718-230-3535 Parthiv Shah, President Elect 718-292-4244 Aniedi Etuk, Vice-President 212-222-3652 Bill Scheer, Treasurer 917-805-4207 Jim Schiffer, Secretary 212-616-7040 BOARD OF DIRECTORS Alex Perchuk, Chairman 718-835-2000 Charles Catalano 718-358-1300 Mike Agovino718-543-3116 Charlie Ciaccio718-452-3261 Vito Columbo718-418-9700 Jim DeTura718-292-1856 Aneidi Etuk212-222-3652 Russell Gellis212-877-3480 Carol Georgiadis718-762-7111 Roy Greif718-363-3300 Robert Hopkins 516-852-1405 Ray Macioci718-823-1085 Boris Mantell 718-591-1040 John Navarra212-213-5570 Joseph Navarra212-213-5570 Boris Natenzon718-720-3710 Roger J. Pagenelli718-364-6100 Dhiren Patel212-281-0488 Richard Schirripa212-860-4152 PSSNY REGIONAL REPS Parthiv ShahBronx Dhiren Patel Manhattan Boris Natenzon Brooklyn, Staten Island Robert HopkinsQueens RECORDING SECRETARY, ACTING Mike Agovino 718-543-3116 NEWSLETTER Jim Schiffer, Senior Editor Designed, Printed & Mailed by: Prestige Litho and Letter 631-231-7300 NYS DOH must disclose results of past Cost of Dispensing (Abandoned) Monthly Survey 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 We need to work together … now! It was only this past December when – looking back on the year 2014 – I wrote about “our triumphant defeat of AAC/COD, protecting us all from onerous and unwarranted cuts in our reimbursement.” Well that was then and this is now. Things in the pharmacy world can change in a split second. You may not have heard the news yet, but unless we can stop it by working together effectively An Update on One Pharmacists Fight for DOH Disclosure… PAAS...........................................20 page 2 JANUARY/FEBRUARY 2015 For over 60 years, Kinray has been the full-line, full-service pharmaceutical wholesaler for independent pharmacies. 877.857.9881 | www.kinray.com | email us at [email protected] © 2014 Cardinal Health. All rights reserved. KINRAY and the Kinray LOGO are trademarks or registered trademarks of Cardinal Health. All other marks are the property of their respective owners. NYCPS NEWSLETTER NYCPS NEWSLETTER A Message FROm pssny president elect roger paganelli As I sit in my office surrounded by snow after the first big storm of the winter, I’m reminded of the cold weather in Saratoga a few short weeks ago. If you didn’t make it to the Mid-Winter meeting the weekend of January 9th, then I guess I’ll have to make you a little jealous. And for those that did, I can remind you of the great meeting that it was. With continuous tracks of CE, SBOP update, e-prescribing update, Diabetes certification program, committees, academies, student functions and connecting with old friends and new, the Mid-Winter at Saratoga Hilton did not disappoint. We had more vendors than ever and we managed to have more than 200 registrants in total. For the first time in as many years that I can remember, every pharmacy school in NYS was represented by their students, and ongoing discussions of the PSSNY chapters being resurrected where they have been inactive for more than 20 years, is looking like a reality. Again, thanks to a great convention committee chaired by Steve Moore of Plattsburgh and the PSSNY staff for an incredibly professional presentation! Hats off to y’all! As legislative chairman, I’d like to report the language for the MAC Appeal legislation has been finalized and is in the hands of our Senate and Assembly sponsors, Senator Kemp Hannon and Assembly-member Linda Rosenthal. We will have a bill number shortly and I urge each of you to contact your State Senator and Assembly person in their district office with the bill # and the talking points. As promised, I will give you an email and phone talk points to send to and/or call your legislators with. Our original plan was to focus on the MAC Appeal with a side of AMMO perform. That was the plan until the Governor’s budget was released last week. In the budget Medicaid reimbursement was announced. Unfortunately this changes the game for our one item focus. PSSNY’s new plan is to forge ahead with the MAC Appeal legislation and at the same time with as much or more energy, convince our legislators that the DOH Medicaid FFS proposed budget cuts are not in any way sustainable. The DOH had an opportunity to hammer JANUARY/FEBRUARY 2015 page 3 this out with the pharmacy stakeholders throughout the summer and into the fall. Our negotiations ended with – no resolve. We cannot let this budget language pass! Please get involved! How? - Pay your PSSNY dues on time. - Read your weekly e-script email and take action when called upon. - Call your Assembly and Senate representatives today in their district office. - Make recurring PAC contribution. - Ask your affiliate for information regarding legislative voter voice campaigns. - GET YOUR COLLECTIVE BUTTS, TO ALBANY ON MARCH 3RD FOR INDEPENDENT PHARMACISTS AND PHARMACY OWNER’S LOBBY DAY. - ??? & COLLEAGUE – PSSNY.ORG -- LOG ON TODAY Wishing you a Happy and Healthy New Year and asking for your support in our efforts. - Roger Paganelli PSSNY President Elect / Legislative Chairman page 4 JANUARY/FEBRUARY 2015 NYCPS NEWSLETTER Treasurer’s Corner CHANGING TIMES I recently had to shop for a new medical insurance coverage. The previous insurance was cancelled, so I went to the NY State Health Exchange to find out how it worked. Actually the site was easy to navigate; I could comparison shop and was able to obtain a better insurance plan for less money than I had paid for the previous policy. The new health plan was Care Connect; it had our existing doctors and hospital in their network. This is the plan being offered by the North Shore –Long Island Jewish Hospital system. Researching the coverage I found the health plan I selected is now part of a group that includes Yale New Haven Hospital, Montefiore Hospital, NYU Langone Hospital, and Phelps Hospital, in other words the whole tri state region. This is the trend nationwide as well. These mega hospital groups have been buying up private medical practices at an accelerated rate, controlling the hospital, doctors and now the reimbursement as well with the addition of the medical insurance component. No longer content to negotiate with the insurance middlemen Free Processing Terminal! Enroll in the Retail Council’s processing program and receive a free terminal valued at $425!* Contact Nicholl for Retail your free, no-obligation C ouncil savings analysis. O F NE W YO RK ST ATE (800) 442-3589 | [email protected] *Terms and conditions apply. Call for details. PSSNY Member Benefit they are taking over the continuum of health care to control their profit margin. Due to the requirements of the Affordable Care Act, these new vertical health care giants will be providing pharmaceutical coverage as well. Needless to say the idea of a large entity offering prescription coverage over a large area will mean the involvement of Pharmaceutical Benefit Managers. With the increase in those covered by the Affordable Care Act, we are expected to see an increase in outpatient prescription utilization. This along with the impact of the aging of the baby boomer population will definitely increase the prescription volume in community based pharmacy. This will mean an effort by these vertical health care organizations to keep the cost they do not directly administer down. That will mean that community pharmacy is again at risk for a ratcheting down of reimbursement by PBMs administering their benefits. Yet drug spending results are less than 10 percent of the total healthcare spending. Retail prescriptions are only about three percent of the spending. Over sixty percent of the spending is attributed to hospitals and physicians. Again we are the easy targets for cuts as we are forced to sign take or leave it type of contracts, either being in a network which can comprise a large portion of our patient population and being reimbursed at greatly reduced levels or losing the patient base altogether. This consolidation is most likely not to the advantage of pharmacy or ultimately the consumer. It will simply allow a monopolistic control of the healthcare marketplace, at the expense of community pharmacy. We have already seen how the PBMs have limited patient access to community pharmacy. They have created specialty networks, with four or five tier formularies now being envisioned and increased copayments by patients. The prospect of Accountable Care Organizations, focused on a collaborative effort from all sectors of healthcare to get better patient outcomes and cut unnecessary expenditures may be the answer. Utilizing the front line pharmacists to accomplish better outcomes for the patients as part of the solution, tying the reimbursement paradigm to a result oriented outcome would result in pharmacy being allowed to show its ability to impact on good healthcare. Our challenge will be to bring community pharmacy into line with the changing focus of healthcare and to make these consolidations work to our advantage, achieving the goal of positive health outcomes for our patients. Our training in Medication Therapy Management and the possibility of Collaborative Therapy Management are the steps bringing us to a greater participation in patient care. Our ability to survive and adapt to new ideas has always been our strength. We must be ready to accept this challenge and move pharmacy into its new role. - Bill Scheer NYCPS NEWSLETTER JANUARY/FEBRUARY 2015 page 5 DON’T WAIT UNTIL IT’S TOO LATE! SPECIALTY PHARMACY IS THE FASTEST GROWING SECTOR OF PHARMA SPENDING TODAY. Y CM MY TIC K A L M AN OCEAN OF OPPORTUNITY WHEN YOU HAVE THE RIGHT SUPPORT. S MEDICATION SCHEDULING SPECIALTY PHARMACY PROGRAM PRIOR AUTHORIZATION MANAGEMENT ORDER VERIFICATION SOURCING OF FINANCIAL ASSISTANCE AN AN PATIENT INTAKE FROM PHYSICIAN’S OFFICES ADHERENCE MANAGEMENT EU CY CMY PHYSICI U FA C T U RERS • M PHARMA C C BENEFITS VERIFICATION/ REIMBURSEMENT SUPPORT • V IDERS PATIENT EDUCATION AND TRAINING S PRO IENT T A P • ER PAY S Introducing a new Specialty Pharmacy program formed through an exclusive partnership between RDC, Quality Care Pharmacies, and Aureus Health Services. Together, we firmly believe Independent Pharmacies are the best suited providers of Specialty services. Our new program offers complete prescription triage, patient care, and manufacturer outreach to help you maximize opportunities in this fast growing sector. CALL RDC AT 800.333.0538 TO LEARN MORE ABOUT ENROLLING IN THIS EXCITING NEW PROGRAM. Exclusively for RDC’s Independent Quality Care Pharmacy network. Call your RDC sales representative today for more information on how to enroll in our Specialty Pharmacy Program. page 6 JANUARY/FEBRUARY 2015 A Message & Greetings From PSSNY Executive Director Help PSSNY Help You! Monday, February 2, I spent the day at the Legislative Office Building in Albany awaiting my turn to testify at the Budget Hearing. From 11am until 4pm I listened to various professional association after association talk about how NY has the lowest reimbursement for (_____) fill in the blank with a health care profession. Many of them complained about cuts every year and all of them made much effort to talk about how well they serve their patients. I watched the legislator’s reactions, some looked interested, some bored, others asked questions and there was usually one that spoke very supportive of the organization presenting. What I did not hear any other association state about the profession that they represent was that they were the “most accessible health care provider”, that they are “paid for a product at a lower rate than they can purchase it for”, or that they “have worked NYCPS NEWSLETTER collaboratively with other stakeholders to come to a solution with the Department of Health.” These statements resonated with the legislators of the Budget Committee. Pharmacy is well respected among these officials and we have to keep the good relations in tack. It is essential that pharmacists throughout the state build strong relationships with their state senator and assembly person. Not just the one that you can vote for, but the one that is in the district of your pharmacy (or pharmacies). When we send a notice to send a letter, it is important that the legislator and their staff know you by name, or recognize your pharmacy. Why is this so important? These relationships are the reason that pharmacy won last year. These relationships create a trust and respect between the pharmacy community and the lawmakers. They know that pharmacists have influence, are trustworthy and will support them. We sent a notice to contact your legislators last week – we had a great response – on average 370 pharmacists delivered messages to multiple legislators and each of the 196 legislators heard from 2-3 pharmacists. The message was clear – SAVE PHARMACY! This is a familiar battle, it seems to happen every year. At some point there needs to be real change – change that stops the constant cut to pharmacy’s bottom line and begins to appreciate the value that pharmacists deliver. We can create this change. There are several bills being introduced (some reintroduced) that will effect this change for pharmacy from regulation over PBMs to payment for services and expanded scope of practice. We need you to attend Lobby Day on March 3. You can register for Lobby Day on the PSSNY website, the link is on the home page. If you cannot attend Lobby Day, we need you to make an appointment and visit your legislator at their district office. PSSNY will provide talking points and background and information that you can leave behind. We also need you to report these meetings so we can have the PSSNY lobbyist follow up to answer any questions or concerns. This is important – not for PSSNY, but for YOU and for PHARMACY! PLEASE HELP PSSNY HELP YOU! These are very critical times in our profession. We need your support to help you survive. - Tracy Russell NYCPS NEWSLETTER Don’t leave money on the table when you transition the ownership of your business. JANUARY/FEBRUARY 2015 page 7 1-(877)-360-0095 www.buy-sellapharmacy.com Do you know the three most common mistakes that pharmacy owners make when contemplating the sale of their pharmacy? To learn what they are, and to learn much more about the services we provide for independent pharmacy owners thinking about ownership transition and/or retirement, visit our web site, www.buysellapharmacy.com. Click on the button on the home page that says “Pharmacy Owner’s Questions” or call your local Buy-Sell Associate directly at any time. By doing so, you will have the opportunity to earn a $100.00 GIFT of valuable marketing materials for use in your pharmacy. Free, no-obligation confidential consultation • Specializing in the sale of community pharmacies to independent pharmacy operators. Jack Collins, RPh. Phone 203.395.6243 Fax 203.368.4432 [email protected] Tony De Nicola, RPh. Phone 860.868.1491 Cell 917.573.5292 Fax 801.751.5685 [email protected] • Over 400 successful transactions. • National buyer database of over 2,500 pharmacists. • Assist buyers with obtaining financing, enable sellers to cash out at closing. • The only financial consulting firm focused exclusively on independent pharmacy that functions in all 50 states. • Eight-member team with over 200 years of pharmacy ownership experience. • Free evaluations and exit strategy planning for owners who list with us. • Competitive fees which are lower than traditional business brokers. • NCPA Corporate Member and marketing partner. • A loyal supporter of all NYCPS activities. “Our 15 year track record of successfully completing more than 400 independent pharmacy sales speaks for itself” page 8 JANUARY/FEBRUARY 2015 NYCPS NEWSLETTER Secretary’s R eport JAN/F EB 2015 Greetings to you in 2015! Let us hope for a healthy, happy and financially rewarding new year as pharmacy enters another challenging year. I am writing this story after returning from a very informative and enjoyable trip to Saratoga Springs New York where PSSNY has concluded another successful MidWinter Conference. You had to be there to understand the value and what you learn for your pharmacy practice. There are many new issues which we face on a daily basis. One of the most pressing issues for many of our members is being locked out of the 2015 Aetna Coventry Medicare Part D Prescription network. I have received many calls from pharmacists trying to figure out what went wrong. After investigating the issue, it seems that we are dealing with the rather cute or “deceptive” maneuver which Aetna has orchestrated a change to their Medicare Part D pharmacy network. It seems that this change in pharmacy access was planned over 6 months ago when Aetna had been working the numbers on the 2015 Medicare Part D offering. Aetna created a number of “tiers” of pharmacy access - - supposedly all in accordance with Centers for Medicare and Medicaid Services (CMS) guidelines, but without disclosing that the Coventry Health Care Medicare Part D access would be limited to the lowest reimbursement tier prepared by Aetna. You see back in May 2013 Aetna acquired Coventry Health Care. Since the structure of the 2014 Medicare Part D drug plan had already been in place back in May 2013, the 2014 Medicare Part D program treated Coventry separately from the Aetna program offerings. Coventry utilized Express Scripts for their pharmacy benefit manager while Aetna has had a long standing contract relationship with CVS Caremark to administer their prescription benefits. CMS has brought Aetna in on the carpet and by the time you receive this newsletter this issue might be old news. CMS has requested that Aetna open up the network for at least 60 days to all willing participants and also and enrolled affected Aetna/Coventry patients have a special opportunity to dis-enroll from this Part D plan until February 28th and pick a replacement Part D Rx plan. Nevertheless the rate of reimbursement for this Coventry program was so unappealing that many of the Pharmacy Service Administrative Organizations (PSAO’s) refused to accept the program offering. According to other sources, it seems Rite Aid also rejected the reimbursement as unrealistic. Some folks who are in the Coventry network are unable to decipher the real discounts off of reimbursement but the generic rate seems to be a flat 90% discount off of AWP. Moving on to other issues is the growth of closed networks in the Medicaid Managed Care arena. It seems that the Medicaid Managed Care model is not a profitable one for the various NYS Managed Care Organizations who are handling the NYS Medicaid population. In the Albany area, the big change in this arena is the move by Capital District Physicians Health Plan (CDPHP) from an open (freedom of choice) approach for the NY Medicaid patients to a change effective January 1, 2015, to a rather restrictive closed network focused on the CVS Pharmacy chain with independent pharmacies sprinkled in as needed. Other changes hitting the Medicaid Managed Care arena are further restrictions on access to supplies such as diapers and food supplements to a single distributor for the patients. Supposedly CDPHP had a huge loss in their ongoing NY Medicaid operations and that pressured the program to restructure their pharmacy network in the hope of saving the program. New York State has been using the various MCO’s as the backbone of the management of healthcare for our Medicaid population. Another interesting twist is the partial settlement by the federal Department of Health & Human Services Office of Inspector General (OIG) by the Visiting Nurses Services of New York (VNS). In this November 2014 settlement agreement, VNS admitted that 1,740 Medicaid long term care patients were referred by social adult day care centers (SADCC), or used SADCC services, and actually were not eligible to be members of the plan; and that various SADCCs in the provider network did not provide services that qualified as “personal care services” under the long term care program contract with New York’s Department of Health. The government alleged that these members were improperly referred by these SADCC, or received services primarily from SADCCs, many of which provided substandard and minimal care. This partial settlement cost VNS nearly $35 million. This was a long standing investigation that both sides wanted to resolve. However, this case is not over because under the settlement, the OIG has the right to continue to investigate the managed health care plan administered by VNS. This in itself is a strange twist because normally the government wants a global resolution of the matter. The settlement agreement carves out any potential claims against the president of the corporation that administered the managed health care plan, so that individual could be the focus of the “Remaining Investigation.” Additionally, while the ongoing issues are under investigation, VNS agrees to monitor and further revise standards for credentialing SADCCs; as well as a commitment from VNS to only credential SADCCs that have all of the required certificates; monitor SADCCs to ensure compliance with credentialing; VNS also will ensure that SADCCs provide proper personal care services; and prohibit marketing practices directed at enrolling members through SADCCs. Remember when Governor Andrew Cuomo was first elected to office? Remember he created a Medicaid Redesign Team (MRT) with all of these recommendations about how to improve the delivery of health care to the poor of NYS through improving the Medicaid system? VNS had Carol Raphael serve as Co-CEO of this MRT of this MRT team. So observers believe it was improper for NYS to put an executive from a participant in the Medicaid program that had such a large audit looming overhead especially to serve as a leader of this important health care reform committee Ms. Raphael did not stay too long at VNS after being appointed to the MRT. What adds to the confusion is that less than two weeks after VNS entered into this partial settlement, the current CEO of VNS, Ms. Mary Ann Christopher resigned. One word sums up this relationship between NYS and VNS, that word is weird. In my opinion, it is weird that Governor Cuomo would allow an executive with a MCO that had a huge audit cloud over their head to be put in a powerful position on the Medicaid Redesign Team. But then again the Governor must know what he is doing. It may just be that the Governor had an agenda, to push the millions of people on NY Medicaid into the managed care world and he wanted the folks running the MCOs in New York to be involved in that process of such movement. We are at the dawn of a new year with new problems emerging. Hopefully we will be able to meet the challenges of our profession and survive 2015 even stronger. - Jim Schiffer Secretary NYCPS NYCPS NEWSLETTER JANUARY/FEBRUARY 2015 page 9 page 10 JANUARY/FEBRUARY 2015 NYCPS NEWSLETTER RECAP OF PHARMACY POLICY VICTORIES IN THE STATES For decades NCPA’s advocacy efforts focused primarily at the federal level. While the push for pharmacyfriendly federal polices continues unabated, three years ago NCPA decided to dramatically expand its efforts to support our pharmacy allies in state legislatures and agencies. With nearly half of all prescriptions being paid for by the federal government, focus on the federal legislation and regulation is still vitally important. However, state legislation and regulation is more nimble and impact can be seen more immediately. What follows is a synopsis of what has transpired during the 2012 to 2014 legislative sessions. For example, while pushing for and seeing some progress at federal Maximum Allowable Costs (MAC) transparency reform, NCPA also turned to the states. The results have been promising as MAC transparency laws with the potential to begin to address delays in MAC payment updates are the law in Arkansas, Colorado, Iowa, Kentucky, Louisiana, Maryland, Michigan, New Mexico, North Dakota, Oklahoma, Oregon, Tennessee, Texas, Utah and Washington. We are thrilled that in many states the votes were unanimous as pharmacy’s common-sense arguments carried the day. None of this is possible without a unified and coordinated message.. NCPA partners with state associations, individual members, and other stakeholders in the respective states. We roll up our sleeves to offer whatever expertise and resources might make the legislative journey easier. Besides MAC transparency, other prominent issues NCPA has actively supported include pharmacy audit reforms (32 states now have new protection or strengthened existing laws) and anti-mandatory mail order legislation. NCPA provided model legislation; testified at state legislative hearings; issued white papers; disseminated press releases; met with elected officials; reached out to NCPA members in the states to ramp up grassroots pressure; and many other efforts to advance these causes. We also supported initiatives to drive greater medication adherence. Along with the National Association of Chain Drug Stores, and the National Alliance of State Pharmacy Associations we championed medication synchronization legislation that is now on the books in Colorado, Connecticut, Oregon, Utah and Vermont. Unfortunately, California’s governor vetoed this legislation, but we will continue to press the case in America’s largest state and others in the coming year. Another victory occurred in North Dakota where, seemingly every election cycle, outsiders seek to change a law that requires retail pharmacies to have in-state, pharmacists as majority owners. On Election Day, Measure 7 was defeated and the proverbial flood of giant corporate chains was once again kept at bay. Now is not the time for pharmacy to rest on its laurels because once a pharmacy-friendly law becomes reality the fight for effective and robust implementation begins. We have to avoid the trap of winning the battle, but losing the war. All too often pharmacy benefit managers (PBMs), which are generally against these bills, view the implementation process as the place to mitigate the effectiveness of the law. Many PBMs are not fully complying with the intent of the respective laws. For example, in Iowa the PBMs national trade association filed a lawsuit designed to render the state’s recent MAC reform law toothless, which is why an “all-handson-deck” approach is needed if defeat is not going to be snatched from the jaws of victory. While we will continue pressing federal officials for effective legislative solutions to issues that threaten the viability of community pharmacies and the wellbeing of the patients they serve, we will continue to support the efforts in the states to enact and implement localized remedies. - B. Douglas Hoey, RPh, MBA National Community Pharmacists Association CEO NYCPS NEWSLETTER JANUARY/FEBRUARY 2015 page 11 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 manufacturers, the medical community, and FDA. ISMP guarantees confidentiality of information received and respects reporters’ wishes as to the level of detail included in publications.” 10-fold decimal point error. A prescription for risperiDONE 2.5 mL by mouth twice daily for a 4- year-old child was brought into a community pharmacy during its peak hours. RisperiDONE oral solution is an atypical antipsychotic agent used to treat autism, bipolar mania, or schizophrenia in the pediatric population. It is available in a 30 mL bottle at a concentration of 1 mg/mL. Since the pharmacy technician was busy helping patients at the pickup counter, the pharmacist decided to complete the entire prescription dispensing process herself. Without noticing, the pharmacist easily bypassed a drug utilization review (DUR) alert, which did not require an override with documentation. The pharmacy did not have enough risperiDONE oral solution in stock to dispense a 30-day (150 mL) supply, so the pharmacist ordered five additional bottles. The next day the pharmacy received the additional risperiDONE. A different pharmacist labeled and dispensed the medication; the patient’s caregivers declined patient education. The patient was administered risperiDONE for seven days until the child experienced seizures and was hospitalized. It was discovered that the decimal point had been misplaced on the original prescription. The prescriber intended to write for 0.25 mL (0.25 mg) but instead wrote for 2.5 mL. As a result, the patient received 2.5 mg twice daily (5 mg total) for seven days. RisperiDONE oral solution is considered a highalert medication (www.ismp.org/communityRx/tools/ ambulatoryhighalert.asp) in the pediatric population as it is a liquid that requires measurement. As such, special safeguards should be implemented to reduce the risk of errors. Modify alerts so that they clearly state the problem, are not easily bypassed, and require documentation to continue the dispensing process. Whenever possible, one person should enter the prescription in the pharmacy computer system and a pharmacist (or second pharmacist if originally entered by a pharmacist) should conduct an independent final verification of the prescription. When additional medication must be ordered to complete the prescription, pharmacies should consider implementing another double check before the additional medication is dispensed to the patient. Also, institute mandatory patient education for highalert medications, including return demonstrations by caregivers and patients of how to measure and administer the medication, to ensure caregiver and patient understanding. Another example of why including the purpose on the Rx may prevent harm. For a patient with known diabetes, a pharmacy technician typed the medication order (Figure 1) as “Lantus inject 80 units at bedtime,” then retrieved three 10 mL vials to fill the order. The pharmacist read the order the same way while checking the technician’s work but said to herself, “This doctor doesn’t know how to spell LANTUS” (insulin glargine). Then, thinking how easy it is to spell Lantus, she checked a little further. When she accessed the patient’s drug profile she saw that the patient was already on LEVEMIR (insulin detemir [rDNA origin] injection) along with LATUDA (lurasidone) 40 mg, an atypical antipsychotic drug. The prescriber intended to increase the Latuda dose to 80 mg. Serious harm could have occurred had the pharmacist not been suspicious enough to check further. This incident serves as a reminder about the importance of communicating the drug’s purpose. Prescribers should also properly write the dosing unit and the route of administration— in the Latuda order on the previous page, mg is expressed as just “m”, and the route is not indicated. Pharmacists should always check the patient’s full profile when verifying prescription data entry for both new medications and refills. Figure 1. Latuda prescription was mistaken as Lantus. page 12 JANUARY/FEBRUARY 2015 / JAN 201 B FE 5 NYCPS NEWSLETTER Jim Schiffer Reporting... News from Around The Pharmacy World JANUARY/FEBRUARY 2015 EDITION Medicare Part D Update Every new year brings surprises to the pharmacist who is serving the senior citizens who have learned to rely on this prescription program for almost ten years. Questions such as, is the drug covered, is the patient covered, is the deductible met yet, is the pharmacy in the network, is the pharmacy in the preferred network. All of these questions occasionally make the patient and the pharmacist crazy. This new year introduced a new twist to those patients enrolled in the Coventry Medicare program. Aetna acquired Coventry in the middle of 2013, (remember Aetna also has a special long term agreement with CVS Caremark to manage the Aetna pharmacy benefit) after the Medicare Part D networks were established for the 2014 calendar year. So the changes to the Coventry network did not take effect until 2015. What most folks did not know was that Aetna made a change to the network status of Coventry patients by limiting the reimbursement to such a low level that chain pharmacies such as Rite Aid rejected their opportunity for participation in the Coventry program for 2015. Many of the Pharmacy Service Administration Organizations also rejected the program because the risk of losing money on the reimbursement rates offered. This change caught many pharmacists by surprise because the way Aetna packaged this change was somewhat cryptic. Naturally, since CVS Caremark is the processor for Aetna, Coventry is now under the CVS Caremark Part D network. In 2014 Coventry had utilized the Express Scripts network which terminated as of the change of the year. As a result of this debacle, thousands of Coventry patients are forced to change pharmacy providers as their current independent or chain pharmacy is no longer in the network. CMS to the rescue. CMS has pressured Aetna / Coventry to re-open the network for at least 60 days (prior to the CMS action independent pharmacies were being told that Aetna was not accepting new providers in their network.) Additionally if a pharmacy provider wants to remain in the 2015 Coventry network, that pharmacy should be offered access (on the same reduced reimbursement rates offered to the existing network pharmacies). Let’s move onto more of a discussion on preferred networks. You all must have seen one or more of the Walgreens commercials about ZERO copays for Medicare patients. Yes Walgreens is running commercials on television nonstop discussing their zero copay (preferred) Medicare Part D programs. It seems that Walgreens has captured the market on preferred networks for the Part D program. To the average senior citizen enrolling in Medicare Part D they are overwhelmed with the information, and then the copayments shown on the Medicare Tool finder do not distinguish the costs for copayments from preferred to non-preferred pharmacies. If a senior is on several medications, the copayment can really add up. Six generic medications with a $6 copayment each at a non-preferred pharmacy can add almost $450 out of pocket on an annual basis. Changes in store for the Medicare Program CMS announced in late January that starting in 2016 Medicare, which has nearly 50 million elderly and disabled Americans under their health care operation, will create a shift in payment calculations to hospitals and related providers, as CMS will base 30 percent of payments on how well health medical providers care for patients, which will now put the providers at financial risk based on the quality of health care they deliver. (Remember the old US Healthcare Capitation system?) By 2018, the intention of CMS is to increase this process to base half of payments made to the new methodology of payments. What this all means for providers such as prescribers and health facilities, CMS will tie in tens, and then hundreds, of billions of dollars in payments to how their patients fare, rather than how much billing and procedures which a doctor or hospital does. This major continued on page 13 NYCPS NEWSLETTER JANUARY/FEBRUARY 2015 page 13 Around the Pharmacy From page 12 philosophical change is starting the process of ending Medicare’s “FEE FOR SERVICE “concept of paying line-by-line for each scan, test and surgery and shifting to an outcomes base of payments. “We believe these goals can drive transformative change,” says Sylvia Mathews Burwell, who is the Secretary of the Health and Human Services Department, the parent agency over CMS, in a printed statement. The change in reimbursement would be a major shift for hospitals, health facilities and physicians, eventually more than doubling the efforts that such concepts utilized by the U.S. CMS claims that this payment process has saved $417 million in reimbursement so far, and the folks at CMS are of the belief that this procedure is how the government hopes to influence, and slow down, health spending. Medicare paid about $362 billion to care providers in 2014, mostly under this Fee for Service concept, according to HHS. The Fee for Service method of payment has long been viewed as an inefficient driver of U.S. health spending, which at more than 17 percent of gross domestic product is the highest in the world. This concept will force the health care providers to be more accountable and force the providers to push for better health outcomes for their patients. Update on the Affordable Care Act The various states which have not yet agreed to the expansion of Medicaid in their states are taking a second look at joining the expansion concept. In Indiana, a state with a republican governor (which many times signals a reluctance to expand their Medicaid program) has announced that they have received a waiver from CMS which will grant Indiana the ability to expand their Medicaid outreach but for the first time, will institute a mandatory modest monthly premium - - based on available income - - which if not paid after a six month failure to pay will allow Indiana to terminate the patient coverage. Tennessee is looking once again at joining the expanded Medicaid rolls but is still attempting to work out the kinks in their proposed operation. You may recall that over twenty years ago Tennessee attempted to create a state wide initiative to provide health insurance to all under the name TennCare. Effective January 1, 1994 TennCare was implemented, replacing the state’s Medicaid program. TennCare covered three groups, Group 1: covered Medicaid eligible, Group 2covered the Uninsured people who lacked access to insurance as of a prior date (March 1, 1993) and who continued to lack access and Group 3 covered Uninsurable people, meaning people who had been turned down for health insurance because of a health condition. As they approached the one year anniversary of TennCare, on December 31, 1994 because TennCare enrollment was approaching capacity, the “Uninsured” category (Group 2, above) was closed and not accepting any new enrollees. As no more new Uninsured people were allowed to enroll it began to defeat the purpose of the entire program which was to eliminate the uninsured, although persons whose Medicaid was ending and who met the “Uninsured” criteria were allowed to stay in the program. The “Uninsurable” category (Group 3, above) remained open, as did Medicaid. As time went on the Tennessee legislature grappled with various attempts to fix the program and although it may technically remain alive in Tennessee, it is merely a shell of what it was intended to accomplish, as the state ran out of money to fund it. Now Tennessee has created a new approach to handling their Medicaid expansion plans and hopes that the transition to a new and hopefully more successful operation will be approved by the Centers for Medicare and Medicaid Services, continued on page 14 page 14 JANUARY/FEBRUARY 2015 Around the Pharmacy From page 13 which is the threshold issue which must grant approval since the federal government pays such a large percentage of the costs. Tennessee officials want to expand the outreach to uninsured residents but want to be able to shift many of these newly insured patients to the managed care world. I think CMS will grant the “waiver” which will allow the Tennessee program to get off the ground. The reason being that it is better to have options for health insurance - -even though these options may not mimic exactly what Washington DC pundents want - - because some new form of health insurance is better than no new form of such health insurance for the uninsured in Tennessee. I will keep all posted when the federal government reviews and makes a decision. There are dozens of other states which have rejected the offer of the US government to cover 90% of newly enrolled Medicaid patients as part of the Affordable Care Act. If you recall, the United States Supreme Court reviewed the Affordable Care Act and only struck the state Medicaid expansion mandate aspect of the law down while allowing the rest of the legislation to stay intact. Currently 28 states have approved the Medicaid expansion through the ACA, of which 10 are led by republican governors, there are 3 states considering the expansion (all republicans), and the remaining 19 states are opposed to such expansion. Of the 19 states opposing such, 16 of these are led by republican governors, one is led by an independent governor and two are led by democratic governors. The two democratic governors actually want to expand Medicaid in their states (Virginia and Missouri) but the state legislature in these two states are republican controlled legislative houses. These folks seem to believe it is better to cut off your nose to spite your face. Instead of assisting the uninsured of their respective states, they instead would rather make a political statement. How short sighted and selfish these politicians are! There is a US Supreme Court case pending as to whether or not residents of states that do not have their own health exchange website but instead are accessing the health exchanges through the federal website are still entitled to obtain federal health insurance subsides as there is a challenge to the way the specific language of the Affordable Care Act is worded. The decision by the US Supreme Court is expected by the middle of June. One has to wonder what will come of the millions of individuals who are receiving tax breaks through the federal exchange if the justices’ rule against the continued tax breaks for the federal exchange. The Affordable Care Act was over 2,000 pages long and issues such as this technical one are not unusual. Under more friendly times, Congress could pass a technical fix to the ACA, but with the tension in Washington, no such technical fix is possible. We will have to wait and see what happens in the US Supreme Court. News reports on the enrollment for the ACA for the second year’s period seem to be a bit better than previously anticipated. The enrollment for the 2015 period (which closes February 15, 2015) may reach or even exceed 10 million individuals. That number appears to be a pleasant surprise to the folks at HHS who were not sure how successful this enrollment period will be. Industry News Have you heard about the NYS Attorney General lawsuit against Actavis? Actavis recently acquired Forest Laboratories and with that came the drug Namenda. It seems that the Namenda (immediate release formulation) has a patent NYCPS NEWSLETTER expiration forthcoming shortly. In order to maximize the value of the Namenda brand, Actavis/Forest has created an extended release (XR) version of Namenda known as Namenda XR. You may have seen television direct to consumer ads for this pharmaceutical line extension on television lately. Well, besides creating an XR version, Actavis/ Forest has also announced that the company intends to discontinue making the immediate release (IR) version of Namenda shortly. Mr. Eric Schneiderman, NYS Attorney General has launched a legal fight to stop Actavis/Forest from discontinuing the IR form of Namenda until the generic version of the product is available which will be sometime in June 2015. A federal judge has sided with Schneiderman on the grounds that the move would be anticompetitive and harmful to patients who are stabilized on the immediate release form of Namenda. So far the Actavis/Forest appeal of the ruling of the court has not been successful, and Actavis/ Forest are forced to continue selling both the IR and the XR form. Once the generic form of the IR is on the market, Mr. Schneiderman claims that Actavis/Forest can do what they want with the IR form. On the EBOLA front, NewLink Genetics Corporation, in partnership with Merck & Co., has moved one step closer to a vaccine for the deadly disease. A research grant has been awarded by the US Biomedical Advanced Research and Development Authority (BARDA), which is an agency under the Department of Health and Human Services, to BioProtection Systems, a subsidiary of biopharmaceutical company NewLink Genetics, in the amount of $30 million to help fund the development and manufacturing an Ebola vaccine. This research grant will cover the cost of clinical development through a new 330-person Phase 1B study. “The current funding provided by BARDA is key to the rapid development of this Ebola vaccine candidate,” said continued on page 16 NYCPS NEWSLETTER JANUARY/FEBRUARY 2015 page 15 page 16 JANUARY/FEBRUARY 2015 Around the Pharmacy From page 14 your fingers crossed this initiative is successful. Dr. Charles J. Link, Jr., NewLink’s founder, chairman, CEO and CSO, in a statement. “These funds will support multiple facets of the accelerated Ebola vaccine program including the expansion of critical vaccine supplies and larger clinical studies.” The vaccine candidate— rVSV-EBOV—was initially developed by the Public Health Agency of Canada, rVSV-EBOV is now is now being developed under an exclusive licensing and collaboration agreement between NewLink Genetics and Merck. Depending upon the results of Phase I trials which are already underway, the US National Institutes of Health has stated they have plans to initiate early this year a large randomized, controlled Phase II/III study to evaluate the safety and efficacy of rVSV-EBOV as well as another investigational Ebola vaccine candidate. Keep Smile for the DEA as they watch you on Interstate 95 It has been reported in the Wall Street Journal that the DEA has set up a huge system of cameras situated in various locations of the United States for the illegal movement of drugs and also for purposes of government confiscation under a program known to help the government seize cars, and other valuable assets in the DEA’s efforts to curb illegal drug usage in this country. The initial location of these cameras were states with border crossings into Mexico such as California, Arizona, Nevada, New Mexico and Texas. This seems logical as this border has been known for large amounts of illegal drugs crossing into the United States. However for the DEA to place cameras along various sections of Interstate 95 between NYCPS NEWSLETTER Washington DC and New York City is somewhat of an overreach. The clarity of these cameras is supposedly so good that DEA technicians are able to identify the facial appearances of the individuals inside of the vehicles. Once the DEA creates a record of the vehicles, the DEA grants local law enforcement access to the database. Some in Congress and the US Senate are troubled by the expansion of this DEA surveillance program, in spite of its legality (according to the US Justice Department). The Wall Street Journal claims that millions of drivers have been tagged by this surveillance program and raise the issue if this type of surveillance is appropriate. Think about it, is it proper for the DEA to be watching so many vehicles and drivers? Are they going too far? Chain Industry News Walgreens has official purchased the remaining shares of continued on page 17 NYCPS NEWSLETTER JANUARY/FEBRUARY 2015 page 17 Around the Pharmacy From page 16 Alliance Boots that they had not yet owned. It has been reported that by combining Walgreens and Alliance Boots will create a new international leader in the pharmacy-based health and wellbeing retail network totaling more than 11,000 retail outlets in 10 countries which includes a huge market of both retail and business brands, in addition to an increasingly international health and beauty product base brands. This combination also will create the world’s largest drug wholesale and distribution network with more than 370 distribution locations delivering pharmaceuticals and related supplies to over 180,000 pharmacies, doctors, health centers and hospitals in 20 countries. The new name of this entity is Walgreens Boots Alliance and this combined operation will be the world’s largest purchaser of prescription drugs and other over the counter, health and wellbeing products. Rite Aid continues to improve their bottom line and they recently announced a new revolving line of credit at a better interest rate. Rite Aid has turned in old and more expensive debt and obtained a better loan interest rate as their bottom line drastically improves. No matter how glamorous Walgreens looks and no matter how Rite Aid improves their bottom line, the talk of the town is the jump in stock price of CVS Caremark, or CVS Health as it is now known. The Wall Street Journal has focused on CVS as a model of health care of the future. Go and grab page A-11 of the January 24, 2015 issue of the Wall Street Journal, (Go to your local library to review it). Over half of this page is dedicated to “The Revolution at the Corner Drugstore”. This story appeared the Saturday after President Obama delivered his state of the union message. The president praised drugstore chain CVS as well as the package delivery service UPS for their programs to train and educate workers, especially those without college degrees. There is a new push at the White House to promote free access for attendance at local community colleges for those interested but that do not have the financial where with all or fortitude to hang in there. CVS Health’s Larry Merlo was in attendance at the State of the Union Address at the President’s request.The Wall Street Journal picks out several of the techniques used by CVS to stem the tied of beating up on the little independent pharmacies who handle CVS Caremark prescription activity. Specialty Drug restrictions which we as pharmacists are deplorable but a way of life. CVS recently dropped the sale of cigarettes continued on page 18 page 18 JANUARY/FEBRUARY 2015 Around the Pharmacy From page 17 which is their effort to overcome the image associated with harmful tobacco products. The addition of Minute Clinics adds to the options that the public has for medical care especially under the push for more medical care access by the ACA mandate. CVS Caremark is also taking a different approach on the oral medications now available for Hepatitis C patients. While Express Scripts has pushed the Gilead products Sovaldi and Harvoni off of their national formulary and instead has placed the alleged inferior Abbvie’s Viekira Pak as the preferred product for oral Hepatitis C treatment, while CVS Health has accepted both Abbvie’s Viekira Pak and the Gilead Sovaldi products. It seems that Express Scripts had bargained for a better rebate on a drug which may not be as effective as the Gilead products, but time will tell how things shake out as Gilead may come back to Express Scripts and offer a better discount for inclusion on their formulary. The New York State Attorney General has launched an investigation into four retail chains sales of herbal supplements sold under store brand labels. Walgreens, Wal-Mart, GNC and Target has been the target of this investigation. According to the NY AG office, four out of the five products studied often contained only cheap fillers like powdered rice, asparagus and houseplants and in some instances some of the products contained unlabeled ingredients which could be dangerous to those individuals allergic to the unlabeled substance. At the time we are going to press the NY AG issued cease and desist letter to all four retail chains and asked each to explain how these retailers verify the actual ingredients labeled on the containers actually are inside of the containers. Stay tuned more on this will follow. This concludes our first report of the new year. With a political shift to a republican controlled US Senate and a larger majority of republicans in the House, President Obama will have to put on his best skills at working with the opposition in the coming two years. In the meantime, the shakeup of Albany politics with the federal arrest of long time NY Assembly Speaker Sheldon Silver will be a game changer for business as usual. For years the NYS budget process was conducted in secret with NYCPS NEWSLETTER three individuals, Senate Majority Leader, Assembly Speaker and the Governor. This year with all of the adverse press, Governor Andrew Cuomo must do his best to distance himself from the scandal which rocked Sheldon Silver out of the leadership slot. Let us see how NY state government functions under the changes which emerged with the election of Bronx Assemblyman Carl Heastie as Assembly Speaker. Heastie has been a friend of pharmacy in the past, let us see if he remembers pharmacy as the state reviews and pushes for a new budget by April 1st. Lets hope for a thawing of the weather too. Stay well, and stay warm - Jim Schiffer ©2014 James R. Schiffer NYCPS NEWSLETTER JANUARY/FEBRUARY 2015 page 19 President’s Message: From page 1 .… and about doing genuine good for others. But does that mean we need to operate below our actual costs? Of course not! Our communities need us to remain viable, so we can continue to serve and support them. But these cynical, unrealistic and savage cuts to reimbursement do exactly the opposite: they’d actually weaken our ability to help. We must not let them stand! We’ve proved it before: when we make our collective voice in Albany as loud, emphatic and united as we can, we have tremendous impact. That’s what we need to do now. Here’s how … First– Join us in Albany for Lobby Day Sign up for Independent Pharmacists and Pharmacy Owner’s Lobby Day on Tuesday March 3rd 2015. Really: join us! Invest this time and effort to protect your business. Help our voice be heard where the decisions are being made by meeting with our elected officials in Albany! Next- Contribute to the RxPAC It’s the simplest of facts: the bigger our budget, the louder our voice. Contribute to the RxPAC: RxPAC contributions can be made on line at the PSSNY website (www. pssny.org) or by calling PSSNY at 800 632 8822. Then - Contact your Legislator You should already have received an email from PSSNY urging you to contact your Lawmaker. If you missed it, or haven’t acted yet, go to the PSSNY website (www.pssny.org) and click the gold box, “Legislative Action.” There you’ll read more about the Governor’s budget that recommends a devastating cut to the Medicaid Fee For Service program. You’ll also find a draft letter to send to your state senator, your assembly person and their staff. https://www.votervoice.net/PSSNY/ campaigns/38341/respond Seriously: even if you do not currently accept much Medicaid Fee For Service … or even if it’s a very small part of your business … you should be concerned. If this terrible bill passes, realize that Medicaid Managed Care is next. Speak out loudly for our future. Please don’t wait: take action now! - Ron Del Gaudio NYCPS President PHARMACY CONSTRUCTION, DESIGN AND DISPLAY EXPERTS! Store Fixtures • General Construction Shelving/Counters • Installations From a Single Fixture to a Total Remodel - WE DO IT ALL! Our experienced, friendly, hands-on staff is here to help! From custom design to general construction and project management, no job is too big or too small for us to handle! • Update the look of your store and increase sales • Shelving, counters, Rx department, installation, ceilings, flooring, painting walls... plus much more! • Electric, plumbing, repairs and maintenance • Immunization rooms/privacy screens • References available Call For A Free Consultation 516-780-9000 | www.RCIKIMBA.COM Kevin Tuite 914-525-4181 Burt Negrin 631-897-0111 page 20 JANUARY/FEBRUARY 2015 NYCPS NEWSLETTER MEDICARE PART B and part d guidance Part B Your physician colleagues are required to provide you with patient medical records for the purposes of supplying DMEPOS items to patients. PAAS recommends that you if you are having difficulties getting medical records from prescribers sending a “Dear Physician Documentation Request Letter” available on your DME MAC website may make it easier. The letter states: DMEPOS suppliers are your partners in caring for your patient. They will not receive payment from Medicare for the items that are ordered if you do not provide information from your medical records when it is requested. Furthermore, not providing this information may result in your patients having to pay for the item themselves. Finally, your cooperation is a legal requirement as outlined in the Social Security Act, the law governing Medicare. Section 1842(p) (4) of the Act mandates that: In case of an item or service… ordered by a physician or a practitioner…but furnished by another entity, if the Secretary (or fiscal agent of the Secretary) requires the entity furnishing the item or service to provide diagnostic or other medical information in order for payment to be made to the entity, the physician or practitioner shall provide that information to the entity at the time that the item or service is ordered by the physician or practitioner. The Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule permits disclosure of protected health information without beneficiary authorization to carry out treatment, payment, or health care operations. The DME MACs perform health care operations as agents of the Centers for Medicare & Medicaid Services (CMS). Providing the requested documentation is in keeping with the HIPAA Privacy Rule. You cannot charge the supplier or the beneficiary to provide this information to the supplier. Finally, if the physician refuses to send you copies of medical records, continued on page 22 DOH Disclosure: From page 1 pharmacists faced just in operating their pharmacies during the emergency situation we all lived in during that period of reconstruction after Sandy left her mark. Just to refresh your memories, DOH’s figures of actual acquisition cost of most of the individual drugs reported were numbers that most pharmacists was unable to find any real evidence of existing. The DOH cost of dispensing survey results were equally as farfetched. (i.e. the surveys of all other states that conducted such similar surveys besides New York, found costs of dispensing ranging from a low of $13.11 [Mississippi] to a high of almost $14.00, while DOH found that The State of New York has an average of $6.77). During the discussions, PSSNY leadership reached a consensus that the best approach to dealing with these apparently fictional survey results was to lobby the New York State Legislature to prevent DOH from imposing their alleged survey results into law which was scheduled to be effective beginning with the state budget on of April 1, 2014. Credit for this one man fight goes to Jerome Schindlinger, who raised the issue of an immediate law suit should to get the raw data held by DOH to be released (immediately) so that organized pharmacy could have an independent analysis of the DOH data in order to prove the common belief that DOH had “cooked the books” or, giving DOH the benefit of the doubt, to learn just where we had made the mistakes in completing the very strange surveys that would have led to our total incomprehension of the factors involved. No real conclusion on a strategy was reached except that the lobbying and legislative approach did not preclude any other action, whether court involved or further discussions with DOH. During those next few days Schindlinger did some in-depth research about the NY Freedom of Information Law (“FOIL”) and concluded that he legally should be successful if he demanded in court, the release of the raw survey data from DOH and then, (possibly with PSSNY’s help or not), have his own analysis of the data performed. Schindlinger expected that he would find that DOH’s methodology in determining both actual acquisition cost and actual cost of dispensing was at least flawed or, at worst, fraudulent. In the next year he learned, sometimes by trial and error, sometimes by his legal research, just how right he was. Around January 17, 2014, he emailed the following Freedom of Information Law (FOIL) request which included: [Please provide me with:] “Copies of the raw data your agency used or is using to propose and/or continued on page 21 NYCPS NEWSLETTER JANUARY/FEBRUARY 2015 page 21 DOH Disclosure: From page 20 promulgate regulations pertaining to prescription drug reimbursement under the New York State MEDICAID fee for service program, which you have informed the general public and pharmacy associations, are anticipated to go into effect on or about April 1, 2014. This includes cost-of-goods-sold surveys and the cost-of-dispensing surveys that all pharmacies were required to complete with[in] the last year or two. I have no objection to you blanking out the names or other [identifiable] sources of the persons or organizations that provided the information to you and, in the event of an error on your part which fails to blank out such information I will maintain the security of such information should I receive same.” As required by the FOIL rules, DOH acknowledged his request within five days, and promised additional information within 20 days (or by around February 10, 2014). When no further response was received from DOH within the legally prescribed time, Schindlinger appealed their obvious de facto denial to the Commissioner. That request was formally denied in early March 2014. He then filed an appeal in New York State Supreme Court which was scheduled to be heard on March 25, 2014. (All of these procedures, times, motions, appeals, etc. were as specifically required by the FOIL rules and regulations.) At the hearing DOH withdrew their denial, claiming it was an administrative error and promised the court that the requested data would be supplied by the end of April. Because the denial had been withdrawn the judge was forced to dismiss the suit since her only jurisdiction was to rule on a denial. However, the dismissal was without prejudice which meant Schindlinger could renew or resubmit without any down side if necessary. Between that hearing date until early June 2014, DOH unilaterally granted themselves more time to fulfill their promise to provide the requested data three times. On June 8, 2014, the ever persistent Schindlinger, by email, demanded the data be provided by close of business that day or he would again appeal. About a week later, in an email dated June 9, 2014 he received an email reply which contained a data file containing names, addresses, telephone numbers, license numbers, employee data, etc. but all of the data actually requested was redacted because it was confidential or a trade secret. When Schindlinger complained he was referred to the Public Officers Law which required that commercial confidential information, such as the data surveys, could not be released if doing so can or would provide a competitive advantage to others. Totally ignored was the fact that DOH had modified the initial FOIL request and included a very large volume of personally identifiable information that Schindlinger had specified that he neither wanted nor needed. Had DOH obeyed his FOIL request and redacted the personal and business identifiable information they chose to include in it and, and then they used that inclusion as their excuse for not providing the requested data. Again, he filed a complaint and appeal with the Commissioner and, when that was denied in due course, again appealed to the NY State Supreme Court. During the previous six or seven months Schindlinger thought he smelled a rat. By this time the smell of this rat was very strong. As part of this appeal he included a request for an Order restraining the DOH from altering or destroying the data that was the subject of this appeal and lawsuit. At the hearing in early August 2014 DOH claimed there was no need for any restraining order because they would never destroy data. The judge, smelling the same rat, ruled that, if DOH would never destroy the data, being ordered not to do so would have no effect but would give Schindlinger legal recourse if they did destroy or otherwise play games. An additional hearing was scheduled for September 25, 2014. At that September 25 hearing, two affidavits were submitted by DOH personnel, one that claimed the cost of goods sold surveys exist only in text files and couldn’t be redacted without printing out some 65,000 pages. They ignored the fact that they had already provided the information to Ernst and Young, their contractor for analysis, in the requested electronic form. They essentially admitted that they had ignored the restraining order or had just lied to the court. The second affidavit contained the purposeful misquote of Schindlinger’s FOIL request, leaving out all mention of his request that personally identifiable information be redacted, instead substituting ellipses (...). As this stand at this point in time, the court decision was handed down on December 17, 2014 and actually received on January 22, 2015, but won’t be completed for a while due to some housekeeping tasks often found necessary when lawyers or judges write arguments or decisions that are best left to the specialists and professionals that understand the intricacies of the matter before the court. All indications are that Schindlinger won a complete victory over DOH and, within a short time he’ll have the demanded data. At that time we’ll provide another update about whether DOH falsified the survey results or whether pharmacists throughout New York State really don’t understand the realities of their business. Our hats are off to a dedicated and persistent pharmacist member who has held the feet of DOH to the fire in his efforts to keep the folks at DOH honest in their dealings with us as health care professionals. (This message was prepared by Jim Schiffer with the assistance of Jerome Schindlinger) page 22 JANUARY/FEBRUARY 2015 PAAS From page 21 even in advance of filling the order, or if they do supply the medical record but failed to meet the documentation requirements in the LCD, then you may provide the patient with an ABN (Advanced Beneficiary Notice of Noncoverage) Form. The patient can sign if they choose to accept responsibility for payment if Medicare denies the claim. Part D Another issue that many pharmacies have called PAAS about is the July 2014 “Prime Audit Advisor” newsletter from Prime Therapeutics. This newsletter reminds pharmacies about the Medicare Part D requirement NYCPS NEWSLETTER that went into effect January 1, 2014 that prohibits auto-shipping of refills to Part D beneficiaries. This rule prevents both retail and mail pharmacies from automatically shipping or delivery medications without beneficiary consent in an effort to minimize fraud, waste and abuse. Here are a few key items to remember: • Only applies to Medicare Part D • Only prohibits automatic shipping or delivery (does not prohibit auto-refills) • Does not impact patients: o who pick up at your pharmacy o who initiated the refill request (e.g. by phone, fax or online) o residing in a Long Term Care Facility • Does impact patients in Assisted Living Facilities CMS has not provided any specific guidance about documentation requirements such as quantity on hand, who called the patient to obtain consent or when the call was made. PAAS suggests that pharmacies evaluate their workflow and documentation practices to adhere to this requirement. As each pharmacy operates under different conditions there is no “one size fits all” approach. You can find the Prime Therapeutics July 2014 newsletter at www.primetherapeutics.com. Click on the “Pharmacists” tab and then look under “Prime audit Advisor Fax Series”. www.PAASnational.com 888-870-7227 MEMBERSHIP APPLICATION—NEW YORK CITY PHARMACISTS SOCIETY 111 Broadway, Suite 2002, New York, NY 10006 NAME DATE OF BIRTH ME NEW MB E NO JOIN RS 12 W F ME MO OR MB NT ER H SH IP HOME ADDRESS HOME PHONE E-MAIL HOME CITY HOME STATE BUSINESS NAME BUS. PHONE ( ) BUSINESS ADDRESS BUS. 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(VOLUNTARY) L.W.C (voluntary) ______________ TOTAL MAKE CHECKS PAYABLE TO nycps/pssny And Mail to: 111 Broadway, Suite 2002, New York, NY 10006 DUES AUTOMATICALLY INCLUDES MEMBERSHIP IN THE PHARMACISTS SOCIETY OF THE STATE OF NEW YORK 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 2014 New York City Pharmacists Society. Under license from our collective authors. All rights reserved. NYCPS NEWSLETTER JANUARY/FEBRUARY 2015 page 23 page 24 JANUARY/FEBRUARY 2015 NYCPS NEWSLETTER