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
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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
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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
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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
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JANUARY/FEBRUARY 2015 page 7
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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
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JAN
201
B
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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
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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
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NYCPS NEWSLETTER
JANUARY/FEBRUARY 2015 page 23
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NYCPS NEWSLETTER