Obamacare Countdown to 2018—Inch by Inch, Rule by Rule

Terri Bernacchi, PharmD, MBA  Health Advisory Professionals 

It’s impossible to predict what the new Congress will do to amend or repeal all or portions of the health care law that we call Obamacare.  Just beholding the tremendous number of provisions of the Patient Protection and Affordable Care Act (PPACA) continues to astonish!  Though the details of the regulations required by each of the elements will unfold only gradually, the timeline has been laid out in an easy-to-use interactive calendar by Employee Benefit News.  (See the link here: http://ebn.benefitnews.com/health-care-reform/timeline.html?mstr_chnnl=ebn_health_care_reform)

Many of us are now several inches deep on specific components (for me, it’s the operational aspects of the Coverage Gap) but only an inch deep on others (for me, it’s almost everything else).  Thus, this 50,000 foot view of the timelines for each provision will continue to be a useful tool. 

Over the course of time, authors contributing to this blog will comment on some of the provisions, as they roll into effect or as they are clarified. 

One of the most insane provisions set to go into effect in 2011  is the one that disallows the use of FSAs, HSAs, or Archer MSAs for covering the cost of an over-the-counter medicine or drug (except insulin) unless a prescription is obtained. This new provision requires that the person must spend ADDITIONAL funds by getting to a physician in order to get the prescription, incurring additional cost for the person but also burdening the provider and payer parts of the system. 

The logic for this new provision? It appears to be tax revenues for the Government to cover the cost burden of Obamacare.

It’s difficult to track down any other logical reason that such a grand idea would be part of PPACA or why this would be in the best interest of any of the players in health care:  new burdens on the doctor, a reduction in the value of the HSA or FSA for the employee, incurring new medical expenses for the health plan or employer by creating MORE reasons to see a doctor.  This stupid provision actually penalizes routine self-care-----patients must again go see a doctor for a prescription for a cough/cold product. 

This seems to simply be a means to reduce the eligible use of pre-tax dollars for health care purposes so that the IRS will have greater access to taxes from that individual. Our IRS lays out its new stipulations in a very matter-of-fact way, but does not offer any other explanation.  Read more about the IRS ruling at the URL:  http://www.irs.gov/pub/irs-drop/n-10-59.pdf.   They would love to hear your comments.

Terri currently works for a large health sciences firm serving payers, pharmaceutical and device manufacturers and other stakeholders in health care as a Senior Principal in Managed Markets.  The thoughts put forth on these postings are not necessarily reflective of the views of her employer nor other Health Thought Leader colleagues.   Terri has had a varied career in health related settings including:  9 years in a clinical hospital pharmacy setting, 3 years as a pharmaceutical sales rep serving government, wholesaler, managed markets and traditional physician sales, 3 years working for the executive team of an integrated health system working with physician practices, 4 years as the director of pharmacy for a large BCBS plan, 12 years experience as founder and primary servant of a health technology company which was sold to her current employer three years ago.   She has both a BS and a PharmD in Pharmacy and an MBA.

Transparency May Have a Few Downsides for Pharma-Doctor Relationships

By---Terri Bernacchi, PharmD, MBA, Health Advisory Professionals 

I received an interesting alert in my email “in-box” today which was linked to a site called ProPublica.org, an investigative web journalism organization sponsored by the Sandler Foundation (See more about the foundation at: http://en.wikipedia.org/wiki/Sandler_Family_Supporting_Foundation). 

The email I received related to the fact that local news organizations can look up how much money an individual physician in their area may have been paid by specific pharmaceutical companies for consulting or speaking engagements.  In theory, the fact that a physician may become tainted or biased by these moneys is something that we all would want to know about; we don’t want the choice of OUR drug to have been bought and biased but to be the right drug for our medical needs. 

However, the facts could also be distorted or misunderstood to malign a physician who is simply a thought leader for other medical professionals in his area and providing educational support to his colleagues.  These programs are often (but not always) partially underwritten by a pharmaceutical manufacturer.  Physicians, like most people, don’t offer their valuable time for free to structure the presentations or do the projects. 

Continuing medical education has been at least partially underwritten by pharmaceutical and device companies for a long time....certainly long before and since I graduated from Pharmacy School the first time in 1979.  Hospitals and medical schools have finite funds for continuing education -------an essential quality requirement for active staff committed to the need for lifelong learning.  (There’s a reason they call it “practice”...the art is always changing as we learn new things.)

And pharmaceutical and device companies DO want to make sure real world practitioners know about evolving trends that cast their products in a favorable light.  However, I have never met a SINGLE professional who is swayed by these programs or the company underwriting them.  When presented, the evidence is shown in a pretty unbiased way, usually, or the speaking physician will endure the snubs and contempt of his audience.  And they won’t come to his programs if he is a shill for the pharma company.

Seven drug companies, including Eli Lilly, GlaxoSmithKline, AstraZeneca, Pfizer, Merck, Johnson & Johnson, and Cephalon have already publicly posted payments to physicians by name and location.  These companies have started posting in anticipation of new regulations: the Physician Payments Sunshine Act requires all US pharmaceutical, device, and biotech companies to disclose all payments over $10 to physicians beginning in 2013. (Read more about the regulation at Kaiser Health: http://www.kaiserhealthnews.org/Stories/2010/April/26/physician-payment-disclosures.aspx  )

The ProPublica group has taken these public postings and created a searchable database to allow “look ups”; the engine includes a place to enter the doctor’s name but also the state. (See: http://projects.propublica.org/docdollars/ )  (Note:  A simple use of a ‘%’ wild card in the doctor’s name box allows you to pull all physicians and payments for the selected geography or for all 30,342 entries.)  

The site has promoted its database to local newspapers so that they can do stories that will “inform” but probably also embarrass some of the very thought leaders that pharmaceutical companies work with to research diseases or bring products to market through active professional interchange.  The industry cannot do this without the participation the medical community and the medical community cannot cure disease without drugs. Of course, we could always conclude that we’ve solved all of our problems and close down the pharmaceutical and device industry. 

While I found the information posted on this site very easy to use, and I believe it to be accurate, I’m not sure if I can conclude anything relevant after having reviewed it for my area.  The names that appear include some folks that are unknown to me.  But I also recognize some leaders from our local Medical Schools and people that have ethics that I personally know are beyond reproach.  Some of them, in fact, have been hostile to the pharmaceutical industry in the past!  

Certainly, there have been findings that are discussed by the ProPublica group involving a small subset of stipend recipients with a history of licensing sanctions.  This may indicate that Pharma needs to better vet their speakers.

At a minimum, the readers of this blog can become informed of the potential uses of information supplied in the name of transparency.  I am afraid one of the unintended consequences of some of this may be, however, a new wet blanket on the funding and support of local continuing education programs, at a time when the budgets of hospitals and medical schools will become ever more constricted due to Health Care Reform and our anemic economy.

Terri currently works for a large health sciences firm serving payers, pharmaceutical and device manufacturers and other stakeholders in health care as a Senior Principal in Managed Markets.  The thoughts put forth on these postings are not necessarily reflective of the views of her employer nor other Health Thought Leader colleagues.   Terri has had a varied career in health related settings including:  9 years in a clinical hospital pharmacy setting, 3 years as a pharmaceutical sales rep serving government, wholesaler, managed markets and traditional physician sales, 3 years working for the executive team of an integrated health system working with physician practices, 4 years as the director of pharmacy for a large BCBS plan, 12 years experience as founder and primary servant of a health technology company which was sold to her current employer three years ago.   She has both a BS and a PharmD in Pharmacy and an MBA.

Drug Coupon Programs, the Empowered Patient, and the New Debate

by Terri Bernacchi, PharmD, MBA, Health Advisory Professionals 

Not that it’s a spectator pass-time, exactly, but I’ve been avidly watching from the sidelines the development of a new contact sport between pharmaceutical companies and health plans:  the war that is being waged over the propriety of drug coupon programs. 

On the one side is a pharmaceutical manufacturer trying to squeeze as much as it can out of a finite and rapidly-expiring patent, surmounting obstacles involving managed care, formularies, REMS, health care reform with new mandates like the Coverage Gap discount, and countless new compliance questions, not to mention a generally bad economy.  Who can blame the product manager for trying to effectively market a product with savings coupons to a patient whose doctor has just prescribed it for an appropriate use?  The empowered patient may actually begin to demand them.   (It’s done all the time in consumer products.) 

On the other side is the health plan (also pressured by competition, cost concerns and the looming reality of reform) that is picking up the tab for whatever is left over after the patient pays his or her established copayment. 

When a coupon is introduced into that drug selection decision, reducing the person’s out-of-pocket cost, it may have negative effects on the plan’s loss ratio (assuming the plan’s cost is higher than an alternate product).  The coupon undermines the formulary and benefit design that underwriters used to predict costs against the premium.  No wonder they’re upset.  It’s wreaking havoc in a cost forecast!  And the cost benefit goes all to the patient and not to the health plan!

According to the Bloomberg article attached to this link, sales using these copay-reduction coupons have more than tripled in the past four years.   It is this growth that has stimulated a lot of dialogue and debate.  And the FDA is reviewing them in the context of “safety”.  (See:  http://webcache.googleusercontent.com/search?q=cache:nKMRppUOPwoJ:www.bloomberg.com/news/2010-10-27/drug-coupon-use-soars-prompting-safety-and-spending-concerns.html+Bloomberg+article+coupon+drug&cd=1&hl=en&ct=clnk&gl=us )

Certainly, there will be more discussion on this topic as the debate goes national and some payers are advocating for local, state or federal regulation that would put a halt to these practices.  

For my part, I think these programs can provide benefit to all parties if they can be done in a collaborative way.  The challenges to the patient, the plan, and the pharma company are real----the copay subsidy or coupon can provide each side with a win-win-win opportunity if structured properly. 

I think the future will show that it would be a mistake to eliminate these programs and lose that prospect altogether.

Terri currently works for a large health sciences firm serving payers, pharmaceutical and device manufacturers and other stakeholders in health care as a Senior Principal in Managed Markets.  The thoughts put forth on these postings are not necessarily reflective of the views of her employer nor other Health Thought Leader colleagues.   Terri has had a varied career in health related settings including:  9 years in a clinical hospital pharmacy setting, 3 years as a pharmaceutical sales rep serving government, wholesaler, managed markets and traditional physician sales, 3 years working for the executive team of an integrated health system working with physician practices, 4 years as the director of pharmacy for a large BCBS plan, 12 years experience as founder and primary servant of a health technology company which was sold to her current employer three years ago.   She has both a BS and a PharmD in Pharmacy and an MBA.

Patient Medication Adherence May Result in Medical Misadventures – PATIENT

Terri Bernacchi, PharmD, MBA Health Advisory Professionals  

Finally!  Someone is recognizing that people don’t always comply with the dosage and instructions for their prescriptions (and are not always forthright with their doctors about the reality of their compliance).  When a physician notes that the medication doesn’t seem to be working, he or she increases the dosage, which may increase side effects and waste resources (at a minimum), if the patient actually does start to comply or is hospitalized and given the higher dose which is "new" to the patient. 

The evidence was collected by Medco Research Institute, the research arm of pharmacy benefit manager Medco Health Solutions.  The study concluded that nearly one-third of patients given increased dosages of antidepressants had not been regularly taking their original prescriptions. This is consistent with other studies of patient non-compliance or non-adherence----and people have a very difficult time being honest about taking or not taking their medications and the reasons they have for not taking them.  http://drugstorenews.com/story.aspx?id=154961&menuid=335

This is a quiet truth, the proverbial elephant in the room---that people lie----that many clinical failures or challenges are directly associated with behaviors that go unrecognized.   The clinical literature itself frequently draws conclusions based on an assumption of subject compliance.  Well-designed studies have measures in place to verify consistent behavior.

Now, the New England Healthcare Institute (NEHI) has called for a “national strategy” to examine the role care teams can have on improving patient adherence to prescription medicines.  The preface to their position paper which calls for Demonstration projects indicates that, “Poor medication adherence in all its manifestations costs the United States upwards of $290 billion per year in unnecessary health care spending, not to mention illnesses and deaths that could be otherwise prevented.”  A copy of the paper can be found at http://www.nehi.net/publications/48/medication_adherence_and_care_teams_a_call_for_demonstration_projects

Terri currently works for a large health sciences firm serving payers, pharmaceutical and device manufacturers and other stakeholders in health care as a Senior Principal in Managed Markets.  The thoughts put forth on these postings are not necessarily reflective of the views of her employer nor other Health Thought Leader colleagues.   Terri has had a varied career in health related settings including:  9 years in a clinical hospital pharmacy setting, 3 years as a pharmaceutical sales rep serving government, wholesaler, managed markets and traditional physician sales, 3 years working for the executive team of an integrated health system working with physician practices, 4 years as the director of pharmacy for a large BCBS plan, 12 years experience as founder and primary servant of a health technology company which was sold to her current employer three years ago.   She has both a BS and a PharmD in Pharmacy and an MBA.

New Anti-Fraud Provisions in PPACA Require Executive Criminal Checks - Government

Terri Bernacchi, PharmD, MBA, Health Advisory Professionals  

As the elements of the Patient Protection and Affordable Care Act (PPACA), as amended by the Health Care and Education Reconciliation Act of 2010 (collectively known as the Affordable Care Act, or the ACA) have begun to be formulated as regulatory rules that providers and other health care players must conform to, it is clear that some of the anti-fraud provisions are more onerous in terms of requirements and penalties than previous laws.  

Under the proposed rules, for example, newly enrolling home health agencies and suppliers of durable medical equipment (which are considered at “high risk” for fraud) will be subject to fingerprinting and background checking.  The provision would apply to apply to the owners, authorized or delegated officials, and managing employees, who theoretically would be more likely to get a financial gain from the act of fraud.

The law itself (under Section 6401(a)) grants the Secretary new and wide discretion to impose temporary moratoria on the enrollment of new Medicare, Medicaid, or CHIP providers and suppliers specifically to prevent or combat fraud, waste, or abuse.  

An October 6, 2010 white paper has been written and is available in the public domain by the National Health Care Anti-Fraud Association.  This URL link should take the reader to that paper:  http://www.nhcaa.org/eweb/docs/nhcaa/PDFs/Member%20Services/WhitePaper_Oct10.pdf

While the problem of health care fraud is a long-standing one for the private and government sector alike, the requirements posited under these regulations will add administrative cost and burden for health care providers.  The money required to build and maintain the government infrastructure for the fraud background screening and program integrity activities will be covered, in part, by the imposition of new $500 fees on the providers and suppliers. (Gee, I wonder if they’ll pass that cost along to patients and other payers?)  Theoretically, however, the costs will be more than offset by savings due to less fraud.  

CMS continues to take comments on its Proposed Rules for screening providers, asking providers and suppliers to submit comments, accepted until 5:00 p.m. on November 16, 2010. 

Terri currently works for a large health sciences firm serving payers, pharmaceutical and device manufacturers and other stakeholders in health care as a Senior Principal in Managed Markets.  The thoughts put forth on these postings are not necessarily reflective of the views of her employer nor other Health Thought Leader colleagues.  Terri has had a varied career in health related settings including:  9 years in a clinical hospital pharmacy setting, 3 years as a pharmaceutical sales rep serving government, wholesaler, managed markets and traditional physician sales, 3 years working for the executive team of an integrated health system working with physician practices, 4 years as the director of pharmacy for a large BCBS plan, 12 years experience as founder and primary servant of a health technology company which was sold to her current employer three years ago.   She has both a BS and a PharmD in Pharmacy and an MBA.

New “Safety” Technology Assists Pharmacists with Drug Identification - PROVIDER

By----Terri Bernacchi, PharmD, MBA,

Health Advisory Professionals 

People often take their meds out of the pill bottle and mix them together so that they don’t have to carry around a dozen bottles; this is especially true if you travel because it’s a hassle to carry around that big bag.  Or, for the sake of convenience, they put them in a pill box, by the day or week. 

Unfortunately, when removed from the ‘label’ that describes what they are and how to take them, a family member or health professional, trying to assess what med is being taken and when, is lost as to what is going on.

Having worked in a hospital pharmacy for a number of years, I can vouch for the following:  It is not uncommon for a patient to arrive (sometimes unconscious) with pills that are mixed in a bag or bottle, without proper identification.  The patient or family is not sure what the drugs are or why they are taking them and the urgent identification of the drug profile is critical to properly care for patients, avoiding potential lethal drug interactions. The pharmacy or doctor’s office profile on the patient may not be up-to-date, so a simple call to one or the other is helpful, but not complete.  And (I know it is shocking), people sometimes share meds that were prescribed for someone else.  The hospital pharmacist is called in to assist with the identification process which consumes precious time in an urgent situation.

Centice Corp has announced the development of a new technology that will “sense” the compounds in these pills, offering not only a safety net for such situations in the real world, but a practical means for helping the pharmacist or physician to identify meds in a regular outpatient setting.   

Centice first optimizes patented computational sensor technology (based on electromagnetic spectrometry) to rapidly generate a unique chemical fingerprint for each sample which is tracked to specific drug compounds.  The product is marketed under the name “PINPOINT Rx” and helps physicians and pharmacists to identify prescription drugs.

For more on this technology, read the link:  http://www.centice.com/news-events/entry/pinpointrx/

Terri currently works for a large health sciences firm serving payers, pharmaceutical and device manufacturers and other stakeholders in health care as a Senior Principal in Managed Markets.  The thoughts put forth on these postings are not necessarily reflective of the views of her employer nor other Health Thought Leader colleagues.   Terri has had a varied career in health related settings including:  9 years in a clinical hospital pharmacy setting, 3 years as a pharmaceutical sales rep serving government, wholesaler, managed markets and traditional physician sales, 3 years working for the executive team of an integrated health system working with physician practices, 4 years as the director of pharmacy for a large BCBS plan, 12 years experience as founder and primary servant of a health technology company which was sold to her current employer three years ago.   She has both a BS and a PharmD in Pharmacy and an MBA

The Inaugural Blog for Health Thought Leaders – GENERAL

By----Terri Bernacchi, PharmD, MBA, Health Advisory Professionals

It’s my birthday tomorrow (10/11), and I’m 54 years old!!  It seems like only yesterday when I had my first really “hard” birthday (when I turned 30) and the thought of ever hitting 50 was absolutely terrifying. But as I mark this small milestone and look at what lies behind me, I find myself just being thankful.  I am healthy and in a good place, in general, in this tumultuous time.  While I don’t know what lies ahead, I see so much opportunity and so much talent around me that it is hard to stay pessimistic for long. 

Particularly in the business of health care, there is SO much promise.  For the last five decades, the strides made in US health care has made us live better and longer, and our expectations for progress have created a societal willingness to push ahead against the forces of “status quo”. 

I have been in health care since I was about 16 years old, starting as a clerk in a pharmacy and doing various other things along the way:  a housekeeper and then a nursing assistant in a skilled nursing home, a pharmacy intern and then a hospital pharmacist for almost nine years, a professional sales representative in a varied hospital, trade, government and managed care  territory for the manufacturer that launched Cipro, a hospital administrator in charge of “physician relations” providing support to vital medical practices, the director of pharmacy for a large Midwest Blues Plan, and the founder of a company that worked in the environment of drug and medical data processing and validation.  My company was acquired a few years ago and I remain with the company that acquired it.

I’ve seen a lot of things from a lot of vantage points, up and down the food chain that is the complex ecosystem of US health care.  Regardless of one's political perspective or the depth of one's understanding of economics, few could argue that we are sitting on the precipice of a financially disastrous future as we try to “fix” challenges in health care.  Even without the mistake that is “Obamacare”, we were headed for the catastrophic collision of an aging populace with limitless demand but a lack of enthusiasm to understand or deal with the actual cost burden of our choices. 

This blog is dedicated to the future of US health care and our hopeful return to the values that brought us here:  quality patient care, personal compassion, and abundant but personal choices.  My colleagues and I will discuss today’s issues, whether they center on the Patient, the Payer, the professional Provider, Pharma or Device Manufacturers, the Government, or the Technology that drives and connects them.   I can’t promise that we will steer clear of opinions that raise your eyebrows (or your blood pressure) but the views contained here are not those of our employers.  We certainly don’t agree with each other frequently, but always our dialogue bears fruit and the listening to the other guy helps us better understand ourselves and the patients and clients we support.   

Hopefully, by the time I turn 94, we will have learned a lot from each other!

Terri currently works for a large health sciences firm serving payers, pharmaceutical and device manufacturers and other stakeholders in health care as a Senior Principal in Managed Markets.  The thoughts put forth on these postings are not necessarily reflective of the views of her employer nor other Health Thought Leader colleagues.   Terri has had a varied career in health related settings including:  9 years in a clinical hospital pharmacy setting, 3 years as a pharmaceutical sales rep serving government, wholesaler, managed markets and traditional physician sales, 3 years working for the executive team of an integrated health system working with physician practices, 4 years as the director of pharmacy for a large BCBS plan, 12 years experience as founder and primary servant of a health technology company which was sold to her current employer three years ago.   She has both a BS and a PharmD in Pharmacy and an MBA.