Catching Up from the Summer

The big event occurring over the summer was the Supreme Court upholding the Accountable Care Act (ACA). Read more here.

How this will effect pharmacy as a whole is still yet to be seen, but certain areas of pharmacy will need to react and change due to requirements and opportunities in the ACA that will begin starting in 2014.

These include:

• The Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) accreditation exemption. This has been in the process for awhile (Click here for more information).
• A new definition of Average Manufacturer's Price (AMP). Independent pharmacy considers the new definition flawed. (For history of issue look here and here).
• Medication Therapy Management Expansion.
• Medicare Part D Donut hole relief for seniors.
• 340B eligibility expanded to: critical access hospitals, sole community hospitals, rural referral centers, and free-standing cancer hospitals. (US government site on 340B)

Other aspects that will have some effect on pharmacy:
A separate ruling stated that the Federal government cannot penalize states for not expanding their Medicaid eligibility. In a way this blunts the law's teeth. Likewise, since twenty-six states sued the federal government over the ACA, these states are behind in the means of getting ready to implement the changes. How the federal to state relationship will play out is still to be seen.

For businesses, there is going to be a formula of determining health care coverage that must be purchased for employees and the penalties involved if such purchases are not made. There will also be formed the Small Business Health Options Program (SHOP) Exchanges in order to help smaller sized businesses shop competitively priced health insurance options for its employees.

There is likely still much to hear on the ACA in the months to come.

H.R. 1971 Update

With the election year underway, a lot of pharmacy politics have been burning in the back corner. H.R. 1971 is being debated (Hill news report here). This was the bill introduced in the summer of 2011 pushing for more transparency with PBMs.

Two issues of concern related to this bill are 1) overfilling and 2) glass house business (businesses being forced to make public their practice information).

My Opinions:
Regarding overfilling, I am not sure I fully understand the concern here. If the concern is overfilling of fraudulent prescriptions, currently in Florida the DEA is cracking down on pharmacies, pharmacists, doctors, and drug manufactures who combined are making the "pill mills" that exist there. While it seems the DEA feels they are understaffed/underfunded to be moving forward as efficiently as they would like, this problem is being addressed.

Regarding glass house business, I can feel a bit more empathy here. If you own a business, your goal is to make a profit by serving the individuals you are able to supply for, this includes PBMs. While PBMs due tend to get the negative flack from NCPA, and from instances I've seen, rightly so, they are still businesses, serving a need in the American health care system. Ideally, we would like to see all businesses working together in harmony to produce the best outcomes for patients while maintaining a respectable profit margin. (Realistically there will continue to be headbutting.) Combine that concept with the concept that you hold yourself to the same standard you hold others to, "judge not, lest you be judged." If PBMs by law must have their books become public knowledge, then reasonably so independent pharmacies must be ready and willing to do the same.

My point is: Fight hard for what you feel is right, but in doing so, don't overshoot and go too far.

Pharmacy Day on the Capitol in Arizona

The Details:
Pharmacy Day on the Capitl here in Arizona is coming up on Wednesday, January 25th. The main goal of this day is to give the profession of pharmacy a presence before those individuals who have influence in decisions made in the direction of our state.

It is a good idea to know who your legislators are prior to going to this event, since, it might be good to A) let them know you are coming and B) look for them there and let them know you are a voting member in their district and the issues you feel are most pressing to you (hopefully pharmacy has something to do with those issues).

If you heard last year, due to the US census data that came out, Arizona needs to redistrict the areas from where representatives are elected. There also was some not-so-nice political moves done to influence the outcome (more info. here and here), and the process is still being completed. That all being said, your representatives now might change, but still is good to know who they are.

To find your representative:

1. Go here
2. Enter your zip code in the bottom left hand corner
3. You will be shown a map with your district number, remember that
4. Next go here and find your one senate representative and your two house representatives.
5. Email, or even better call, your representatives and say "Hi, my name is ____________. You're my representative and I just wanted to let you know I will be outside the Senate/House on January 25th, next Wednesday from 10 AM to 2 PM, and I am excited to have you come out and let me show you the important benefits pharmacy can offer the state of Arizona, and how using pharmacists can alleviate some problems in the health-care issues you are facing. We can talk over lunch; we'll provide. Thank you so much and I look forward to seeing you."
6. Be ready to talk to your representatives about your passion for your profession. (You're spending at least $80,000 on it; you have to have some passion for it! Sorry, wrong section to say that in =P)

I will post information on what issues specifically the UoA will be talking about when I know which issues are considered most prominent.

My Feelings:
Pharmacy Day at the Capitol can be a very useful day. It gives some of us the first opportunity to get the nerve up to actually speak face-to-face with our legislators. This is government in the United States in action. Be a part of it; it is part of who you are being here. On the flip side, it can also become a pointless bit of show-and-tell, much like an elementary school science fair. The difference between the two is the passion you have for what you will do, not what you have done. Legislation is all about the future, as Mike Huckabee put it at the NCPA trade show in Nashville, it is about "aiming for the next bend." What you've done will demonstrate what you can do in the future, so use it as such. When you go to to Phoenix, have solidly in your mind the reason you are going into pharmacy. Yes, I think many of us want a good pay check and a stable career, but why did you choose pharmacy specifically, and what can you offer Arizona in the future? An personal and honest answer to that will make legislators sit up and listen, especially when they know you vote for them.

Making It Dot.pharmacy

The Details:
The Internet Corporation for Assigned Names and Numbers (ICANN), which is the international regulator of domain names on the Internet, is starting to accept applications to purchase new domain areas. Previously they limited the domains to .com, .edu, .net, .gov, and a few more, however; now they are opening it up to basically anything provided it is reviewed and found favorable.

More Information

My Feelings:
Its a new way of looking at the Internet. Previously you would have the entity's name followed by the suffix domain which described the entity. Now the suffix would be the entity. For big entities this is a boon, but for smaller entities this is a huge, near essential, resource purchase ($185,000 just to apply) that may never come to any use outside of simply protecting yourself. Does the pharmaceutical sphere as a whole buy that suffix? Who gets to control it then? Academia? Commercial pharmacy? Pharmacy Benefit Managers? Does one group buy it simply to stockpile it against another group? I don't know, but it seems to open up a concern for competition of that which is incredibly scarce, yet potentially useful in the increasing ubiquity of the Internet.

Drug Shortages, Retoric, and Super Committee Failure, Oh My!

The Details:
Most of what to report are big news items, but it might be good to bring them together to see how pharmacy may be impacted in the coming months.

First off, starting even last year, drug shortages continue. Debate continues over the reasons, and likely it is a combination of factors. One of those factors may be that as demand exceeds supply, regulations do not allow production to be increased at the same rate. The FDA sees the mass illegal production of medication and thus tightens its demands on all production. Coupled with this may be the 2003 Medicare drug law, which limits price increases on drugs to doctors and hospitals. This in turn makes it so producers have to make a profit by means of quantity, but if expansion is sluggish at best, it leads to a deficit in supply.

Being the huge problem that it is, it has been addressed politically on a number of fronts. On October 31, President Obama's We Can't Wait speech addressed the drug shortage issue by commanding the FDA to look into the problem and make any form of price gouging illegal. Congress also enacted two bills, similar in nature H.R. 2245 and S. 296 to also make it a federal directive to address drug shortages.

Great Britain is also having drug shortages seemingly because the US is importing more to meet its shortfalls.

Finally, from Thanksgiving week, we have found out the Super Committee failed to come to a budget deduction agreement. This would mean an across-the-board budget cuts for all areas of government spending. Given that healthcare is one of the governments biggest money expenditures, it is definitely going to impact pharmacy.

My Take:
Regarding the drug short fall, it still needs to be determined what exactly the issue is. If it is FDA stickiness, preventing expanding production, this would have to be an area looked at to be fixed. Obviously we want strict guidelines on medication, but if it is not improving medication quality and only increasing a burden on production, makes sense to relax it.

The President's speech and Congress bills are good, but really are easy political bandwagons, which may not really address the issue. I don't see these bills not passing.

The Super Committee failure may be unfortunate, but again, was probably the easiest move politically to do. It is easier to commit the crime of omission in politics, because then you blame the other guy. Sadly though this means both the more efficient and less efficient expenditures will be cut equally. And given that many talk about the $1.2 trillion the Super Committee looked at as not even being the $4 trillion that is needed, we're on the way for some rocky traveling.

113th NCPA Annual Convention and Trade Exposition Update

The 113th Annual National Community Pharmacists Association Convention and Trade Exposition was phenomenal. It was an excellent mix of learning and fun, with plenty of both. If you did not get an opportunity to attend this year, please keep it in mind for next year when the 114th will be in San Diego, CA.

As always with these events there is a lot of information on the morphology of pharmacy in politics. So without further ado, let us get to the updates:

The Obama Administration's stance on PBMs

In President Obama's Plan for Economic Growth and Deficit Reduction, on page 41, the President starts indicating that drug deal programs (both PBMs and pharmaceutical manufacturers) need to be audited to make sure the government is getting the savings that they are supposed to be getting. On page 43, the President implies that using current PBMs is not a very efficient means of saving money, and suggests the government negotiate directly for coverage of employees. (Plan for Economic Growth and Deficit Reduction)

My thoughts: While this is not a "slam dunk" against PBMs, it definitely shows that the hard questions which need to be asked are starting to be asked.

DME bill being kicked around by the "Super Committee"

The Diabetic Medical Equipment reimbursement through Medicare and Medicaid and how it will be done by competitive bidding and if independent pharmacies of size 10 stores or less will be exempt is currently part of the larger debate of how to cut costs which the congressional "super committee" is contemplating. For more information on the specifics of the DME issue, click here.

My thoughts: What is at issue here is access to diabetic equipment (test strips, testers, and lancets) from smaller pharmacies, since obviously the larger pharmaceutical chains will be able to bid lower being able to supplement losses by sheer volume of sales. Living in Arizona, our senator, Jon Kyl is on the super committee and while he is not seeking reelection, it does provide us with some say in what is going on.

To contact Jon Kyl, click here.

Continual push against mandatory mail order

The popular trend to save money in healthcare is the concept that if mail order medications can save money for some individuals, then it must be able to save money for everyone. Thus there is a trend toward making mail order medication mandatory in insurance plans. NCPA has continued to push against this, demonstrating that in many cases mandatory mail order actually costs the taxpaying public far more than it saves. NCPA information

My Thoughts: In some rare cases I could see mail order medication saving money, such as a pharmacist ordering his or her own medication (if they don't own their own pharmacy). The need to have a personal relationship with a pharmacist who will take your medication list seriously cannot be overstated. My mother is a good and experienced pediatrician; she and my father both get their medications via mail order since it does cost less, but even still she let's me review their medication to look for issues that might come up.

Continual push toward transparent MACs

Maximum Allowable Costs are the ceiling price that pharmacies can get back for the product they have allowed to be sold in their store. Under the current system, there can be multiple MACs for different situations and PBMs can change MACs without letting pharmacies know of the change until after the product has been sold and gone. The government has begun to get involved in solidifying and making MACs transparent under a new system called NADAC (more information).

Continual push toward PBM transparency

There appears to be some progress in this front given the latest push from the Federal government (more information). NCPA stance, click here

Push toward collective bargaining rights

The issue here is if independent pharmacies can join together against contracts where because an individual pharmacy is so "small" the larger insurance company (PBM) can make it a take-it-or-leave-it contract, where the pharmacy has no choice but to accept the terms because it would hurt its patients' options.

5 Star rating system

The Centers for Medicare and Medicaid Systems (CMS) is implementing a 5 star rating system for insurance plans in order to promote consumer health and information. (Sadly, Wikipedia has a good summary )

My Thoughts: While this star rating system might be good, given that it takes patient opinion into account, it does not seem to take pharmacy and pharmacist opinion into account (I'm also fuzzy on if they take doctor opinion into account). This seems to leave those professionals who know the system, know how it works and how it can be played out of the rating system.

Continual push toward pharmacists being reimbursed for professional time

This continues to be the aim of most pharmacy organizations. Medicine Therapy Management has helped push towards this goal, but there continues to be a long way to go.

Updates from DEA

The focus of the DEA right now is shutting down "pain clinics" specifically in Florida, where individuals are being prescribed abuse potential controlled substances in large and uncontrolled quantities. (more information) The DEA is also holding manufactures and distributors accountable for selling and shipping such large quantities of drugs when it should be clear from the volume it is intended for questionably legal purposes.

The DEA is also aware of and disturbed by the current trend in society in thinking that pharmaceuticals are safe and ok to take, specifically referencing drug parties, where social goers bring random pills to add to a "candy bowl." Also they see an alarming number of high profile deaths due to prescription drug over dose.

The DEA is also very disturbed by the concept of medical marijuana, specifically referring back to the trend in society, they see it as associating two concepts, medicine and illegal drug, which only further strengthens the current trend in society, which leads to dangerous results.

My Thoughts: I really have nothing to add to the DEA's stance.

Use of NPI in reimbursement

When submitting claims for reimbursement specific information needs to be on the claim in order for the pharmacy to receive its claim. The environment seems to be shifting towards the NPI, National Provider Identifier, being the main means of identifying the prescriber in the claim.

That was a large update. Thank you for taking time to educate yourself on what's going on in pharmacy and as always, keep sending me information you find so I can incorporate it.

Do Secret Deals Create Savings? Uh-huh...

The Details:
The US Government is beginning to tackle the need for PBM's to be more transparent in their negotiations, sales and rebates. The PBM's claim this transparency would not allow them to get special discounts to pass savings on to their customers. (More info.)

My Feelings:
Normally I don't like using expletives, but this is one of the biggest lines of (insert your choice of a colorful metaphor here) I have ever heard. Basic rules of supply and demand indicate that initially when the consumer does not know roughly where the intersection of the two curves are, the consumer usually overpays. The seller can undersell too, but let's be honest here, if you run a business which is driven by stock market pressures to increase stock price, you are going to do your own studies to know where the intersection could lie. Thus they can claim to give the "best price" but nobody can prove it. And if you cannot prove it, given stock market pressures, you're going to try to get as much money as possible, whatever the means. How quickly will people do something against the law if they know they will not get caught? Same principle.

Also, thinking who the biggest consumer is, the government, it means more tax dollars of ours being spent on a non-transparent system.

Aggravating.