Saturday, November 26, 2011

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.

Monday, October 17, 2011

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.

Tuesday, October 4, 2011

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.

Thursday, September 22, 2011

Victory for Compounding

Background:
In 2009 a president of a Venezuelan Banking Association sent his team of polo horses to compete in the 2009 U.S. Open Polo Championships. While in the US, a veterinarian prescribed a supplement for the horses to prevent rhabdomyolysis (more info. here). The prescription contained an error, far too high of a dose (oral sources indicate the pharmacist called the veterinarian to verify the high dose and was told it was correct), the pharmacy compounded the prescription as stated and 21 horses died. (More details) The both the FDA and the Florida State Board of pharmacy investigated the compounding pharmacy, Franck's Lab, Inc., which had been compounding veterinarian medication for nearly 25 years. The Florida Board was content with its investigation, but the FDA continued to investigate the pharmacy, including bringing the lawsuit US vs. Franck's Lab, Inc. against the pharmacy and all compounding pharmacies in general.


Results:
On September 13th, Judge Timothy Corrigan of the US District Court for the Middle District of Florida has issued his ruling:
  • The FDA does not have authority over compounded medications dispensed by a licensed pharmacy so long as the pharmacy’s activities are not manufacturing. That authority rests with individual state Boards of Pharmacy.
  • Congress did not give FDA jurisdictional authority, when it enacted the Food, Drug and Cosmetics Act (FDCA) in 1938, to take enforcement action against a pharmacy that is engaged in traditional compounding practice.
  • The FDA cannot use its Compliance Policy Guidelines (CPG) for veterinary compounding issued in 2003 as the basis for enforcement action.
  • The regulations enacted by the FDA based on the 1994 Animal Medicinal Drug Use Clarification Act (AMDUCA) are in error. This legislation did not give FDA authority to prohibit the use of bulk active pharmaceutical ingredients APS) in veterinary compounding.
  • The size and scope of a compounding pharmacy does not mean the pharmacy is a manufacturer.
  • The use of bulk APIs in compounding for humans and the prohibition of bulk APIs for compounding for non-food producing animals is an illogical position for the FDA to take and contraindicated by its own actions over the past 50+ years.
This ruling is a huge event for compounding pharmacies in that it sets the degree to how much the FDA can intervene in traditional compounding activities.

Medco-Express Scripts Too Big?

The background to this update is the acquisition of Medco Health Solutions Inc. by Express Scripts (more info.)

Both Medco and Express Scripts are large Pharmacy Benefit Managers (more info on PBMs) and the combined acquisition would result in a single PBM having a huge share of the market. This has led many to cite the merger as a monopolistic practice.

At the end of August, the Justice Department blocked a merger between AT&T and T-Mobile (video info here). Given the Justice Department's stance on this merger, some are wondering if it is a harbinger of their stances on other mergers which exist.(Cracking the Door)

A number of consumer advocacy groups are filing complaints against the merger, arguing that such a conglomeration would harm consumers. (More info.) Oddly enough NCPA is not one of the groups in this formal proposal.

Express Scripts is already taking the offensive and arguing that such a merger would not harm consumers/patients. (More info.)

My Feelings:
Coporations are under a tremendous amount of pressure to "knuckle under" to increase their bottom line. Basically: increase stock prices or investors will move to a different company. The larger you make a company, the higher the incentive is for the company either to perform ethically questionable activities to increase stock value or to throw its weight around to eliminate the competition, neither of which really helps patients or consumers. Given that the pharmaceutical development/distribution sphere is already highly convoluded and shrouded from public scrutiny, this only encourages larger companies to perform the above stated activites. Competition and economic destruction/creation is good, so long as the playing field remains transparent and balanced. If a few select companies get special privilages due to their size or political power, its the same as a sports team cheating in a game, and the referees looking the other way.

Tuesday, August 30, 2011

National Average Drug Acquisition Costs (NADAC)

The Center for Medicare and Medicaid Services (CMS) is looking to change its model to set drug reimbursement costs given to open-door--patients can come in and drop off prescriptions--community pharmacies. It is being called the National Average Drug Acquisition Cost (NADAC).

The current model is for states to reimburse open-door community pharmacies based off of a Average Wholesale Price (AWP). Both look at an average cost of medication to a pharmacy as a means to setting a baseline of reimbursement. The difference between this method and the new method proposed is the issue of transparency.

A pharmacy purchases its drugs, sells its drugs and then submits its cost to the state (or Pharmacy Benefit Manager, a.k.a. PBM) for reimbursement. This composes of a time lag between when the product leaves the pharmacy and when the anticipated payment is made. If the price fluctuates, the pharmacy lost control of what drug it would sell for what price. This makes the operation of a business fundamentally challenging and often frustrating.

With AWP, there are ways states, PBMs (and even pharmacies, hence the introduction of Maximum Allowable Costs, a.k.a. MAC) try to circumvent or change the amount reimbursed in order to try to save money. This often leaves the pharmacy stuck with the bill. The hope is that NADAC will make the amount a pharmacy receives in reimbursement transparent so pharmacies can more accurately count for what payment they will receive.

Sunday, June 26, 2011

Low Drug Costs to Get In

The Details:
An interesting angle to NCPA's push for The Medicare Access to Diabetes Act.

Market analysis is seeming to show that Wal-Mart is using its low cost prescriptions, to the point of losing money per prescription filled, as a means to get customers in the door, only to increase the costs on other items (here diabetes supplies) to make up the difference.

My Feelings:
There are many angles of consideration here, and one of these days I will try to exhaustively list my feelings on the issue. In short: I am in NCPA because I feel independent business is vitally important to a thriving economy, and Wal-Mart has caused many independent businesses to go out of business. Yet, it is not Wal-Mart that does that, since it is the customers who opt to go to Wal-Mart who do so. In economic terms Wal-Mart has operated efficiently, and should be respected for such. My supreme concern is that the economic playing field be balanced and open. If one business is allowed to muscle its way through because of its size, and because it can sustain a larger game of attrition or it can get away with questionable practices, then the customer/patient suffers.

Vermont Pharmaceutical Information Ruling by Supreme Court

The Details:
The U.S. Supreme Court made a ruling on Thursday (June 23) on a case of pharmaceutical information in Vermont.

The case involved the sale of prescribing information (only what doctor prescribed what drug, not to whom) from pharmacies to "data miners," who would in turn compile the information and sell it back to pharmaceutical manufacturers, who would in turn use the information to fine tune their marketing strategies to doctors.

Vermont law made the above practice illegal, but allowed the sale of prescribing information for other non-marketing reasons, such as health research.

The Supreme Court ruled that the Vermont law was invalid since it unconstitutionally burdened the pharmaceutical manufacturer's free speech, i.e. marketing, in comparison to the other entities who had access to the information.

My Feelings:
This is a tough one in my opinion. If the law allows one entity to receive the information, but bans another, it is by definition unfair and discriminatory. But, at what point does that unfairness or discrimination become unconstitutional?

What I find most interesting, and maybe slightly disturbing, is that the acquisition of information is considered part of free speech. Creation and dissemination, yes, but acquisition?

Wednesday, June 15, 2011

Pharmacy Benefit Managers

For those interested in going into independent pharmacy, one will quickly hear about Pharmacy Benefit Managers, or PBM's. Essentially these are the insurance companies that go out and market an insurance plan to businesses or individuals in order to cover their perscriptions. They are also the entities that pharmacies need to work with and through in order to get reimbursements for drugs sold to individuals under the respective insurance plans.

One of NCPA's largest complaints, and I fundamentally believe rightfully so, is that PBMs do not act fairly. Two major reasons for this are their size and the lack of transparency to observe what they are doing. This sets up economic incentives for PBMs to perform questionable behavior, succumming to the market pressure to maximize bottom lines.

Here is a good summary of some of the issues and complaints that are against PBMs.

NCPA Legislative Conference 2011 Summary

NCPA had its 2011 Legislative Conference in Washington D.C. The major pieces of legislation that were pushed were:

1) A push for congress men and women to join the pharmacy caucus. This would demonstrate that the member of congress is publicly saying they are concerned about the issues of pharmacy.

2) The Pharmacy Competition and Consumer Choice Act. House Version: HR 1971, Senate Version: S 1058. These bills aim to make Pharmacy Benefit Managers (PBMs) more transparent. To understand more about PBMs read here.

3) The Medicare Access to Diabetes Supplies Act. House Version: HR 1936. In order to try to lower government spending, the Centers for Medicare and Medicaid Services (CMS) feel that having diabetic supplies covered under Medicare Part D being sold only through those who can bid the lowest price would reduce overall spending. What this means is whoever could offer the lowest Diabetes supplies reimbursement, would get sole Medicare Part D funding to cover the sales. This would mean that only large chain organizations could offer Medicare Part D covered Diabetes supplies without 1) charging patient full market price or 2) selling Diabetes supplies at a business loss. Essentially bottom line cost reduction will reduce availability, which would especially hurt rural areas and independent pharmacies.

4) The Medication Therapy Management (MTM) Benefits Act of 2011. House Version: HR 891. This bill seeks to lower the requirements (conditions and number of drugs) a patient must have in order to have MTMs covered under Medicare Part D. This is to increase the pharmacist's role in MTMs, by allowing more reimbursements for time spend doing MTMs to more patients.

Saturday, April 16, 2011

HB 2067

Summary:
HB 2067 in the original form was to grant three additional powers to a county board of supervisors to further govern over their counties, on top of what they already could do. These three additional powers were: use county resources for search and rescue, contract out to provide search and rescue services, and to contract with an ambulance business to provide ambulance service to rural areas. HB 2067 was then amended to also give the county board of supervisors the ability to shop around for the best deal to contract out police services.

On 4/8/2011 The Arizona Board of Regents, who oversees the three state universities along with the board of UA Healthcare,  voted to reduce the size of the combined board of supervisors of UA Healthcare from 26 to 19. UA Healthcare is a conglomerate of University Medical Center and University Physician's Hospital. Originally UMC had 13 members on its own board, and UPH had 13 on its own board. The plan was to join the two hospitals along with a partnership with the health colleges of the UoA to form a large research and educational health care system in southern Arizona.

After this vote, Kevin Burns, who was Interim President and CEO of UA Healthcare submitted his resignation.

On 4/13/2011, an additional floor amendment was added to HB 2067 which would completely strip the Arizona Board of Regents of all control over the health-care conglomerate of UA Healthcare and it would be replaced by a new Board of Directors.

On 4/14/2011 HB 2067 passed the Senate (27 to 3) and is currently waiting for House voting.

My feelings:
Clearly this is a political power-play. Why would a floor amendment, which fruit-basket-upsets a specific established governing unit, which is on paper a philanthropic organization, be attached last minute to a bill, which basically does run-of-the-mill good amending to general county policies? The two acts of legislation clearly do not mesh.

What seems to be happening is that some on the original board of supervisors are upset with the potential of losing their positions, which lead to pulling the right political strings to get this amendment attached to a pretty decent act of legislation. There also seems to be animosity in State Congress toward the universities, because while in the end life will likely go on as usual, what essentially is being said is, "Bad UoA, bad!" As a student in pharmacy school, this really angers me that a conglomerate that could potentially be extremely beneficial, educational, and informational is told to "back off" because some people has a bone to gnaw. That being said, I do not know all that went on behind closed doors, but the fight is definitely out in the open now, and the whole principle of attaching one group's personal vendetta against another group onto a good piece of legislation is politics at its worst.

If you opt to contact the Governor Brewer regarding this, here is the information:
http://www.azgovernor.gov/Contact.asp
Telephone (602) 542-4331
In State Toll Free 1-(800) 253-0883 (outside Maricopa County only)
Fax (602) 542-1381
 
Update (4/21/2011):
On 4/19/2011 HB 2067 passed the House.
It seems the major discontent and reason for this bill is the Legislature feels the Board of Regents did not communicate properly or well. Maybe something needed to be done. Still, using another piece of legislation as the vehicle for chastisement is not right.

Update (5/1/2011):
Governor Jan Brewer vetoed HB 2067 along with 28 other bills on 4/29/2011. She also signed into law 357 bills into law.

Sunday, April 3, 2011

Taxing Poor Choices

Politics in Arizona is picking another major nerve to poke regarding health care. The proposal is to start taxing individuals who are on AHCCCS who make poor health-care choices regarding smoking, being overweight or regarding their diabetes. (More Information)

My Feelings:
From a economic, ethical and health-care stance I feel this measure barely scratches the surface. At issue here is the definition of what welfare should be. Does depending upon society for aid mean you still have the right to do whatever you want? Does it mean that you can continually harm yourself against medical advice and expect everyone else to pick up the bill for the consequences? Does it mean you should get care over someone else who is trying to take care of himself? Scarcity dictates that there is not enough money for everything, so who gets the care?

Also at issue here is incentives to encourage individuals to make better choices for themselves. Yes, taxes on indulgences can seem not nice, but by mere supply/demand they keep fewer individuals from doing them. As a health-care provider-to-be, I want to see people healthier, and logic dictates that means it may be a rough road for some. Of note, if individuals are healthier on average, that would decrease costs on the health-care system.

Finally, ethics play a major role. Coming from a Biblical background I will quote Scripture, "If a man will not work, he shall not eat." (2 Thessalonians 3:10). Since even Paul, who was physically handicapped (1 Corinthians 16:21, 2 Corinthians 12:7, etc.) knew that work meant more than just physical activity, even if someone cannot physically work, the mindset should be concern for one's fellow person. Those physically disabled can still encourage, give advice, develop their intellect, and, if you believe in the power of prayer, they can pray for others. If the mindset of welfare is "what can society give me?" instead of "what can I do with the help society provides?" the individual becomes a hole that only takes and does not give back. Why should this individual receive help over another individual who desires to give back? (again scarcity)

These are issue arguing questions, and I mean them as such. This issue is extremely important because it pokes at the very central nerve of why welfare provides health-care benefits.

Please feel free to post your comments regarding this below. Also please use this post to organize your thoughts, feelings and rationals regarding this issue and take a few minutes to write your legislators.

Wednesday, February 9, 2011

Federal Action to Take

National Health Services Corps offers loan repayment options for trained medical workers to work full time (also an option for part time) in an under served community (an accredited NHSC site). Currently it only has physicians and nurses as being specifically named in the option for this repayment, with pharmacists falling under "other schools of health profession." A bill (S. 48) is currently being considered in the Senate that would change the wording to specifically include pharmacists.

This may not seem like that much, but getting the name pharmacist in there specifically equalizes pharmacy to a valid medical profession as medicine and nursing.

Please take a little time and write your senators so that we can have support in getting this bill to pass.

Passed

Well a good day for Arizona pharmacy today:

SB1298 passed the Senate which allows (1) the pharmacist can modify prescriptions if working in conjunction with either a physician or nurse practitioner (2) the pharmacist to administer influenza vaccines to children 6-17 without a prescription or if a state of health emergency is declared by the state Governor and (3) student interns can administer vaccines if certified and under supervision of certified pharmacists.

Now it just remains to pass the House.

Saturday, February 5, 2011

Arizona: List of Bills Involving Pharmacy

Here is a link to Arizona Pharmacy Alliance bi-weekly publication that lists the bills that have been submitted to Arizona Congress in 2011 (pages 3-8).

Of note:
  • S1298 allows pharmacists to vaccinate children 6-17 for influenza w/o prescription, 6-17 w/ prescription for other vaccinations, and w/o prescription in response to public health emergency, if passed.
  • H2398 makes illegal the sale of salvia divinorum to those under 21.
  • Multiple bills regarding changes to AHCCCS, which either tighten coverage or shift payments.
  • A number of bills regarding abortion: requiring informed consent and disallowing public funding.
  • S1202 expands of what is defined as dangerous drugs to include geometric isomers of already defined dangerous drugs.
Also of note on February 16th, from 3:00-6:00, ADHS will hold a public meeting in Tucson on the draft rules for medical marijuana. It will be at the University of Arizona: James E. Rodgers College of Law, Ares Auditorium on 1201 E. Speedway.

Thursday, January 20, 2011

Arizona Pharmacy Day, Know Your Legislators

Here is a quick link to help you find your legislators for where you live. Type in your address AND zip code in the upper right area of the screen. This will give you your district number. Then using your district number check here for a list of legislators both senate and house. Remember you have two house representatives.

Also, to recap the top issues Arizona pharmacy is focusing on for Pharmacy Day:
1. Immunizations of children 6-17: influenza w/o prescription; other vaccinations w/ prescription
2. Student pharmacists who are certified in vaccination may vaccinate under the supervision of a vaccination certified pharmacist.
3. Improve pharmacist's scope of practice by being able to prescribe via collaboration with physician(s).