*** UPDATE ***

I recently spoke with an individual from the International Academy of Pain Management regarding the previously discussed CMS Medicare billing issue. From this discussion, it has been suggested that CMS acknowledges that pharmacies billing Medicare for implanted drug pump medication provided “incident to” a physician service is “questionable” practice. It was also suggested that this issue will most likely come to a head in the coming months.

One compounding pharmacy in particular who submits billing has admitted to this IACP source that their organization is aggressively trying to grow business in an attempt to gain market share before governmental agencies possibly ban this act – which is rumored to be happening in the next six months or so.

Please be clear that Hartley Medical is not stating that what these pharmacies are doing is illegal – but we are stating that their actions are questionable. We also cannot be 100 percent certain whether or not governmental agencies will choose to allow Medicare billing on behalf of the patient to be legal, but our research points to “not.”

Here is what Hartley Medical asks of you: Please do not switch some or all of your pump practice from your current provider to one that submits billing to Medicare. If this is something that you have been contemplating, consider delaying your decision-making process. It appears that CMS will be announcing its decision regarding this matter in July or August, and enacting it by October. We recommend that you postpone your decision until CMS has  reached a definitive judgment on the legalities of this issue. Do not let these companies entice you to switch in their efforts to grow their own market share by capitalizing on questionable practices that could soon be banned.

I also must throw out these questions:

• - Are these pharmacies operating at the highest of quality standards to ensure patient safety?
• - By switching providers predominantly to alleviate the headaches of reimbursement billing, is patient safety being compromised?
• - Are all aspects of these compounding pharmacies being researched and considered in these provider change decisions?

If you are not fully aware of the CMS billing issue, on December 15, 2011, the Centers for Medicare and Medicaid Services (CMS) issued news for Medicare Part B Providers to reflect Change Request (CR) 7397 – which clarifies policy with respect to restrictions on pharmacy billing for drugs provided “incident to” a physician service.

Pharmacies, Suppliers and Providers may not bill Medicare Part B for drugs dispensed directly to a beneficiary for administration “incident to” a physician service, such as refilling an implanted drug pump. These claims must be denied. (See Medicare Claims Processing Manual, Publication 100-04, Chapter 17, section 50.B and Medicare Benefit Policy Manual, Publication 100-02, Chapter 15, sections 50.3.)

Pharmacies may not bill Medicare Part B for drugs furnished to a physician for administration to a Medicare beneficiary. When these drugs are administered in the physician’s office to a beneficiary, the only way these drugs can be billed to Medicare is if the physician purchases the drugs from the pharmacy. In this case, the drugs are being administered “incident to” a physician’s service and pharmacies may not bill Medicare Part B under the “incident to” provision. (See Medicare Benefit Policy Manual, Publication 100-02, Chapter 15, sections 50.3 and 60.1.)

Anticipating these changes, many practices across the country have taken steps toward developing efficient reimbursement policies and procedures. Due to the various, albeit subtle, differences seen across regional carriers, this development has been more difficult for some than for others.

Hartley Medical understands the challenges involved with reimbursement. As one of the nation’s leading compounding pharmacies, let us be a resource to you and your staff. We offer reimbursement guidance, and we can refer you to a reimbursement specialist within your specific region.

For more information, call 888.671.2888, or e-mail questions@hartleymedical.com.

To read the CMS’s full Change Request, click here.

Watch the video above to listen as William Stuart, RPh, provides a commentary regarding Frequently Asked Questions (FAQs) for researching sterile compounding facilities. To receive a list of our FAQs, e-mail us at questions@hartleymedical.com or call 888.671.2888.

This being said, one of the articles posted in our In the News section sparked some controversy. This article, entitled “Reject Costly Pain Management Bill,” discusses a bill proposed in Tennessee  legislature  that would prevent individuals in Tennessee from receiving pain management services provided by certain health-care professionals; primarily certified registered nurse anesthetists (CRNAs).  One doctor in particular expressed:

“[…] There is a significant gulf separating nurses from physicians in terms of education, training and experience. I have had the responsibility of working with a number of Advanced Practice Nurses (APNs) in my career and have noted, more frequently than not, the information that they do NOT possess and the professional judgment that is lacking. This, of course, is a result of not receiving the astonishing quantity of information imparted during Medical School and Residency and of not being trained to practice Medicine independently as we are.”

We, at Hartley Medical, assured this doctor that we were neither advocating for nor against this topic of discussion, but rather providing an article that is currently at the forefront of the pain world today. We believe that some of the strongest conversations develop through opposing viewpoints on controversial topics.

Hartley Medical services a wide range of clients, which includes practices run by nurse practitioners. Information that may be relevant to those practices may not be relevant to others; some may even be contrary to the personal philosophies and practices of other practitioners. We trust, however, that no matter your stance, you’ll agree with the necessity of bringing topics such as these to light, if only for the sake of education and awareness.

We assure you that our purpose of the “In the News” portion of our newsletter is not to endorse or promote one particular practice or idea over another; we simply hope to inform our readers of the ever-changing world of medicine.  Whether this change is for the better is for the reader to decide.

This being said, we are interested to hear your opinions regarding this topic. To read the full article, click here. To view the May-June 2012 issue of The Hartley Standard, click here.

Hartley Medical’s USP compliant sterile preparation area consists of three areas: 1) a gowning room, 2) an ante room, and 3) a sterile preparation room. To meet USP 797 guidelines, a buffer room should be ISO Class 7 or better (less than 352,000 particles-per-cubic-meter), and the gowning room and ante room should be Class 8 or better (less than 3,520,000 particles-per-cubic meter). And, since workers are the largest contamination source, all rooms should be isolated through the use of sealed doors and pathways. Hartley Medical exceeds USP guidelines by utilizing an ISO Class 6 sterile prep-room, and ISO 7 for ante and gowning rooms. Access in and out of this preparation area, as well as from room-to-room inside, is through sealed, self-closing doors.

Additionally, per USP guidelines, clean rooms for non-hazardous compounded sterile preparations are to be supplied with air through ceiling HEPA filters with low wall-mounted return vents. Air is typically introduced into  the cleanroom at the ceiling level after passing through a fan-powered HEPA filter that removes particles as small as 0.3 microns. This creates a pressurized room in which the air pressure is greater than that outside the room, i.e. positive pressure. The air, and any contaminants in it, is then pushed down toward the floors and out the lower vents. This produces dynamic airflow where the air and contaminants from the processes are constantly flowing out of the room. Hartley Medical’s ventilation system surpasses the standards set forth by 797. In fact, USP mandates that clean rooms should experience no less than 30 air changes per hour (ACHP). Hartley Medical experiences nearly 200 ACPH.

Hartley Medical is Setting the Standard^TM nationally for quality and safety. We are dedicated to protecting our patients by practicing safe, high-quality compounding.

“Almost all surveyed pharmacy professionals believe outdated federal mandates requiring adherence to drug labels and expiration dates contribute to the national drug shortage, according to an American Medical News report.”

The Institute for Safe Medication Practices (ISMP) surveyed 715 hospital-based pharmacists and pharmacy managers where 96 percent of respondents consider a CMS mandate to follow FDA-approved drug labels and expiration dates a contributor to the drug shortages. According to the report, respondents believe that some drugs may have a longer shelf life – demonstrated through medical research.

The article cited the example of neuromuscular blocker drug succinylcholine that is labeled as “stable” for 14 days at room temperature. However, research reveals the drug may be stable for 30 days at room temperature, and its shelf life extends as room temperature drops. More than 1/3 of respondents claim that adhering to FDA labeling often results in wasted drugs, while another 43 percent believe that following labels always results in wasted drugs.

I posted this same discussion on LinkedIn a few weeks back, and I received mixed responses on the topic. A pain relief specialist from the UK stated:

 “Drugs are wasted most of the time as they not only do not produce the cure, but also cause so many misunderstood or so called side-effects. … We may consider drug shortages are because of the economic downturn and the drug companies’ instructions from shareholders to cut back to pave the way for dividends.”

A Florida MD added:

“I know for a fact that many of the expired drugs end up in Latin America when missions are organized to go there by some US medical schools.”

I have performed numerous stability tests with compounded sterile pharmaceuticals to investigate use dates, and I have found many drugs to be within USP specifications well beyond the labeled use date. I am simply stating that I have performed critical analyses regarding this topic and found several labeled expiration dates to be premature; by no means am I saying that beyond-date drugs should be used for patients.

Do I believe that outdated federal mandates contribute to the drug shortage crisis? I don’t know. I have done a lot research into the drug shortages, and most signs point to delays in new and existing manufacturing facility applications, plant shutdowns due to quality assurance issues and outdated manufacturing technologies, and stringent government price controls for generic drugs. Are there other contributing factors, such as the economic downturn and shareholder cutbacks? Possibly, but my research has not confirmed this.

Patient safety is at the forefront of all medical professionals’ minds. Therefore, we would never provide patients with drugs that could be harmful or life-threatening. But if science has proven that drugs are stable beyond current federal mandates, and if we trust utilizing expired drugs for patients of countries lacking proper medical regulation as suggested by the Florida MD, then should we consider the possibility of extending certain drug use dates if there is sound research supporting such a move? If this could decrease drug waste and somewhat alleviate shortage problems, might it be a win-win?

I would be interested in hearing your comments on both use dating and the drug shortage dilemma. Please write to questions@hartleymedical.com. Or make a comment in the comment box provided below. Thanks!

Source: http://www.beckershospitalreview.com/quality/pharmacy-professionals-believe-cms-rules-contribute-to-drug-shortages.html…

Hartley Medical is the nation’s leading provider of compounded intrathecal sterile products, and we are emerging as a primary resource for pain management information. We are constantly evolving to meet the needs of our pain physicians, their patients, and staffs. We are thrilled to announce that we have a new web portal providing you with sources of information about pain management.

Our new Knowledge Center is now active at www.hartleymedical.com/knowledgecenter.html.  It features ALL of our videos, blog postings, past newsletters, and select articles pertaining to sterile compounding and pain management. Even better, it is indexed by category so that you don’t have to sift through all of the resources to find what you need. Simply click on the topic of interest and it is presented to you.

Have a question about a topic that isn’t in the Knowledge Center? No problem! Simply write to us at questions@hartleymedical.com and we will provide you with our response. We will then post it to the Knowledge Center so that others can also take advantage of the information.

Here at Hartley Medical, we are Setting the Standard^TM. We appreciate the opportunity to be of service to you.

America’s current drug shortage problem is affecting thousands, possibly tens of thousands, of patients, physicians, and hospitals throughout the nation. Those with severe, life-threatening illnesses are being affected the most. A number of cancer drugs are among the 240 types of medications that are currently in short supply; and patients fear for their lives because missing multiple treatments can sharply reduce the chances of alleviating the disease.

According to the article FDA: New Suppliers to Ease Two Cancer Drug Shortages by Linda A. Johnson, “The shortages are caused primarily by problems with sterility and other serious issues that have led to shutdowns of production lines and occasionally entire factories.”[1]

Drug shortages have increased dramatically in the U.S. over the past six years, particularly for generic injected drugs, and at least 15 deaths since 2010 have been blamed on the shortages – which is a record high in the past five years for deaths linked to shortages.[1]

The FDA recently announced its approval of importing an unapproved drug, Lipodox (a replacement for Doxil – a medication for treating ovarian cancer) from India. According to the FDA, “Temporary importation of unapproved foreign drugs is considered ‘only in rare cases’ when there is a shortage of a treatment ‘that is critical to patients’ and can’t be resolved in a timely fashion with already approved drugs.”[2]

But is the FDA doing enough to help alleviate this problem? For many, that answer is, “no.”

For some, this problem has forced them to take legal action. In Pennsylvania, two attorneys and 25 Fabry’s Disease patients filed a lawsuit in the U.S. District Court in Washington, D.C., in a vigorous attempt to push the government to help with a shortage of Fabrazyme – the only drug approved in the U.S. for the debilitating genetic condition.[3] Though not a cancer disease, Fabry’s patients are one of the many serious non-cancer illnesses that have also been affected by the shortages. Genzyme, the maker of Fabrazyme, was previously accused of sending this medication to Europe – where a competitor offers the drug – while rationing to Americans.

In 2011, there were 267 drug shortages reported; today there is just under 240. Is this a drop? Yes. But most of these shortages remain unresolved. According to Awi Federgruen of The Wall Street Journal, this is partly due to government’s oversight of manufacturing safety and quality and their stringent price controls for generic drugs. (For more information, click here to read our blog entry entitled, “Drug Shortages: What is Causing Them and How Can They Be Fixed?”)

So what can you do to help? First of all, start utilizing compounding pharmacies. Many experts agree that compounding pharmacies can help alleviate the problem because they can compound commercially unavailable products. Second, make sure that you purchase from compounding pharmacies that work at only the highest-quality standards (click here for William’s guide to choosing the right compounding pharmacy). Hartley Medical continually asks, “Do you know what your sterile compounding pharmacy is doing?” It is time to make sure that your answer to this is, “yes!” And lastly, stay informed. Check your supplies and let your compounding pharmacy know if you have any stock that will be in short supply soon. This way, we can try our best to get the proper medications in advance to fulfill your needs.

Here at Hartley Medical, we have an unwavering dedication to providing only the highest-quality sterile pharmaceuticals; therefore, we compound these medications only to the highest quality standards. We think first and foremost about patient safety.

If Hartley Medical can assist you in any way during these shortages, please contact us. We are here to serve you. Click here to see a list of drugs that are currently in short supply.

Recently, as a result of fungal infections found in several patients, a pharmacy located in the southeast has placed a recall on one of its compounded ophthalmic medications.  The contributing factor to these contaminations has yet to be determined, but the underlying caution is quite clear: be aware of, and comfortable with, the level at which your compounding pharmacy operates.  Evidence shows that it is no longer sufficient to know that a pharmacy can compound a particular medication.  It’s important to know how that particular pharmacy goes about compounding that medication.  Compounding demands disciplined methods for examining the quality of preparations, and nearly every facet of the compounding process requires the utmost scrutiny to ensure that patients are the beneficiaries of superior products for medical treatment.

Shortages are difficult to work through, but the patient’s safety requires, at all times, that his or her medical provider be diligent on all fronts.  There are questions you can ask, and indicators that can and will make you more comfortable with your pharmacy’s operations. (Click here to read my recommendations as to choosing the right compounding pharmacy).  Demand and expect more from your pharmacy.  You’ll rest easier knowing that anything that can be done to guarantee the highest level of quality products has been done.

To read more about the fungal contamination, click here.

Watch the video above to learn how Hartley Medical’s staff undergo rigorous training to prevent potential contamination in compounded sterile products.

I recently received a call from a buyer where the doctor was about to utilize a drug, looked at the syringe and saw “Hartley Medical,” and questioned the product. The issue here was unfamiliarity. The doctor was expecting the commercially available name, but saw something else. After a conversation occurred between me and the doctor, he was beyond comfortable utilizing our product. But this doesn’t change the fact that unexpected change can lead to initial uncertainty. Therefore, physicians want verification that the product they are administering into a patient’s body is one that they know and trust.

Here at Hartley Medical, we understand that the drug shortages have forced change. We recommend that physicians be informed in advance that they are utilizing a substitute medication. This way, they can call and ask questions about the product prior to its use. In situations where this is not option, however, Hartley Medical welcomes phone calls regarding the policies, procedures, processes, and testing that occurs while compounding our sterile pharmaceuticals.

We compound products at a level exceeding USP 797.

If you have any questions, please call 888.671.2888, or e-mail questions@hartleymedical.com

We are here to serve you!

To view William’s Notations on the Drug Shortages, watch the video below:

Patented by Janssen Pharmaceuticals in 1963, fentanyl is a potent narcotic analgesic primarily used for spinal analgesia. This drug is a congener of meperidine and has poor hypnotic effects.  The metabolites of fentanyl are inactive and make an ideal treatment for patients with renal conditions. The drug possesses a high solubility, with a maximum concentration of 25,000 mcg per milliliter. Fentanyl is extremely lipophilic in comparison to morphine sulfate (580:1) that results in a more rapid onset. This property limits its spinal distribution; a fact that must be considered in the treatment of pain at the site of nociception. A review of the literature indicates fentanyl to be 100 times more potent than morphine sulfate for acute pain and 40 to 50 times more potent in chronic pain.

Conversion from Morphine
Often when a physician contacts Hartley Medical for drug conversion assistance, we discuss pertinent literature and then employ mathematical calculations to derive a beginning intraspinal fentanyl dose. We frequently modify our specific calculation of the dosage based on my experience with patients treated with fentanyl. In my many conversations with physicians having extensive experience in fentanyl, these practitioners favored converting patients from morphine to fentanyl utilizing smaller ratios, such as 1/10 to 1/25 of the daily morphine sulfate dose.

With such a broad conversion range, clinicians unfamiliar with intraspinal administration of fentanyl should seek consultation prior to drug conversion. With regard to dosing, the spectrum is also wide for pain providers. Some physicians have reported dosing as low as 4 mcg per day and others, approximately 5,000 mcg per day.

Maintaining Stability
Clinically, fentanyl citrate has been administered intraspinally in combination with many pharmaceuticals. However, there is little published information regarding the stability of fentanyl in combination with such agents. A 1992 study showed fentanyl 20 mcg/mL to be stable with bupivacaine 1.25 mg/mL in normal saline. In a recent publication, David Shields of the former Elan Pharmaceuticals (now Jazz Pharmaceuticals)  found fentanyl to be stable for four weeks when combined with ziconotide. His study is consistent with Hartley Medical’s post-infusion analysis indicating that fentanyl citrate is stable when combined with other intraspinal pharmaceuticals.

• Pharmacies, Suppliers and Providers may not bill Medicare Part B for drugs dispensed directly to a beneficiary for administration “incident to” a physician service, such as refilling an implanted drug pump. These claims must be denied. (See Medicare Claims Processing Manual, Publication 100-04, Chapter 17, section 50.B and Medicare Benefit Policy Manual, Publication 100-02, Chapter 15, sections 50.3.)

• Pharmacies may not bill Medicare Part B for drugs furnished to a physician for administration to a Medicare beneficiary. When these drugs are administered in the physician’s office to a beneficiary, the only way these drugs can be billed to Medicare is if the physician purchases the drugs from the pharmacy. In this case, the drugs are being administered “incident to” a physician’s service and pharmacies may not bill Medicare Part B under the “incident to” provision. (See Medicare Benefit Policy Manual, Publication 100-02, Chapter 15, sections 50.3 and 60.1.)

Anticipating these changes, many practices across the country have taken steps toward developing efficient reimbursement policies and procedures. Due to the various, albeit subtle, differences seen across regional carriers, this development has been more difficult for some than for others.

Hartley Medical understands many of the challenges involved with reimbursement. As one of the nation’s leading compounding pharmacies, let us be a resource to you and your staff. We offer reimbursement guidance, and can refer you to a reimbursement specialist within your specific region.

So, if your sterile compounding pharmacy is billing Medicare, and you are looking to submit your own billing as a proactive solution to this issue, please contact us. We are happy to help make this transition as smooth as possible.

For more information, call 888.671.2888, or e-mail questions@hartleymedical.com.

To read the CMS’s full Change Request, click here. For more information on reimbursement for intrathecal medications, visit our blog entry entitled, “Difficult Reimbursement Conditions.”