Archive for the ‘Policy’ Category

Bye Bye Generic Vicodin

Friday, June 15th, 2012

Let the wailing and gnashing of teeth begin.

Vicodin pills are about to get a lot more expensive.

You see, according to this Abbott Vicodin Announcement (.pdf file), Abbott Labs is very concerned about the Tylenol content in its combination pain medications. After all, too much acetaminophen per dose in prescription medications may cause “severe liver injury from acetaminophen overdosing.”

In bowing to pressure from the FDA, Abbott decided to stop making the combination pills containing hydrocodone with 325 mg Tylenol or more and decided to start producing all of its combination pills with 300 mg Tylenol, instead.

Phew. I’m glad they took care of that. I’m sure that the extra 25 mg of acetaminophen in the current formulation was just causing an untenable overload of all the liver transplant centers throughout the country.

The other thing that creating a new formulation and discontinuing the current formulation does is create a new patent on the medication. Which will undoubtedly mean that, much like how the cost of colchicine went from 10 cents per pill to $5 per pill, the cost of brand name Vicodin will soon skyrocket as the medication goes “non-generic”.
Since states don’t like spending a lot of money on medical care, it is also likely that the “safer” brand name Vicodin will no longer be covered under state insurance plans. I’m sure there will still be generic versions of hydrocodone/acetaminophen available along with Oxycontin and Tylenol with codeine — until the remaining manufacturers also create their own “safer” versions of the medications.

For now, any time that a physician writes a prescription for the brand “Vicodin”, patients are going to not only have pain in their body, but they will also have pain in their wallets. I’m predicting $2.50/pill price point.

Look for lots more hassles to both pharmacists and to the doctors writing the prescriptions.

Microbial Armageddon

Wednesday, May 9th, 2012

Any patient who demands a ZeePack for a runny nose, who wants amoxicillin for sinus congestion, or who wants Levaquin to “keep this bronchitis from developing into pneumonia” needs to read this Bloomberg article.

We are heading toward a situation where people die from infections that no antibiotics can treat. The article discussed one infant in a pediatric ICU that died because the infection that the child developed was resistant to all antibiotics used for treatment. Six similar incidents occurred during the course of 16 months. Estimates are that 100 million people in India have been colonized with organisms carrying the genetic mutation. Medical tourism in India is decreasing as a result.

Even the director of the CDC cites the situation an example of why we have to limit antibiotic prescriptions: “We are looking at the specter of untreatable illness.”

Oh, and remember how the Centers for Medicare and Medicaid Services assert that if hospitals don’t give antibiotics to every single pneumonia patient within 6 hours of arrival – even though a large proportion of pneumonias are viral in nature – that the hospitals are falling outside of “quality” guidelines? Our government’s own “quality” guidelines may be contributing to the looming microbial Armageddon in this country.

Dr. Google, meet Pharmacist Bing

Tuesday, May 8th, 2012

FDA decides whether to allow patients to purchase prescription medications over the counter for many common ailments.

This idea is controversial.

On one hand, deregulation would remove one of the largest barriers to receiving treatment for some conditions – the doctor’s visit. If no doctor’s visit is necessary to receive necessary blood pressure medications or diabetes medications, then patients don’t have to wait for an appointment and the patient/government doesn’t have to pay for the doctor’s visit. The move would also purportedly cost patients more money for their prescriptions because insurance companies (including Medicaid) don’t pay for over the counter medications. Therefore the costs for medications that go over the counter would be shifted to the patients who purchase the medications.

But on the other side, I’m sure that patients will “Bing” what medications they think they need, and the proposed plan would require patients to answer questions online or at a kiosk and then get input from a pharmacist before the prescriptions could be purchased. So there really isn’t unfettered access to the selected prescription medications.

According to the article, the American Pharmacists Association is embracing the concept while many doctors’ groups are opposing the idea. Pharmacists believe that their increasing role in a patient’s medical care will be a good thing while physicians see many of their “bread and butter” patients skipping appointments and instead going to the pharmacy kiosk.

Some of the conjectures about such a policy should be addressed.

Will prescription costs for patients go up? If patients have to pay out-of-pocket, then perhaps they would be paying more money for prescriptions, but I doubt that the amount of money would be much more than the copay they were previously paying. I imagine that most of the medications considered for over the counter use would be generic medications from the notorious “$4 list,” so the financial burden on a vast majority of patients would not be great.
However, there are certain medications that have no alternatives. Consider colchicine, vancomycin, and Plavix. Medications similar to these would continue to command a higher price. If patients need such medications or desire name brand medications, then they will keep going to the doctor in order to get their designer medications for a $20 copay.
However, medications that do have a generic or over the counter equivalent will see downward pressure on their pricing. Who in their right mind would buy a $300/month name brand medication when the $4 generics (or a combination of $4 generics) work just as well? So pharmaceutical manufacturers would have to justify the price of their expensive medications or would have to lower the price until patients felt that the price justified the benefits over generic medications. That’s free market at work.

Will the public be in imminent danger if they are allowed to self-prescribe? I doubt it. The Angry Pharmacist has a different take on the matter (read the post from behind a blast shield because it is rife with f-bombs). He believes that patients who take some medications need to be medically monitored for adverse effects from the medications. For example, patients who take ACE inhibitors may have deterioration in their kidney function from the medication and may even develop renal failure. If patients are worried about the effects on their kidneys, they can see their doctors for such testing. There are also some online labs that will provide direct-to-patient testing. But if we consider the renal function example, we can also look at Mexico where patients can purchase many medications over the counter. The rates of chronic kidney disease are no higher in Mexico where people can purchase ACE inhibitors over the counter than they are in the US where people cannot purchase ACE inhibitors over the counter. Maybe the adverse effects of medications are balanced by fewer people developing hypertension-related kidney disease because they are controlling their blood pressure. Lots of potential explanations, but we won’t know the real cause and effect without specifically studying the issues. Perhaps this isn’t the most accurate indicator of adverse effects from medications, but comparing health issues in the two countries may show that some of the health concerns raised against this policy are overblown.

Will pharmacists be happy with this policy? Decidedly not. If patients are allowed to purchase prescription medications over the counter, pharmacists all over the country are going to have another very significant and time-consuming task added to their laundry list of things to do while simultaneously being expected by their employers to fill prescriptions at the rate of no less than two per minute. Consider the intent of this policy. What the government is trying to do is shift patients from a paid physician service to an unpaid pharmacist service. Pharmacists are going to be doing a lot of extra work for which they will receive no extra compensation. And … if the patient does develop a serious side effect from over the counter medications provided at a pharmacist’s advice, then the patient (or the family of the dead patient) will have only the pharmacist or the pharmacy to blame because no physician was involved in prescribing the medication. Pharmacy malpractice insurance premiums are about to go up. The Angry Pharmacist notes that there is no one to sue in Mexico if there is a bad reaction to a drug. Do pharmacists really want the target painted on their backs?
This is a case in which I think pharmacists should be careful about what they ask for.

So what’s the right answer?

Deregulation. We shouldn’t stop with medications, either. We also need to deregulate radiologic testing, lab testing, and many medical devices as well.

Under this proposed policy, there shouldn’t be any input required from medical providers before patients purchase a medication, either. If patients want to ask about a medication before purchasing it, that’s fine. Patients don’t need pharmacist input to purchase vitamins, ibuprofen, Tylenol, Prilosec, or Claritin, so why should patients require pharmacist input before they purchase blood pressure medications? Just as with current over the counter medications, the onus should be on patients to research the side effects and interactions of medications before taking them. For that matter, why should patients need a doctor’s permission to get a CBC, have their cholesterol checked, or get an x-ray of an injured ankle? All that the regulations are doing is causing a barrier to access. Very few people are refused x-rays if they go to a doctor and really want them.

There should be some limits on what can be purchased over the counter, though. Controlled substances and antibiotics are a couple of examples of things that should still be off limits to the general public. In fact, so many physicians inappropriately prescribe antibiotics that I think antibiotics should be a controlled substance and that physicians should lose their ability to prescribe antibiotics if they demonstrate a disregard for proper prescribing practices. Coughs, runny noses, and simple toothaches do not require antibiotics, doc. We need to practice 21st century medicine.

So let patients purchase most medications over the counter. Yes, medical providers will still have to be Vicodin police and ZeePack police. For the rest of the medications, have at it. There will inevitably be some adverse outcomes and even deaths from wrong doses and from medication reactions. When these adverse outcomes occur, patients will gradually begin to see the value in the services that pharmacists and physicians provide.

We’re there to try to watch out for your interests, we’re not there to keep you from getting care and treatment that you truly need.

If you don’t believe me, you should be able to go and purchase medications yourself, knowing that you alone are responsible for any adverse outcomes that come from using the medications you purchase.

I think that is a fair trade-off.

UPDATE 05-14-2012:
Cross-posted at Kevin MD here with additional commenters.


Drug Shortages

Wednesday, March 28th, 2012

Just got word that several additional medications have been added to the national list of “drug shortages”. Doctors better start learning more about wilderness medicine at this rate.

I can see the management of our next unstable patient now …

[Call comes in on telemetry line]
“We’re coming to you with a 44 year old male hypotensive and unresponsive. Short transport time.”
[15 minutes later, the crew arrives]
“Sorry it took so long, our ambulance ran out of gas because we couldn’t afford to fill the tank due to the high gas prices and low Medicare/Medicaid reimbursements. We had to call for assist with transport from the Amish Ambulance Service with its horse and buggy. By the way, do you know where I can get a broom and a very large shovel?”

[Patient is hooked up to the monitor. Wide complex bradycardia. Pressure 60/40. Dialysis graft is noticed in his arm.]
“Dialysis patient. He may be acidotic and hyperkalemic. Give him an amp of bicarb STAT.”
“Sorry doc, we’re out. There’s a national shortage.”
“Keep that fluid bolus going. Let’s start some Levophed on him to raise his blood pressure.”
“Sorry, doc. We don’t have any of that either. National shortage.”
“Well let’s at least give him some Vancomycin in case he’s septic.”
“I’d like to, but I can’t. That’s on national shortage, too.”
“Well, he’s not responding very well. At least let’s get him intubated. Can someone push some Rocuronium?”
“Don’t have that, either. National shortage.”
“Nope. That’s out, too.”
“Nope. National shortage.”

[patient now loses his pulse]
“He’s CODING! Start CPR. Give him an amp of epinephrine, STAT.”
“Sorry, doc. National shortage. Don’t have any.”
“OoooKayyy. Give him an amp of atropine, then.”
“Don’t you know that atropine isn’t part of ACLS protocol any more? Besides, we don’t have any and there’s a national shortage of atropine, too.”
[patient is unable to be resuscitated and dies]

Six weeks later, the doctor receives a letter from the Arizona State Nursing Board [for those who don’t regularly follow this blog, this is parody — background here] informing him that he is being investigated for failure to properly manage the patient and failure to properly look out for the patient’s best interests, too. He must submit to a psychiatric evaluation, must submit to a genetic test to assess his future intellectual capacity, and must submit to a hearing in front of the whole nursing board to explain himself or else his name will be posted somewhere on the Arizona State Nursing Board’s web site and he will never be allowed to be a nurse in Arizona.

“I think I’m going to be sick.”
“Hope not. We’re out of Zofran, too. National shortage.”

[fade to black]

Good thing I had extra coffee and some old jumper cables laying around to jolt my heart back into a normal rhythm after seeing the Instalanche! Thanks, Glenn!

“Safer” Conscious Sedation

Wednesday, March 21st, 2012

I’ve performed conscious sedation dozens of times. Never had a problem. Not once.

Until now.

For some unforeseen reason, our hospital has now decided that there are multiple additional hoops through which physicians must jump in order to be credentialed to perform conscious sedation. We have to be certified in ACLS. We have to sit through a course on conscious sedation so that we know the difference between light/moderate/heavy sedation and general anesthesia. Then we have to take a test on the medications we prescribe to make sure that we know that the medications may … make patients drowsy. There are several “pre-procedure” forms that we have to complete to determine how difficult a patient may be to intubate … if intubation is needed. And, while the patients are in their sedated state, there is a six page form that the physicians must complete – in addition to another several page form that the nurses must complete. Looking through all the additional proposed paperwork, I’m not really sure how there will be time to do the procedures when all of the paperwork is required to be filled out and medical care will obviously just get in the way.

Yup. Conscious sedation just became a whole lot “safer.”

I’m glad.

But I just don’t think that the paperwork is appropriate, and I think the overwhelming focus on paperwork is bad medicine. Because of that, I withdrew my privileges for performing conscious sedation. I’m not the only doctor who has done so, either.
Now, if patients need conscious sedation performed while I’m working, the hospital has decided that I am no longer competent to perform the procedure.
From this point forward, patients who need conscious sedation in the emergency department will get an anesthesiology consult and the anesthesiologist can deal with the hassles if every last one of the multitude of checkboxes hasn’t been completed make sure that the conscious sedation is performed properly. That will cost substantially more money be safer.
And from this point forward, if the anesthesiologist is busy in the operating room (which is likely during the day) or is gone for the day (which is likely at night) and can’t come to administer the same medications that emergency physicians administer all the time, the patient will have to be admitted and the procedure will need to be performed in the operating room. That will be even more expensive and time consuming safe.
Patients with dislocations or other painful conditions who need procedures performed will have to wait. I’m competent to give them IV pain medications (we’ll see how long that lasts), but just not IV sedation. Patients who need IV sedation will need to speak to the anesthesia specialists. I’d like to help and I’m able to help, but I’m just no longer certified to help. Everyone is just looking out for your safety.

Now the Medical Marijuana Advocates (nee “the Joint Commission”) has further justified its existence because it can now REVIEW the stack of charting required for every patient that has received conscious sedation and threaten the hospital with decredentialing if every last check box on every last form hasn’t been completed correctly make sure that things are safe. It might even be able to create a booklet to describe how to pass inspection for said paperwork which will cost $595 per year be made available to hospitals. Hospitals will then be able to hire advanced consultants to look over all the paperwork and make sure it is complete before JCAHO comes to visit.

But patients will be “safer” …

at least on paper.

Isn’t that all that matters?


How Time is Spent During an Emergency Department Shift

Tuesday, March 6th, 2012

During one shift last week, I felt as if I was spending too much time doing computerized charting, computerized order entry, and computerized admit orders [contractually required to write them – don’t ask] and not enough time with patients and their families.

This week, I decided to account for every minute of my time during a 12 hour shift in a moderately busy emergency department where I was the only physician working. I had to scrap the first time I tried it because I kept forgetting to write things down. The next shift, I put the notes where I wouldn’t forget – right next to the computer keyboard with portable clock sitting on top of them.

There is a little bit of overlap between categories when I was multitasking. For example, if I was speaking to a doctor on the phone while charting, I counted the time as only speaking to the doctor. Out of a total of 720 minutes in the shift, I calculated that I spent the following amount of time performing the following tasks:

Seeing patients: 247 minutes
Time on computer: 365 minutes including …
–Charting/entering orders and labs to be done: 219 minutes
–Looking up old medical records: 42 minutes
–Entering discharge instructions/prescriptions: 41 minutes
–Entering admit orders/completing transfer forms: 63 minutes
Discussions with other physicians: 69 minutes
Researching medical issues: 13 minutes
Eating lunch: 5 minutes
Personal phone call: 4 minutes
Miscellaneous down time: 12 minutes
Sign out to oncoming physician: 5 minutes

Longest time between patient exams: 47 minutes
Involving: 24 combined minutes charting patient’s condition and entering orders, 13 minutes discussing the patient condition with three physicians, 10 minutes completing transfer documents and giving report to medics

I probably write more than most docs on my patient charts. Even so, more than half of my time was spent making sure that the charts were documented sufficiently to satisfy hospital administrators, to please governmental payors, and to smite plaintiff attorneys.
I’ve had some nurses tell me that I spend too much time with patients. My shift averaged 7-11 minutes per patient, with a few outliers. In total, I spent only one-third of my 12 hour shift with patients and their families. That’s too much?

Kind of disappointing to realize how the practice of medicine has “evolved.”

Pay Up or Leave

Thursday, February 23rd, 2012

Want non-emergency care in the emergency department? Pay up first.

After performing a federally-mandated screening exam, many hospitals are now charging an up-front fee of $100 to $150 to be treated for non-urgent complaints. Don’t want to pay? You’ll get a list of other health care resources and can leave.

And it is happeningalloverthecountry.

ACEP is against such a policy, arguing that 2 to 7 percent of patients determined to have “nonemergency” conditions are admitted to a hospital within 24 hours and that a vast majority of patients have conditions requiring urgent treatment.

I don’t think the policy is a bad idea, provided that patients have an alternative source for routine care. Medical care costs money … a lot of money.

The problem is that when the practice becomes commonplace and a public outcry occurs, I can only imagine what new laws that will be created to force hospitals/providers to provide treatment to all emergency department patients.

Legislative Fixes

Friday, February 17th, 2012

Washington State drops its plans to limit Medicaid patients to three emergency department visits per year. Instead, Washington plans to institute a policy of refusing to pay for any emergency department visits by Medicaid patients that are deemed “unnecessary.”

What effect will this policy have?

Medicaid patients can’t/won’t be charged for the “unnecessary” visits.
Washington state will no longer pay for the “unnecessary” visits.
Therefore, hospitals and medical providers take a financial hit if the state makes a retrospective determination that a visit is “unnecessary.”

In order to make the determination whether a visit is “necessary” or not, Washington State officials must rely upon what is written in the patient’s chart to determine a patient’s complaints, diagnosis, and workups. Who controls what complaints are emphasized on the charts and how the complaints are worked up? The same providers that will be financially liable if the visits are deemed “unnecessary.”

If this policy survives the legal challenges that are being mounted against it, look for a sharp increase in the number of patients diagnoses that Washington State does not deem “unnecessary.”

The funny thing is that when you pay for a result, you often get the result. Remember when Medicare started docking hospitals that had central line related bloodstream infections? When hospitals don’t get paid for patients with central line related bloodstream infections, the incidence of such infections plummets. But the incidence of bloodstream infections in general goes up. It’s all in how you define the issue.
With emergency patients, the demographics won’t change. The patient complaints won’t change. The diagnoses will change a lot – especially if patients know that they might be triaged out of the emergency department without receiving care and sent to a medical clinic if they have certain “unnecessary” complaints. If I was running a hospital, I would even put a sign up in the waiting room stating which complaints/conditions that Washington State would pay for and telling patients that after they receive their federally mandated triage exam, they may be sent to a clinic for their care if they do not have one of those conditions.

Because reimbursable diagnoses are usually paid at a higher level, I think it’s a safe bet that Washington State will end up paying out more money for emergency department visits by Medicaid patients. Your baby needs to be seen for a cough? Coughing is an “unnecessary” complaint. But, that cough could represent RSV pneumonitis or pneumonia. Those aren’t “unnecessary” diagnoses. Instead of giving you some cough medication and discharging you, we should probably do some blood work, a chest x-ray, and get a nebulizer treatment going just to make sure that there’s no pneumonia or RSV present.

When legislators try to fix a system that they know nothing about, they often just make the system worse.
And then they need to create more regulations to try to fix the problems they created with the initial regulations.

We’re from the government. We’re here to help.

Healthcare Update — 01-23-2012

Monday, January 23rd, 2012

See more medical news from around the web over at the Satellite Edition of this week’s Update at ER Stories.

The story of “Dr. Douchebag” and why morale is declining in many of this country’s emergency departments. Even if you say “thank you, sir” for the abuse, your job may still be threatened because of bad Press Ganey scores.

More than 80% of medical mistakes go unreported by hospitals. Let’s just get this out of the way: Doctors kill every single patient that they treat and plaintiff attorneys should be paid even more money to sue our way to better health care. That should do it.

Indiana woman awarded $1.5 million after surgeon did not operate on abdomen soon enough. Two days after initial presentation, she required emergency surgery for ischemic bowel requiring that a large portion of her intestines be removed.

Sorry, Grandma, I know that your bone cancer is causing you excruciating pain, but you can’t have any more pain medication. As Florida cracks down on doctors who treat chronic pain patients, the patients are having more difficulty getting their medications. Where do the patients end up? In the emergency departments.
When pill abusing patients go to the emergency department and don’t get their medications, some become abusive and violent.
Now some Florida hospitals are implementing a “chronic pain management plan” which requires doctors to “help educate patients about the dangers of abusing prescription drugs and addiction.” Got that, Granny? You have bone cancer and you have six months to live, but abusing oxycontin is dangerous and can kill you.
As part of the “plan,” emergency physicians then will “refer the patient to a primary care physician” – who has already been “cracked down upon” and who won’t prescribe the pain medications, either.
End result? In an attempt to curb abuse by criminalizing the prescription of pain medications, Florida is now affecting the ability of patients who are legitimately in pain to receive necessary treatment. Cancer pain patients in Florida now more likely to get bounced around the system and die in pain.
And people blame the physicians instead of the legislators.

Why let a little thing like a gangrenous appendix get between you and your wedding? Ceremony held in hospital. Both bride and groom wear “gowns.”

New York jury awards 18 year old patient $3 million for delay in c-section at birth that allegedly caused patient’s cerebral palsy.

Patients gone wild in Pennsylvania. Woman gives medical staff hard time in ED, pulls out IV, threatens to infect everyone around her with HIV, kicks a security guard in the cha-chas when trying to escape, then is wheeled out of the hospital by police kicking and screaming in a wheelchair. Initially charged with three felonies, but those charges were dropped by persecutors er, um prosecutors. Of course, if the security guard was an off duty police officer, the patient would be doing 20 to life in Leavenworth.

Patients gone wild then … police gone wild? Patient becomes combative in emergency department. Police called, then allegedly “strike the patient, place him in a headlock, pull and twist his head and forced handcuffs on him with force and violence.” Another officer allegedly “pushed the handcuffed man over a metal chair arm with the force of his weight pressing upon him.” The officers could face jail time and fines if found guilty.

Patients gone wild — Twilight Edition. Toledo woman allegedly tries to steal baby from hospital. When ED nurse approaches her, the woman turns around and bites her. Then she hisses, turns into a bat, and flies away.

The Medical Marijuana Advocates create even more safety policies. Now they’re recommending that health care organizations assess “fatigue risks” and develop a “fatigue management plan” which includes “strategic caffeine consumption.”
My kid kept me up last night. I’m a little fatigued. I want to come to work and sleep, then when I wake up, I want free double mocha lattes. OK, nanny?
The problem is that “fatigue” is determined in a retrospective manner and the Marijuana Advocates don’t tell anyone how to determine fatigue prospectively. Make people afraid of it and tell people who’s to blame for it. That’s how you win elections.
Of course, it didn’t take the plaintiff’s attorneys much time to jump on how providing services while “fatigued” is negligent and will kill people.

While many patients can’t afford health care at all, some hospitals cater to the ultra-rich, charging them between $450 and $4,500 per day in order to have a butler, swank hospital rooms, and an exclusive menu. Meanwhile, other patients wait in the emergency department for days before a hospital bed opens up. Oh, and medical residents aren’t allowed on the units, either — only attending physicians.

Kevin Pho from Kevin, MD wrote an article in USA Today providing some suggestions on how to reduce malpractice lawsuits. Some people commenting on the article demanded that physicians’ hours be cut back so that they aren’t overworked while trying to pay for their “expensive houses, cars, and boats” (see comments section).
I say “be careful what you wish for.”
In other countries, people are demanding that physicians work more hours because patients can’t get the care they need when the doctors work banker’s hours.

Too Many CT Scans … or Not Enough?

Friday, January 20th, 2012

Scary findings.

Patients using Coumadin who have any head injury need repeat CT scans.

The study looked at 116 patients who were taking Coumadin and who had any head injury with a GCS of 14 or 15 – regardless of loss of consciousness (patients with lower GCS were presumably at higher risk of intracranial bleeding). CT scans were performed on all patients. Of those initial 116, nineteen patients (16%) had bleeding on their initial exam. Of the remaining 97 patients with normal initial CT scans, ten refused to be in the study. Repeat CT scans were performed on the remaining 87 patients 24 hours after the first normal CT scan and showed 5 cases of new hemorrhage. Three of those patients required hospitalization and one delayed bleeding patient required brain surgery.
Even after a normal CT scan 24 hours later … two additional patients still developed symptomatic subdural hematomas — one patient 2 days later, one patient 8 days later. Both of those patients had INRs greater than 3.0. The study recommends admitting patients overnight and repeating CT scans in 24 hours. Original study here (.pdf).

While admission and repeat CT scan for minor head trauma hasn’t become the standard of care in the United States, this study raises questions about the optimal care of minor head injuries in patients taking blood thinners.

Also at issue is the Medicare policy not to pay for “normal” CT scans of the head in atraumatic headaches. Will this policy spill over to deny elderly nursing home patients from receiving CT scans when they can’t remember whether they have hit their heads?

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