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Health Policy

$1,600 for a Diaper Rash Treatment?

Alarmed by a rapid increase in spending on compounded drugs, like a $1,600 baby balm, insurers and others are acting to control their use.

Drug compounding involves a pharmacist making medicines for a patient who cannot be helped by mass-manufactured drugs. Compounded drugs do not require FDA approval, though Congress recently has moved to enact regulatory legislation. They might be used when a patients is allergic to an ingredient in a commercial product, or a patient needs a liquid formulation of a medication rather than it being in pill form.

Pharmacy benefit managers say there is scant evidence that these combinations of ingredients are safe or any more effective than conventional drugs. Express Scripts, the largest PMB, has said it will stop paying for more than 1,000 ingredients used in compounding, cutting spending by its health plan clients on such medicines by 95 percent. It said such spending had grown to $171 million in the first quarter of this year from $28 million in the first quarter of 2012.

When Posting Baby Photos Became Illegal

Though no identifiers such as names or contact information are included, it is illegal for doctors and midwives to post photos of the babies of their patients on their office wall, though this has been a common practice since not long after the advent of photography.

Under HIPAA (the Health Insurance Portability and Accountability Act), baby photos are a type of protected health information, no less than a medical chart, birth date or Social Security number, according to the Department of Health and Human Services. Even if a parent sends in the photo, it is considered private unless the parent also sends written authorization for its posting, which almost no one does. A thoughtful piece in The New York Times mulls over this and is worth the read for those involved with protecting health information. The comments are thought-provoking as well, such as this one:

“Yes, the HIPAA privacy rules do forbid public displays of baby pictures. That’s perhaps too bad, but it’s not life threatening.

“The real problem with the HIPAA privacy regulations is that while they do address a real issue – the use and often abuse of private medical information for non-medical purposes (for example marketing), the rules have brought about a much more serious problem: the frequent inavailability to legitimate health care providers of important medical information regarding patients, information these doctors (and other providers) need to make urgent, life saving, medical decisions.

“The HIPAA rules and data security requirements are well intentioned, but complex and difficult to implement, and the penalties for non-compliance severe. In the real world it’s hard for the custodians of medical data (such as hospitals) to prohibit unauthorized access, while at the same time permitting it for care providers with a real need to know. And sometimes medical care suffers as a result. The security requirements can be particularly troublesome, as it’s hard with present technology to implement data security that is both secure and functional.

“HIPAA regulations will probably some day find the right balance. But we’re not there yet. And medical care is sometimes shortchanged as a result.”

Certainly the IME and peer review industry has been impacted in recent years, as has the larger world of health care and insurance, with ongoing focus and concerns on maintaining data security, to where it is a cornerstone of providing quality services to claimants. As this reader notes, it is important to remember what the purpose of these industries is—providing for the health of the patient—and to ensure our procedures all work to this end.

The Happiness Calculation for Smokers

How do you quantify happiness levels? The question has relates to a longstanding requirement — first codified under the Clinton administration — that every set of federal regulations with more than a $100 million effect on the economy needs an analysis to prevent the adoption of regulations with high costs and low benefits.

Now it is being applied to the government’s new tobacco regulations proposed this past April, specifically to a cost-benefit calculation which assumes that the benefits from reducing smoking — fewer early deaths and diseases of the lungs and heart — have to be discounted by 70 percent to offset the loss in pleasure that smokers suffer when they give up their habit.

Is this a problem? Well, yes, according to many, as the proposed regulations could water down the agency’s ability to regulate tobacco products. If the formula for assessing costs and benefits remains unchanged in the final version of the regulations, it could set a dangerous precedent that would constrain public-policy making for years to come.

“This is the single biggest obstacle facing the F.D.A. in executing the job Congress gave it,” said Matthew L. Myers, president of the Campaign for Tobacco-Free Kids, an advocacy group. “There’s no way the F.D.A. can do its job if this is applied.”

An F.D.A. spokeswoman, Jennifer Haliski, said that there was “still a great deal of uncertainty” surrounding the calculation, and that the agency was helping fund research to explore the issue. So far the Food and Drug Administration has received at least 69,000 public comments on the new regulations, some quite high profile. Earlier this month a group of economists, including one Nobel Prize winner, weighed in, asking that the calculation be changed before the ruling takes effect. Read more…

What Happens When Hospitals Buy Clinics?

One thing that happens is that the prices increase for services at these clinics. According to hospitals, one reason is that because hospitals (unlike individual doctors) must maintain 24-hour emergency room coverage and cannot turn away patients, they need to raise revenue elsewhere to help absorb this expense. Thus hospitals charge higher rates for many items than do private practices. Nationally, hospitals are buying more and more clinics, where they are also charging higher rates.

As the Affordable Care Act attempts to steer people away from pricey inpatient admissions, hospitals have begun buying up doctors’ offices in hopes of increasing their revenue and market share. The number of oncology practices owned by hospitals, for instance, increased by 24 percent from 2011 to 2012.

Cancer drugs often double in price when hospital systems charge for them. A treatment of Herceptin, a breast cancer drug, costs private insurers $2,740 when used in an independent clinic and $5,350 in a hospital outpatient setting, according to an analysis of 2012 claims by PricewaterhouseCoopers’ Health Research Institute. The price of Avastin increased from $6,620 to $14,100 when used in a hospital setting, the Health Research Institute says.

In some instances conflicts have arisen between insurance companies and hospitals over how much to pay for treatment. In one case, the insurer says reverting to lower payments for roughly 20,000 Pennsylvania chemotherapy patients should $200 million a year.

Steven Weiss, spokesman for the American Cancer Society’s Cancer Action Network, said in an e-mail. “For years, patients have paid different prices for the same procedure or drug, depending on where they are treated,” he said, and “long-standing trends like this one continue to threaten patient access to lifesaving care.” Read more…

Trying to Bring Down Oz

Concerned with the public health impact of Dr. Mehmet Oz’s health advice, in 2013 University of Rochester medical student Benjamin Mazur asked state and national medical associations to take action. However, though for over a hundred years the federal government has passed legislation and created agencies to prevent consumers from being deceived or harmed by “bad medicine,” the situation is a complicated one. For instance, though the Federal Trade Commission has the legal authority to prosecute people who mislead and injure consumers, they can’t do anything about Oz since he’s not actually selling the products he talks about.

With regard to his concerns, Mazur noted: “I’m definitely not the only one.”  Sen. Claire McCaskill, for instance, told Dr. Oz during a Capital Hill hearing: “The scientific community is almost monolithic against you in terms of the efficacy of…three products that you called miracles.”

Mazur explains his concerns:

This issue was brought up by a number of physicians I worked with during my family medicine clerkship. We had all of this first-hand experience with patients who really liked his show and trusted him quite a bit. [Dr. Oz] would give advice that was really not great or it had no medical basis. It might sound harmless when you talk about things like herbal pills or supplements. But when the physicians’ advice conflicted with Oz, the patients would believe Oz.

Mazur is not entirely anti-Oz, of course; as he explains, “I would probably say that he does have the health interest of his viewers in mind. But in the long term, undermining good science and the relationship patients have with their current physicians is probably doing much more harm than good. If they’re not going to listen to advice from physicians—who are providing good, evidence-based advice—if they’re going to listen to other doctors on the show, it’s going to do more harm than good.” Read more…

The Growing Risk of Measles

MCNTalk has written about the question of foregoing childhood immunizations multiple times over the past few years. As these two articles (Measles Cases in U.S. Reach a 20-Year High and Putting Us All at Risk for Measles) notes, consequences of individual choices are serious ones, not just for those involved in the decision to not vaccinate, but for society at large. As editorialist Pauline W. Chen, MD succinctly explains: In any given population, there would always be individuals who would not develop immunity to measles, even after receiving the vaccine, or who could not receive the vaccine because they were too young (less than a year old) or had immune systems already weakened from diseases like cancer or AIDS.

But health care experts discovered that if at least 95 percent of a community were immunized against measles, all the members of that group would be safe. Even if someone with the disease entered the community, the immunized majority would serve as a “buffer zone” preventing further spread to unimmunized individuals.

The initial study indicating a possible connection between vaccinations and autism has been thoroughly debunked, and its author debarred from the practice of medicine for ethical lapses, but the number of measles cases in the US and worldwide continues to increase. In fact, measles remains the greatest vaccine-preventable cause of death among children worldwide. At what point do individual rights outweigh the public good? Read more…

Vaccinations: The Soaring Price of Prevention

MCNTalk has long taken on the vaccination story and has advocated rational and life saving public health policies that promote vaccination.

As this article demonstrates, the dark side of vaccinations is not the overstated risk of side effects, but the predatory cost escalation. The short answer to why the manufacturers are driving up prices is because they can.

This is further enabled by the requirements that some vaccinations be administered for school admission and other public good.

Also the lack of marketplace pressures since the cost is generally borne by government and insurance carriers promotes insensitivity and indifference among those who benefit from them. Finally, monopolies granted via patents and regulations do nothing to induce competition among manufacturers.

Politicians’ Prescriptions for Marijuana Defy Doctors and Data

Brian L. Grant MD

This is a fascinating article on a number of levels. The comments by readers as well as the article are illuminating. I come to it as a person who came of age in the 70s, trained in psychiatry and reside in Washington State. I also have an interest in medical anthropology which among other issues looks at cross-cultural health care systems and beliefs. Finally, I have a strong interest in medical politics and economics which are major drivers of policy and practice in US Healthcare.

Washington State is one where medical marijuana (cannabis) is legal and recreational marijuana will be legal in July with a rigorous permitting and taxation system. In observing the medical marijuana “industry” and practice in Washington, what has been clear is that it is a parallel system whereby anyone can obtain a prescription for medical marijuana and that a tiny minority have the sorts of diagnoses such as glaucoma, terminal pain, cancer, and the like that were invoked to justify medical marijuana in the first place. Furthermore, given the wide array of symptoms that may be “helped” by medical marijuana, most of which are subjective, such as pain and anxiety – there is not a person reading this post who could not receive authorization if they so choose. The dispensaries that provide pot use nice euphemisms such as “medicine” to describe cannabis, and “donations” as what one pays to receive their medicine. Whether one can obtain marijuana while declining a donation is not clear.

So in my view, medical marijuana at least in principle, if not in practice, is by and large a sham. It makes liars out of decent people who want to get high, have a good time, harm nobody in most cases, and perhaps relieve some real symptoms. Similarly, it promotes disingenuous behavior on the part of practitioners who prescribe it, some of whom are true believers, but all of whom are paid good money to write a script often based upon one visit with someone they will never see again.

Therefore, with reasonable reservations and concerns, one should be pleased to see marijuana become legal for recreational use. Like alcohol, which was touted during prohibition as having medicinal value as a way to access whiskey and other drinks  and more, read here and here), marijuana as a medical substance has by and large been a back door to access by those who want to smoke it for its mood altering attributes.

There are many similarities between alcohol and marijuana. Both are substances that can alter one’s thinking and are psychoactive. Both can be sources of enjoyment and conviviality and both can and do cause harm. One is by and large legal and the other not and therein lies the problem. If we as a society wish to ban all substances and behaviors with potential for harm, the list would be long, not end with alcohol, and would certainly start with tobacco and include excessive caloric consumption and other quite legal and common substances. Unlike alcohol, or increasingly prescribed opiates, marijuana has little propensity for physical addiction and tolerance.

Relatively speaking, the end organ damage and aggressive behaviors that excess or chronic use of alcohol induce significantly outweigh the degree of harm seen in typical marijuana users. The numbers of those who use alcohol abusively with resulting damage to themselves or others is significant. Since marijuana use is generally defined as abuse per se, studies looking at actual damage from the use of marijuana need to focus on objective rather than regulatory criteria. Is marijuana harmless? Of course not. Dosages are imprecise as one smokes something with inconsistent intake and varying amounts of active THC. “Edibles” can be misused or accidentally fall into the hands of children. One can simply lack balance and overuse marijuana in lieu of more productive and useful activities, just as could happen with alcohol consumption. And the impact of smoking marijuana is of unknown concern as at least one study suggests that lung damage from typical use is not an issue.

Neither cannabis nor alcohol belong in the hands or mouths of children and make no mistake – increased access to either creates some collateral damage that non-use would avoid, just like opiates or the 70 MPH speed limit on the highways.

Interesting systemic questions include: What is the role of the health care system in deciding that it owns a portion of the human experience, or that something is a medical issue rather than a component of general life? What are the economics of the system and the impact of a substance like marijuana that can be easily grown and distributed outside of the pharmaceutical industry with no inherent barriers to entry other than access to sun or artificial light, soil, fertilizer, water and seed stock? Could there be an element of those in power wanting to maintain control of an income stream, resulting in criminalization, and restrictive regulations along with false or distorted claims of harm to control distribution and access?

Finally, what damage has flowed from criminality of cannabis? How many have died as a result of criminal and gang drug traffic? How many harmless individuals have been prosecuted and jailed for use or distribution of marijuana? How many of the judges, prosecutors, and jurors sitting in judgment on these defendants can with a straight face deny their own use of cannabis in their own lives at some point? What can we learn from countries like Holland where cannabis has long been legal?

We are about to embark on an experiment in Washington state, already started in Colorado, with legal recreational marijuana. The ultimate results remain to be seen. Whatever one’s personal views on legalization of cannabis, facts and data should inform both personal and government decisions on the policies and use of cannabis and other products. Unfortunately the subject is often polarized by advocates and opponents.

How Health Plans Refusing Coverage Can Be of Benefit

by Brian L. Grant, MD

As noted in this New York Times article, more health plans are refusing to cover certain drugs unless the companies charge less for them.

Imagine a world in which food, housing, clothing, cars or other items we consume increased in price by 14% or more per year? What keeps this from happening in general is the pressure of the free market, responding to the pain that we feel every time we pull out our wallet to pay for something – motivating us to shop smartly, consider alternatives, and sometimes make a choice that is not what we would select if money were no object. How many of us work in companies where we can raise our prices by double digits annually, or see our pay increase by similar amounts year over year?

Not so in the world of specialty pharmaceuticals. We have been shielded from price by the impact of insurance payments and convinced that nothing but “the best” is good enough for us patients and that the insurance company writing the check (after our employers or government pay for the insurance), has no business exercising its economic power and “interfere” in what doctor thinks is best.

Nonsense! So long as we have abrogated payment to a third party, these third parties, be they government or commercial, have an obligation to introduce competition and create some pain and perhaps friction in the system. The days of patients paying for their own care are not likely to return. Kudos to the creative efforts to weigh cost and benefits, create formularies, and hopefully drive down some of the egregious pricing that appears to be in play.

Some drug companies choose to do end runs around co-pay requirements by giving rebates to patients, while still getting the big dollars from the carriers for the higher priced drugs. The move to escalate the fight by deleting certain drugs from formularies, forcing patients to pay the entire cost if they or their doctor refuse the alternatives, is a rational and needed escalation.

Boeing’s Flight Plan for a New Era of Health Care

In the fall, 30,000 Puget Sound-area Boeing employees and retirees will be able to choose between two accountable care organizations (ACOs) for their personal and family health plan, a coverage option Boeing is calling the “Preferred Partnership.”

There were more than 600 ACOs nationwide at the start of the year, and they are being touted as a key strategy for curbing U.S. health-care costs.

The fundamental idea is that doctors and hospitals are rewarded for keeping and making patients healthy, rather than a “fee for service” approach where they earn more for prescribing lots of tests or scheduling appointments regardless of how a patient fares.

The contracts also include quality goals that matter to patients, such as the ability to schedule appointments in a timely manner and maintaining patient safety and satisfaction.

There are additional benchmarks tied to costs, including reducing readmissions to hospitals after treatments and effectively managing chronic conditions such as diabetes and heart disease.

Dr. Elliott Fisher, director of the Dartmouth Institute for Health Policy and Clinical Practice in New Hampshire, is hopeful the ACOs can help heal an inefficient health-care system. “There is so much waste,” Fisher said. “ACO arrangements are intermediate steps toward more fundamental reforms.”

Read more…