Category Archives: Laws and Regulations

This is a Very Bad Idea

I was stunned when I saw this headline in the New York Times last week: “Court sides against FDA in ‘off-label’ drug promotion case.” In case you missed it, here is the lede:

The maker of a prescription fish-oil pill won an early victory Friday against the Food and Drug Administration over its right to publicize unapproved uses of its drug.

The gist of the story is that the pharmaceutical company successfully claimed that restricting its ability to promote off-label use with (in the words of the court) “truthful and non-misleading information” violated its First Amendment right to free speech.

Let me be clear here. I am all for maintaining the longstanding prerogative that physicians and other licensed prescribers have to prescribe approved medications for unapproved indications.  That’s not what this is about.

Continue reading This is a Very Bad Idea

Price Transparency

About a year ago, I shared details of my own out of pocket medical expenses and concluded that we have to have to be more transparent with our patients (and potential patients) about the costs they will face for our services. The urgency of price transparency as a business imperative and a professional responsibility has only increased since then.

Consider that we are now a year in to the implementation of the Affordable Care Act. Everything that I have read suggests that consumers were intensely price sensitive when it came to choosing which plans they elected. Well, duh! The benefits are defined by “metal” levels (e.g., Bronze, Silver, etc.), and there is almost no way for people to compare the quality of competing narrow networks or individual providers, so price differences drove decision-making. Likewise, the healthy people who bought insurance because they were compelled to by the individual mandate generally chose high deductible plans to minimize their monthly payments. This, in turn, makes them much more price sensitive at the point of care. That means that patients may resist recommended treatment. It also means that physician offices will face more challenges in collecting fees from patients who have not yet met their deductible for the year. At the very least, patients will be more interested in learning what costs they will be exposed to.

Continue reading Price Transparency

Physician Drug Testing

The New York Times reported last week on a ballot initiative in California that would mandate random routine drug and alcohol testing of physicians, and targeted testing after major adverse patient events. The full text of the proposal is available here.

Proponents of the measure (Proposition 46) highlight the danger posed by impaired physicians and the ubiquity of drug testing for other professionals such as airline pilots and public safety officers. Continue reading Physician Drug Testing

More Sunshine

I wrote recently about the release of physician billing information by CMS  and noted that news organizations had quickly provided tools to look-up individual physicians. Propublica  an “independent, non-profit newsroom that produces investigative journalism in the public interest” has gone one better. In keeping with their mission to “expose abuses of power and betrayals of the public trust… through the sustained spotlighting of wrongdoing” they recently posted a more powerful online tool for analyzing and viewing  the CMS data along with a companion story of what they found by using it. Continue reading More Sunshine

Now What?

I really do not understand how Congress “works.” While it busied itself with passing a law that fails to fix the clearly broken “sustainable growth rate” formula for Medicare physician payments, it added in a surprise for the entire healthcare industry: a provision that mandates a delay in the adoption of ICD-10 by CMS. Continue reading Now What?

Why does ICD-10 feel so bad?

It has been freezing cold in much of the country for the last two months, but things have been heating up in the controversy over the implementation of ICD-10. First, a quick primer for those of you who have not been following this. Continue reading Why does ICD-10 feel so bad?

Functioning Health Exchanges

There has been a lot of understandable outrage over the troubles plaguing Healthcare.gov, the federal website for purchasing individual or family health insurance under the Affordable Care Act (aka Obamacare). Opponents of the law (Republicans), recovering from their self-inflicted wounds over the government shutdown, see this as evidence of the fundamental unworkability of the law, and of the folly of a “government solution” to a complex problem. Supporters of the law (Democrats) are terrified that the difficulty in buying insurance will dissuade the so-called “young invincibles” (healthy young people who have limited needs for health care services) from buying coverage. Continue reading Functioning Health Exchanges

Week Two

The irony continues. The federal government is “shut down” but health insurance exchanges at the center of the law that provoked Republicans to hold the country hostage have been up and running, and attracting a lot of interest. Although there have been some well-publicized (and expected) technical glitches, millions of people have visited State and Federal websites to learn more about their options for purchasing health insurance.

At the same time, the New York Times reported this week that millions of other citizens, who have incomes too low to qualify for subsidized private insurance on the exchanges, will continue to be uninsured. Remember that the Affordable Care Act was designed to expand health insurance coverage in two ways: for those with the lowest incomes, states were offered new funds from the federal government to expand Medicaid, which would have covered nearly all of the new expense at the outset, and about 90% thereafter. For those with higher incomes, the exchanges were created to provide new access to private insurance and subsidies based on income. Continue reading Week Two

Opening Day

October 1 marks what should be an important milestone in the implementation of the Affordable Care Act (ACA), informally known as “Obamacare.” Sadly, this has been overshadowed and even threatened by irresponsible and reactionary posturing by Republican members of the US House of Representatives.

Today was supposed to be the day that a signature element of the legislation was realized – the opening of Web-based “exchanges” through which individuals without employer-provided health insurance could purchase it from private insurance companies with progressive government subsidies based on income. Together with federal funds for the expansion of Medicaid, the patch-quilt of state health insurance programs for the poor, the goal of providing affordable (get it?) insurance to nearly all citizens was to be achieved. Instead, the news is filled with talk of a government shutdown or even a default on repaying federal debt, either of which would be a completely avoidable, self-inflicted wound to our prosperity. Continue reading Opening Day

Practice Guideline Overload

I think I am like many practicing physicians in my “love-hate” relationship with clinical practice guidelines. On the one hand, it is often helpful to look up a set of evidence-based recommendations on a particular clinical issue, and I feel particularly fortunate that the American College of Cardiology and the American Heart Association have collaborated to produce high quality guidelines on a wide-range of subjects relevant to my practice. On the other hand, I am well aware of the shortcomings of practice guidelines, including the limitations of the underlying evidence base, the challenge of synthesizing the available evidence into guidelines, and the often limited applicability of recommendations to clinical practice. Continue reading Practice Guideline Overload