Medicare coverage litigation--Jimmo v. Sebelius

I'm a few days late covering this vitally important settlement of litigation between patient groups and Medicare, but I thought I'd give a small taste of what it's really about.

My mother-in-law passed away in January of ALS (Lou Gherig's disease). That disease, among other things, gradually eliminates your ability to control your limbs, while leaving you with full sensation. In other words (to take an easily understood example), you can be lying in your bed, wishing you could roll over because your arm is in an uncomfortable position, but not be able to roll yourself over. All night.

Physical therapy, you can easily imagine, was a great relief to my mother-in-law. It's a huge benefit to have your body moved around by someone else, in the ways you'd like to move it yourself, if you could: stretching, twisting, opening up. Even just 20 minutes of externally-supplied mobility each day goes a long way toward making up for the immobility the ALS patient faces the other 23 hours and 40 minutes of each day.

But the Massachusetts entity that holds the contract to administer Medicare (along with very many other state contract-holders) decided that Medicare should not pay for my mother-in-law's physical therapy, because it did not stand any chance of curing her.

At some level, of course, one can understand a cost-controlling rule that says, "We're not paying for things that don't work." It was such a rule that Massachusetts's and other states's intermediaries were attempting to follow. But it's simply false to think that anything that doesn't cure you doesn't "work." Think of physical therapy, or nursing attention, for example: many who are chronically or terminally ill can benefit from those kinds of interventions, even if they hold out no prospect for cure.

And that's what the government agreed to in its settlement of Jimmo v. Sebelius. Manuals that guide the decision-making of contractors who administer Medicare at the state level will no longer permit denials of payment to therapies simply on grounds that they don't cure. They'll now explicitly permit payments for treatments that help maintain the patient's current condition or that prevent further deterioration. Mind you, the holding isn't as generous as a rule that might permit payment for every treatment that keeps a patient comfortable, or that reduces a patient's suffering; but it's a big improvement over the "we only pay for cures" position that a number of Medicare intermediaries had been taking.

My mother-in-law offered testimony in this case. Luckily, during the pendency of the case, my father-in-law had sufficient private funds to pay for the therapy she needed to keep herself comfortable during the months of her ALS decline. But she always knew that the Massachusetts Medicare intermediary's position just wasn't right; that it couldn't be the case that national health insurance wouldn't pay for care that met people's basic human needs, even if it wouldn't cure them.

So now, after this settlement, Medicare will pay for those needs. That will certainly drive up the cost of Medicare. But I don't mind. I don't mind paying the extra taxes necessary to ensure that patients, like my mother-in-law, who are paralyzed with ALS, will be able to get their legs manipulated, or their arms massaged, if that's what will bring them comfort.

Mary would be very pleased that her lawsuit was settled favorably to patients. She and her husband didn't need the money; to them, it was a question of principle. But this settlement brings real relief to thousands of people who have no other means of paying for the care they need.

It's a big deal. I offer now a toast, to our now-departed litigant, Mary: You won. You're gone, and can't enjoy the victory, but that doesn't matter. You weren't fundamentally fighting this battle for yourself. And many thousands will benefit from the lawsuit you supported.

Morning-After Pill: Contrasting News

President Obama defended HHS Secretary Sebelius's decision yesterday to override the FDA's recommendation that morning-after contraceptive pills like Plan B be made available over-the-counter to women and girls of any age. Critics were accusing Obama of having directed the override in order to avoid controversy during the upcoming election. Obama today said that he wasn't in on the decision, but that he approved of it, "as the father of two daughters." As a result of the override, the drug will remain behind pharmacy counters, available without a prescription only to women over 17 years of age. Proponents of the FDA's plan saw its main advantage in putting the drug out on the pharmacy floor, where sexually active women could easily locate it, rather than in making it available to young girls; one expert observed that "not many 11-year-old girls" go into drugstores to buy anything, let alone single pills that cost $50.

Meanwhile in the UK the British Pregnancy Advisory Service is offering to make morning-after pills available free to women over 17 via post, after a preliminary telephone interview with a nurse ensures that they understand the pill's use. The charitable organization, which is the UK's largest abortion provider, is urging women to stock up in advance of the holidays, when unwanted pregnancies occur with higher-than-average frequency. The pills are sold online and in pharmacies to girls and women over 16, and are widely available, free of charge, in doctors' offices and NHS clinics.

Plan B Availability Blocked by Sebelius

FDA Commissioner Margaret Hamburg has just released a statement on the FDA's plan to allow the emergency contraceptive Plan B to be sold over-the-counter to women and girls of all ages. FDA found the drug safe and effective for emergency contraceptive use, over-the-counter, for all women and girls of child-bearing potential. But then--this morning--came the politics. From Hamburg's press release:

"[T]his morning I received a memorandum from the Secretary of Health and Human Services invoking her authority under the Federal Food, Drug, and Cosmetic Act to execute its provisions and stating that she does not agree with the Agency’s decision to allow the marketing of Plan B One-Step nonprescription for all females of child-bearing potential. Because of her disagreement with FDA’s determination, the Secretary has directed me to issue a complete response letter, which means that the supplement for nonprescription use in females under the age of 17 is not approved. Following Secretary Sebelius’s direction, FDA sent the complete response letter to Teva today. Plan B One-Step will remain on the market and will remain available for all ages, but a prescription will continue to be required for females under the age of 17."