January 16, 2018

Who's Alex?

Alex Azar is almost certain to be confirmed as the next head of the Department of Health and Human Services, taking the place of Tom Price, the previous chief, who resigned after a few months following the revelation that he frequently used taxpayer money to pay for chartered flights for himself. Azar will likely be confirmed despite a major conflict of interest: for ten years (2007-2017) he worked for Eli Lilly, the 14th largest pharmaceutical company in the US, starting out as a top lobbyist and ending up as President. He left Lilly to start a consulting company, Seraphim Strategies, which doesn’t seem to have a website but reportedly consults to the pharmaceutical and health insurance industries. My guess is that the consultations involve helping Pharma and the insurance companies get what they want from Congress.

The reason I suspect this conflict between Azar’s work for Pharma and his role as head of HHS won’t matter to Congress is that Tom Price’s purchase of stock in a biomedical firm when he was a member of the House of Representatives didn’t bother Congress, even though Price bought the stock just before Congress was to pass legislation that would benefit the company in which he was investing. And Azar, unlike most of Trump’s cabinet appointees, is both smart and knowledgeable about the agency he is to head—he served as deputy secretary of HHS under Bush 2.

There are some positives with respect to the Azar nomination. I was pleased to learn that during his confirmation hearings this past week, he supported mandatory participation in “bundling;” an approach to payment introduced under Obama in which physicians, hospitals, and rehab facilities receive a single payment for a given “illness episode” such as hip replacement, giving them an incentive to work together to optimize care. The reason that Azar didn’t favor voluntary participation in such a program is that he understands that if we are to collect meaningful data on its efficacy, we mustn’t confine participation to those institutions that wanted to participate. He’s right, and seems to endorse the value of assessment of new programs and to understand what constitutes scientifically valid evaluation. There’s another aspect of his background that is in Azar’s favor: his grandfather immigrated to the U.S. from Lebanon, which he would do well to remember when he participates in Cabinet meetings at which immigration is discussed.

As I already indicated, I’m not sanguine about stopping the nomination of someone just because of his past dedication to the pharmaceutical industry. Yes, prices of drugs such as insulin tripled during his tenure as President of Eli Lilly. Yes, Lilly paid a $1.415 billion settlement to the Department of Justice in 2008 for illegally promoting the off-label uses of the antipsychotic drug (in particular, Lilly peddled the drug to nursing homes, alleging it was effective in treating dementia, which has not been established). And yes, the settlement included a $515 criminal fine, the largest ever health care payment of this kind—but the bad behavior occurred before Azar’s time at Lilly and the settlement with the DOJ occurred before he became President.

But I do think that Azar is the most conspicuous case yet of the “revolving door” in which former government employees draw on their experience and contacts in Congress to serve as highly paid lobbyists. Azar left his modestly paying job as deputy secretary of Health and Human Services for a far better paying job at Eli Lilly. The current value of his portfolio, according to disclosures he made to the Office of Government Ethics, is somewhere between $9.5 and $20.6 million.

Why is this phenomenon so pernicious? We’ve heard a growing chorus of complaints about the corruption that results because members of Congress spend so much of their time fundraising. Not only do legislators spend more time on the phone to potential donors than on the floor of the House or Senate; they are then beholden to their donors to pass legislation that is in their interest, not necessarily that of the public. But as Zephyr Teachout, a lawyer and would-be politician, argues in Corruption in America, the problem is both broader and deeper, and it’s something the founding fathers sought to guard against through constitutional prohibitions against public officials’ receiving gifts. “Corruption, in the American tradition,” she argues, “does not just include blatant bribes and theft from the public till, but encompasses many situations where politicians…serve private interests at the public’s expense.” And unlike England or France, the US “felt the need to constitute a political society with civic virtues and a deep commitment to representative responsiveness at the core.” Temptation and influence, in short, undermine the ability of our elected representatives to work in our interest.

How can we close the “revolving door” which Alex Azar waltzed through before and will no doubt use again? We already have a “cooling off -period,” following public office, during which lobbying is not permissible. But former government employees get around this by managing a group of lobbyists rather than serving on the front lines and registering as a lobbyist. Banning lobbying altogether seems too draconian and Congress is unlikely to shoot itself in the foot this way. 

What we need is a fundamental revision of the entire lobbying system that profoundly undercuts the ways in which corporations exert influence over government. In medicine, a multi-pronged effort was undertaken by state legislatures, hospitals, and professional physician associations to limit the baleful influence of pharmaceutical companies on the practice of medicine. “Pharmaceutical representatives,” otherwise known as “drug reps,” are now persona non grata in most hospitals and physicians’ offices. True, the industry responded by using more direct-to-consumer advertising than ever before, and by introducing “point of marketing” ads, in which they bombard patients with infomercials as they sit in physician waiting rooms. Constant vigilance is necessary to keep Pharma at bay. But surely putting a long-time advocate for the industry in the position of head of the Department of Health and Human Services is the wrong way to start. We need to double down on this major problem.

January 01, 2018

Hip Hip Hooray


             You might think it wouldn’t be difficult to figure out whether vitamin D and calcium supplements help prevent hip fracture in older people. You would be wrong. For the last twenty or thirty years, researchers have asked this question and have reached differing conclusions. The last time I blogged about the question, a study had come out showing that vitamin D matters, at least when taken in sufficient quantities (800 units a day). Since then, I’ve been dutifully taking the suggested amount of vitamin D. I still take TUMS, too, to get some extra calcium, but I haven’t been as conscientious about this because the data is weaker. Now, JAMA  has published an article that looked specifically at community-dwelling older people (that is, it excludes nursing home residents)—and concluded that neither calcium not vitamin D nor the combination of them has any discernible effect in preventing hip fractures.
            Granted, this study is a “meta-analysis,” a study of studies, rather than the gold standard, a randomized controlled trial. Granted, this study looks primarily at hip fractures, arguing that they have the greatest effect on quality of life (and health care costs), though plenty of older people manage to break a wrist or suffer from back pain due to compression fractures without breaking a hip. Maybe the real reason that the individual studies that form the basis of the current analysis have not consistently any benefit from vitamin D or calcium is that few people actually take the drugs that they say they’re taking. Whatever the explanation for the findings, the hard, cold reality is that the current research is another blow, a particularly powerful blow, against the view that diet can prevent fractures in older people.
            Here it is, New Year’s Day. Should I resolve to stop taking vitamin D and calcium? It would be an exceptionally easy resolution to stick to. It’s tempting. I might make the irrational decision to keep taking vitamin D until the bottle that I currently have is empty. Or I might wait until I see my primary care physician for my next routine appointment and do whatever she advises. But here’s what I think I will do: I will continue taking vitamin D, knowing that it probably isn’t effective, but recognizing that it might be in light of the studies to date that have arrived at differing conclusions. I will continue taking TUMS for calcium in the same somewhat haphazard way I've been doing. As long as there is almost no down side of taking these, I’ll take them. Right now, it’s fairly inexpensive, I have no trouble swallowing the pills, I’m not taking other medications, and I have had no side effects of the vitamin or calcium. This is the key point: there are almost no adverse effects of vitamin D; ditto for calcium when taken in moderation. How often can we say that about a medical intervention?

December 17, 2017

Act Now!

        This time “repeal and replace” is just repeal. And because it’s tucked away in the massive tax cut bill rather than being labelled as health care reform, Congress is hoping Americans won’t notice. Or that we’re suffering from protest fatigue. But quite apart from the concern I expressed last week that passage of the proposed tax bill will lead to enormous cuts in Medicare and Medicaid, the only plausible way to begin to pay for the planned handouts to corporations and the wealthy, there’s another issue: basic access to health care. Medicare, for all its imperfections, has for fifty years assured that people over 65 have access to medical care. Out-of-pocket expenditures have been rising as co-payments and drug prices have gone up, but the big-ticket items such as hospitalization are covered. The Affordable Care Act was intended to provide comparable access to medical care for the 47 million Americans without health insurance. While there are still millions without insurance today, the ACA has cut that number of 47 in half. The tax bill that will go to both chambers of Congress next week would eviscerate the ACA by removing the mandate to buy health insurance. The way that insurance works is by spreading the risk; if healthy people can opt out of sharing in the risk, the system collapses. Health care is no different.


            The access to health insurance, and by inference to medical care, that is at stake is primarily an issue for people under age 65. But it affects those over 65 as well—if fifty-year-olds don’t have health insurance and get sick, they won’t be able to serve as the support system for their parents and grandparents. And the 62-year olds who were laid off and are unemployable because of their age will soon, if they can hang in there just a few more years, enroll in Medicare. If they've been uninsured for several years, they will likely enter Medicare in less than vigorous health. The effect will be an influx of sicker people into the Medicare program—placing a further stress on Medicare resources. So don’t let protest fatigue sink in—contact Susan Collins and John McCain and Lisa Murkowski and any other senator who isn’t ready to repeal the ACA, now, before it’s too late.

December 08, 2017

Better Watch Out, Better Do Cry

          The new tax law hasn’t passed yet—the Senate and the House still need to reconcile their disparate versions of the legislation—but odds are that we will have a bill very soon. And whatever compromise is reached is going to feature a major cut in the corporate tax rate, a big cut in the income tax rate for the wealthy, and modest or minimal reductions in the tax rate for the middle class, with a resulting whopping $1.5 trillion projected increase in the deficit over the next ten years. There’s only one way to compensate for that kind of deficit, and that’s cutting federal expenditures. And as Paul Ryan, Speaker of the House, acknowledged just this week, that’s exactly what he wants to do. “Frankly, it’s the health-care entitlements that are the big drivers of our debt,” he said in an interview. “We [will] spend more time on the health-care entitlements—because that’s really where the problem lies, fiscally speaking.”
            Now I’m all in favor of reforms to the Medicare program. I’ve argued many times on this blog that Medicare is still too focused on acute care, on hospital-based care, and on technologically-intensive care, despite its recognition that chronic illness, in fact multiple chronic illness is what afflicts much of the older population. But Ryan et al aren’t talking about modifying Medicare; they are talking about slashing Medicare. I thought it might be a good idea to look at just what Medicare covers now, enabling us to better advocate for keeping what matters. I figured I’d start with a benefit about which there is widespread ignorance and much confusion, the home health benefit. It’s only a small slice of the Medicare pie—something like 3 percent, but when total Medicare expenditures top $632 billion, even 3 percent is far from trivial.
            As luck would have it, the AARP Public Policy Institute just last month wrote a brief report called “Understanding Medicare’s Home Health Benefit.” It’s important to realize that this affects a great many people—3.5 million, in fact, as of 2015. And as is always the case, protestations about “socialized medicine” notwithstanding, Medicare doesn’t actually provide any services—it just certifies home health agencies as meeting federal standards and reimburses them for their services, in accordance with Congressionally mandated criteria. In fact, there are over 12,000 home health agencies in the U.S.
            The services that Medicare authorizes under the Home Health benefit are intermittent. They include principally professional services, or what Medicare calls skilled care:  nursing care, physical therapy, speech therapy, occupational therapy, and social work. They also pay for limited home health aide care and some durable medical equipment, supplies such as wheelchairs and walkers.
            Not just anybody enrolled in Medicare qualifies for these services. To be eligible, you have to be homebound and a physician (it has to be an MD) has to certify that you’re homebound and that s/he has approved a “plan of care” for you that spells out what services you will receive and why you need them.  “Homebound,” in turn, means that you cannot leave your home without “considerable and taxing effort” and you need the help of another person or specialized equipment to go anywhere. A couple of years ago, Medicare introduced the requirement for a face to face visit to certify eligibility. A nurse practitioner or physician assistant working with a physician can make the face to face visit, but only the MD can sign off on the certification. Certification must be renewed every sixty days but can, in principle, continue as long as the services are necessary for the individual to maintain his level of functioning or to improve.
            Medicare has already invoked “re-balancing” to downwardly revise its payments for home care services. Another change under consideration include charging a co-pay of $150 or more if the home care service is initiated without a prior hospital stay. While this is meant to deter fraud and abuse, it sounds much like the notorious “three-day rule,” that says Medicare will only pay for a skilled nursing facility stay if it is preceded by a hospitalization of at least three days. The problem with that rule, as has been pointed out, is that far from assuring that patients don’t unnecessarily use SNF facilities, it promotes unnecessary use of the hospital as the only legitimate means to gain access to inpatient rehabilitative services! Similarly, if home physical therapy is what a patient needs, not hospital care with orthopedic consultation, MRIs, and other procedures, why should Medicare deprive patients of that option?
            Other strategies for slashing the home care budget may well be adopted unless we are vigilant. So you better watch out, better do cry, the Grinch is coming to town.