Showing posts with label CMS. Show all posts
Showing posts with label CMS. Show all posts

Thursday, 14 January 2016

Death of EHR "Meaningul Use" imminent.  (Hopefully the death of the 'National Programme for Health IT in the HHS' is imminent, too.)

Death of EHR "Meaningul Use" imminent. (Hopefully the death of the 'National Programme for Health IT in the HHS' is imminent, too.)

I've written a number of posts on the Orwellian-named "Meaningful Use" experiment with electronic health records systems, imposed upon United States physicians by the Department of Health and Human Services through its Office of the National Coordinator for Health Information Technology (ONC).

See these posts and others retrieved by query link http://hcrenewal.blogspot.com/search/label/meaningful%20use:

Meaningful Use Final Rule: Have the Administration and ONC Put the Cart Before the Horse on Health IT?

Meaningfully Experimental Protocols and Interfaces to Nowhere? Nagging Questions On Healthcare IT Remain

Science or Politics? The New England Journal and "The 'Meaningful Use' Regulation for Electronic Health Records"

"Meaningful Use" not so meaningul: Multiple medical specialty societies now go on record about hazards of EHR misdirection, mismanagement and sloppy hospital computing

EHRs and "Meaningful Use": Begging the Question in the New England Journal of Medicine

The Scientific Justification for Meaningul Use, Stage 2: The NWB Methodology

Meaningful Use and the Devil in the Details: A Reader's View

  
In these posts and others I expressed significant skepticism about the 'Meaningful Use' scheme.

But what did I know?  Our betters in government and academia knew far better how to seriously annoy physicians, make more burdensome (and hence more dangerous) the already onerous task of EHR use, and waste the tax money we hard-working Americans pay to an increasingly bloated bureaucracy that acts as if money grows on trees (the U.S. debt has doubled in recent years to almost $19 billion, see http://www.usdebtclock.org/).

From the horse's mouth (or perhaps the animal's other end) at https://www.healthit.gov/providers-professionals/meaningful-use-definition-objectives:

Meaningful Use Defined

Meaningful use is using certified electronic health record (EHR) technology to:
  • Improve quality, safety, efficiency, and reduce health disparities
  • Engage patients and family
  • Improve care coordination, and population and public health
  • Maintain privacy and security of patient health information

I note that none of this was backed by science at the time of its formulation.

The end result of the MU experiment is this:

CMS’s Slavitt: End of meaningful use imminent in 2016
Internal Medicine News
WHITNEY MCKNIGHT
January 12, 2016
http://www.internalmedicinenews.com/practice-economics/health-reform/single-article/cmss-slavitt-end-of-meaningful-use-imminent-in-2016/94653f2ba164a8131ca214d5325c0d74.html

Meaningful use is on its way out.

Andy Slavitt, acting administrator of the Centers for Medicare & Medicaid Services, told investors attending the annual J.P. Morgan Healthcare Conference that CMS is pulling back from the health care IT incentive program in the coming months.

“The meaningful use program as it has existed will now be effectively over and replaced with something better,” Mr. Slavitt said. Without providing full details, he said that March 25 would be an important date as concerns the rollout of the new health IT initiatives.

The waste of resources and time, and the alienation of physicians by this grand(-ly foolish) experiment is significant:

“We have to get the hearts and minds of physicians back. I think we’ve lost them,” Mr. Slavitt said.

No foolin'.  Ya think?

This was predictable by anyone with half a brain about healthcare information technology reality.  (It's a real loss that hyper-enthusiast health IT geniuses responsible can't be fired and banned from the domain of healthcare - for life.)

Perhaps the officials at HHS got their first clue about clinician unhappiness via a long January 2015 letter from about 40 medical societies, including the AMA, American College of Physicians, American College of Surgeons, and numerous others that they did not exactly love these systems and the MU experiment.  See my January 28, 2015 post "Meaningful Use not so meaningful: Multiple medical specialty societies now go on record about hazards of EHR misdirection, mismanagement and sloppy hospital computing" at http://hcrenewal.blogspot.com/2015/01/meaningful-use-not-so-meaningul.html and the letter itself at http://mb.cision.com/Public/373/9710840/9053557230dbb768.pdf.

He noted that, when the meaningful use incentive program began, few physicians and practices used electronic health records and concerns were that many would not willingly embrace information technology. Now that “virtually everywhere care is delivered has a computer,” it’s time to make health care technology serve beneficiaries and the physicians who serve them, Mr. Slavitt said.

The revealing nature of this candid statement is breathtaking.  He's admitting that 1) many physicians, rightfully reluctant to not "willingly embrace" IT, had the technology imposed upon them by government (due to its "concerns") via penalties for non-adopters and 2) with the systems in the physicians' faces at the cost of hundreds of billions of dollars that could have been better spent on healthcare itself (e.g., for those subject to 'disparities", i.e., the poor), now it's time to make the systems serve patients and physicians.

Brilliant.

The cost, however, was too high, Mr. Slavitt said. “As any physician will tell you, physician burden and frustration levels are real. Programs that are designed to improve often distract. Done poorly, measures are divorced from how physicians practice and add to the cynicism that the people who build these programs just don’t get it.”

The 'cynicism' (def: inclination to believe that people are motivated purely by self-interest; skepticism) that the builders of these programs don't "get it?"  It's not cynicism.  It's a rational conclusion arrived at via empirical observation.

I also recall in the not-so-distant past that physician complaints were dismissed as the complaints of "Luddites."  I've heard this at Informatics meetings, at medical meetings, at commercial health IT meetings (e.g., Microsoft's Health Users Group, and at HIMSS), at government meetings (e.g., GS1 healthcare), and others.

It's rewarding to finally have government officials admit those charges were, to be blunt about it, lies or delusions.

Soon, CMS will no longer reward health care providers for using technology, but will instead focus on patient outcomes through the merit-based incentive pay systems created by last year’s Medicare Access and CHIP Reauthorization Act (MACRA) legislation. 

Perhaps that's a move in the right direction; time will tell.  However, I'm sure physicians have GREAT confidence in how well that will work out, yet another government experimental project.

In addition to asking physicians to work with health care IT innovators to create systems that work best according to their practice’s respective needs, CMS is calling on the private sector to create apps and analytic tools that will keep data secure while fostering true and widespread interoperability.

This is in the realm of delusion.  Physicians "asked" to "work with" (for free?) the same "innovators" (i.e, health IT companies) whose "innovation" led to the massive disaffection for today's health IT, and the burdens that technology has placed on the medical profession, nurses and other clinicians as well?   Further, it's actually believed that the companies will listen, when they've failed to do so for several decades running?  My head spins.

Anyone seeking to block data transfer will find CMS is not their friend. Mr. Slavitt said. “We’re deadly serious about interoperability. Technology companies that look for ways to practice data blocking in opposition to new regulations will find that it will not be tolerated.”

And who, exactly, is going to enforce that edict on proprietary systems, which health IT companies view (correctly, from the business perspective) as giving them a competitive edge?  I'm sure the health IT companies, who now hold medicine captive, are shaking in their boots.

Dr. James L. Madara, CEO of the American Medical Association, echoed Mr. Slavitt’s comments on the current, negative impact of EHRs on physicians’ practices. He noted that many physicians are spending at least 2 hours each workday using their EHR and may click up to 4,000 times per 8-hour shift.

I should open a clinic for health IT-caused carpal tunnel syndrome and repetitive motion injuries.  Oh wait!  There's no ICD-10 code for that to bill (see http://hcrenewal.blogspot.com/2016/01/repeated-crushing-by-alligators-and.html).

Dr. Madara outlined three AMA goals to help restore the physician-patient relationship. The first is to restructure the medical school curriculum, which he said essentially is the same as it has been for 100 years. New generations of physicians should be taught how to deliver collaborative care that includes telemedicine, more ambulatory care, and home care. Community-based partnerships, he said, would become key to treating chronic diseases like diabetes and would have to be factored into reimbursement models. The AMA also seeks to improve health outcomes and ensure thriving physician practices.

Central to the AMA’s plan for the future: Helping physicians restructure practice via technology. He announced that the AMA is a founding partner in the Silicon Valley (Calif.) based Health2047, a company focused on supporting health IT and other entrepreneurs in their efforts to provide physicians with digital tools that improve patient outcomes, among other innovations.

As to "helping physicians restructure practice via [information] technology", this seems an example of what I termed "Heath IT hyper-enthusiasm" writ large.  See My March 11, 2012 post "Doctors and EHRs: Reframing the 'Modernists v. Luddites' Canard to The Accurate 'Ardent Technophiles vs. Pragmatists' Reality" at http://hcrenewal.blogspot.com/2012/03/doctors-and-ehrs-reframing-modernists-v.html.

What is needed, as I have repeatedly written, is not to have physicians "restructure" practice to adopt to IT, rather to restructure IT (the systems themselves, the developmental methodologies, the backgrounds of the industry leadership, the industry itself) to match the needs of physicians and patients.

The AMA holds a minority of the nation's physicians as members; a 2011 article "American Medical Association membership woes continue" (CMAJ. 2011 Aug 9; 183(11): E713–E714, http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3153537/) indicated this:

In the early 1950s, about 75% of US physicians were AMA members. That percentage has steadily decreased over the years. In June, at the annual meeting of its policy-making body, the House of Delegates, the AMA announced that it lost another 12 000 members last year. That brings total membership below 216 000. Up to a third of those members don’t pay the full $420 annual dues, including medical students and residents. Not counting those members, somewhere in the neighbourhood of 15% of practising US doctors now belong to the AMA.

Hair-brained schemes to "restructure practice via technology" will likely drop those numbers further.

The National Programme for IT in the NHS (NPfIT) died several years ago (http://hcrenewal.blogspot.com/2011/09/npfit-programme-going-pffft.html).

It is my hope the death of "meaningful use" heralds the death of the equally wasteful and ill-thought-out National Program for health IT in the HHS, a.k.a. HITECH, and a return to recognition of the truth: that health IT is experimental, that it (and its subjects) must be treated with that in mind, that its progress cannot be mandated, and that the technology, as any other IT, needs to be approached with great skepticism e.g. per this article:

Pessimism, Computer Failure, and Information Systems Development in the Public Sector.  (Public Administration Review 67;5:917-929, Sept/Oct. 2007, Shaun Goldfinch, University of Otago, New Zealand).  Cautionary article on IT that should be read by every healthcare executive documenting the widespread nature of IT difficulties and failure, the lack of attention to the issues responsible, and recommending much more critical attitudes towards IT.  linkto pdf

-- SS

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Friday, 17 July 2015

Turn, Turn, Turn - from Columbia/ HCA Executive, to Virginia Secretary of Health and Human Resources, to Director of the Center for Medicare and Medicaid Services (CMS), to America's Healt Insurance Plans (AHIP)

Turn, Turn, Turn - from Columbia/ HCA Executive, to Virginia Secretary of Health and Human Resources, to Director of the Center for Medicare and Medicaid Services (CMS), to America's Healt Insurance Plans (AHIP)

Marilyn Tavenner's career continues to revolve, er, evolve.

Columbia/ HCA

Marilyn Tavenner worked for Columbia / HCA, now HCA, although details of her job there are sketchy.  Apparently she worked there for a long time, according to a 2015 article in the Nashville Business Journal,

Tavenner work [sic] in a variety of roles for Nashville-based HCA Holdings Inc for 25 years.

She worked long enough to earn a fairly generous pension.  As a 2012 a Washington Times article stated,

In a recent filing with the U.S. Office of Government Ethics, she reported that through a supplemental executive retirement plan at HCA, 'I will continue to receive $162,524 for life.'

There are only sketchy accounts available about what she did at HCA.  The same Washington Times article noted she left in 2006, and

'Ms. Tavenner was a senior executive at HCA who retired from the company over six years ago,' said HCA spokesman Ed Fishbough.

The only description I could find of her duties there was in a Forbes blog post by Bruce Jepsen in 2015,

Tavenner, ... had experience working for investor-owned hospitals and with insurers when she was at HCA....

What does seem certain is that her career at Columbia / HCA overlapped that of CEO Rick Scott, and included some of the time when the company performed actions that led to some serious charges.  In a 2011 Boston Globe blog post, Suzanne Gordon wrote,

While Tavenner worked for HCA, the company was busily enhancing its profit margin by defrauding the Medicare, Medicaid, and TRICARE systems. Terry Leap’s new book, '"Phantom Billing, Fake Prescriptions, and the High Cost of Medicine: Health Care Fraud and What To Do About It,' details HCA’s sorry history. In 2000, for example, HCA paid fines of $840 million for improperly billing the government and in 2003 HCA had to fork over another $631 million.


We discussed the billion dollar plus Columbia / HCA fraud case, which did involve corporate guilty pleas, but like most other legal settlements between the government and big health care organizations, no consequences for any individuals who authorized, planned, or implemented the bad behavior.  There were many allegations that then Columbia / HCA Rick Scott, who is now the Republican Governor of the great state of Florida, created a business culture that enabled the fraud, and even knew about it, but he was never charged with a crime.

Ms Tavenner's role in Columbia / HCA when this was happening was never clear.


Virginia Department of Health and Human Resources

After her work at Columbia / HCA, Ms Tavenner became Secretary of Health and Human Resources for the great state of Virginia.  I could find little news coverage of her time there, much less any suggestion that her previous role with Columbia / HCA might have been viewed as a problem. 

Center for Medicare and Medicaid Services (CMS)

In 2010, Ms Tavenner went to work for the US Department of Health and Human Services.  In 2011, Ms Tavenner became acting administrator of CMS.


The only concerns raised about Ms Tavenner's former work with Columbia / HCA at the time she was appointed to run CMS came from the Boston Globe blog post noted above.

Although Tavenner may not have been personally involved in these scandals, it hardly seems wise to put her in charge of the government system her company helped defraud.

Nonetheless she got the position.  In 2014, a Wall Street Journal article from 2014 suggested Ms Tavenner remained cozy with here former boss, former Columbia / HCA CEO,  and now Florida Governor Rick Scott.  It recounted that a CMS contractor had been investigating a Florida nursing home chain,

Medicare investigators began looking into Florida skilled-nursing facilities in 2011 and found what they considered suspicious billing patterns at 33 homes. CMS contractor SafeGuard Services LLC was concerned about how often Florida nursing facilities were charging for the costliest physical and occupational-therapy services, according to documents. About a quarter of the 33 facilities were paid at least 20% more a day than their local rivals, a Journal analysis of Medicare data found.

Three of the 33 are owned by Plaza Health Network. Plaza Chief Executive William Zubkoff previously ran a hospital that was barred in 2006 from billing Medicare and other federal health-care programs following fraud allegations.

But then,

Some of the nursing homes contacted the Florida Health Care Association, a trade group. It asked lawmakers and Florida Governor Rick Scott, a Republican, for assistance, according to the group’s director and emails.

Gov. Scott contacted Ms. Tavenner, according to a person familiar with the investigation. The two had once worked together at hospital operator HCA Holdings Inc., where both had been executives. The governor’s office connected CMS to the Florida Health Care Association. The trade group put an owner of two of the nursing homes, William Kelsey, on the phone with Ms. Tavenner.

Mr. Kelsey told her the prepayment reviews were 'creating a real hardship on the business, staff and residents,' he recalled recently.

On Aug. 22, 2012, Ms. Tavenner ordered the agency’s antifraud officials to release payments for the 33 homes, including the two operated by Mr. Kelsey, according to emails.

A CMS spokesman said Ms. Tavenner got involved to ensure the agency was 'preserving access and quality of care.' The spokesman said Ms. Tavenner 'often discusses issues and concerns with elected officials…including Gov. Scott.'


Of course, Ms Tavenner had a previous relationship with Governor Scott due to their shared time at Columbia / HCA which probably was not like her relationships with other elected officials.  In any case, I could find no real echoes from this story, but Ms Tavenner resigned from CMS in 2015, not completely covered in glory.  A Bloomberg account of her resignation included,

 Marilyn Tavenner, the U.S. official who directed the stumbling roll-out of Obamacare as well as its recovery in recent months, will resign as head of the Centers for Medicare and Medicaid Services.

Tavenner said in an e-mail to staff that she’ll step down at the end of next month. She didn’t give her reasons for leaving.

The article suggested that she had her troubles in her role as head of CMS,

 As head of the agency, Tavenner was arguably the person most responsible for construction of healthcare.gov, the federal health insurance website that collapsed when it opened for business in October 2013. A UnitedHealth Group unit -- then run by Slavitt -- was hired to lead repairs.

In November of last year, Tavenner also acknowledged that her agency had made a mistake in its calculation of the number of people enrolled under Obamacare for 2014. About 393,000 individuals with both health and dental coverage were 'inadvertently counted twice,' she said in a letter to Representative Darrell Issa, a California Republican whose committee discovered the error.

'Tavenner had to go,' Issa said in a statement today. 'She presided over HHS as it deceptively padded the Obamacare enrollment numbers.'

On the other hand, Forbes blogger Jepsen did suggest that some in industry thought better of her than did Representative Issa.

 Tavenner, who had experience working for investor-owned hospitals and with insurers when she was at HCA, was seen as friendly to the health insurance industry and medical care providers. She had respect among lobbies and among both Democrats and Republicans on Capitol Hill....

The for-profit health insurance industry seemed to particularly like here,

'Marilyn leaves behind a legacy of leadership at a time of unprecedented change in our health care system,' said Karen Ignagni, chief executive of America’s Health Insurance Plans, the health insurance lobby....  'She was a thoughtful strategist and balanced manager who time and time again rolled up her sleeves to work with all stakeholders on solutions to advance patient care.'

One wonders whether some stakeholders, like AHIP, thought that she was treating them particularly well.  What the average Medicare patient or health care professional thought of her was not explored.


America's Health Insurance Plans (AHIP) (and LifePoint)

This suspicion was bolstered when Ms Tavenner, despite the negative opinions of people, even Republican people like Representative Issa, was named to be Ms Ignangni's successor.   That was announced just yesterday, July 15, 2015.  In Modern Healthcare we saw,

Marilyn Tavenner, the former head of the CMS who stepped down just six months ago, will now lead the country's dominant health insurance lobbying group.

The board of America's Health Insurance Plans on Wednesday named Tavenner as the group's next president and CEO. She replaces Karen Ignagni, who served as AHIP's top lobbyist for 22 years....

This job transition was covered in media outlets, but so far, only Modern Healthcare raised any doubts,

Her decision to head to AHIP raises uncomfortable questions about the dynamics between Washington politics and business. Tavenner will now be representing and lobbying on behalf of some of the country's largest health insurers—the same companies who are regulated by the CMS and are devoting more of their business to Medicare and Medicaid in the form of privatized managed care.

For her role in these dynamics, she likely will be well paid,

Tavenner is primed for a big pay raise as the top leader of AHIP. Ignagni made more than $2 million as AHIP's CEO in 2013. Tavenner made $165,300 last year, according to government records. She is also expected to make more than $300,000 in cash and stock as a board member of LifePoint Health, a for-profit hospital chain based in Brentwood, Tenn. Tavenner joined LifePoint's board in April.

Conclusions

So now Marilyn Tavenner shows she is securely within that club of insiders that run health care in the US.  Some celebrate the US health care "free market," in which one might expect for-profit insurers will fight with provider organizations, like for-profit hospital chains, over payment policies, overseen by government's impartial regulators.  Yet it appears that many of these organizations' leaders come out of the same pool of insider managers, and that individuals can lead or govern organizations that are supposed to be negotiating at arm's length.  For example, note that now Ms Tavenner is leading a for-profit insurance lobbbying group while governing a for-profit hospital chain.

One might think that such arrangements might not be good for the organizations that are supposed to be at arm's length.  One might think such arrangements might be worse for patients, health care professionals and the public at large.  If the large organizations that are supposed to be competing and negotiating in the market are led out of a single cozy in group, maybe instead of competing and negotiating they will mainly be about benefiting their leaders.

As we wrote before,...

 the constant interchange of health care insiders among government, large health care corporations, and the lobbying and legal firms which represent them certainly suggests that health care, like many other sectors, seems to be run by an amorphous group of insiders who owe allegiance neither to government nor industry.

However, those who work in government are supposed to be working for the people, and those who work on health care within government are supposed to be working for patients' and the public health.  If they are constantly looking over their shoulders at potential private employers who might offer big checks, who indeed are they working for?


Attempts to turn government toward private gain and away from being of the people, by the people, and for the people have no doubt been going on since the beginning of government (and since the Constitution was signed, in the case of the US).  However, true health care reform  would require curtailing the severe sorts of conflicts of interest created by the revolving door.

Real heath care reform would require  multiyear cooling off periods before someone who worked in the commercial world can get a job in a government whose work has direct effect on his or her previous employer or industry sector, and before someone who worked in government whose work had direct effect on a particular economic sector can accept a job for a company in that sector.

But real reform might spoil the party for those who transit the revolving door, so don't expect such reform to come easily.... 
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Thursday, 18 June 2015

The US' Multinational Trade Negotiations - Trading Away Its Own and Other Countries' Current and Future Restraints on Drug Prices?

The US' Multinational Trade Negotiations - Trading Away Its Own and Other Countries' Current and Future Restraints on Drug Prices?

Trade Agreements More about Deregulation than Trade

International trade negotiations, especially their more technical aspects, seem far removed from health care and health policy, and unrelated to health care dysfunction.  However, it seems that such trade negotiations have become a back door route to affect health policy, especially national efforts to regulate health care intended to improve patients' and the public's health.  

We recently discussed how current multinational trade negotiations seem to be more about changing regulation in favor of big corporations than broadly advancing trade.  Some of the effects of the proposed trade pacts could have bad effects on patients' and the public's health, particularly by allowing corporations to challenge particular countries' public health policies outside of these countries' judicial systems, in kangarooish courts seemingly designed to favor corporate interests.  Also, the trade pacts' focus on intellectual property could lead to longer patent protection on drugs, biologics, and devices, raising health care costs.  However, attempts to figure out how proposed trade agreements could affect health care and public health were hindered by the secrecy surrounding the negotiations.

"Procedural Fairness" for Pharmaceutical Companies, not You and Me

Earlier in June, 2015, a part of the current draft of the Trans-Pacific Partnership (TPP) appeared on  Wikileaks, revealing yet another set of concerns about how the agreement could affect health care.  It was entitled "Annex on Transparency and Procedural Fairness for Pharmaceutical Products and Medical Devices," and hence was specifically about health care.

The bulk of the annex seemed to be about improving the treatment of drug, device and biotechnology companies by national agencies that make decisions about payments for their products. The annex apparently proposed establishing the companies' rights to rapid reviews, access to applicable procedures and guidelines, access to written decisions, company appeals of the agencies' decisions, and protection of corporate confidential information. On the other hand, there was nothing I could see in the annex about the rights of, say, patients or health care professionals.

We have noted the concern that international trade agreements may make government regulation subject to corporate appeal in "investor-state dispute settlement" (ISDS) processes, essentially international quasi-courts that are not subject to national judicial systems, may not provide for any input by parties other than governments and corporations (that is, by, for example citizens, patients or health professionals), and may not allow appeal.  Thus, by specifically incorporating new protections for corporations seeking favorable payments for their new products from national agencies, the annex could make it possible for the corporations to appeal to ISDS, going around national court systems.  As reported in the Huffington Post,

According to an analysis of the leaked document by Jane Kelsey, a law professor at the University of Auckland in New Zealand, these rules are enough to expose national health authorities to legal challenges under TPP’s investor-state dispute settlement process, or ISDS. ISDS empowers companies to challenge countries’ domestic laws before a tribunal of international judges if they believe the laws unfairly limit investment. The tribunals have the power to impose significant fines on countries if their laws are found responsible for the investment hardship in question. While pharmaceutical companies could not challenge national health programs’ policies through ISDS, their grievances would be eligible for ISDS if the companies claimed the policies hindered investment.

In fact, the Huffington Post article noted suspicions that the US Trade Representative (USTR) has been negotiating on behalf of big US drug, device and biotechnology companies to target price regulations in Australia and New Zealand,

Among the United States’ TPP negotiating partners, pharmaceutical provisions have faced the greatest opposition from Australia and New Zealand, which have national health authorities that provide prescription drugs to their citizens at heavily discounted rates. The U.S. Trade Representative and U.S. pharmaceutical companies have targeted the cost containment measures in those countries’ prescription drug programs for years. Pharmaceutical companies also claim that New Zealand’s drug approval process is opaque and difficult to navigate.
Why Explicitly Include the US Center for Medicare and Medicaid Services (CMS)?

However, anyone in the US who thinks that all the burden from the trade pact is only on other countries, particularly those down under, should think again. The draft trade pact annex also seemed designed to prevent any future attempts by the US government to control drug and device costs, especially for the US Medicare program, even though the current US President has proposed such attempts. 

Note that when the US program was extended to cover drugs, the legislation specifically forbade the government from negotiating prices, a provision that seemed more about protecting corporate revenues than the federal budget.  So, as reported by the New York Times,

The newly leaked annex, dated Dec. 17, 2014, lists Medicare and the Centers for Medicare and Medicaid Services as falling under its strictures.

The USTR pooh poohed any concerns about that,

Officials at the United States trade representative’s office, while declining to comment on a leak they would not acknowledge, said rules in the Pacific accord would have no impact on the United States because Medicare already adhered to them. The trade representative’s office helped develop the proposals.

'Already, transparency and procedural fairness are integral parts of the U.S. legal system and as such are principles reflected in U.S. trade agreements,' the representative’s office said in a statement.


Maybe preventing any government negotiation about, much less control of drug and device prices may be part of what the USTR called "procedural fairness."  In any case, if the US, and specifically CMS are doing so well, why bother giving this trade pact jurisdiction over them, unless to prevent any uppity future US government from daring to negotiate with the pharmaceutical industry?

The Huffington Post noted that

In an earlier statement, [Director of Public Citizen's Global Access to Medicine Project Peter]  Maybarduk expressed concern that the rules would 'limit Congress’ ability to enact policy reforms that would reduce prescription drug costs for Americans –- and might even open to challenge aspects of our health care system today.'

He expanded on that in a commentary for The Hill,

Earlier this week, WikiLeaks published the draft TPP 'Annex' on healthcare technologies. In the five-page document, the U.S. government commits Medicare to rules and procedures that would make it difficult — if not impossible — to implement a national formulary that would provide leverage for proposed negotiations with drugmakers under Medicare Part D.

Medicare costs are expected to more than double from $77 billion in 2015 to about $174 billion in the next decade. In February, the president called for giving Medicare the power to negotiate prices with drug manufacturers to ameliorate this cost burden. Americans support giving Medicare negotiating power by wide margins and across party lines.

Negotiations are most effective if the U.S. government has leverage. Experts suggest that key leverage in Medicare negotiations should come from developing a national drug formulary — a list of drugs that Medicare would cover. A formulary would stimulate competition, reduce prices and lead to healthier outcomes for patients and the healthcare system.

But the leaked TPP 'Annex' shows that the pact would impose procedural requirements on formulary decisions, exact significant administrative costs and open up the drug review process to increased corporate influence. Medicare would have to live by these rules. The result could be a toothless negotiator, and a formulary filled with expensive drugs that have questionable public health benefits, if any.

Summary

So why did the US Trade Representative acquiesce to, if not actively promote, a trade pact that would limit the ability of the US government, specifically, CMS to try to put a damper on the ever rising health care prices that threaten to bankrupt individuals and maybe eventually the Medicare program itself? And why, incidentally did it do so when this appeared to contradict the current US President's own stated goal to have Medicare negotiate the prices it pays for drugs?  (And why, incidentally, did it promote a pact that would give international tribunals jurisdiction over US government actions when that may be unconstitutional according to an increasing number of experts?

The best speculation we offered before was that the USTR has been "captured" by industry, in part through the conflicts of interest generated by multiple passages through the revolving door by current and former USTR personnel. 

At the moment, the TPP has stalled again in the US Congress.  However, do not underestimate the ability of its proponents to get it moving again.  The now intermittent drip of secrets from the ongoing trade negotiations showing how little they have to do with trade, and how much they have to do with advancing corporate interests suggest the need for much more vigilance in defense of patients' and the public's health.

Meanwhile, I repeat again that we need to do a lot more to undo regulatory capture that affects health care, and stop the incessantly spinning revolving door.    Attempts to turn government toward private gain and away from being of the people, by the people, and for the people have no doubt been going on since the beginning of government (and since the Constitution was signed, in the case of the US).  However, true health care reform  would require curtailing the severe sorts of conflicts of interest created by the revolving door.

Real heath care reform would require  multiyear cooling off periods before someone who worked in the commercial world can get a job in a government whose work has direct effect on his or her previous employer or industry sector, and before someone who worked in government whose work had direct effect on a particular economic sector can accept a job for a company in that sector.

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Tuesday, 3 March 2015

Turn, Turn, Turn - Another Health Care Revolving Door Update

Turn, Turn, Turn - Another Health Care Revolving Door Update

It has been a while since our last revolving door update, so it's time to take another spin.


Summary of the Revolving Door Phenomenon

Before we get to some cases, though, let me summarize an important article on the revolving door that came out since.  This was published by U4, the "anti-corruption resource center" NGO based in lovely Bergen, Norway.  The title was "The Revolving Door Indicator: Estimating the distortionary power of the revolving door."  Although it's main point was to summarize a new measure the importance of the revolving door in a particular economic sector, it started with a very useful summary of the revolving door phenomenon.  It included a useful definition

According to Transparency International UK, the term 'revolving door' refers to 'the movement of   individuals between positions of public office and jobs in the private sector, in either direction.'

To expand,

The revolving door involves two distinct types of movement.  The first is from the public to the private sector, as regulators (ministers, cabinet secretaries, legislators, high-level officials, advisers) leave the public sector to enter the private sector they have regulated. The second is from the private to the public sector, as high-level executives of regulated companies enter the executive branch, the legislature, or key regulatory agencies.

It also included some idea of prevalence

The revolving door is particularly common in countries where explicit bribes cannot be paid safely, and thus regulators look forward to future employment with the regulated firms

We will discuss what the U4 report said about the implications of the revolving door after a quick review of the cases we have run across since May, 2014, involving the US government.  They will be listed in order of their appearance in the news.

Former National Coordinator for Health Information Technology and Colleague at ONC to Aledade (Company Supporting Accountable Care Organizations)

In June, 2014, various versions of this story appeared.  The Modern Healthcare version stated,

Dr. Farzad Mostashari, former head of the Office of the National Coordinator for Health Information Technology, is starting a new firm, Aledade, to help independent primary-care physicians form accountable care organizations. The startup has $4.5 million in seed funding from venture capital firm Venrock.

Independent practices looking to form ACOs have to expend money 'to hire the people, to get the agreements, to get the licenses, to do the legal work, to hire the executive director, and a medical director, practice transformation, the analytics software, the data warehousing, the EHR interfaces,' he said. 'All of that takes money,' often $1 million to $2 million.

Note that the current concept of the "accountable care organization" [ACO] includes heavy dependence on the electronic health records (EHRs) and other health information technology that Dr Mostashari had been so vigorously promoting as head of the ONC, so this transition seems to fit the revolving door rubric.

It also turns out that one of Dr Mostashari's former ONC colleagues was already at Aledade  

Mostashari will be joined by Mat Kendall, a former leader with the regional extension center program at ONC, who will be executive vice president

Former US Senators to Lobby for Medtronic and Covidien

In August, 2014, per Bloomberg,

Former U.S. Senators Trent Lott and John Breaux are part of a lobbying effort by companies that want to preserve the option of reducing their corporate taxes by moving their legal addresses overseas.

Nine U.S. companies that have sought cross-border mergers for tax reasons, are considering doing so or are targets of such deals have been pressuring lawmakers since April on legislation to stop the practice, federal disclosure reports show.

They include Medtronic Inc., the Minneapolis-based company that is seeking to acquire Dublin-based Covidien Plc. Medtronic paid Breaux-Lott Leadership Group $200,000 in June to block legislation from moving forward. Breaux, a Democrat, was once a member of the Senate Finance Committee. Lott, a Republican, is a former Senate majority leader.

Note that as Senator, Breaux had an important role in health policy, particularly the passage of the Affordable Care Act (ACA).

Former Assistant Secretary of Health and Human Services to Drinker Biddle & Reath (Lobbying Firm)

In August, 2014, per the Washington Post,

District Policy Group, the lobbying unit of law firm Drinker Biddle & Reath, is experimenting with a new model of using outside consultants to capture new business in the health-care field.

The group, which lobbies primarily on health-care policy, has taken the unusual step of forming an advisory board that includes external consultants. The outside advisers are not employees of the firm and instead receive a consultant’s fee, which means the firm does not have to pay their salary or benefits, but can still tout their services to clients.

The board was formed in July and is made up of four Drinker Biddle attorneys and two outside consultants, Tracy Sefl, a Democratic communications strategist, and Michael O’Grady, a health economics specialist and former Health and Human Services assistant secretary under President George W. Bush. Both Sefl and O’Grady have day jobs running their own consulting shops.

This seems to require no further comment.

Former Federal Trade Commissioner to Herbalife

In October, 2014, per the Hill,

Herbalife has hired a former federal regulator to run its compliance program as it deals with allegations of running a pyramid scheme.

Pamela Jones Harbour, who served at the Federal Trade Commission (FTC) from 2003 to 2010, has been named the company’s senior vice president of global member compliance and privacy, according to media reports.

The FTC opened a probe into Herbalife’s business practices earlier this year after lobbyists, interest groups and policymakers asked for a review.

Shortly after the FTC announced its investigation, the FBI began looking into how the direct-selling company recruits new distributors.

Herbalife is best known for its meal-replacement shakes and dietary supplement products. Harbour says she has been a Herbalife customer since 2004, according to Reuters, favoring the company’s Formula 1 shake mix.

Note that the FTC devotes considerable energy to health care issues, and Herbalife styles itself a "a global nutrition company" which makes "weight management" and "energy and fitness" products.

Director of US Centers for Disease Control and Prevention (CDC) to Merck as President of Merck Vaccines, then Executive Vice President for Strategic Communications, Global Public Policy and Population Health

In December, 2014, per a news release on BusinessWire,

Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced the appointment of Dr. Julie Gerberding, 59, as executive vice president for strategic communications, global public policy and population health, effective Dec. 15. In this newly created Executive Committee position, Gerberding, who most recently served as president of Merck Vaccines, will be responsible for Merck’s global public policy, corporate responsibility and communications functions, as well as the Merck Foundation and the Merck for Mothers program.

Note that

Prior to joining Merck, Gerberding served as director of the U.S. Centers for Disease Control and Prevention (CDC) from 2002-2009 and before that served as director of the Division of Healthcare Quality Promotion.

From UnitedHealth (Optum Subsidiary) Executive to Administrator of the Center for Medicare and Medicaid Services (CMS) of the Department of Health and Human Services

In January, 2015, per the Business Journals,

Marilyn Tavenner's replacement at the Center for Medicare and Medicaid Services is a former executive at one of the contractors for the initially botched HealthCare.gov insurance exchange.

Andy Slavitt, former group executive vice president of United Health Group's Optum unit, joined CMS last June to help fix HealthCare.gov. Now he'll be acting administrator of CMS.

An Optum subsidiary, Quality Software Services Inc., was one of the original contractors for HealthCare.gov. QSSI developed the exchange's data services hub and a registration tool that allows users to create secure accounts.

Apparently nothing succeeds like failure.


Discussion

I apologize for the somewhat desultory way I have been summarizing health care revolving door cases.  My excuse is that such cases are almost never publicized as such.  Most of the stories above were found when looking for something else.  Despite its potential importance, the revolving door phenomenon gets little consistent coverage in the news media, and the particular issue of the revolving door affecting health care is particularly anechoic.  (If one searches for "'health care revolving door," one finds discussion of patients who are frequently re-admitted to the hospital.)  There is one website devoted to the revolving door affecting the US government, (OpenSecrets.org has a database here.)   However, it is not searchable by sector, and seems not to be complete (that is, for example, it fails to contain most of the cases I listed above). 

None of the cases above got more than minimal media coverage, yet they all involved people who at one time held high government positions, including US Senators, director of the Centers for Disease Control and Prevention (CDC), a Federal Trade Commission (FTC) commissioner, the director of Center for Medicare and Medicaid Services (CMS) within the US Department of Health and Human Services (DHHS), an Assistant Secretary of DHHS, and the National Coordinator for Healthcare Information Technology. So the anechoic effect persists regarding this issue.

Yet the revolving door is a significant issue.  As discussed in the U4 article

The literature makes clear that the revolving door process is a source of valuable political connections for private firms. But it generates corruption risks and has strong distortionary effects on the economy, especially when this power is concentrated within a few firms.

Also, the principal way the revolving door can benefit a company is...

The rent-seeking channel: The revolving door is used to capture public resources, through legal and illegal means, rather than to increase production or efficiency.  Transparency International UK (2011) and the OECD (2009) point out that the revolving door may lead to various schemes involving conflicts of interest, both during and after a regulator’s term in public office. This in turn generates undue bureaucratic and political power for firms using such schemes

Furthermore,

The revolving door is also related to lawful behaviours (Brezis 2013), termed 'legal corruption' by Kaufmann and Vicente (2011). This phrase refers to 'efforts by companies and individuals to shape law or policies to their advantage, often done quasi-legally, via campaign finance, lobbying or exchange of favors to politicians, regulators and other government officials. […] In its more extreme form, legal corruption can lead to control of entire states, through the phenomenon dubbed ‘state capture,’ and result in enormous losses for societies'

So,

Firms connected through the revolving door may therefore derive undue advantages by legally and illegally influencing the formulation, adoption, and implementation of laws, regulations, and public policies. For example, when firms are connected to (former) members of Parliament [or the legislature], they may influence the enactment of laws and regulations in their favour. When firms are connected to (former) ministers [or in the US, cabinet secretaries] and their advisers, they may influence the upstream formulation and implementation of policies and regulations in their favour. When firms are connected to (former) high-level officials, they may influence the downstream implementation of regulations in their favour.

Finally,

Empirical studies suggest that the revolving door gives firms political and bureaucratic power that enables them to divert state resources by biasing public procurement processes (Goldman, Rocholl, and So 2013; Cingano and Pinotti 2013), obtaining preferential access to public finance (Faccio, Masulis, and McConnell 2006; Boubakri et al. 2012), and unduly benefiting from tax exemption, arrears, and subsidies (Faccio 2010; Slinko, Yakovlev, and Zhuravskaya 2005; Johnson and Mitton 2003).

Therefore, firms politically connected through the revolving door tend to shape laws and regulations in their favour and to divert state resources to their own benefit. They are unlikely to gain a productivity advantage, and indeed may reduce productivity in the private and the public sectors. The literature on state capture and political influence (Hellman and Kaufmann 2004; Hellman, Jones, and Kaufmann 2003; Slinko, Yakovlev, and Zhuravskaya 2005) supports the thesis that such distortions result from the high concentration of political and bureaucratic power among a few powerful firms.
That all suggests that the revolving door in health care ought to get attention beyond posts in Health Care Renewal, but so far there has been precious little of that.  The continuing egregiousness of the revolving door in health care shows how health care leadership can play mutually beneficial games, regardless of the their effects on patients' and the public's health.  Once again, true health care reform would cut the ties between government and corporate leaders that have lead to government of, for and by corporate executives rather than the people at large

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Friday, 30 January 2015

CMS: Millions of patients across the nation are benefiting from the - um - potential - of Health IT?

I presume this is, in part, a response to the Jan. 21 letter from AMA and the other medical societies as I wrote about two days ago at http://hcrenewal.blogspot.com/2015/01/meaningful-use-not-so-meaningul.html:

CMS intends to modify requirements for Meaningful Use
http://blog.cms.gov/2015/01/29/cms-intends-to-modify-requirements-for-meaningful-use/

January 29
By Patrick Conway, MD

Today, we at the Centers for Medicare & Medicaid Services (CMS) are pleased to announce our intent to engage in rulemaking to update the Medicare and Medicaid Electronic Health Record (EHR) Incentive Programs beginning in 2015. These intended changes would help to reduce the reporting burden on providers, while supporting the long term goals of the program.

Read the document at the link above.

Note in particular this cheerful statement:

Since the first year of the EHR Incentive Programs in 2011, the United States has seen unprecedented growth in the adoption and meaningful use of EHRs. To date, more than 400,000 eligible providers have joined the ranks of hospitals and professionals that have adopted or are meaningfully using EHRs. This means that millions of patients across the nation are benefiting from the potential of better coordinated care among professionals, more accurate prescribing, and improved communication.

How does one, I ask, benefit from "potential of better care"?

How about the more factual "millions of patients are being put at risk and actually being harmed by the non-potential, but in fact actual, flaws in the technology?"

Until our leadership stops the mental cheerleading like this (or is it a form of subliminal messaging?), which blinds the uninformed to the reality ... the situation with healthcare IT will not improve, in my opinion.


And this after a formal letter of complaint about health IT disruptions to care, dangers, etc. from these organizations:

American Medical Association
AMDA – The Society for Post-Acute and Long-Term Care Medicine
American Academy of Allergy, Asthma and Immunology
American Academy of Dermatology Association
American Academy of Facial Plastic
American Academy of Family Physicians
American Academy of Home Care Medicine American Academy of Neurology
American Academy of Ophthalmology
American Academy of Otolaryngology—Head and Neck Surgery
American Academy of Physical Medicine and Rehabilitation
American Association of Clinical Endocrinologists
American Association of Neurological Surgeons
American Association of Orthopaedic Surgeons
American College of Allergy, Asthma and Immunology
American College of Emergency Physicians
American College of Osteopathic Surgeons
American College of Physicians
American College of Surgeons
American Congress of Obstetricians and Gynecologists
American Osteopathic Association
American Society for Radiology and Oncology
American Society of Anesthesiologists
American Society of Cataract and Refractive Surgery and Reconstructive Surgery
American Society of Clinical Oncology
American Society of Nephrology
College of Healthcare Information Management Executives
Congress of Neurological Surgeons
Heart Rhythm Society
Joint Council on Allergy, Asthma and Immunology
Medical Group Management Association
National Association of Spine Specialists
Renal Physicians Association
Society for Cardiovascular Angiography and Interventions
Society for Vascular Surgery


-- SS

Addendum 1/30/15:

Also see my April 26, 2014 post "Followup to CMS does not have any information that supports or refutes claims that a broader adoption of EHRs can save lives" at http://hcrenewal.blogspot.com/2014/04/followup-to-cms-does-not-have-any.html with its attached March 2014 lettert from CMS.  This document was obtained by the American Association of Physicians and Surgeons (AAPS) via FOIA on the "potential" benefits patients are realizing from the hundreds of billions of dollars spent on this technology to date:

CMS: "we do not have any information that supports or refutes claims that a broader adoption of EHRs can save lives."  [But millions of patients are already benefiting from the potential!]  Click to enlarge.

-- SS
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