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9 posts from August 2008

August 26, 2008

Contractual joint ventures: the OIG hangs tough

The OIG released an advisory opinion today finding that a proposed block leasing arrangement between two physician group practices -- one a practice providing cancer treatment services, including IMRT, the other a urology group -- whereby the urology group would bring the IMRT services in-house through a series of contracts, would be barred as an impermissible contractual joint venture, assuming the requisite intent (to exchange payment for referrals) were present. 

There has been very little advisory opinion activity related to the contractual joint venture special advisory bulletin issued by the OIG in 2003.  Only three advisory opinions before today's even mention the special advisory bulletin.  One of those, however, trod the same ground as today's advisory opinion.  The 2004 advisory opinion regarding pathology lab contractual joint ventures is essentially identical to the most recent opinion. 

In the opinion, the OIG observes that

the Special Advisory Bulletin describes an arrangement very similar to the Proposed Arrangement:

[A] health care provider in one line of business (hereafter referred to as the “Owner”) expands into a related health care business by contracting with an existing provider of a related item or service (hereafter referred to as the “Manager/Supplier”) to provide the new item or service to the Owner’s existing patient population, including federal health care program patients. The Manager/Supplier not only manages the new line of business, but may also supply it with inventory, employees, space, billing and other services. In other words, the Owner contracts out substantially the entire operation of the related line of business to the Manager/Supplier – otherwise a potential competitor – receiving in return the profits of the business as remuneration for its federal program referrals.

In these circumstances, the OIG is unimpressed by claims that each element of the arrangement fits into a safe harbor.  Also, significantly, the OIG notes that the analysis of the proposed arrangement requires not only a review of each component of payment running from the urologists to the other physician group, but an analysis of the remuneration running from the cancer care group to the urologists, equal to the difference between the federal program payments to the urology group for services and the contract prices paid by the urology group.

For all of these reasons, the proposed arrangement failed to gain the approbation of the OIG
.

Providers with existing or proposed contractual arrangements anywhere the zip code of the arran
gements described in these advisories would be well advised to review them carefully in light of this most recent opinion, which seems to reinvigorate a somnolent area of enforcement.

-- David Harlow

August 21, 2008

Beach Blanket Health Wonk Review

Julie Ferguson's beach edition of HWR is up at Workers' Comp Insider.  My fellow health wonks may be blogging from the beach (I hope they are!) but I've either been inside to get out of the rain, or out biking (and I haven't yet mastered the art of blogging while biking -- nor am I sure I really want to try).

-- David Harlow

August 19, 2008

The "S" word: Single-payor, Obama and the Wall Street Journal

Even when denying that he plans to institute a single-payor model, Obama gets raked over the coals by most of the readers who commented on today's WSJ Health Blog post regarding his health plan. 

Obama says that if we were starting with a clean sheet of paper, a single-payor system would make sense.  So far, so good: all industrialized democracies other than our own have taken the leap into this "monolithic" approach -- and their systems work better than ours, as recent reports have borne out. We in the US of A spend far more per capita for health care than other nations, and we fare more poorly on a number of key quality indicators.  Obama also says, wisely, that since we aren't starting with a clean sheet of paper, we shouldn't destroy the existing system.  Rather, we should work on improvements around the edges. As I've written in posts over the past year or so: "Incrementalism, baby." It's the only way to go.

Otherwise, as Obama recognizes, we risk seeing dislocations that are too great. It should also be clear to any observer of our health care system that serious change must get underway in order to address the three-headed monster of cost, access (both in terms of coverage and availability of providers) and quality.  Since it seems an insurmountable obstacle, the all-too-human reaction is to shrug and think about something else.

Clearly, we need to attack one or another of these issues head-on. We can't realistically address all of them at once. Obama's plan makes one rational choice; other choices could be equally rational. The key is that we need to start somewhere, and soon.

Denying that a problem exists or that any potential solution brought forward, however imperfect, might advance the ball a bit, is a bit unrealistic at this stage of the game. Ultimately, the solution will involve -- and benefit -- all of us.

-- David Harlow

August 18, 2008

A Phelpsian Blawg Review

Dive into this week's Phelpsian edition of Blawg Review, up at David Donoghue's Chicago IP Litigation Blog.

-- David Harlow

August 14, 2008

Another wonderful ride for a good cause -- 2008 Pan Mass Challenge wrap-up

About two weeks after the Pan Mass Challenge, I feel reintegrated into the rest of my life, and no longer part of a 10,000-person village on wheels.  (The PMC is the annual two-day bicycle fundraiser for Boston's Dana Farber Cancer Institute's Jimmy Fund.)  Monday morning after the ride, I was sitting in front of my computer, but my head was still out on the road.

In my neck of the woods, if it's the first weekend in August, it must be the Pan Mass Challenge.  Two days, 5300 riders, 2500 volunteers, thousands of supporters, 192 miles.  Since I carried a rain jacket in my bike jersey pocket, we didn't get caught in any rain; the rain waited until after the biking was over each day.  Late Saturday afternoon, once we had arrived at the Mass Maritime Academy -- where later we had our massages, dinner, and slept until reveille at 4 a.m. -- the wind whipped up the 4000-person food tent into such a fury that a giant pole came loose and crashed down on one of the serving tables -- luckily, no one was hurt.  Sunday afternoon brought some weather, too.  (The PMC's photo highlights linked to below include a few dramatic rainbow shots from the ferry back to Boston from the Provincetown finish.)

I rode at my fastest pace of the whole season (not too-too fast; just fast for me), thanks to the adrenaline rush of riding with so many other riders, and being cheered on by so many well-wishers, and overall I felt really great about the ride. (Of course I couldn't climb stairs very well on Monday or Tuesday.)

The well-wishers were out all day -- the Sturbridge High School cheerleaders out at breakfast and at the start before 6 a.m. Saturday, bubble-blowers along the first hill before 6:30, the annual block party as we ride down Cherry Street in Wrentham -- complete with teenage rock band on the front lawn at 9:00 a.m, the "over-the-hill cheerleaders" at the last big hill on the Cape.  

As usual, the water stops were staffed by enthusiastic volunteers. The theme at the Nickerson State Park water stop on the Cape was "PB&J Ranch" -- as we rode in, we passed bales of hay and wagon wheels, tables were covered with red and white checked tablecloths, volunteers were wearing straw cowboy hats and bandannas and carrying around platters of PB&J sandwiches, one water bottle filling station was a prairie schooner, and they had giant plastic sheets with images of outhouse doors plastered onto the port-a-potties' doors.  One other feature of that water stop, independent of the theme, is washcloths soaked in ice water, which feel good on the head and neck.  Oh -- and many of the water stops were stocked with wiffle ball bats, to use in stirring huge vats of Gatorade.  You can see the prairie schooner and get a visual sense of the event-- and even catch some elusive photos of me in spandex -- in my PMC photo album.  Also please check out the PMC's own photo highlights, and the video montage of the PMC weekend

I relaxed, of course, on the ever-popular ice couch at the last water stop, in Wellfleet -- this year the theme there was disco, and volunteers were wearing mini mirrored balls around their necks.  (The ice couch is an oversized couch-shaped object made up of many bags of ice and covered with leopard-skin-patterned throws.)

There was the usual smattering of bagpipers, including one in full dress regalia at the middle of the Bourne Bridge at 6 a.m. Sunday.  There was also a group of young girls wearing togas on the Cape end of the bridge.  I think it was because it's the "Pan" Mass Challenge.  Get it?  Pan?

The riding, the well-wishers along the route,the feeling of being part of a village on wheels, and the sense of being part of something larger than all of us, all added up to an incredible weekend experience. 

Thanks to everyone who has helped me personally with the ride and the fundraising this year, and each of the past years I've done this.  In particular, thanks are due to my wife, Heather, the self-described "bike widow," and to my riding partner, Hillel, who got me into this crazy subculture about five years ago. 

For those who haven't done so yet, please click here and join me by donating to the Jimmy Fund on line.  The PMC motto is "Let's Make Cancer History."  Each year, we raise money to help the researchers and clinicians at Dana Farber work to do just that.  We are well on our way to meeting this year's $34 million fundraising goal, so help push us over the top.

-- David Harlow 

August 12, 2008

Grand Rounds is up at Medical Humanities Blog

Check out this week's edition of Grand Rounds, hosted by Daniel Goldberg at his very sharp looking Medical Humanities Blog, hitting all the high points of this week's offerings in the medblogosphere, from Oprah to the Olympics.

-- David Harlow

The latest health care legislation from the People's Republic of Massachusetts

Once again, Massachusetts is out in front on a number of hot issues.  The legislation, championed by Senate President Therese Murray, was signed by Gov. Patrick earlier this week.  See the full text of AN ACT TO PROMOTE COST CONTAINMENT, TRANSPARENCY AND EFFICIENCY IN THE DELIVERY OF QUALITY HEALTH CARE and the Boston Globe story on the new health care law.  The Globe highlights parts of the act that: 

  • Limit pharma industry gifts to providers
  • Provide some funding to get physician offices on EHR systems
  • Require UMass Medical School to graduate more PCPs
  • Institute closer oversight of health insurance premiums

Also of interest are:

  • The mandate for hospitals and community health centers to all be on EHRs by 2015
  • The requirement that facility with EHRs and CPOE be made a condition of physician licensure
  • The HAI and med error reporting requirements, and
  • The reintroduction of DON (that's CON for the rest of the country) jurisdiction
    • for outpatient projects if the capital budget is $25 million or more (ambulatory projects were deregulated years and years ago), and
    • for all ambulatory surgery centers -- not just multispecialty ASCs, and including physician office based ASCs.

A few observations: 

The doom and gloom gang at PhRMA say the gift limits and disclosure requirements will end up marginalizing Massachusetts-based researchers.  Seems unlikely to me.

The $25 million set aside for EHRs is a nice gesture.

More PCPs are key to making the universal health insurance law work -- we have a whole buch of newly-insured folks here in Massachusetts (325,000 or so), and not all of them can access a PCP, because we just don't have enough.

I still have that central health planning gene (thanks to a stint in state government a long while ago), so from the system perspective I am not that put off by the expansion of DON jurisdiction.  I reserve the right to argue differently, of course, in the case of a particular project.

And last of all, let's hope that the HAI and med error reporting system yields some new learning that can help avoid future incidents and errors.

-- David Harlow

August 10, 2008

Does the DNS security hole worry the EHR and PHR worlds?

I read a disturbing article in the NY Times last Friday about Dan Kaminsky's talk at the Black Hat conference: he's been beating the drum for a while now, warning of what sounds like a serious security hole in Domain Name Server software offering an open door to hackers of websites containing confidential information and into email (which could allow phishing for usernames and passwords for otherwise protected sites).  The technorati seem to agree that he's identified a serious problem, and it seems that not all affected parts of the internet infrastructure have applied patches or upgraded their software.

Yet another reason to be wary of assurances that if the internet is safe for banking then it's safe for health care information.  Even the latest compact on privacy doesn't count for much in the face of a technical issue of this magnitude.

Providers that have not adopted EHR systems to date could use this sort of news as an additional excuse to try to delay the inevitable.  A study published in the NEJM a couple of months ago found that the reason most often given for lack of EHR in a practice is cost.  (One commentator takes issue with that conclusion.  I've also posted in the past about issues other than cost that stand in the way of EHR adoption.)

On the PHR front, this sort of news could scare off many people from uploading their health data into Google Health or Microsoft's HealthVault.

However, the bottom line is that there is clinical value to using electronic health records and personal health records, and to the extent that providers and patients see that value, the benefit can be weighed against the cost of a potential security breach.  The cost-benefit analysis will vary from person to person, depending on a variety of factors ranging from EHR considerations like the short-term effect of EHR adoption on productivity vs. the clinical benefits that can accrue to patients, to PHR considerations like tolerance for junk mail, a snowbird's desire to keep doctors in two locations up to speed on conditions and treatments, and concerns about being denied employment due to a genetic predisposition to an occupational disease.  (I know that's supposed to be illegal, but, gee, do you think that might happen sometimes anyway?)

Would I prefer to stand firm and insist on perfect online privacy protections for financial and health care information?  Of course!  Is that practical?  Of course not! 

A few years back, my credit card information was inappropriately released by a vendor that apologized semi-profusely and paid for a year's worth of fraud monitoring and reporting.  Have I stopped using credit cards?  No.  The cost would be too great.  Am I concerned that my physician's EHR system could be hacked into?  Well, my thinking on that is that hackers with limited resources probably want to go after something with greater interest, or at least greater value in the marketplace (e.g., Britney Spears' medical records) so I am willing to continue to be part of the online system.

I am resigned to living with some of the burdens of modernity.  Having completed my own cost-benefit analysis, I am not willing to live "off the grid."  Some of you out there may be willing to do so -- you'll maintain your privacy, but you won't be able to read HealthBlawg any more.

-- David Harlow


August 08, 2008

2009 IPPS rule released by CMS

CMS put the 2009 IPPS rule (that's the acute hospital inpatient prospective payment system rule) on display last week, and it will be published in the Federal Register later this month (August 19, if you must know), to be effective October 1.  It was released in draft form in May (see HealthBlawg post on the draft 2009 IPPS rule).  The final version is described in a series of CMS 2009 IPPS fact sheets on Medicare hospital payment policy changes, more never events, pay for reporting and Stark and hospital ownership disclosure.  Gainsharing thoughts in the draft version found another home inthe draft 2009 MPFS regulation.

-- David Harlow