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Background

H.R. 2914 is a bill filed by Congresswoman Speier that is intended (among other things) to prohibit medical practices providing the following sorts of medical services (“Non-ancillary Services”) to their own patients—

*The technical or professional component of (i) surgical pathology, (ii) cytopathology, (iii) hematology, (iv) blood banking, or (v) pathology consultation and clinical lab interpretation services

*Radiation therapy services and supplies

*Advanced diagnostic imaging studies (which include for instance MR and CT)

*Physical therapy services

The Bill, or concepts the Bill is based upon, are supported by a variety of organizations and legislators, including:

●Government Accountability Office (GAO)

●Medicare Payment Advisory Commission

●Alliance for Integrity in Medicine (AIM)*

●The American Society for Radiation Oncology

●The American College of Radiology

●The American Society for Clinical Pathology

●The Wall Street Journal

●The Washington Post

●The Baltimore Sun

●Representative Waxman

●Representative McDermott

●Congresswoman Titus

●Congresswoman Speier

*AIM members include American Clinical Laboratory Association; American College of Radiology; American Physical Therapy Association; American Society for Clinical Pathology; American Society for Radiation Oncology; Association for Quality Imaging; College of American Pathologists and Radiology Business Management Association.

The Bill

Though the backers of the Bill are clearly industry representatives that stand to gain financially if the Bill passes, it is very interesting to dig into the ideas set forth in the Bill that drive the conclusion that certain big changes need to be made to the law.

“Recent studies by the Government Accountability Office (GAO) examining self-referral practices in advanced diagnostic imaging and anatomic pathology determined that financial incentives were the most likely cause of increases in self referrals.”

The key GAO reports referred to are:  The July, 2013 Report re the higher use of prostate cancer treatment (IMRT) by physicians who self refer and the June, 2013 Report re higher use of anatomic pathology by providers who self refer.

Prostate Cancer Report.  The Report was done because of questions raised re the role of self referral in Medicare expenditures.   The Report focused on referrals by urologists who treat prostate cancer and who self refer for IMRT.  What did the GAO recommend?  That the Secretary of HHS require providers who self refer to disclose the financial interest and monitor such instances.  American Urological Association (AUA) representatives criticized the Report and stated (in part)—

●There has been a trend in patients receiving care in physician offices who previously received care in hospital outpatient departments

●There was insufficient emphasis in the Report on the issue of patient choice

●Brachytherapy used to be the sole treatment option recommended for intermediate and high risk prostate cancer, but treatment options now include IMRT

Anatomic Pathology Report.  This Report was done because of questions about self referral’s role in Medicare expenditures for anatomic pathology (AP).  The GAO recommended that CMS identify self referred anatomic pathology and address their higher use.  The Report addressed self referral for AP involving dermatologists, gastroenterologists and urologists.  The American Academy of Dermatology Association (AADA) criticized the Report and offered comments such as—there has been an increase in patient volume and also increasing provider specialization influences the trend in AP referrals.  American Gastroenterological Association (AGA) representatives also criticized the Report.

Report Shortcomings

There is no information in the Reports re what organizations instigated the study and whether they are financially interested in the studies.  Moreover, there is no mention or comment in either Report on whether the referrals were medically necessary or not.  They looked only at volume.  Presumably the referrals were medically necessary, because if they were not, reimbursement for those services would have been denied.  Similarly, there was no mention re the need for diagnosis, diagnoses trends (because of demographics or other external factors) or the effect of state professional liability laws in the targeted referral behavior.  Reported data was not broken down by geographic origin, nor was there a sufficient indication of the practice settings examined or who referred.  For instance, was the practice multi specialty, corporate based, physician owned?  Were the referrals for IMRT for instance all by urologists or other physicians in the practice?  Was there an economic benefit to the ordering provider for the provision of IMRT or was IMRT simply a service offered by the group?  None of this is explained in the Report.  Nor is there, in the Prostate/IMRT Report any meaningful exploration of the relative risks and benefits of the different prostate cancer treatment options, which might have explained for instance why IMRT was chosen versus radical prostatectomy, which has an increased risk of bladder incontinence and erectile dysfunction.  Interestingly, the cost of IMRT treatment in a physician office is reportedly $406 per treatment and $484 per treatment in hospital outpatient departments.  The entire focus was on Prostate/IMRT Report for prostate cancer treatment, which states that in 2010, there were about 218,000 new cases of prostate cancer and about 32,000 deaths due to prostate cancer.

H.R. 2914

Defects aside, the Reports were narrowly drawn.  Neither of them concluded that any sort of referral ban, let alone one that applies to all physicians in private practices, even for services that were outside the scope of the Reports, was advisable.  How then did H.R. 2914 come into being and cite as support the Reports for the need for a referral ban?

Some of the Bill’s contents are illuminating—

In addition to the GAO Reports, the Bill cites as sources (1) a statement by the Medicare Payment Advisory Commission, (2) a 2010 Health Affairs Study, (3) an October, 2011 Laboratory Economics report, (4) a Bloomberg News investigative report, and (5) investigations by the Wall Street Journal, the Washington Post and the Baltimore Sun.

Though there may be some who would make a case for the inherent ability of journalists to formulate and implement healthcare policy, it is doubtful that any journalist responsible for the above would feel qualified.  The Health Affairs website states it is “the leading journal of health policy thought and research.”  It appears to be a hub of thought and idea exchange regarding healthcare.  The website of Laboratory Economics states it offers “Financial News and Analysis for Laboratory Management Decision Makers.”

Whether intentional or not, the clear effect of the Bill, if it passes, would be to move some expenditures out of physician offices and into hospitals, free standing centers and other sites of services, nearly all of which are higher cost centers.  Apparently, no study has been done to date that answers the question of whether there would be a cost saving to the healthcare system a whole (instead of a reallocation of healthcare dollars) by further restricting application of the In Office Ancillary Services Exception.

Admittedly, the issues raised in the Reports are highly complex.  And the role of business considerations is huge in the debate.  The American Physical Therapy Association (APTA) for instance, supports HR 2914, which would remove the ability of physician practices to provide PT services while, at the same time supporting Assembly Bill 1000 in California, which would allow physician practices to do the very same thing they oppose in HR 2914.

Physician organizations are not taking these developments lightly.  The Coalition for Patient Centered Imaging (CPCI), for instance, is a big supporter of in-office imaging.  CPCI will likely be a force to be reckoned with over time and whose members include:  American Academy of Neurology; American Association of Clinical Urologists; American Association of Neurological Surgeons; American Association of Orthopedic Surgeons; American College of Cardiology; American College of Rheumatology; American Congress of Obstetricians and Gynecologists; American Medical Group Association; American Society of Neuroimaging; American Society of Echocardiography; American Society of Nuclear cardiology; American Urological Association; Association of Black Cardiologists; Cardiology Advocacy Alliance; Congress of Neurological Surgeons; Medical Group Management Association; Society of Maternal-Fetal Medicine and the US Oncology Network.

Physicians are perhaps the least cohesive link in the healthcare chain.  It is far easier for ten hospitals to collaborate on issues of common interest than it is for ten medical practices to do so.  Sadly, for that reason, physicians seem to bear the brunt of policy attack in the healthcare sector.  They are easy prey, and at a time when their voice and input has never been more important.  Perhaps organizations like CPCI will be able to be a strong voice in this time of tremendous change.

Conclusion

The content of the Reports has been questioned and even criticized by a number of serious writers.  The best one can say about them is that they raise issues that bear closer study.  To call the nexus between the Reports and the Bill a “logical leap” would be misguided.  There simply is no connection at all!

More importantly, the Bill is a dangerous step further along the road of “corporatizing” medicine.  There is a reason why there has historically been tension between physicians and hospitals (and other business centers).  It is because their interests are different, and necessarily so.  The tension between different balances of quality and business considerations is a good one; and diluting the role and presence of independent medical judgment in healthcare that physicians bring to the table is just dangerous.  HR 2914, supported as it is by business interests, is not even one small step for humankind.  It’s a giant leap for big business.