May 17, 2012
The Honorable Fred Upton
Chairman of the Energy and Commerce Committee
United States House of Representatives
Washington, DC 20510
The Honorable Henry Waxman
Ranking Member of the Energy and Commerce Committee
United States House of Representatives
Washington, DC 20510
Dear Chairman Upton and Ranking Member Waxman:
We write to ask for your support for bipartisan legislation pending before the House Energy and Commerce Committee. H.R. 816, The Provider Shield Act, sponsored by Rep. Phil Gingrey (R-GA) and Henry Cuellar (D-TX), will clarify that the Patient Protection and Affordable Care Act ( PPACA) does not create new theories of liability or alter the rules governing medical professional liability lawsuits. We are concerned that certain provisions of the law could be used by judges and personal injury lawyers to establish a national “standard of care” to prove negligence in such lawsuits when a physician’s personalized care for his or her patients may not adhere to the federal payment or billing/coding guidelines. Such a threat can have a chilling effect on patient safety and stifle future efforts to improve the standard of care for all patients.
The Patient Protection and Affordable Care Act creates dozens of new payment rules and programs, many of which partially condition provider payments on the accomplishment of certain objectives. Some examples include the Value-Based Payment Modifier for physician services; expansion of the Physician Quality Reporting System; creation of Accountable Care Organizations that tie a global payment to cost savings and quality metrics; expansion of the Healthcare Acquired Conditions (HAC) program to Medicaid and required payment sanctions under Medicare for hospitals falling into the lowest quartile in terms of the number of HACs and new measures of “avoidable” hospital readmissions with associated payment sanctions.
This effort to tie Medicare and Medicaid payment rules to various incentives that are intended to promote improvements in cost efficiency and the quality of care has generally been supported on a bipartisan basis. But these programs have not been developed with the intent that they be applied in medical professional liability cases to determine the applicable standard of care or otherwise. There is a danger in conflating these government payment rules with liability standards -- compliance with or deviation from these rules should not be the basis for protection from or exposure to litigation. The confusion of payment rules with liability rules would be harmful to both the legal process for resolving negligence actions and the government’s efforts to promote value based purchasing. Among other outcomes, the development of these payment rules will become embroiled in extensive contention if they are to be allowed to be used as legal evidence.
Congress can and should act now to clarify the demarcation of new incentive-oriented payment rules and liability rules. This is what H.R. 816 does -- it enacts straightforward legislative language that clarifies that these payment rules should not be construed as liability rules. The scope of this legislation is quite modest. It would simply preserve the status quo with respect to the medical professional liability adjudication process. It would not change the rules of evidence or any other aspect of the processes used in the various states to resolve liability cases. Nor would it in any way affect the ability of an expert witness to discuss the applicable standard of care. Its only effect would be in a situation where one party introduces into evidence the fact that a provider deviated from or adhered to a federal government payment rule. In this situation, the other party could respond by noting that Congress did not create these payment rules with the intent that they be used to determine the standard of care.
The House version of the health reform legislation contained language very similar to H.R. 816. The House bill also contained a "savings clause" (also included in H.R. 816) clarifying that nothing in the Act was meant to preempt state medical malpractice laws. The Senate version of the bill took a different approach by instructing the GAO to study 14 sections of the bill and report back to Congress on whether they create new causes of action. Unfortunately, the Senate bill became the base bill and was enacted into law without any changes even though there was agreement that the House language should be included in a conference report. Subsequent “budget reconciliation” legislation could not change this provision because it did not have a direct revenue impact.
Following final passage of the PPACA in each chamber, Rep. Henry Waxman (D-CA) and Senator Dianne Feinstein (D-CA) read statements into the Congressional Record stating in part, that it was not the intent of the PPACA to “create any new actions or claims based on the issuance or implementation of any guideline or other standard of care;” “nor …to supersede, modify or impair State medical liability law governing the legal standards or procedures used in medical malpractice cases.” Two months later, on May 21, 2010, Rep. Gingrey, Rep. Graves and 51 of their Republican colleagues sent the attached letter to then-Chairman Waxman asking him to ensure that this statement in the record was written into statutory language and offering to work with him toward that end. Although legislation (H.R. 5243) was introduced by Rep. Henry Cuellar (D-TX) late in the 111th Congress to achieve that goal, it unfortunately did not pass in the short time left before the end of the Congress.
On March 23, 2012, the above-referenced GAO report was sent to the congressional leadership, a copy of which is attached. The report concludes that “…the guidelines and standards developed, recognized and implemented under these provisions could shape the standard of care against which a provider’s conduct is measured in a medical malpractice case.” We agree with the statements of legislative intent read into the congressional record during passage of the PPACA, as well as the conclusion of the GAO report that these provisions were intended to improve quality and efficiency in the delivery of health care and reduce costs, but could, over time, lead to new theories of medical professional liability against healthcare providers. This is why we see a need to remove the ambiguity surrounding this intent through statutory clarification. H.R. 816 will allow providers to continue to personalize the care they provide for their patients and to participate in federal programs intended to improve quality and efficiency, without fear that they are opening themselves up to additional exposure to lawsuits.
Today, the standard of care is established by medical societies seeking to improve outcomes and patient safety. This process has led to consistent medical innovation and progress. Absent federal statute, rogue judges and trial lawyers that tie the standard of care to billing practices will retard and eventually stop this continual care improvement process. It is this chilling effect that H.R.816 seeks to avoid and is why the bill has bipartisan support.
H.R. 816 now has 24 bipartisan cosponsors, including six members of your committee and Rep. Lamar Smith (R-TX), Chairman of the Judiciary Committee, where the bill has also been referred. H.R. 816 also has the support of all of the undersigned organizations, which are dedicated to improving patient access to health care and efficiencies in the delivery of that care. In October of last year, the American Medical Association and 98 other state and national medical organizations sent the attached letter to the Co-Chairs of the Joint Select Committee on Deficit Reduction urging them to include certain medical liability reforms in the deficit reduction legislation they were crafting. Included in the requested reforms were H.R. 816 and “liability protections for physicians and other health care providers so that evidence of nonpayment or payment adjustments based on…CMS policies would be inadmissible as evidence in a liability claim or lawsuit to prove liability or establish a presumption of liability on behalf of a physician or other health care provider.”
H.R. 816 is non-controversial, bipartisan legislation that can and should be passed this year and that will make a true difference in the ability of health care providers to improve access and quality of care for their patients. We strongly support its enactment into law and ask that you work with us to accomplish this goal. Thank you very much for your consideration of this request and we look forward to working with you to put these important protections for health care providers into law.
Cooperative of American Physicians, Inc.
The Doctors Company
NORCAL Mutual Insurance Company
Physicians Insurance Association of America
Texas Medical Liability Trust
cc: Rep. Phil Gingrey
Rep. Henry Cuellar
Rep. Lamar Smith