Lyme Protection Amdt. May Hurt NY Docs

In Dec 2014, Governor Cuomo signed the Lyme disease doctor protection bill into law. When he signed, he indicated he only signed on the condition an amendment would be passed in the New Year (2015), and at that time, the amendment was not made public, but some groups were told it would be just a “technical” amendment. Due to the uncertain nature of that amendment and lack of process transparency, the LDA withheld its judgment on the New York bill with the upcoming amendment and how it might affect New York doctors treating long term. After examining the amendment, now released by NYS and yet to be passed, the LDA does NOT support its adoption.

(UPDATE NOTE: NY Voices of Lyme posted on Feb 11 the following: On February 10th, the chapter amendment to the NYS Doctor Protection/Patient Rights Law was passed in the NYS Assembly Health Committee. The NYS Assembly is on recess until February 25th, so the chapter amendment will not be brought to a floor in the NYS Assembly vote until after that date. On February 9th, the chapter amendment to the NYS Patient Rights/Doctor Protection Law passed on the floor of the NYS Senate.)

On balance, the proposed new language may be more harmful than helpful in protecting licensed health care practitioners from intrusive investigations lacking a meritorious basis and may facilitate rather than discourage investigations (no matter how they are labeled) launched to find something wrong. The question becomes, “Why pass something that, in the best case, would be unlikely to provide any significant benefit or relief, but may likely make things significantly worse?”

(See amendment text here

Click to here for LDA letter to Gov. Cuomo to sign 2014 bill

History: Before the 2014 NYS law passage, the 2005 memo served as a finding that a treatment modality in itself was not misconduct and closed the case without identifying or investigating the licensee. Because one could argue the legal weight of the 2005 memo, some New York legislators, groups and individual residents wanted to codify it, which was done by the 2014 legislation. The 2005 memo provided that, so long as a treatment modality effectively treats human disease, [etc.], it is contrary to the policy and practice of the Office of Professional Medical Conduct (OPMC) to identify, investigate or charge (emphasis added) a physician, PA, or specialist assistant based solely on that practitioner’s recommendation or provision of such a treatment modality.

The bill signed into law in Dec. 2014, modified the language on the memo, but seemed to largely preserve the provisions and the intent of the memo. The language as cited above, “based solely on” and “a treatment modality that effectively treats human disease,” provided the board for professional misconduct and the OPMC a great deal of flexibility and latitude to conduct investigations or initiate investigations.

Proposed Amendment: The newest amendment language agreed to by the NY Governor and legislature behind the scenes and now awaiting action, largely guts the 2005 memo and the Dec. 2014 bill signed into law of their practitioner protections. In our opinion, not only does the 2015 proposed amendment not strengthen health care practitioner protections, it makes it easier to go after licensed practitioners – requiring initiation of an investigation no matter the source or the basis of a complaint and mandating that the investigation include a review of clinical practices.

Sec. 230 of the existing Public Health Law (codified) paragraph 10.(a)(i) [Scroll to page 6 of Public Health Law here] says that the board and the OPMC may investigate on its own any suspected professional misconduct, and shall investigate each complaint received regardless of the source. Paragraph 10(a)(i) is being modified by the proposed amendment to add language: “By the conclusion of a preliminary review, including an internal clinical review (emphasis added), the Director shall determine if a report is based solely on the upon the recommendation or provision of a treatment modality by a licensee that is not universally accepted by the medical profession, including but not limited to varying modalities used in the treatment of Lyme disease or other TBD. Upon a determination that a report is based solely upon the provisions of a treatment modality that is not universally accepted, no further review shall be conducted and no charges shall be brought. Nothing in this section shall preclude the Director from making such a determination earlier in, or subsequent to, a preliminary review.”

The new amendment provides that only after the conclusion of a “preliminary review, including an internal clinical review” will the Director make a determination on the merits of a complaint/report. Proponents of the new amendment language say that it is only a “preliminary investigation.” However, a search for a definition of a preliminary investigation in NYS law that would cover the Public Health Law has not been unearthed by LDA. The new language says that the preliminary investigation will (NOT MAY) include an “internal clinical review.” Not only will a practitioner be identified and an investigation launched, but every review shall include at least some type of “internal clinical review.” So how “preliminary” is that?

We could not find a definition of “internal clinical review” in Sec. 230 of the Public Health Law,” but paragraph 10.(a)(ii) [Scroll to page 7 of Public Health Law here] does say, “If the investigation of cases referred to an investigation committee involves issues of clinical practice, medical experts shall be consulted.” Since the “preliminary review” is mandated by new language to include issues of clinical practice, it may mean that medical experts are mandated to be brought into the investigation no matter the merits of the complaint/report, i.e., in all cases. LDA does not think that saying “internal” clinical review precludes the use of “medical experts.” In addition, to say that the Director may make a determination “earlier in, or subsequent to, a preliminary review” does not seem to provide meaningful relief, since the phrase “earlier in” has no meaning in that “preliminary review” has no definition or limits and “subsequent to” just means after the review has been conducted.

Other language added by the proposed amendment is problematic. New amendment language also modifies the underlying law by adding the language “for which the licensee is treating a patient” after “recommends or provides a treatment modality that effectively treats human disease, pain, injury, deformity or physical condition.” This opens wide the door to arguing that longer-term antibiotic treatment is not effective in treating Lyme, as opposed to the existing language specifying that the treatment modality (i.e., longer-term use of antibiotics) be effective at treating human disease. Also – in the same sentence, the new language “to a particular patient” is added after “provision of that modality.” Addition of the new language “to a particular patient” facilitates making arguments that a “pattern” of providing a treatment modality to patients is misconduct or possible misconduct requiring further investigation.

One also needs to question whether the signing into law of a bill in Dec. 2014 on the condition of amending it in the New Year was a tactic to generate a sense of complacency in those who wanted real doctor protection. If this language had been offered last year, it likely would have been soundly rejected, but as an agreed upon amendment to an already passed bill, who knows if it can even be stopped.