Massachusetts PMP Registry data re: Vimpat/lacosamide

To Whom It May Concern:

Pursuant to the Massachusetts Public Records Law, I hereby request the following records:

All prescription and dispensation data submitted to the Prescription Monitoring Program (PMP) for Vimpat (lacosamide), a Schedule V drug.

I also request that, if appropriate, fees be waived as we believe this request is in the public interest, as suggested but not stipulated by the recommendations of the Massachusetts Supervisor of Public Records. The requested documents will be made available to the general public free of charge as part of the public information service at MuckRock.com, processed by a representative of the news media/press and is made in the process of news gathering and not for commercial usage.

I expect the request to be filled in an accessible format, including for screen readers, which provide text-to-speech for persons unable to read print. Files that are not accessible to screen readers include, for example, .pdf image files as well as physical documents.

In the event that there are fees, I would be grateful if you would inform me of the total charges in advance of fulfilling my request. I would prefer the request filled electronically, by e-mail attachment if available or CD-ROM if not.

Thank you in advance for your anticipated cooperation in this matter. I look forward to receiving your response to this request within 10 business days, as the statute requires.

Sincerely,

Shawn Musgrave

Hello Charlena,

Thank you for your response. I am not interested in data that would identify individuals, prescribing doctors, or facilitites, which is at the heart of the cited exceptions. Is your office able to provide aggregate data that indicates how many Vimpat prescriptions have been issued by year? I am speaking with other state PMP agencies about providing the same de-identified data. The Texas Pharmacy Board, for example, has already provided me de-identified data on Vimpat prescriptions.

Thank you for your response!

Best,
Shawn

To Whom It May Concern:

I hereby the denial of this request for aggregate data from the Prescription Monitoring Program (PMP) regarding Vimpat (lacosamide), a Schedule V drug.

In denying my request, the Department of Public Health (DPH) interpreted both my request and the statutory exemptions to the public records law broadly rather than narrowly, as required under Massachusetts law. See, e.g., Attorney Gen. v. Assistant Comm’r of the Real Property Dep’t of Boston, 380 Mass. 623, 625 (1980) (the statutory exemptions are to be strictly and narrowly construed).

As I clarified to DPH, my request seeks aggregate data regarding Vimpat. This request does not seek data that would identify individuals, prescribing doctors, or facilities, which is at the heart of the cited exceptions. The agency failed to construe all exemptions narrowly as required.

Further, DPH ignored a crucial carveout from the PMP exemption codified in M.G.L. 94C §24A(d): M.G.L. 94C §24A(h) specifically allows DPH to "provide de-identified information to a public or private entity for statistical research or educational purposes."

My request for de-identified PMP statistical data about Vimpat clearly falls within this carveout from the PMP exemption. As I explained to DPH, I am researching Vimpat prescriptions in several states. My request furthers my purpose of educating the public and policymakers in Washington, DC, about the erroneous inclusion on the DEA's schedule of controlled substances. DPH seemingly failed even to consider this carveout, and so failed again to abide by its obligations under the statute. And given the statutory obligation to apply exemptions narrowly in favor of the presumption of access to records, I have satisfied any burden on me as the requester to indicate that I qualify under this carveout to the PMP exemption.

As such, the Supervisor should remand this request to DPH and direct that the de-identified data be released.

Respectfully,
Shawn

Dear Helen,

To preserve my appeal rights, I've submitted an appeal to the Supervisor of Records regarding this denial. However, I wanted to draw your attention to a crucial carveout from the PMP exemption you've cited, which is codified in M.G.L. 94C §24A(h): DPH may "provide de-identified information to a public or private entity for statistical research or educational purposes."

As I wrote to the Supervisor, my request for de-identified PMP statistical data about Vimpat clearly falls within this carveout from the PMP exemption. As I previously explained in our correspondence, I am researching Vimpat prescriptions in several states. My request furthers my purpose of educating the public and policymakers in Washington, DC, about the erroneous inclusion of Vimpat on the DEA's schedule of controlled substances. Given the statutory obligation for agencies to apply exemptions narrowly in favor of the presumption of access to records, I have satisfied any burden on me as the requester to indicate that I qualify under this carveout to the PMP exemption.

I am happy to withdraw my appeal to the Supervisor if you confirm that I qualify for the carveout under M.G.L. 94C §24A(h) and agree to provide the de-identified data I have requested.

Best,
Shawn

Hello all,

Many thanks to the Supervisor of Records for its vigilant oversight of my appeal.

For the reasons stated in my appeal -- which I also reiterated to DPH immediately following submission of my appeal -- I fully expect that my request for deidentified data will be fulfilled in a timely manner. If it is not, I fully intend to re-file this appeal and even to litigate if necessary to obtain this data, which is clearly subject to disclosure.

Respectfully,
Shawn

On Thu, Dec 23, 2021, 10:35 AM Plante, Emma (SEC) <emma.plante@state.ma.us> wrote:

Hello,

Please be aware, the Supervisor of Records has issued a determination relating to an appeal in which you were involved. This determination is attached, and available online at: http://www.sec.state.ma.us/AppealsWeb/AppealsStatus.aspx.

If you have any questions, please contact the Public Records Division at 617-727-2832 or pre@sec.state.ma.us.

Thank you,

Emma Plante

Office of the Secretary of the Commonwealth

Public Records Division

One Ashburton Place, Room 1719

Boston, MA 02108

(617) 727-2832 (office)

(617) 727-5914 (fax)

http://www.sec.state.ma.us/pre/preidx.htm

A Guide to Public Records Law: https://www.sec.state.ma.us/pre/prepdf/guide.pdf

Review appeal determinations online: http://www.sec.state.ma.us/appealsweb/appealsstatus.aspx

To Whom It May Concern:

For a second time, I appeal an unsupported denial by the Department of Public Health ("DPH") of my request under the Massachusetts Public Records Law for de-identified data from the Prescription Monitoring Program ("PMP"). DPH assigned this request tracking number BHPL 2021-603, and SPR assigned my first appeal tracking number SPR21/3209.

Once again, despite my numerous efforts, DPH has rejected my request without acknowledging — much less attempting to address — a statutory provision that requires the department to release the requested data. As such, I request that the Supervisor review not only DPH's incorrect determination but also DPH's procedures for reviewing and fulfilling public records requests. If DPH has engaged in this ridiculous behavior in responding to an experienced requestor such as myself — an attorney and reporter with extensive knowledge of Massachusetts public records law — I worry about how DPH responds to less experienced requestors.

Given that this is my second appeal regarding the same request, I will keep this relatively short, since I have already made all of the substantive arguments in my first appeal (see attached). I incorporate by reference all of the arguments made in that prior appeal.

Following submission of my initial appeal, SPR indicated as follows (see attached): "Based upon a conversation between a Public Records Division staff attorney and a Department representative, it is my understanding that the Department intends on providing a subsequent response to Mr. Musgrave."

As directed, DPH did issue a subsequent response, but again failed to meet its burden. On January 10, 2022, DPH issued a near-identical rejection of my request (see attached). In relevant part, DPH argued, "Even in aggregate form, the data you seek is exempt under public records law." As before, DPH cited M.G.L. 94C §24A(d), which exempts “[p]rescription information submitted to the department” via the PMP. However, once again DPH failed to address my argument that this request for de-identified data (i.e., "aggregate data") is not subject to its cited exemption. In fact, as I previously argued in my initial appeal, in the same section of the M.G.L., the Massachusetts legislature explicitly codified my right to obtain this data. Under M.G.L. 94C §24A(h), "The department may provide de-identified information to a public or private entity for statistical research or educational purposes." This is precisely what I have requested ("de-identified information") and for exactly the specified purpose ("statistical research"). DPH did not address this argument whatsoever in its subsequent response. The Department cannot continue to flout the Massachusetts legislature's explicit directions by repeating its own incomplete arguments and ignoring my own.

As an attorney and experienced journalist, I tend not to file frivolous records requests, much less fight denials that seem to square with the law. Here, the Department's failure to produce any authority to support that my request falls outside the M.G.L. 94C §24A(h) carveout strongly suggests (1) that no such authority exists and (2) that the Department has no viable legal grounds to deny my request. Rather, this is one of the clearer instances where a request lines up with a particular situation which the anticipated and provided crystal clear instructions: Where a requestor asks for de-identified data from the PMP for statistical research purposes, DPH must produce it. The data I have requested much be released.

Finally, given DPH's inexcusable behavior, I ask that the Supervisor exercise whatever authority it has to review the Department's procedures for processing records requests, or else refer this structural matter to whatever state body has this review power. As mentioned above, if DPH has acted as it has here when faced with such a clear request and dogged insistence on compliance from an experienced requestor, I worry about its statutory compliance on receiving more borderline requests submitted by novices. DPH has wasted too of my time, the Supervisor's time, and its own staffers' time, which leads me to wonder whether it has denied other requestors documents they had every right to receive and on specious legal grounds. I urge the Supervisor to hold DPH to its obligations, not just to fulfill this request but to follow the law.

Respectfully,
Shawn Musgrave

Hello,

Per the Supervisor of Record's determination dated Jan. 26, 2022 (available online here: https://cdn.muckrock.com/foia_files/2022/02/07/spr220059.pdf and also sent to you by email on the same date), the Department of Health is obligated to provide another substantive determination to this request within 10 business days. I believe today is the deadline.

I look forward to receiving the requested data today.

Best,
Shawn

Hello,

I did not receive the response yesterday. Please let me know if you intend to comply with the Supervisor's determination and the legal deadline it triggered.

Respectfully,
Shawn

Dear Ms. Rush-Lloyd,

The DPH's belated response to my request is once again plainly inadequate under both the Massachusetts Public Records Law and the explicit terms of the Supervisor of Records determination dated January 26, 2022. Contrary to the Supervisor's orders, you have sent a virtually identical denial for a third time without any additional legal justification.

The Supervisor of Records ordered DPH to provide a legally sufficient response to my request on the following basis: "I find that the Department’s response does not explain how de-identified data may be withheld pursuant to G.L. 94C, § 24A(h). As a result, the Department has not sufficiently explained how the records are exempt from disclosure in their entirety pursuant to Exemption (a)." That is, DPH was explicitly ordered to address the relationship between G.L. 94C, § 24A(d) and G.L. 94C, § 24A(h), which plainly allows DPH to released de-identified data for statistical purposes (and is thus a carveout to G.L. 94C, § 24A(d)).

Unfortunately, in your latest denial letter, the only references to G.L. 94C, § 24A(h) are (1) a lengthy quote from one of my own communications to the Supervisor; and (2) a verbatim recitation of G.L. 94C, § 24A(h) accompanied by a website link to a data request form. Once again, DPH has made no attempt to explain its legal justification for withholding de-identified data, in defiance of direct instructions from the Supervisor of Records and your obligations under the Public Records Law.

This is unacceptable behavior from a government agency, and I will be appealing to the Supervisor for a third time. Please let me know if DPH intends to provide an actual response with actual legal arguments, in which case I will hold off on submitting my appeal in the interest of ending this ridiculous cycle. Otherwise I will send submit my appeal at the end of business on Friday, February 11.

Regards,
Shawn

Dear Supervisor of Public Records Murray,

Unfortunately, here we are yet again. This is the third appeal I have filed with your office regarding the same request to the Department of Public Health. And this is the second appeal I have filed over the Department's unlawful refusal to comply with clear orders from your office to provide legally sufficient justification for denying my request. In the latest iteration, the Department even missed its deadline as ordered by your office, only to issue a near-identical denial without any additional legal analysis.

Given the Department's repeated defiance of its legal obligations, the Supervisor should not grant them any more chances to make the legal case they should have made months ago. Rather, it is time for your office to conduct your own legal analysis, order the records released, and refer the Department to the Attorney General for noncompliance with two separate orders, pursuant to G. L. c. 66, § 10A(b).

Since this is my third appeal, I will try not to belabor familiar facts. But to summarize: I filed this request for data from the Prescription Monitoring Program (PMP) regarding Vimpat on September 10, 2021. The Department first denied my request on September 27, 2021, pursuant to G.L. 94C, § 24A(d). In subsequent communications I made clear that I was not seeking the patient-specific confidential information protected by G.L. 94C, § 24A(d), but only de-identified data, which is permitted under the statutory carveout in G.L. 94C, § 24A(h). The Department refused to explain its legal basis for withholding de-identified data.

I filed my first appeal in December (SPR21/3209), and on December 23, 2021, the Supervisor issued a determination: "Based upon a conversation between a Public Records Division staff attorney and a Department representative, it is my understanding that the Department intends on providing a subsequent response to Mr. Musgrave. Accordingly, the Department is ordered to provide Mr. Musgrave with a response to his request in a manner consistent with the Public Records Law and its Regulations within ten business days."

On January 10, 2022, the Department sent its second denial (attached), which did not address G.L. 94C, § 24A(h) at all. I appealed for a second time on January 11, 2022 (SPR22/0059) on this basis. On January 26, 2022, the Supervisor issued a determination that found the Department's second denial was legally insufficient: "I find that the Department’s response does not explain how de-identified data may be withheld pursuant to G.L. 94C, § 24A(h). As a result, the Department has not sufficiently explained how the records are exempt from disclosure in their entirety pursuant to Exemption (a)." The Supervisor ordered the Department to provide me a sufficient response within ten business days.

On February 9, 2022, the day its response was due, the Department failed to send such a response. Rather, a records officer indicated, "The Response to your appeal is being reviewed and we hope to have it to you by the end of the day."

The next day, on February 10, 2022, the Department issued its third plainly inadequate denial (attached). As I immediately pointed out in an emailed reply, despite the Supervisor's explicit orders to do so, the Department did not supplement the substance of its legal justification whatsoever to address G.L. 94C, § 24A(h). In fact, the only references to G.L. 94C, § 24A(h) to be found in the Department's belated third denial were (1) a lengthy quote from my own prior communications to the Supervisor; and (2) a recitation of G.L. 94C, § 24A(h) accompanied by a website link to a data request form. For the third time, then, DPH made no attempt to explain its legal justification for withholding de-identified PMP data, in defiance of direct instructions from the Supervisor of Records and its obligations under the Public Records Law.

In hopes of ending this ridiculous appeal-deny-appeal-deny cycle, I offered to delay filing this third appeal if the Department intended to muster any good faith legal arguments. The Department did not respond, and it is thus seems it still has no such arguments to offer.

So I have no choice but to appeal yet again. On this third loop, I hope the Supervisor will not reward the Department by giving it yet another chance. If, however, the Supervisor finds it must ask the Department to make some semblance of a legal case, I again assert that I should have the opportunity to rebut it. Further, I ask the Supervisor to consider referring the Department to the Attorney General, pursuant to G. L. c. 66, § 10A(b), since the Department has defied two orders to provide a legally sufficient response. State agencies entrusted to safeguard public records should not be able to ignore the Supervisor's orders so flagrantly as the Department has in this case.

Respectfully,
Shawn Musgrave