[authors: Tom Crane and Brian Dunphy]
On September 19th, the Massachusetts Department of Public Health (“DPH”) published emergency amendments to its regulations, 105 CMR 970.000 et seq. (“Proposed Regulations”), designed to implement recent changes to the Massachusetts Pharmaceutical and Medical Device Manufacturer Code of Conduct, M.G.L. c. 111N (the “Gift Ban Law”). The amendments to the Gift Ban Law were discussed in more detail in a previous post. Although the Gift Ban Law’s strict prohibitions on payments and other transfers of value to health care practitioners (“HCPs”) remain largely intact, the Gift Ban Law now permits pharmaceutical and medical device manufacturers covered by the Gift Ban Law (“Manufacturers”) to:
provide “modest meals and refreshments” (as defined by DPH) for educational presentations that are designed to educate HCPs about the benefits, risks, and appropriate uses of prescription drugs or medical devices, disease states, or other scientific information, but such meals must be reported to DPH if they are not for CME; and
continue to pay reasonable expenses necessary for technical training on the use of a medical device, but without the need for a vendor purchase contract.
In addition, Manufacturers no longer must disclose certain information to DPH if they have made disclosures required by the federal Physician Payments Sunshine Act (“Sunshine Act”). The effective date of the Proposed Regulations is September 19, 2012, but DPH will hold a public hearing on October 19, 2012, and will accept testimony until October 26, 2012, as described below.
Modest Meals and Refreshments
Before the amendments to the Gift Ban Law, Manufacturers were generally only permitted to provide modest meals in a HCP’s office or a hospital setting. Now, the Gift Ban Law allows Manufacturers to “provide or provide payment for” modest meals and refreshments both inside and outside of the HCP’s office or a hospital setting.
In the HCP’s office or a hospital setting – meals must be provided in connection with “informational or educational meetings or presentations.” 105 CMR 970.006(2).
Outside of the HCP’s office or a hospital setting – meals may be provided for “the purpose of educating and informing health care practitioners about the benefits, risks and appropriate uses [defined to exclude promotion of 'off-label' uses] of prescription drugs or medical devices, disease states or other scientific information.” These presentations must occur “in a venue and manner conducive to informational communication.” 105 CMR 970.006(3).
Modest meals are defined somewhat broadly, and without any specific cost limitations, as: “food and/or drinks provided by or paid for by” a Manufacturer to a HCP that, “as judged by local standards, are similar to what a health care practitioner might purchase when dining at his or her own expense.” 105 CMR 970.004.
Reporting Certain Modest Meals and Refreshments to DPH
Although the Gift Ban Law has softened the limitations on providing meals, non-CME related meals must be reported. The Proposed Regulations allow meals or refreshments, which are otherwise permitted under 105 CMR 970.006(3), to be provided in connection with “non-CME educational presentations” if they are reported to DPH on a quarterly basis. DPH proposes that these quarterly reports detail all non-CME educational presentations at which meals or refreshments were provided. The reports must include the following information:
the location of the non-CME presentation;
a description of any pharmaceutical products, medical devices, or other products discussed at such presentation;
the total amount expended on the presentation; and
an estimate of the amount expended per participant, factoring any meals, refreshments or other items of economic value provided at such presentation.
105 CMR 970.006(4).
Technical Training on the Use of a Medical Device
The amendments to the Gift Ban Law also removed a limitation whereby Manufacturers could pay an HCP for reasonable expenses necessary for technical training on the use of a medical device only where the parties had a written purchase contract. The Proposed Regulations implement this amendment by striking the limitation from 105 CMR 970.008(2)(b) (“[n]othing in 105 CMR 970.000 shall prohibit the following: . . . Payment or reimbursement for the reasonable expenses, including travel and lodging related expenses necessary for technical training of health care practitioners on the use of a medical device.”).
Annual Reports to DPH/ Sunshine Act Reports
The Gift Ban Law requires Manufacturers to annually report any fee, payment, subsidy, or other economic benefit to a HCP with a value of at least $50 (“MA Disclosures”), but Manufacturers will be required to report similar information to the Secretary of the Department of Health and Human Services under the Sunshine Act (which expressly preempts any state or local laws requiring reporting of payments or other transfers of value reported under the Sunshine Act). The amendments to the Gift Ban Law prohibit DPH from requiring Manufacturers to disclose to DHP information reported under the federal Sunshine Act. Although data collection must begin on January 1, 2013, the Centers for Medicare & Medicaid Services has not published final regulations implementing the Sunshine Act, so that start date is currently in question. After Manufacturers submit MA Disclosures covering calendar year 2012, the Proposed Regulations would no longer require Manufacturers to submit these disclosures to DPH. 105 CMR 970.009(1). DPH will also deem disclosures under the Sunshine Act to satisfy the reporting obligations under the Gift Ban Law. 105 CMR 970.009(6).
The Proposed Regulations would also require Manufacturers to report all incidents of non-compliance with 105 CMR 970.000 to the Department and to the Office of the Attorney General in a format specified by the Department. 105 CMR 970.005(5).
Hearing and Comment Period
DPH will conduct a hearing on the Proposed Regulations on October 19, 2012 at 10:00 a.m. Interested parties may also submit “testimony” electronically to Reg.Testimony@state.ma.us, or in writing to LouAnn Stanton, Office of the General Counsel, Department of Public Health, 250 Washington Street, Boston, MA 02108. All testimony must be submitted by 5:00 p.m. on October 26, 2012.