The Massachusetts legislature has targeted July 1, 2017 as the date by which it will have legislation on Governor Charlie Baker’s desk regarding the commercial cultivation, processing, and sale of non-medicinal cannabis products for adult use. On June 23rd, the House and Senate each appointed members to a 6-member conference committee that is tasked with resolving the differences between the (renumbered) House and Senate bills, H.3776 and S.2097. There are a number of differences to be addressed, including taxation, enforcement, and the ability of communities to limit or prohibit the establishment of cannabis businesses, even when a community has allowed a registered medical marijuana dispensary. ML Strategies has issued a Client Alert summarizing the progress of this issue from passage of the November 16, 2016 ballot question establishing “recreational” production and sale of cannabis products, through this most recent legislative activity. Stay tuned for further coverage.
Recognizing the importance of telemedicine, a committee of the Massachusetts Health Policy Commission recently voted on a grant program that will award up to $500,000 each for two telemedicine pilots that target the behavioral health needs of children, homebound seniors, and people with substance use disorders. The two grants will be awarded with monies from a 2016 budget provision that authorized a one-year, regional pilot program “to further the development and utilization of telemedicine in the commonwealth.” The Commission expects to release a request for proposals in February and announce the awards in the spring.
Massachusetts joins other states in taking needed steps to expand the use of telemedicine. Last year was an important year for the expansion of Medicaid and private insurance coverage of telemedicine services with many states passing laws to ensure that telemedicine visits would be covered and paid for similar to office based visits. We expect this to be one of many trends that continue into 2016, as telemedicine continues to grow, highlighted in our recent post “Telemedicine – 2015 Year in Review.”
Last week, the Massachusetts’ Secretary of Health and Human Services, John Polanowicz, announced the launch of a new $5 million program designed to detect and prevent provider fraud, waste, and abuse in MassHealth, the Commonwealth’s Medicaid program. Under the MassHealth anti-fraud program, the Medicaid agency will freeze payments to health care providers with suspicious Medicaid claims pending further investigation by state agencies. This state-based program mirrors the Centers for Medicare & Medicaid Services’ use of payment suspensions at the federal level under the authority of Section 6402(h) of the Patient Protection and Affordable Care Act (“ACA”). In fact, the federal government is providing a majority of the funding for the MassHealth anti-fraud program. Continue Reading Massachusetts Launches New Program to Combat Provider Fraud
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. Continue Reading Massachusetts DPH Proposes Amendments to Regulations to Implement Gift Ban Law Changes
On July 8, 2012, Massachusetts Governor Deval Patrick signed into law amendments to the Massachusetts Pharmaceutical and Medical Device Manufacturer Code of Conduct, frequently referred to as the “gift ban law.” The amendments softened the strict gift ban law in several ways.
First, pharmaceutical and medical device manufacturers are now permitted to provide “modest meals and refreshments” (to be defined by the Massachusetts Department of Public Health (“DPH”) through regulations) in connection with educational presentations to educate health care practitioners about the benefits, risks, and appropriate uses of their products, or to provide scientific information.
However, manufacturers must file a quarterly report with DPH detailing all of the “non-CME educational presentations at which such meals or refreshments are provided.” The report must include:
- The location of the non-CME presentation;
- A description of any pharmaceutical products, medical devices, or other products discussed during the presentation; and
- The total amount expended on the presentation, along with an estimate of the amount expended per participant (accounting for meals, refreshments, or other items of economic value provided).
Second, medical device manufacturers may pay for a health care practitioner’s “reasonable expenses” necessary for technical training on the use of a medical device. The gift ban law no longer requires the expense to be part of the vendor’s purchase contract for a device; meaning that the training may occur before a sales agreement has been made.
Third, the amendments prohibit DPH from requiring manufacturers to disclose information disclosed under federal law, including the Physician Payment Sunshine Act. DPH is, however, required to make the data that manufacturers will disclose under the Sunshine Act publicly available and searchable on its website.
While these amendments loosen the gift ban law to some degree, most of the restrictions and obligations imposed by the gift ban law remain unchanged. As a result, manufacturers must continue to carefully comply with the gift ban law.
My colleagues from ML Strategies, George Atanasov and Julie Cox, published a client alert discussing changes to the Massachusetts Pharmaceutical and Medical Device Manufacturer Code of Conduct. The text of the alert is included below:
The Massachusetts Legislature today voted 147-3 to pass the FY2013 budget conference report which includes sections that will alter key provisions of M.G.L. Chapter 111N, the state’s so-called Gift Ban Law. After weeks of deliberations, the six-member legislative conference committee filed the compromise budget last night. The final product addresses differences between the initial House and Senate budget proposals in which the House attempted to repeal entire sections of the Gift Ban Law and the Senate opted not to address the issue.
The compromise language amends Section 2 of the Gift Ban Law in several ways, including:
- Permitting the payment of reasonable expenses necessary for technical training on the use of a medical device without a requirement for a pre-existing vendor purchase contract
- Allowing for the payment of “modest meals and refreshments” for non-CME educational presentations that are designed to educate health care practitioners about the benefits, risks and appropriate uses of prescription drugs or medical devices
- Charging the Department of Public Health (DPH) with the responsibility to promulgate regulations that define “modest meals and refreshments” and
- Relieving pharmaceutical and medical device companies from disclosing certain information to the DPH where the companies have already done so pursuant to federal law
The new provisions would take effect upon Governor Deval Patrick’s signature.