Life Science Compliance Update

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September 16, 2013

Massachusetts Legislature: Bi-Annual Hearing on Restricting Physician Interactions with Industry and Promoting Academic Detailing

At the beginning of each legislative session in Massachusetts a flurry of anti-pharma, bio and device bills are filed by various legislators. Bills can range from forcing doctors to eat only when the speaker is talking to banning marketing and advertising of medical products all together. There can be a legislative competition for whose bill will be the most restrictive. Also, each session in the fall of the first year of the two year legislative session, a hearing is held to listen to all these bills simultaneously.

According to Massachusetts insiders the portion of the hearing devoted to restrictions on pharmaceutical and device companies starts out with speaker after speaker describing the "evils" of manufacture sales and marketing and extolling the virtues of government academic detailing. Then they are brought back to reality that one of Massachusetts main employers are these same manufactures that they are pummeling. These hearings allow the legislators to voice their aggressions out on manufactures in one session.

This year is no exception, a total of 10 bills of which two were duplicates (house and senate versions) were filed in early January. Many of the bills filed were similar or identical bills to ones introduced in 2012. A joint committee hearing for the Massachusetts Committee on Health is scheduled for Tuesday October 1, 2013 at 10:00 AM in A-1 in the Massachusetts State Capitol Building to discuss these bills.

Below is a summary of the bills:

Bill S.1051 "An Act to prevent undue influence on prescriber behavior"

Sponsors: Mark C. Montigny

Hearing Scheduled for 10/1/2013 at 10:00 AM in A-1

Bill H.2018 "An Act to define modest meals and refreshments in prescriber educational settings"

Sponsors: Jason M. Lewis

These bills adds the following text before the definition of "Person" in Section 1o f chapter 111N of the General Laws: "Modest Meals and Refreshments," food and/or drinks provided by or paid for by a pharmaceutical or medical device manufacturing company or agent to a health care practitioner, the cost of which does not exceed the allowance defined by the U.S. General Services Administration for the Massachusetts per diem localities. The allowable amounts for modest meals and refreshments shall be updated on an annual basis in accordance with the U.S. General Services Administration meal allowance rates.

In addition, presentations "that occur in a manner conducive to informational communication" shall prohibit the provision of and pharmaceutical or medical device manufacturing company payment for any form of alcoholic beverage.

Meals and refreshments shall be provided within the context of the informational presentation, and shall not occur prior to or following the educational presentation. The presentations shall not occur in locations that are otherwise recreational in nature, including, but not limited to, resorts, sporting clubs, casinos or other vacation destinations.

The Bill also amends Section 2A of chapter 111N by inserting, after clause

(3), adding the following requirements relating to the tracking of expenditures:

(4) total amount spent on meals

(5) for such presentation; total amount spent on the venue for such presentation; (6) a description of the content of such presentation;

(7) total number of prescriber attendees at such presentation;

(8) names of attendees present at such presentation;

(9) names and credentials of presenters at such presentation;

(10) and total amount spent on other items of economic value provided at such presentation.

The department of public health shall collect receipts for all required reporting expenditures.

Analysis: This bill proposes to ban all venues for physicians with the word resort or casino in it. I recently attended a medical meeting in Las Vegas, the room costs were less than $100/night, the total cost of the venue was significantly cheaper than non-casino hotels, the same holds true for "resorts" in off season" many ski "resorts" make for great meeting venues at a reduced price.

The Massachusetts legislators may have to be reminded that many of them and their colleagues participate in meetings and retreats in "resorts," "casinos," "sporting clubs", or "other vacation destinations"

Also, they may want to remind themselves there is a significant "resort" business in Massachusetts on Cape Cod.

The bill also proposes a draconian tracking system for FDA mandated education, including who presented, a description of the content, the total amount spent on presentations. The legislators should consider being more transparent in their motives and just simply push for a ban of such presentations which is their ultimate goal, rather than just making these events so difficult that they discontinue.

Bill S.1052 "An Act to restore integrity in the marketing of pharmaceutical products and medical devices"

Sponsors: Mark C. Montigny

Hearing Scheduled for 10/1/2013 at 10:00 AM in A-1

This Bill establishes that a pharmaceutical or medical device manufacturer agent shall not knowingly and willfully offer or give to a health care practitioner, a member of a health care practitioner's immediate family, a health care practitioner's employee or agent, a health care facility or employee or agent of a health care facility, a gift of any value. However, it does not prohibit the provision, distribution, dissemination, or receipt of peer reviewed academic, scientific or clinical information. It also does not prohibit the purchase of advertising in peer reviewed academic, scientific or clinical journals.

By July first of each year, every pharmaceutical or medical device manufacturing company shall disclose to the department of public health the value, nature, purpose, and recipient of any fee, payment, subsidy, or other economic benefit not prohibited by this Bill, which is provided by the company, directly or through its agents, to any physician, hospital, nursing home, pharmacist, health benefit plan administrator, health care practitioner or any other person in this state authorized to prescribe, dispense, or purchase prescription drugs or medical devices in this state. A person who violates any requirements in this Bill will be punished by a fine of not more than $5,000 for each transaction, occurrence or event is in violation.

Furthermore, the department of public health shall make all disclosed data publicly available and easily searchable on its website. Also, the department of public health will consult the board of registration of pharmacy and board of registration of medicine to promulgate regulations requiring the licensing of all pharmaceutical and medical device manufacturer agents.

Analysis: Through the Massachusetts Pharmaceutical and Medical Device Manufacturer Code of Conduct the commonwealth already collect information related to payments to healthcare providers, in addition with the implementation of the physician payment sunshine act this information is already collected.

As far as banning gifts, Massachusetts passed in 2009 a ban on "gifts" and the PhRMA and AdvaMed Codes prohibiting gifts have been in place for over 4 1/2 years. The Senator should ask a physician is he or she has seen any "gifts" from pharmaceutical companies in the last five years. 

Bill H.2020 "An Act to reduce healthcare costs by promoting non-biased prescriber education"

Sponsors: Jason M. Lewis

Bill S.1050 "An Act to reduce health care costs by promoting evidence-based prescriber education"

Sponsors: Mark C. Montigny

Hearing Scheduled for 10/1/2013 at 10:00 AM in A-1

This Bill calls for the development, implementation and promotion of an evidence-based outreach and education program about the therapeutic and cost-effective utilization of prescription drugs for physicians, pharmacists and other health care professionals authorized to prescribe and dispense prescription drugs. In developing the program, the department shall consult with physicians, pharmacists, private insurers, hospitals, pharmacy benefit managers, and the MassHealth drug utilization review board.

Analysis: This is an academic detailing bill, where the government has "sales representatives" to discuss the virtues of inexpensive, less effective, generic drugs and cheaper devices.

Bill H.2061 "An Act prohibiting advertising by pharmaceutical companies"

Sponsors: Kathi-Anne Reinstein

Hearing Scheduled for 10/1/2013 at 10:00 AM in A-1

This Bill states that no pharmaceutical company shall advertise on any media in the commonwealth or by any other means.

Analysis: This is by far the most efficient form of restrictions – just ban anyone from knowing anything. This legislator deserves an award for honesty.

Bill S.1032 "An Act relative to the in-office sales of medical devices and products"

Sponsors: John F. Keenan

Hearing Scheduled for 10/1/2013 at 10:00 AM in A-1

The Bill is designed to regulate certain aspects of the practice of in-office sales of medical devices or products. Any health care practitioner engaging in the in-office sale of medical devices or products must observe the following conditions. In-office sales not in compliance with all of the conditions listed in this section shall be prohibited, and subject to the penalties. The conditions:

(1) The health care practitioner must disclose to the patient any profit gained or financial interest held by the health care practitioner, or any immediate family member, in the sale of the medical device or product, or any professional or other relationship between the health care practitioner and the manufacturer or marketer of the medical device or product;

(2) The health care practitioner must advise the patient as the availability of the medical device or product, or any reasonable equivalents, for purchase at a retail pharmacy or other commercial retail source, and as to the market price of said devices or products or equivalents if purchased at another source;

(3) The medical device or product sold must provide a reasonable potential for therapeutic and medical gain specific to the patient's medical condition or complaint; 

(4) The health care practitioner must have available, and upon request must provide to the patient, easily understandable literature or an explanation of the device's or product's medical or therapeutic benefits, and any risks associated with the device or product, and the scientific evidence upon which any claims of said benefits or risks are based;

(5) The office in which in-office sales occur must have notice prominently posted, or must otherwise reasonably communicate to the patient, that the patient is under no obligation to purchase the medical device or product in the office; provided further that such notice or communication shall also include an explanation to the patient of how to contact the board if the patient feels the in-office sale or discussion promoting said sale creates undue pressure on the patient to purchase a medical device or product, or otherwise violates the standards for professional conduct applicable to the health care practitioner.

(6) Any other conditions deemed appropriate and as may be established in regulation by the board under which the health care practitioner primarily involved in the execution of the in-office sale is registered or licensed.

Analysis: One cannot imagine physicians in the commonwealth of Massachusetts having the time to devote to all the types of disclosure discussed in this bill. If you think about it, a doctor only has so many hours in the day to see patients, and occasionally he or she would like to see their family or significant other. Also, having recently bought a device at a medical office, it seemed significantly more efficient than trying to track down that device somewhere else.

Bill H.1962 "An Act relative to the substitution of generic drugs"

Sponsors: William C. Galvin

Hearing Scheduled for 10/1/2013 at 10:00 AM in A-1

This Bill regulates prescriptions dispensed in a hospital licensed under section 51 of chapter 111 and prescriptions dispensed by a hospitalist or doctor. It provides that no hospital, hospitalist or doctor shall change a drug prescribed by the primary care physician of the patient without consent of the patient and his or her primary care physician; and provided further that all outpatient prescriptions dispensed in a hospital shall be on prescription forms as required by this section and that no retail pharmacy, however organized, shall be exempted from the provisions of this section.

Discussion: Though the goal of this bill not to switch medications at the hospital has good intentions, hospitals and their staff need to have the flexibility to treat the patient with the medication on hand at the facility. Also, as a patient moves through the system they may need different medications.

Additional bills

The following two bills are not subject to the hearing, but introduced in the legislature.

Bill S.543 "An Act to ensure the privacy of patient prescription records"

Sponsors: Richard T. Moore

This Bill requires pharmacists licensed in the Commonwealth, and pharmacies operating in the Commonwealth, and all other persons who control, own, license, use or share pharmacy records shall protect the privacy and confidentiality of provider-identifiable prescription information as if such information constituted "protected health information" within the meaning of the federal Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule (45 CFR Parts 160 & 164). Each violation of this provision shall carry a fine of $1,000 per affected record. Suit to enforce this provision may be brought by the Attorney General or by any affected patient or provider. This provision is a state expansion of medical privacy rights, as permitted by Section 264(c)(2) of HIPAA (Public Law 104-191).

Bill H.1978 "Resolve relative to responsible prescription prescribing"

Sponsors: Thomas A. Golden, Jr.

This Bill establishes a special commission to investigate responsible prescription practices in Massachusetts.

The commission shall consist of 3 members of the house of representatives, 1 of whom shall be appointed by the minority leader of the house of representatives;

3 members of the senate, 1 of whom shall be appointed by the minority leader of the Senate;

1 representative from the executive office for administration and finance; the commissioner of public health drug control program or the commissioner's designee; the director of the prescription monitoring program or the director's designee; and

3 members appointed by the governor that represent the medical and pharmaceutical community with specialty experience in drug regulation, prescription, treatment and abuse.

The commission's investigation, shall include, but not be limited to best practices for responsible prescription. The commission shall submit a report of its findings, including legislative recommendations, if any, to the joint committee on public health and the house and senate committees on ways and means by April 15, 2014.

Conclusion

Additional bills discussed at the hearing include bills for prostate cancer medication, prohibiting clinical laboratory self-referral, generic substitution, state and wide discounts for pharmaceuticals.

We will be follow these bills if they get past the initial hearing phase. Given the current jobs environment in Massachusetts the chances of these bills going anywhere seems highly unlikely.

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