Life Science Compliance Update

July 21, 2017

The California Hurdle - SB 790 and Pharma

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Seven states and the District of Columbia currently have regulations that limit or ban industry gifts to physicians, and it seems as though others are following suit. The California state Senate passed SB 790 in May 2017, a bill restricting pharmaceutical companies from giving gifts and incentives to medical professionals. This article reviews the changes SB 790 calls for, and what compliance professionals should keep an eye on.

The California Senate passed a bill (“SB 790”) in May 2017 that, if enacted, will change how pharmaceutical companies interact with health care professionals (“HCPs”). While standards and requirements for transfers of value are not new to pharmaceutical companies, SB 790 introduces new concepts for California, including:

• new standards for ‘allowable expenditures,’ which includes limitations on sponsorship of conferences or seminars that are educational, policy making, medical, or scientific;

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July 10, 2017

The Ohio “Drug Price Relief Act” Has Some Enemies

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In November 2017, the state of Ohio will have a proposed statute included on the ballot for voters to approve, known as the “Ohio Drug Price Relief Act.” The proposal was written by California activist Michael Weinstein, the same author of California’s “Proposition 61,” which was not only defeated (53% to 47%) in the 2016 election season, but was also opposed by every major newspaper in the state.

The Ohio proposition would prohibit Ohio from paying more for prescription drugs than the lowest price paid by the United States Department of Veterans Affairs. It would also give the four co-sponsors of the ballot issue an unprecedented right to intervene – at taxpayer expense – in any post-election legal challenge that may be filed against the initiative or its implementation.

It is expected that this ballot issue will likely gain its fair share of enemies, the way California’s similar proposition did. So far, there is one seemingly well put together group, Ohioans Against the Deceptive Rx Ballot Issue. The coalition is made up of associations of doctors, nurses, pharmacists and psychiatrists, veterans groups, at least one faith alliance, and business groups. The Ohio Manufacturers Association and the Ohio Chamber of Commerce are also members.

“There are seven million Ohioans, about 64 percent of the state’s population, who don’t get their drugs through the state programs they get it through private insurance, insurance provided by employers, Medicare for example is not covered under this anyway, so if this thing were workable and if the drug companies were forced to sell to the state like any other business they make that up by raising prices for those of us who aren’t covered by this which is the majority of people of our state,” said Coalition spokesman Dale Butland.

The Coalition has put together several well thought out fact sheets: a summary of Deceptive Rx Issues, a info sheet about why the proposal is bad for business, a fact sheet about why the proposal is bad for patients and health care providers, a fact sheet focused on why it is bad for taxpayers, and a fact sheet on the negative effects the proposal will have on veterans.

The Coalition, In Its Own Words

According to Coalition Campaign Manager Curt Steiner: 

While everyone agrees that Ohioans need access to affordable medicines, this deceptive and vaguely worded initiative won’t fix the problem or do what it promises. In fact, experts who have studied the proposal—including three former Ohio Medicaid Directors and a former state Budget Director—say it’s not only unworkable, but could actually increase prescription drug costs for the majority of Ohioans and reduce patient access to needed medications. The so-called Drug Price Relief Act is a Trojan Horse we can’t afford to let into our state.

Dale Butland agreed, adding

That’s why more than 30 Ohio organizations and associations so far—representing doctors, nurses, patients, veterans, organized labor and the business community—have joined together to oppose this misguided ballot initiative. Starting today, we’ll be supplementing our voter education efforts with a robust paid media campaign that will run on broadcast and cable TV all across the state, as well as on mobile and digital platforms. We urge all Ohioans to get the facts at www.DeceptiveRxIssue.org. Once voters know the truth, we’re confident they will give this ballot issue the defeat it so richly deserves.

June 28, 2017

Anti-MOC Laws Picking Up Steam Across the United States

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Lawmakers across America have started to take a variety of matters into their own hands, the most recent of which is Maintenance of Certification (MOC) licensure requirements. This trend started late last year when Oklahoma became the first state to pass legislation that prohibited MOC as a condition of medical licensure and hospital admitting privileges.

So far seven states (Georgia, Maryland, Missouri, North Carolina, Oklahoma, Tennesse and Texas) have passed laws that prevent hospitals, licensing boards, insurance companies and health systems from requiring MOC.  Bellow is a summary of bills and laws in states taking MOC under consideration.

Alaska

The Alaska State Legislature has introduced legislation, HB 191 – An Act relating to the practice of medicine and osteopathy, that stated, “Maintenance of Certification and osteopathic continuous certification. Nothing in this chapter may be construed to require a physician to secure a maintenance of certification as a condition of licensure, reimbursement, employment, or admitting privileges at a hospital in this state.” The legislation was referred to the Health and Social Services Committee on March 22, 2017, and no further action has been taken.

California

California Senate Bill 487 – Practice of Medicine: Hospitals was introduced in February 2017, and has yet to be heard by the committee, though it was set for hearing twice (and canceled twice). The relevant portion of the legislation reads, “The regular practice of medicine in a licensed general or specialized hospital having five or more physicians and surgeons on the medical staff, which does not have rules established by the board of directors thereof of the hospital to govern the operation of the hospital, which rules include, among other provisions, all the following, constitutes unprofessional conduct: … (c) Provision that the award or maintenance of hospital or clinical privileges, or both, shall not be contingent on participation in a program for maintenance of certification.”

Florida

Florida had legislation introduced in the state House of Representatives that would have prohibited that Boards of Medicine and Osteopathic Medicine and the DOH from requiring certain certifications as conditions of licensure, reimbursement, or admitting privileges. The bill, fortunately, never made it out of Committee discussions.

Georgia

Georgia’s legislation that prohibits MOC from being required as a condition of licensure was signed by the Governor on May 8, 2017, and is effective as of July 1, 2017. The relevant language states, “maintenance of certification shall not be required as a condition of licensure to practice medicine, staff privileges, employment in certain facilities, reimbursement, or malpractice insurance coverage; to provide for definitions; to provide for related matters; to repeal conflicting laws; and for other purposes.”

Maine

Both houses of the Maine legislature have introduced legislation that aims to change the way physicians and surgeons are licensed. Relevant language states, “Nothing in this chapter may be construed to require an osteopathic physician or surgeon licensed under this chapter to secure a maintenance of certification as a condition of licensure, reimbursement, employment or admitting privileges at a hospital in the State.” The passed legislation is currently awaiting the governor’s signature.

Maryland

The Maryland legislation has been passed by both the House and Senate, and was signed by Governor Larry Hogan and will become effective on October 1, 2017. The relevant language states, “The Board may not require as a qualification to obtain a license or as a condition to renew a license certification by a nationally recognized accrediting organization that specializes in a specific area of medicine; or maintenance of certification by a nationally recognized accrediting organization that specializes in a specific area of medicine that includes continuous reexamination to measure core competencies in the practice of medicine as a requirement for maintenance of certification.”

Massachusetts

Bill H.2446 was introduced in the Massachusetts House of Representatives in January 2017, but did not make it into law. The relevant language of the legislation stated, “Nothing in this Chapter shall be construed as to require a physician to secure a Maintenance of Certification (MOC) as a condition of licensure, reimbursement, employment, or admitting privileges at a hospital in this state.”

Michigan

The Michigan legislature introduced two separate bills relating to MOC, HB 4134 and HB 4135. The two bills, neither of which became law, dovetailed off one another, stating, “Notwithstanding any provision of this Act to the contrary, the Department or the Board of Medicine or Board of Osteopathic Medicine and Surgery shall not by order, rule, or other method require a physician applicant or licensee under its jurisdiction to maintain a national or regional certification that is not otherwise specifically required to maintain a national or regional certification that is not otherwise specifically required in this article before it issues a license or license renewal to that physician applicant or licensee under this article,” and “An insurer that delivers, issues for delivery, or renews in this state a health insurance policy or health maintenance that issues a health maintenance contract shall not require a condition precedent to the payment or reimbursement of a claim under the policy or contract that an allopathic or osteopathic physician maintain a national or regional certification not otherwise specifically required for licensure.”

Missouri

Missouri joins Oklahoma as one of the first in the country to enact anti-MOC legislation. In July 2016, the state enacted law that stated, “The state shall not require any form of maintenance of licensure as a condition of physician licensure including requiring any form of maintenance of licensure tied to maintenance of certification. Current requirements including continuing medical education shall suffice to demonstrate professional competency. The state shall not require any form of specialty medical board certification or any maintenance of certification to practice medicine within the state. There shall be no discrimination by the state board of registration for the healing arts or any other state agency against physicians who do not maintain specialty medical board certification including recertification.” In 2017, the legislature introduced a bill that made it so “No provision of law shall be construed as to require any form of maintenance of licensure as a condition of physician licensure, reimbursement, employment, or admitting privileges at a hospital in this state, including requiring any form of maintenance of certification. Current requirements, including continuing medical education, shall suffice to demonstrate professional competency.”

New York

New York AO4914 states, “It shall be an improper practice for a governing body of a hospital to refuse to act upon an application or to deny or to withhold staff membership or professional privileges of a physician solely because such physician is not board-certified. A health care plan may not refuse to approve an application from a physician to participate in the in-network portion of the health care plan's network solely because such physician is not board-certified.” The legislation was introduced into the Assembly and referred to the health committee.

North Carolina

In Summer 2016, the North Carolina legislature presented HB 728 to the Governor for signature. The Governor signed, and the law states that the North Carolina Medical Board “shall not deny a licensee’s annual registration based solely on the licensee’s failure to become board certified.”

Ohio

The Patient Access Expansion Act (HB 273) prohibits a physician from being required to secure MOC as a condition of obtaining licensure, reimbursement, employment, or obtaining admitting privileges or surgical privileges at a hospital or health care facility. It was introduced in the House in June 2017 and referred to the Health Committee, where it is currently sitting.

Oklahoma

In April 2016, SB 1148 was signed into Oklahoma law. The legislation states: "Nothing in the Oklahoma Allopathic Medical and Surgical Licensure and Supervision Act shall be construed as to require a physician to secure a Maintenance of Certification (MOC) as a condition of licensure, reimbursement, employment, or admitting privileges at a hospital in this state. For the purposes of this subsection, Maintenance of Certification (MOC) shall mean a continuing education program measuring core competencies in the practice of medicine and surgery and approved by a nationally recognized accrediting organization."

Rhode Island

The Rhode Island general assembly introduced H 5671 in January 2017, which states in relevant part, “The state and its instrumentalities are prohibited from requiring any form of specialty medical board certification and any maintenance of certification to practice medicine within the state. Within the state, there shall be no discrimination by the board of medical licensure and discipline, or any other agency or facility which accepts state funds, against physicians who do not maintain specialty medical board certification, including re-certification.”

Tennessee

This legislation was signed into law on May 25, 2017, and states that “No facility licensed under this chapter shall deny a physician a hospital's staff privileges based solely on the physician's decision not to participate in any form of maintenance of licensure, including requiring any form of maintenance of licensure tied to maintenance of certification.  This section does not prevent a facility's credentials committee from requiring physicians licensed pursuant to title 63, chapters 6 and 9, to meet continuing medical education requirements, as outlined in the rules of the appropriate state licensing board.”

Texas

The Texas bill was recently signed by the Governor and will become law on January 1, 2018. The relevant part of the legislation states, Except as otherwise provided by this section, the following entities may not differentiate between physicians based on a physician's maintenance of certification: if the facility or hospital has an organized medical staff or a process for credentialing physicians; …. (b) An entity described by Subsection (a) may differentiate between physicians based on a physician's maintenance of certification if: (1) the entity's designation under law or certification or accreditation by a national certifying or accrediting organization is contingent on the entity requiring a specific maintenance of certification by physicians seeking staff privileges or credentialing at the entity; and (2) the differentiation is limited to those physicians whose maintenance of certification is required for the entity's designation, certification, or accreditation as described by Subdivision (1). (c) An entity described by Subsection (a) may differentiate between physicians based on a physician's maintenance of certification if the voting physician members of the entity's organized medical staff vote to authorize the differentiation. (d) An authorization described by Subsection (c) may: (1) be made only by the voting physician members of the entity's organized medical staff and not by the entity's governing body, administration, or any other person; (2) subject to Subsection (e), establish terms applicable to the entity's differentiation, including: (A) appropriate grandfathering provisions; and (B) limiting the differentiation to certain medical specialties; and (3) be rescinded at any time by a vote of the voting physician members of the entity's organized medical staff.

Conclusion

The anti-MOC rhetoric is real, and heated. A quick google search shows at least two websites dedicated to the anti-MOC movement. Change Board Recertification, seems to collect articles about MOC and re-publish them all in one convenient website. The DOCS4Patient Care Foundation shows that – presumably in an attempt to gain more followers – proponents of anti-MOC legislation like to frame the issue as “right to care” laws, an interesting tactic.

Proponents of the anti-MOC laws believe that MOC restricts patient access by forcing older physicians into early retirement. It is our belief, however, that with the speed of innovation today, MOC is a critical part of patient care and upholding the Hippocratic Oath. By allowing physicians to continue practicing medicine without requiring MOC, patients may be put at risk.

In an attempt to keep up with the changing landscape, we will provide regular updates of bills introduced, passed and the subsequent regulations that are adopted.

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