Life Science Compliance Update

July 17, 2017

CME Continues to Grow and Evolve

Accme

The Accreditation Council for Continuing Medical Education (ACCME®) recently released the ACCME Data Report: Growth and Evolution in Continuing Medical Education — 2016. The 2016 report includes data from a community of over 1,800 accredited continuing medical education (CME) providers that offer physicians and healthcare teams an array of resources to promote quality, safety, and the evolution of healthcare.

Key Report Takeaways
The report highlights the fact that CME is a vibrant – and growing – community. Last year, ACCME along with more than 1,800 accredited CME providers offered close to 159,000 educational activities, comprising more than one million hours of instruction and interactions with 27 million health care professionals.

Since 2015, the number of educational events has increased 7% while hours of instruction increased by 9% and interactions with clinicians increased by 5%. Even more impressive, the number of activities and interactions have increased each year since 2010, despite some consolidation among CME providers.

The numbers of physician interactions have either increased over the years, or remained stable. The number of interactions with non-physician health care professionals such as nurses, physician assistants, and pharmacists shows steady growth.

Accredited CME providers represent a range of organizations from national physician membership organizations to rural hospitals. Some specialize in local, community-based health issues, others focus on national and international health priorities, and others advance interprofessional continuing education (IPCE) and team-based care. The ACCME recently began accrediting organizations outside the US, and this report includes their data as well.

The geographic distribution and diversity of CME providers means that clinicians and teams have access to education where they live and work that addresses local, national, and international healthcare priorities.

“Every day, across the country, clinicians can choose from more than 3,000 hours of accredited CME. Accredited CME is a tremendous resource — offering clinicians, educators, and health leaders the power and capacity to address many of the challenges we face in our changing healthcare environment,” said Graham McMahon, MD, MMSc, President and CEO, ACCME.

In his introduction to the report, Dr. McMahon also noted,

I’m delighted about the growth because it means that clinicians are increasingly engaged in education that promotes quality, safety, and the evolution of healthcare. Behind the numbers in the ACCME Data Report are educators who work every day to engage clinicians where they live, work, and learn. CME providers are creating “educational homes” that tackle health challenges while nurturing the professional development — and passion — of clinicians and teams.

He continues,

As this report demonstrates, accredited CME aims at changing more than knowledge—CME providers design and evaluate activities for meaningful change in skills, performance, and patient health outcomes. Organizations ranging from small, rural hospitals to national institutions such as the Food and Drug Administration and Centers for Medicare & Medicaid Services have recognized the value of accredited CME in advancing public health imperatives.

Dr. McMahon created a video introduction to the data, which can be found here.

Excel tables with data used to create reports can be found here.

ACCME Data Report Addendum can be found here.

ACCME Data Report Addendum Excel tables can be found here

 

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.

June 21, 2017

CMS Releases Proposed 2018 MACRA Rule (Including QI CME as Improvement Activity)

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On Tuesday, the Centers for Medicare & Medicaid Services (CMS) released the long-anticipated proposed rule updating the Quality Payment Program – the program implementing the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) – for 2018. The rule continues the CMS trend of allowing more and more physicians to delay MACRA implementation, as many smaller and rural providers have said their lack of capital and resources make compliance difficult.

MACRA will eliminate the sustainable growth formula and replace it with a .5% annual rate increase through 2019, when physicians are encouraged to shift to either a Merit-Based Incentive Payment System (MIPS) or an Alternative Payment Model (APM). CMS also used provider feedback to shape the second year of the program. If the rule becomes finalized, it will advance CMS’ goal of regulatory relief, program simplification, and state and local flexibility in the creation of innovative approaches to healthcare delivery.

Below is a comparison of current and proposed polices.

Policy Topic

Current Transition Year (CY 2017)

Second Year (CY 2018)

MIPS Policy

Low-Volume Threshold

Exclude individual MIPS eligible clinicians or groups with ≤$30,000 in Part B allowed charges OR ≤100 Part B beneficiaries during a low-volume threshold determination period that occurs during the performance period or a prior period.

Increase the threshold to exclude individual MIPS eligible clinicians or groups with ≤$90,000 in Part B allowed charges or ≤200 Part B beneficiaries during a low-volume threshold determination period that occurs during the performance period or a prior period.

Starting with 2019 MIPS performance period: let clinicians opt-in to MIPS if they exceed 1 or 2 of the low-volume threshold components: Medicare revenue, or Number of Medicare patients.

Additionally, CMS is proposing that in 2019 the opt-in process would be allowable for 3 items, and is seeking comment on a 3rd potential component: Number of Part B items and services

Virtual Groups

Not available

Key Proposals:

· Adding Virtual Groups as participation option for year 2, which would be composed of solo practitioners and groups of 10 or fewer eligible clinicians who come together “virtually” with at least 1 other such solo practitioner or group to participate in MIPS for a performance period of a year.

· In order for solo practitioners to be eligible to join a Virtual Group, they would need to meet the definition of a MIPS eligible clinician and not be excluded from MIPS based on one of the 4 exclusions (new Medicare-enrolled eligible clinician; Qualifying APM Participant; Partial Qualifying APM Participant who chooses not to report on measures and activities under MIPS; and those who do not exceed the low-volume threshold). In order for groups of 10 or fewer eligible clinicians to be eligible to participate in MIPS as part of a Virtual Group, groups would need to exceed the low-volume threshold at the group level. A group that is part of a Virtual Group may include eligible clinicians who do not meet the definition of a MIPS eligible clinician or may be excluded from MIPS based on one of the four exclusions.

· Allow flexibility for solo practitioners and groups of 10 or fewer eligible clinicians to decide if they want to join or form a Virtual Group with other solo practitioners or groups of 10 or fewer eligible clinicians, regardless of location or specialties.

· If the group chooses to join or form a Virtual Group, all eligible clinicians under the TIN would be part of the Virtual Group.

· CMS proposes various components that would need to be included in a formal written agreement between each member of the Virtual Group.

Virtual Groups that choose this participation option would need to make an election prior to the 2018 performance period (as outlined in the MACRA legislation).

· If/when TIN/NPIs move to an APM, CMS proposes to exercise waiver authority so that CMS can use the APM score instead of the Virtual Group score.

· Generally, policies that apply to groups would apply to Virtual Groups, except the following group-related policies:

  o Definition of non-patient facing MIPS eligible clinician.

  o Small practice status.

  o Rural area and Health Professional Shortage Area designations.

Facility-Based Measurement

Not available

Implement an optional voluntary facility-based scoring mechanism based on the Hospital Value Based Purchasing Program.

Available only for facility-based clinicians who have at least 75% of their covered professional services supplied in the inpatient hospital setting or emergency department.

The facility-based measurement option converts a hospital Total Performance Score into a MIPS Quality performance category and Cost performance category score.

Quality

Weight to final score:

· 60% in 2019 payment year.

· 50% in 2020 payment year.

· 30% in 2021 payment year and beyond.

Data completeness:

· 50% for submission mechanisms except for Web Interface and CAHPS.

· Measures that do not meet the data completeness criteria receive 3 points.

Scoring:

· 3-point floor for measures scored against a benchmark.

· 3 points for measures that don’t have a benchmark or don’t meet case minimum requirements.

· 3 points for measures that do not meet data completeness.

· Bonus for additional high priority measures up to 10%.

· Bonus for end-to-end electronic reporting up to 10%.

Weight to final score:

· 60% in 2020 payment year.

· 30% in 2021 payment year and beyond.

Data completeness:

· No change, but CMS proposes to increase the data completeness threshold to 60% for the 2019 MIPS performance period.

· Measures that do not meet data completeness criteria will get 1 point instead of 3 points, except that small practices will continue to get 3 points.

Scoring:

· Keep 3-point floor for measures scored against a benchmark.

· Keep 3 points for measures that don’t have a benchmark or don’t meet case minimum requirement.

· Measures that do not meet data completeness requirements will get 1 point instead of 3 points, except that small practices will continue to get 3 points.

· No change to bonuses.

· Proposed changes to the CAHPS for MIPS survey collection and scoring

Cost

Weight to final score:

· 0% in 2019 payment year.

· 10% in 2020 payment year.

· 30% in 2021 payment year and beyond.

Measures:

· Will include the Medicare Spending per Beneficiary (MSPB) and total per capita cost measures.

· 10 episode-based cost measures.

· Measures do not contribute to the score, feedback is provided for these measures.

Weight to final score:

· CMS proposes 0% in 2020 MIPS payment year, but are soliciting feedback on keeping the weight at 10%.

· 30% in 2021 MIPS payment year and beyond.

Measures:

· Include only the Medicare Spending per Beneficiary (MSPB) and total per capita cost measures in calculating Cost performance category score for the 2018 MIPS performance period. However, these measures will not contribute to the 2018 final score if the Cost performance category is finalized to be weighted at 0%.

· CMS expects to replace previous episode-based cost measures are developed in collaboration with expert clinicians and other stakeholders.

Improvement Activities

Weight to final score:

· 15% and measured based on a selection of different medium and high-weighted activities.

Number of activities:

· No more than 2 activities (2 medium or 1 high-weighted activity) are needed to receive the full score for small practices, practices in rural areas, geographic HPSAs, and non-patient facing MIPS eligible clinicians.

· No more than 4 activities (4 medium or 2 high-weighted activities, or a combination) for all other MIPS eligible clinicians.

· Total of 40 points.

· 92 activities were included in the Inventory.

Definition of certified patient-entered medical home:

· Includes accreditation as a patient-centered medical home from 1 of 4 nationally-recognized accreditation organizations; a Medicaid Medical Home Model or Medical Home Model; NCQA patient-centered specialty recognition; and certification from other payer, state or regional programs as a patient-centered medical home if the certifying body has 500 or more certified member practices.

· Only 1 practice within a TIN has to be recognized as a patient-centered medical home or comparable specialty practice for the TIN to get full credit in the category.

Scoring:

· All APMs get at least 1/2 of the highest score, but CMS will give MIPS APMs an additional score to reach the highest score based on their model. All other APMs must choose other activities to get additional points for the highest score.

· Designated specific activities within the performance category that also qualify for Advancing Care Information bonus.

· For group reporting, only 1 MIPS eligible clinician in a TIN must perform the Improvement Activity for the TIN to get credit.

· Allow simple attestation of Improvement Activities

Weight to final score:

· No change.

Number of activities:

· No change in the number of activities that MIPS eligible clinicians have to report to reach a total of 40 points.

· CMS is proposing more activities to choose from and changes to existing activities for the Inventory.

· MIPS eligible clinicians in small practices and practices in a rural areas will keep reporting on no more than 2 medium or 1 high-weighted activity to reach the highest score.

Definition of certified patient-centered medical home:

· CMS proposes to expand the definition of certified patient-centered medical home to include the CPC+ APM model.

· CMS proposes to make it clear that the term “recognized” is the same as the term “certified” as a patient-centered medical home or comparable specialty practice.

· CMS proposes a threshold of 50% for 2018 for the number of practices within a TIN that need to be recognized as patient-centered medical homes for the TIN to get the full credit for the Improvement Activities performance category.

Scoring:

· No change to the scoring policy for APMs and MIPS APMs.

· Keep designated activities within the performance category that also qualify for an Advancing Care Information bonus.

· For group participation, only 1 MIPS eligible clinician in a TIN has to perform the Improvement Activity for the TIN to get credit. CMS is soliciting comments on alternatives for a future threshold.

· Keep allowing simple attestation of Improvement Activities

Additional summaries can be found here, including proposed changes to the APM policy and other options/policies in the final and proposed rules.

Changes to CME

The proposed rule also includes changes that allow CME as an improvement activity. The relevant language is:

Completion of an accredited performance improvement continuing medical education program that addresses performance or quality improvement according to the following criteria:

  • The activity must address a quality or safety gap that is supported by a needs assessment or problem analysis, or must support the completion of such a needs assessment as part of the activity;
  • The activity must have specific, measurable aim(s) for improvement;
  • The activity must include interventions intended to result in improvement;
  • The activity must include data collection and analysis of performance data to assess the impact of the interventions; and
  • The accredited program must define meaningful clinician participation in their activity, describe the mechanism for identifying clinicians who meet the requirements and provide participant completion information.

“The proposed rule will provide more flexibility and freedom for educators to engage with clinicians in a learner-centered quality improvement process," said Graham McMahon, MD, MMSc, President and CEO, Accreditation Council for Continuing Medical Education (ACCME®). "We are pleased that the CMS proposal reflects the value of accredited CME and look forward to working together to address the quality and safety needs of communities and the patients we all serve.”  

CMS is focused on making the Quality Payment Program easier.  “We’ve heard the concerns that too many quality programs, technology requirements, and measures get between the doctor and the patient,” said CMS Administrator Seema Verma. “That’s why we’re taking a hard look at reducing burdens. By proposing this rule, we aim to improve Medicare by helping doctors and clinicians concentrate on caring for their patients rather than filling out paperwork. CMS will continue to listen and take actionable steps towards alleviating burdens and improving health outcomes for all Americans that we serve.”

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