Life Science Compliance Update

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.”

June 16, 2017

California "Gift" Ban Bill Amended to Drop Fines and Requires Accreditation for Education Events

Californiastatecapitol

California has not been known to be the most “business friendly” state in the union in recent history. We recently wrote about legislation passed in the California state senate that was intended to restrict pharmaceutical companies from giving gifts and incentives to medical professionals. The bill prohibits drug manufacturers from offering or giving a gift to a health care provider.

The bill also prohibits a manufacturer or an entity on behalf of a manufacturer from providing a fee, payment, subsidy, or other economic benefit to a health care provider in connection with the provider’s participation in research. Exempts the annual direct salary support for principal investigators and other health care professionals for the purposes of a bona fide clinical trial from this provision.

The Bill was amended in the California assembly on June 13, 2017, to remove the penalty provisions. The bill passed in the assembly does not allow the Attorney General to bring an action seeking injunction relief, costs, attorney fees and a civil penalty up to $10,000 for each violation of the law, nor does it allow the Attorney General to

investigate and obtain remedies as are granted to the Director of Consumer Affairs pursuant to Chapter 4 (commencing with Section 300) of Division 1 of the Business and Professions Code.

Additionally, as those provisions were dropped, the amended legislation would ban doctors from participating as faculty or speakers in events that are not accredited by the Accreditation Council for Continuing Medical Education (ACCME) – or a comparable organization.

The legislation, as written, specifically lists monetary benefits that shall be excluded from the prohibition, and therefore, considered to be permitted notwithstanding the passage of this bill. Some of those include:

  • Samples of a prescribed product or reasonable quantities of an over-the-counter drug, an item of medical food as defined in Section 360ee of Title 21 of the United States Code, or infant formula as defined in Section 321 of Title 21 of the United States Code, that are provided to a health care provider for free distribution to patients.
  • The provision, distribution, dissemination, or receipt of peer-reviewed academic, scientific, or clinical articles or journals and other items that serve a genuine educational function provided to a health care provider for the benefit of patients.
  • Scholarship or other support for medical students, residents, and fellows to attend a significant educational, scientific, or policymaking conference or seminar of a national, regional, or specialty medical or other professional association if the recipient of the scholarship or other support is selected by the association.
  • Rebates and discounts for prescribed products provided in the normal course of business.
  • Labels approved by the federal Food and Drug Administration for prescribed products.
  • The provision to a free clinic of financial donations or of free prescription drugs, over-the-counter drugs, biological products, combination products, medical food, or infant formula.
  • Prescribed products distributed free of charge or at a discounted price pursuant to a manufacturer-sponsored or manufactured-funded patient assistance program.
  • Fellowship salary support provided to fellows through grants for manufacturers of prescribed products, provided that all of the following conditions are satisfied:

(1) The grants are applied for by an academic institution or hospital.

(2) The institution or hospital selects the recipient fellows.

(3) The manufacturer imposes no further demands or limits on the institution’s, hospital’s, or fellow’s use of the funds.

(4) Fellowships are not named for a manufacturer and no individual recipient’s fellowship is attributed to a particular manufacturer of prescribed products.

Industry Reaction

The Biotechnology Innovation Organization (BIO) states that their member companies know the importance of basing relationships with health care practitioners on high standards of ethics and professional conduct, which is why they strictly adhere to federal statutes, regulations, and internal policies already in place. BIO is concerned that this bill could encumber important interactions between biopharmaceutical manufacturers and health care practitioners.

The Pharmaceutical Research and Manufacturers of America (PhRMA) writes that this bill is unnecessary because current law already addresses interactions between health care practitioners and drug manufacturers, public disclosures are already required, and they know of no problem that has surfaced recently which would give rise to more legislation in this area.

May 10, 2017

ABIM and ACCME Increase CME and QI Opportunities for Physicians

ABIM_rotating-01

The American Board of Internal Medicine (ABIM) and the Accreditation Council for Continuing Medical Education (ACCME) have expanded their collaboration to recognize more accredited continuing medical education (CME) for Maintenance of Certification (MOC). With this expansion, accredited providers are now able to register activities that meet ABIM’s requirements for Medical Knowledge and/or Practice Assessment MOC.

ABIM and ACCME expanded their collaboration to increase the number and diversity of accredited CME activities that earn both CME credit and MOC points in support of physicians participating in lifelong learning and quality improvement to make a meaningful difference in patient care.

While ABIM has extended its decision to not require Practice Assessment in its MOC program through December 31, 2018, MOC points are still available to physicians who complete Practice Assessment activities.

Additionally, using the online CME Finder tool, physicians can choose from over 3,000 accredited CME activities that count for ABIM MOC.

Richard J. Baron, MD, President and CEO of ABIM, noted, "In less than two years, ABIM’s collaboration with ACCME has resulted in over 3.3 million MOC points earned by more than 68,000 physicians for accredited CME activities they are already doing to stay current and improve the care they provide. As our collaboration expands we want to offer physicians even more choice and convenience for how they fulfill ongoing education and certification requirements. With this expansion, many new types of activities that combine lifelong learning and quality improvement will also be available for dual credit."

A Simpler, Unified Process

Accredited CME providers can now use the ACCME Program and Activity Reporting System (PARS) to register CME activities that are offered in any format, similar to what they have been doing for Medical Knowledge activities. Activities may be registered for a single type of ABIM MOC credit or for combinations of credit types, including Medical Knowledge and Practice Assessment, so long as they meet the guidelines described in the ABIM MOC Assessment Recognition Program Guide.

Building on Success

The expansion builds on the ongoing success of the ABIM/ACCME collaboration. Since the collaboration’s launch in 2015, the number and diversity of accredited CME activities that count for ABIM MOC has increased substantially, as has learner participation. More than 240 accredited CME providers registered over 7,000 activities that count for ABIM MOC in PARS.

Graham McMahon, MD, MMSc, President and CEO of ACCME, stated, "We celebrate the expansion of our collaboration with ABIM, because it will generate many more opportunities for accredited CME providers to support physician engagement in education that focuses on quality and safety improvement. Since its inception in 2015, our collaboration has succeeded in making a real and meaningful difference to physicians and educators who are working every day to improve healthcare in their communities. I look forward to building on that success and continuing to work together with ABIM, accredited CME providers, and physicians to leverage the power of education to optimize care for the patients we all serve."

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