Life Science Compliance Update

July 03, 2017

CMS Releases 2016 Open Payments Data

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2016 Open Payments Data was released on Friday, June 30, 2017. In 2016, the total dollar amount of payments totaled $8.18 billion. The total amount of general payments made amounted to $2.80 billion; the total amount of research payments amounted to $4.36 billion; and the value of ownership or investment interest totaled $1.02 billion.

Where Did The Money Go?

The $8.18 billion was given to 631,000 clinicians and 1,146 teaching hospitals. Drug and device makers are required to report any “transfer of value” of $10 or more, or transfers of value that add up to more than $100 per year.

Roughly 75% of the $2.8 billion ($2.07 billion) in general payments went to clinicians, including physicians, dentists, optometrists, podiatrists, and chiropractors. Teaching hospitals received $724.51 million in general payments.

Research payments largely went to teaching hospitals: $867.95 million, compared to the $95.21 million that went to physicians. The physician research payment total includes payments where the company making the payment has named a physician as the primary recipient, as well as payments to a research institution or entity where a physician is named as a principal investigator on the research project.

Year to Year Comparisons

The below tables show comparisons of different data points over the past few years.

1

The above table compares the percent change in total payments and records. The percent change in payments and interest from 2015 to 2016 totaled 1.11% ($8.09 billion to $8.18 billion).

2

The above table compares the percent changes in three different payment categories: general payments (4.5%); research payments (-2%); and ownership interest (6.3%).

3

The above table compares the 2014 to 2016 change in number of companies reporting (-8.24%); physicians receiving payments (.96%); and teaching hospitals receiving payments (1.69%).

Medscape joined the “fake news” craze, by stating the increase was 8.8% from last year’s payments. However, the actual rise was less than 1.1%.

Conclusion

Visitors to the CMS Open Payments website can look up individual clinicians and hospitals to see what they have received from drug and device makers and compare their payments to national and specialty averages.

June 22, 2017

MACRA Letters Went Out, Finally

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The Centers for Medicare and Medicaid Services (CMS) finally mailed out letters to medical practices, providing clinicians with their participation status in the Merit-based Incentive Payment System (MIPS). MIPS is one of two payment tracks within the Medicare Access and CHIP Reauthorization Act (MACRA). The letters were supposed to go out in December, but that deadline came and went without any letters mailed. Roughly 419,000 providers were notified that they are participating in MIPS and must meet the reporting requirements for 2017. CMS uses historical claims data and data from the performance period to make the determination whether or not a physician/other healthcare provider is eligible for MIPS participation.

Meanwhile, there were over 800,000 providers who received the news that they do not need to participate in the MIPS program this year. Physicians are exempt from MIPS participation if they have less than $30,000 in Medicare charges and less than 100 Medicare patients per year. Additionally, physicians who are new to Medicare this year are also exempt.

Depending on whether a particular medical practice reports as a group, even physicians who do meet those exemption requirements may be required to participate. If the medical practice reports as a group all of the providers within the group’s Tax Identification Number (TIN), all providers will be included, even if an individual provider falls below the minimum thresholds above. Additionally, if providers participate in more than one TIN, they will need to verify their reporting status with each practice.

The number of clinicians who will participate in MACRA overall, however, will be higher than the estimated 419,000 participating in MIPS. The others will participate via alternative payment models (APMs). CMS expects that more physician practices will participate under MIPS as opposed to APMs, as MIPS allows the greatest financial reward, but also requires the doctors to take on more risks.

The number of MIPS participants differed from estimates made in the MACRA final rule released last fall, based on an updated eligibility formula. Under MIPS, physicians will receive Medicare payments based on quality measures and their use of electronic health records.

The letter provides instructions on what steps MIPS participants need to take, as well as reinforces deadlines to help physicians avoid a four percent negative payment adjustment for not participating. The letter also comes with an attachment with additional participation information and a list of frequently asked questions.

Physicians still unsure if they must participate in MIPS can visit qpp.cms.gov, click on the MIPS Participation Look-up Tool and use their National Provider Identifier (NPI) to check their status. The look-up tool can also be helpful to practice administrators or clinicians who did not personally view the letter mailed because it was received by administrative leaders or a corporate office.

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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