Life Science Compliance Update

December 06, 2016

Money in Medicine Report

Money-medicine

In late November, a report was released that focused on money in medicine, and the top thirty drugs that were associated with pharmaceutical industry payments to Oregon doctors. Interestingly, the top thirty list did not include many drugs that are known to be household names. For example, the top three drugs – Bydureon, Invokana, and Toujeo – are prescribed for diabetes, a highly prevalent disease in America. Three others on the list are prescribed for multiple sclerosis, a debilitating condition that is incurable and can be hard to live with. Hysingla, an abuse-deterrent hydrocodone pill, is also high on the list.

According to the series, $2.6 billion in non-research payments were made by drug and device developers to U.S. teaching hospitals and physicians in 2015. In Oregon, 100 doctors collected $9 million in payments from industry.

This is interesting, in part because the media is always harping on the pharmaceutical industry for spending money and having “influence” on physicians. However, this article and the data show that the drugs (at least in Oregon) that are most associated with pharmaceutical industry payments tend to be drugs for diseases that are highly prevalent or diseases that are hard to beat. The author of the series also gives much time and attention to the physicians themselves, who help her (and the public) understand the benefits.

Doctors who receive the payments state that they are “being compensated for their time and expertise, or in several cases, the technology they devised to advance patient care.” They also “argue that safeguards are in place to prevent undue influence from industry, such as a prohibition on receiving royalties from your own practice or even region.”

Dr. L. Nelson Hopkins, a neurosurgeon and president of the Gates Vascular Institute at Buffalo General Medical Center, believes it is important for physicians and industry to have a good relationship, “To say that physicians shouldn’t work with industry is to say that innovation shouldn’t happen. If physicians weren’t working with industry to develop concepts and to advise industry on how it’s going in the marketplace, and working with industry to iterate the product to get better and better, then that technology would be stymied.”

Gerald Williams, Jr., both a practicing physician and the president of the American Academy of Orthopaedic Surgeons, notes that it makes sense that many of his group’s members account for a large portion of the non-research compensation because their practice areas account for almost 40 percent of the total health care spending in the United States. Williams states that many orthopedic surgeons fund their own product and equipment innovations, and that even more are asked by device makers to lend their expertise in developing new tools and approaches to delivering care.

Dr. Bryan Mehlhaff, a Springfield urologist who makes presentations about cutting-edge prostate cancer drugs, sums it up quite well, “this is very FDA regulated. A lot of my patients know I’m a speaker and that I participate on advisory boards and ask if I’ve heard anything new. A lot of them like that I’m on top of new developments and on the cutting edge of what might be possible for them.”

December 05, 2016

Part Two: MACRA More MIPS, and APMs

MIPS_blog

In part two of our MACRA analysis, we continue our look at MIPS and evaluate the APM pathway of MACRA’s new quality payment program.

Small Practice Considerations

Exemption

Key finalized policies include a small practice-friendly low volume threshold. In 2017, the threshold has been set at “less than or equal to $30,000 in Medicare Part B allowed charges or less than or equal to 100 Medicare patients.” CMS says this new threshold represents 32.5 percent of Medicare clinicians but only 5 percent Medicare Part B spending.

CMS says that the new flexibilities from the final rule lessen the impact on small and solo practices. CMS says “we believe that small and solo practices will respond to MIPS by participating at a rate close to that of other practice sizes.” CMS estimates each practice size will achieve either an 80 percent or 90 percent participation rate, and that at least 80 percent of clinicians in small practices will receive a positive or neutral adjustment.

Virtual Groups

MACRA allows solo and small practices to join “virtual groups” to combine their MIPS reporting. Many commenters asked CMS to allow groups with more than 10 clinicians to participate as virtual groups, even though the statute limits virtual groups to groups of not more than 10 clinicians. CMS notes that it is not implementing virtual groups in the first year of the program, and that it believes it has addressed some of the concerns expressed by clinicians hesitant to participate in the Quality Payment Program. It left the question open and said it would work with stakeholders on how it would structure and implement virtual groups going forward.

In a letter signed by Robert Horne, Executive Director of Health IT Now addressed stakeholder concern over virtual groups. Dated October 17, 2016, the group wrote to CMS:

“There is growing recognition among lawmakers and the public that implementation of the MACRA statute will be challenging for both physicians and CMS. Establishment of virtual group reporting options appear no different. We recognize that part of the problem may lie with the CMS legacy IT system, which some suggest are incapable of performing many functions that are commonplace among IT systems today. While we believe it imperative that Congress work with the administration to identify ways that the CMS computer systems can be updated to increase Medicare’s efficiency and reduce costs, we do not believe such a barrier need impact the effectiveness of the virtual group concept. Rather, we believe that the solution can be found in closer collaboration with health IT industry leaders.

“Many members of Health IT Now (HITN), and the health IT community more generally, have platforms and expertise in technology solutions that could facilitate provider engagement in virtual groups, performance feedback in real-time, and other solutions that might better prepare providers to meaningfully engage in APMs. We want to collaborate more closely with CMS to put such ideas into practice.

“We encourage CMS to establish a virtual group reporting option, or at the very least begin laying the foundation for such an option, as soon as possible. There is ample public support for such a move, as demonstrated by comments on the proposed rule from various stakeholders. HITN has a number of ideas on how to accomplish this lofty goal, and stands ready to support your efforts.”

Problems for IT vendors

Beginning in 2018, physicians must use EHR technology that is certified for 2015 instead of 2014. That could be a problem, since more than 75% of the providers participating in the Medicare EHR Incentive Program as of July had 2014-certified edition technology, according to the Office of the National Coordinator for Health Information Technology, which establishes the certification criteria. This, as reported by Modern Healthcare, could be burdensome on smaller EHR vendors.

According to Corinne Proctor Boudreau, senior manager of marketing for physician experience at Meditech, a Westwood, Mass.-based developer of hospital and physician EHRs, under the meaningful-use program, “you have seen some of those smaller vendors not be able to make those requirements. But this is the direction the industry has been going in. It's a little bit the cost of doing business,” Boudreau said.

“This situation is unfortunate for providers who have invested in an EHR that does not acclimate to agile change at scale,” but it's not an issue for others, including athenahealth. According to a statement from Allison LaValley, executive director for quality performance and value-based care at athenahealth, “As a cloud-based network, we are very nimble and can adapt not just to MACRA but to anything the government throws forward.”

However, as noted by others in the industry, the rule did make concessions to the health IT community. EHR testing and certification launched in 2006 under the Office of National Coordinator for Health IT (ONC).  Since that time and accelerated by the Meaningful Use programs, there has been an ongoing narrowing of EHR vendors leaving healthcare providers to comtemplate a “rip and replace” IT strategy. Advancing Care Information (ACI) will not take an all-or-nothing approach to EHR requirements, especially since the final rule reduced the total number of required measures to five, ultimatley down from 18 under stage 2 meaningful use. The five ACI requirements include basic measures:

  • Security risk analysis,
  • e-Prescribing,
  • Providing patient access,
  • Sending a summary of care, and
  • Requesting and accepting a summary of care.

The rule also no longer requires reporting on measures for clinical decision support and computerized provider order entry.  The reduction was designed to ease the burden on providers and allow the EHR industry to address issues of usability and interoperability.

Arguably, CMS “reduced the number of measures … but the measures you do have to meet are predicated on interoperability,” which is often outside the control of the physician, said Mari Savickis, vice president of federal affairs at the College of Healthcare Information Management Executives, an association of chief information officers at hospitals and health systems. Yet Boudreau points out that interoperability-related measures such as sending and receiving a summary of care through EHRs “have been out there for a while for physicians that have been (participating in) meaningful use.” She supports the idea that the reduction in required measures under MACRA gives vendors some “breathing room” to develop certain tech capabilities. LaValley said vendors such as athenahealth have “skin in the game” regarding their clients' success under MACRA. More importantly, "the industry is rife with EHRs that are not architected to enable cross-continuum care coordination and connectedness, which is critical to long-term MACRA success.”

MIPS APMs

MIPS APM provides participants a pathway improve their MIPS scores through APMs that do not meet criteria to be Advanced APMs or do not meet the revenue or patient thresholds to be exempt from MIPS. Potentially included in these MIPS APMs, Medicare Shared Savings Program and Next Generation ACOs would report MIPS quality measures on behalf of their participants; and, the CPIA and ACI performance categories will be reweighted to 20 percent and 80 percent respectively. Non-ACO MIPS APM participants will have their quality score reweighted to zero for the 2017 performance period and the CPIA and ACI performance categories will be reweighted to 25 percent and 75 percent respectively.

Each year, CMS will compare the requirements of recognized APMs with the list of Improvement Activities and score those measures in the same manner they are otherwise scored for MIPS eligible clinicians. Prior to the start of each performance period, CMS will publish a list of the pre-assigned Improvement Activities score for each MIPS APM. In the event that the assigned score does not represent the maximum Improvement Activities score, APM Entities will have the opportunity to report additional Improvement Activities.

General thoughts on changes made by CMS in final MIPS rule

As pointed out in an article at Healthcare Informatics, John Goodson, M.D., staff internist at Massachusetts General Hospital and associate professor at Harvard Medical School, believes CMS’ decision to modify reporting measures and timelines in the final rule serves as a “strategic movie” to get more physicians invested in the program. Many physicians did not participate in PQRS, and Goodson noted that the reporting required in MACRA’s Quality Payment Program will necessitate good, solid data which CMS will never get unless they get doctors to buy into the reporting mechanisms. As such, the pathways laid out by the federal agency are attempts to at the least, get the community of providers engaged at a minor level, Goodson says.

Additionally, much of MACRA is already in law because of what has been spelled out by through bipartisan, bicameral Congressional efforts. Goodson does not think Congress will readdress the program right now and wants to see how it plays out. At some point physicians will have to make the choice between staying in Medicare or getting out. “There is a fear that this whole system will implode because doctors won’t want to play this game anymore. They think it’s too demanding and crazy.” However, Goodson believes that in the end, most providers want to partake in Medicare, and the key will be to be able to obtain the meaningful data that these programs under MACRA will inevitably require.

However, “getting out of Medicare” is a flawed strategy and here’s why.  MACRA has accelerated a growing industry trend towards APM contracting across the payer system at large.  For example, in Aug. 2016 UnitedHealth paid $148 million in performance-base bonuses to almost 1,900 primary care physicians.  37 Blue plans have over 350 value-based programs spanning 49 states, D.C., and Puerto Rico impacting more than 215,000 providers, including 237 ACO contracts with over 93,000 participating physicians.  As states privatize Medicaid through managed care contracting, value-based payment design is an increasing requirement.

Regarding smaller practices, Goodson believes they have more equity in their patient panel, leading to good will and trust, which is the way to save money in healthcare, he says. “Trust allows you to use time as a diagnostic tool and a therapeutic intervention. So if you’re close to your patients, live in the community, and have a relationship with them, you can be a high quality, low cost provider.” Goodson adds that the key thing for these small practices is to have complete control over their data. This means that they know exactly who their patients are, what their problems and medications are, and what all their diagnostic codes are, so every single thing that has been identified as a problem with the patient maps to an ICD code.

Given the growing role of data and measurement in a provider’s economic future, codified data capture within the encounter note, diagnostic results and pharmacologic therapies offer strength in positioning for future requirements.  Many of the larger EHR products map to a growing plethora of coded nomenclatures such as SNOMED, LOINC and NDC.

However, there is a risk the system could be “gamed,” by which a physician practices self-selection and reports only those measures in which they do well while not truly striving for improvements in care. This is particularly pronounced around attribution of patients to the physician and risk adjustment which have not been fully addressed by CMS. Goodson is quoted asking, “How will we as providers know who we are responsible for and held accountable for?” And for risk adjustment, he notes, “People worry so much about cherry picking, so if I deal with a complicated group of patients, will I be judged against someone who selects a much less demanding group of patients? If that happens, if people figure out how to cherry pick the system, things could start to melt down,” Goodson speculates.

Advanced Alternative Payment Models

Clinicians are exempt from MIPS and eligible for up to a five percent bonus payment through calendar year 2024 if they receive a sufficient portion of their payments or see a sufficient portion of their patients through an Advanced APM. These clinicians are referred to as APM Qualified Participants or “QPs.”

In step with MACRA legislative requirements, APMs seeking to qualify as an Advanced APM must meet what CMS describes as “ambitious but achievable goals,” including:

  • The use of certified EHR technology;
  • Payment for covered professional services based on quality measures comparable to those in MIPS’ quality performance category; and
  • Either (a) the bearing of downside financial risk in excess of a nominal amount or (b) being a nationally recognized accredited patient-centered medical home, expanded under section 1115A(c) of the Social Security Act.

Under the finalized nominal risk standard, APMs could qualify as Advanced APMs if the total annual amount that an APM Entity potentially owes CMS or foregoes is equal to at least:

  • For QP Performance Periods in 2017 and 2018, eight percent of the average estimated total Medicare Parts A and B revenues of participating APM Entities (the “revenue-based standard”); or,
  • For all QP Performance Periods, three percent (down from four percent as proposed) of the expected expenditures for which an APM Entity is responsible under the APM (the “benchmark-based standard”).

Physicians should be aware that they must have at least 25% of their Medicare Part B services or at least 20% of their Medicare Part B patients attributed to the APM to individually qualify for the 5% bonus payment. Nearly every primary care physician in an ACO model will easily push past these thresholds, but specialists and physicians in other models should be wary of this provision especially as it ramps up to 50% and 35% respectively in 2021 (reporting year 2019) and all the way to 75 and 50% in 2023 (reporting year 2021).

CMS understands that widespread clinician participation in Advanced APMs is unlikely, estimating a participation rate in the transition year of only 70,000 and 120,000 clinicians. CMS is clearly interested in encouraging clinician participation in APMs, as evidenced by the planned introduction of MIPS APMs and the ACO Track 1+ model.

Physician-Focused Payment Models

As for Physician-Focused Payment Models (PFPMs), the final rule expanded the definition of PFPM to include practitioners other than physicians. Payment models can target the quality and costs of services that other practitioners provide, order, or significantly influence, rather than just physician services. CMS proposed that in carrying out its review of PFPMs, the Physician-Focused Payment Model Technical Advisory Committee (PTAC, pronounced “P-tack”) shall assess whether the PFPM meets the following criteria:

  1. Incentives: Pay for Higher-Value Care
  • Value Over Volume: Provide incentives to practitioners to deliver high-quality healthcare.
  • Flexibility: Provide the flexibility needed for practitioners to deliver high-quality healthcare.
  • Payment Methodology: Pay APM Entities with a payment methodology designed to achieve the goals of the PFPM criteria. Addresses in detail through this methodology how Medicare and other payers, if applicable, pay APM Entities, how the payment methodology differs from current payment methodologies and why the Physician-Focused Payment Model cannot be tested under current payment methodologies.
  • Scope: Aim to either directly address an issue in payment policy that broadens and expands the CMS APM portfolio or include APM Entities whose opportunities to participate in APMs have been limited.
  • Ability to Be Evaluated: Have evaluable goals for quality of care, cost and any other goals of the PFPM.
  1. Care Delivery Improvements: Promote Better Care Coordination, Protect Patient Safety and Encourage Patient Engagement
  • Integration and Care Coordination: Encourage greater integration and care coordination among practitioners and across settings where multiple practitioners or settings are relevant to delivering care to the population treated under the PFPM.
  • Patient Choice: Encourage greater attention to the health of the population served while also supporting the unique needs and preferences of individual patients.
  • Patient Safety: Aim to maintain or improve standards of patient safety.
  1. Information Enhancements: Improving the Availability of Information to Guide Decision-Making
  • Health Information Technology: Encourage use of health information technology to inform care.

CMS is finalizing its proposed criteria for PFPMs with one modification: broadening the proposed scope criterion. The final scope criterion now requires that PFPMs aim to broaden or expand the CMS APM portfolio by addressing an issue in payment policy in a new way or including APM Entities whose opportunities to participate in APMs have been limited. What does all this mean? PTAC is an official 11-member federal advisory committee on APM payment innovation. While PTAC does not have the authority to approve a provider or community’s alternative payment model as qualifying for the advanced APM payment track, it does have the ability to make recommendations along those lines including whether the APM needs refinement, piloting, additional study and/or implementation. 

CMS initiative: “Reducing medical record review for clinicians participating in certain Advanced Alternative Payment Models”

Responding to concerns of excess paperwork burdens on physician practices, CMS recently launched an initiative that intends to allow physicians to spend more time on patient care and less time on paperwork. A recent study that was sponsored by the AMA found that for every hour physicians spend providing clinical care to patients, they spend two hours on administrative tasks. Another study found physician frustrations run so high that more than half of the doctors in a national survey have considered leaving the profession, with many saying they want to spend more time with patients and less with electronic health records.

As a first step, CMS announced a medical review reduction program to ease the reporting burden for physicians. This 18-month pilot program will relieve doctors who participate in specified advanced alternative payment models (APMs) from additional scrutiny under certain Medicare medical review programs, CMS said. Seeking aligned incentives, the agency identified APMs for the pilot with participating clinicians who shared financial risk with the Medicare program, specifically:

  • Next Generation ACOs,
  • Medicare Shared Savings Program ACOs – Tracks 2 and 3,
  • Pioneer ACOs, and
  • Oncology Care Model 2-side Track participants

The pilot program is part of a broader initiative seeking to boost engagement among clinicians and combat provider alienation driven by economic reform. “The new initiative will launch a nationwide effort to work with the clinician community to improve Medicare regulations, policies, and interaction points to address issues and to help get physicians back to the most important thing they do--taking care of patients,” said CMS Acting Administrator Andrew Slavitt, in announcing the program. CMS said it will analyze results of the pilot program and consider expansion of the program to additional APMs, specialties and provider types. For more details about the pilot program, physicians can find a fact sheet on the initiative.

Do you need to know where your APM lands in the MACRA payment effort?  CMS published the following chart to outline current Advanced APMs and MIPS APMs, based on the criteria outlined in the final rule:

2017 APM List Based on Final Criteria

APM

MIPS APM under  the APM Scoring Standard

Medical Home  Model

Use of CEHRT Criterion

Quality Measures Criterion

Financial Risk Criterion

Advanced

APM

Accountable Health

Communities (AHC)

no

no

no

no

no

no

ACO Investment Model

(AIM)

no

no

no

no

no

no

Bundled Payment for

Care Improvement

Model  2 (BPCI)

no

no

no

no

YES

no

Bundled Payment for

Care Improvement

Model  3 (BPCI)

no

no

no

no

YES

no

Bundled Payment for

Care Improvement

Model  4 (BPCI)

no

no

no

no

YES

no

Comprehensive Care for

Joint Replacement

(non-CEHRT)

no

no

no

YES

YES

no

Comprehensive ESRD Care (CEC) Model  (LDO

arrangement)

YES

no

YES

YES

YES

YES

Comprehensive ESRD Care (CEC) Model  (non- LDO two-sided risk

arrangement)

YES

no

YES

YES

YES

YES

Comprehensive ESRD Care (CEC) Model  (non- LDO arrangement one-

sided risk arrangement)

YES

no

YES

YES

no

no

Comprehensive Primary

Care Plus (CPC +) Model

YES

YES

YES

YES

YES

YES

Financial Alignment

Initiative1

N/A

N/A

N/A

N/A

N/A

N/A

Frontier Community Health Integration Program (FCHIP)

no

no

no

no

no

no

1This table reflects the design of the Financial Alignment Initiative agreements between CMS and state and health plan participants.  CMS will assess agreements between states or health plans and health care providers under the All-Payer Combination Option.

APM

MIPS APM under  the APM Scoring Standard

Medical Home  Model

Use of CEHRT Criterion

Quality Measures Criterion

Financial Risk Criterion

Advanced

APM

Oncology  Care Model

(OCM) (two-sided risk arrangement)

YES

no

YES

YES

YES

YES

Prior Authorization: Repetitive Scheduled  Non-Emergent

Ambulance Transport

no

no

no

no

no

no

Prior Authorization: Non- Emergent Hyperbaric Oxygen Therapy Model

no

no

no

no

no

no

Initiative to Reduce Preventable Hospitalization Among Nursing Home Residents:

Phase 2

no

no

no

no

no

no

State Innovation

Models—Round 2 (SIM

2)2

N/A

N/A

N/A

N/A

N/A

N/A

Strong Start For Mothers

And Newborns

no

no

no

YES

no

no

Transforming Clinical

Practice Initiative (TCPI)

no

no

no

no

no

no

December 02, 2016

New Report Demonstrates Effectiveness of IPCE

Report-writing

On April 20, 2016, the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC) convened a Leadership Summit for Jointly Accredited Providers at the ACCME’s offices in Chicago.  

The goal of the summit was to provide an opportunity for jointly accredited providers – as leaders in the continuing healthcare education community – to work collaboratively to identify organizational models that are effective in promoting and improving interprofessional collaborative practice (IPCP) through interprofessional continuing education (IPCE) and to share success stories that demonstrate the impact of their educational efforts.

A new report, crafted based on the 2016 Joint Accreditation Leadership Summit, shows how IPCE contributes to improving healthcare team collaboration and patient care. The report includes best practices, challenges, case examples, key recommendations, and data about the value and impact of IPCE.

Report Highlights

Inclusive Team

IPCE builds team collaboration across multiple professions, from chaplains to community health workers – from physicians to psychologists – from safety experts to social workers. Additionally, teamwork takes a fundamental, on-going commitment to the principles of IPCE – the secret to collaboration is to actually collaborate.

Patient-Centered Teams

IPCE also creates a safe space where all learners, including patients, have a voice. Education that includes patients as planners, teachers, and learners, motivates powerful and lasting change. The report encouraged participants to ask: how is the structure helping patients? What professions affect patient outcomes? It is important to remember that the purpose and value of the program is to support the patient.

Cultural Care, Compassionate Value

By bringing together teams, IPCE effectively builds skills that are essential for improving care for patients and communities, such as cultural competency, compassionate values, and communications. The report notes that IPCE is a philosophy and that you “have to be a true believer, keep on living it, preaching it,” encouraging leaders to “infuse your enthusiasm into the program.”

Public Health Priorities

IPCE programs partner with institutions and communities to address quality, safety, and public health concerns such as sepsis, obesity, end-of-life care, heart disease, and cancer.

Recommendations

The report also included eight recommendations for creating and sustaining a successful ICPE program: develop buy-in from leadership; support your organization’s strategic mission; build your IPCE team and model best practices; involve patients; implement a phased-in approach; focus on quality; measure outcomes; and communicate the value of IPCE.

Videos

Along with the report a series of videos was released, which feature educators describing their goals and accomplishments, what brings them joy and pride in their work, and advice for creating IPCE programs.

Comments from Leadership

All three jointly accredited provider groups support the report, with each having a representative offer comments on the report.

“This report illustrates how jointly accredited providers are working every day to make a difference. These efforts have made, and will continue to make, a substantial difference to healthcare teams and the patients they serve. Interprofessional continuing education creates empowered teams that think courageously together, solve complex problems, and see the value of their own and their colleagues’ contributions. I encourage health system leaders and other stakeholders to recognize that an investment in education is an investment in people and to think about how they can leverage the power of education to support their community of clinicians and patients.”— Graham McMahon, MD, MMSc, President and CEO, ACCME

“We are not going to change the healthcare system unless professionals in practice learn from, about, and with each other and foster that learning in the students coming up behind them. This report shows the important work being done by jointly accredited providers and documents the benefits and outcomes of their work. As accreditors, it shows us what we need to do better to support that work going forward.”—Peter H. Vlasses, PharmD, DSc (Hon), BCPS, FCCP, Executive Director, ACPE

“As evidenced by this report, our community of continuing education providers has demonstrably improved collaborative care among healthcare professionals and patient outcomes. ANCC is so proud of the enthusiasm, commitment, and dedication that shines through in their examples. We hope that the stories and strategies provide both inspiration and practical tips for educators across the healthcare professions who are striving to benefit patients by building stronger teams.” — Kathy Chappell, PhD, RN, FNAP, FAAN, Senior Vice President, Certification/Measurement, Accreditation and Research, ANCC

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