Life Science Compliance Update

May 02, 2016

Do Gold-Standard CIAs Get Blue Ribbon Approval?

Corporate Integrity Agreements are thought to set the standard for compliance programs, but when viewed against the norms set out by a new report from the Ethics and Compliance Initiative's Blue Ribbon Panel, CIAs fall short. This article is the first in a series examining the gap between the compliance programs outlined in CIAs and the Blue Ribbon Panel ethics and compliance (E&C) guidelines, and what companies can do to move their program from a CIA-standards based program to a Blue Ribbon "high-quality" E&C program.

Corporate integrity agreements have long set the standard for comprehensive and effective compliance programs within the life science community. It also is where those seeking to stay ahead of government enforcement look for guidance on how to build their programs. Given that in the event of an investigation, federal officials will look for these elements, they are important considerations for companies looking to maintain an effective compliance program that is eligible for mitigating credit under the Federal Sentencing Guidelines. However, when viewed against the standards set out in the Ethics and Compliance Initiative's (ECI) new report, CIAs fall short of meeting the "exemplary" standard set out by the ECI's Blue Ribbon Panel of practitioners, former enforcement officials, academics, legal experts and public officials. The draft special report issued by ECI's Blue Ribbon Panel in December guides organizations wishing to improve their ethics and compliance ("E&C") programs, identifying what panelists believe to be the characteristics of "exemplary" E&C efforts.8 According to the Blue Ribbon Panel, there are five principles of a high-quality E&C program ("HQP")

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April 29, 2016

Medicare Access and Chip Reauthorization Act (MACRA) Proposed Rule, MIPS, APM’s and Advanced Care Information

The Centers for Medicare and Medicaid Services (CMS) released its proposed 962 page rule for the Medicare Access and CHIP Reauthorization Act (MACRA) of that links Medicare provider payments to quality patient care. The proposed regulation is the first major step taken by the government to implement the 2015 MACRA.

The proposed rule creates a "Quality Payment Program" to replace old reporting programs. There two tracks, the first called the Merit-based Incentive Payment System (MIPS) consolidates components of the Physician Quality Reporting System (PQRS), the Value-based Payment Modifier (VM), and the Medicare Electronic Health Record (EHR) Incentive Program. A second track involves alternative payment models (APM). Because of the high bar set to qualify for the APM track, CMS projects that only 30,000 to 90,000 clinicians will be in the APM track. An estimated 687,000 to 746,000 physicians will be in MIPS.

The program will begin grading physicians in 2017 for changes in their payments starting 2019.

Merit-based Incentive Payment System (MIPS)

CMS anticipates that most Medicare clinicians will initially participate in the Quality Payment Program through MIPS. CMS's is hopeful that the proposed rule would improve the relevancy and depth Medicare's quality-based payments and increase clinician flexibility by allowing clinicians to choose measures and activities appropriate to the type of care they provide.

CMS believes that MIPS allows Medicare clinicians to be paid for providing high value care through success in four performance categories: Quality, Advancing Care Information, Clinical Practice Improvement Activities, and Cost.

  • Quality (50 percent of total score in 2017): For this category, clinicians would choose to report six measures from among a list of options that accommodate differences among specialties and practices.
  • Advancing Care Information – Formerly Meaningful Use (25 percent of total score in 2017): For this category, clinicians would choose to report customizable measures that reflect how they use technology in their day-to-day practice, with a particular emphasis on interoperability and information exchange. Unlike the existing reporting program, this category would not require all-or-nothing EHR measurement or redundant quality reporting.
  • Clinical Practice Improvement Activities (15 percent of total score in 2017): This category would reward clinical practice improvements, such as activities focused on care coordination, beneficiary engagement, and patient safety. Clinicians may select activities that match their practices' goals from a list of more than 90 options.
  • Cost (10 percent of total score in 2017): For this category, the score would be based on Medicare claims, meaning no reporting requirements for clinicians. This category would use 40 episode-specific measures to account for differences among specialties.

Winners and Losers

CMS estimates that there will be significant winners and losers under MIPS with some classes of eligible providers receiving positive adjustments and some negative the range is staggering between 79% positive adjustments and 98% negative adjustments or penalties. CMS estimates that small and solo practices will be especially hard hit by penalties under MIPS with 87% of solo practices estimated to be penalized.

Estimated MIPS Adjustments

Winners 

Positive Adjustment 

Cardiology 

62.1% 

Endocrinology 

67.3%

Emergency Medicine 

64.0% 

Colorectal Surgeons 

59.7% 

Family Practice 

59.5% 

Gastroenterology 

61.5% 

Nurse Practitioners 

62.0% 

Pediatrics 

79.3% 

Physician Assistant 

67.1% 

Rheumatology 

67.7% 

Thoracic Cardiac Surgery 

61.8% 

Urology 

59.2% 

 

Negative Adjustment

Losers 

 

Chiropractors 

-98.4% 

Dentists 

-68.9% 

General Practice 

-69.4% 

Optometry 

-79.7% 

Podiatry 

-78.0% 

Plastic Surgery 

-65.4% 

Psychiatry  

-68.8% 

Physical Medicine 

-57.9% 

Source CMS MACRA Proposed Rule, Table 63, pages 672-675

Changes to Meaningful Use

One of the biggest changes as a result of the regulation could be the sunset of the Meaningful Use program through the "advancing care information" proposal (25 percent of the MIPS score). Under this new program, physicians will be allowed to select the measures that reflect how they use EHR technology and what suits their practices. CMS will no longer require all-or-nothing EHR measurement or quality reporting. The number of measures will be reduced from 18 to a new all-time low of 11. Reporting of clinical decision support and computerized physician order entry will no longer be required. EPs only have to report to a single public health immunization registry. Some physicians will also be exempt from reporting when EHR technology is less applicable.

The rule also emphasizes interoperability, information exchange and security measures and requires patients to have access to their health information through of APIs.

The program would align with the Office of the National Coordinator for Health IT's 2015 certification criteria. These changes apply to professionals in the Medicare Meaningful Use program; however, penalties for the program do not end until the end of 2018 (performance year 2016). But the proposed rules will not impact professionals in the Medicaid program or hospitals

Quality

Quality is 50 percent of the score and clinicians pick six measures from a range of options that accommodate different specialties and practice settings. The final 10 percent of the MIPS score in the first year is related to cost. The score would be based on Medicare claims and uses 40 episode-specific measures to account for differences among specialties.  There will also be significant credit given under MIPS for participation in an ACO or Patient Centered Medical Home,

Clinical Practice Improvement Activities and CME

Starting in 2017 (with payments in 2019 being impacted), the proposal outlines the four components of MIPS. MIPS is based on a 100 point score with clinical practice improvement activities (CPIA) representing 15 percent of the score. This is an area where CME should play an important role in helping CMS achieve its quality measure objectives. The proposed rule leaves great discretion to the Secretary of HHS to define what will be included in these activities. As stated in the rule's preamble: "Clinical Practice Improvement Activity (CPIA) means an activity that relevant eligible clinician organizations and other relevant stakeholders identify as improving clinical practice or care delivery and that the Secretary determines, when effectively executed, is likely to result in improved outcomes."

According to the statute, any CPIA measure must be "relevant to an existing CPIA subcategory (or a proposed new subcategory)" as defined in §414.1365. Unfortunately, those subcategories do not currently include a specific reference to medical education or a related area. The subcategories outlined in the proposed rule include: (1) expanded practice access; (2) population management; (3) care coordination; (4) beneficiary engagement; (5) patient safety and practice assessment; (6) participation in an APM; (7) achieving health equity; (8) emergency preparedness and response; and (9) integrated behavioral and mental health.

However, the language defining CPIA, and authority granted to the Secretary of HHS as proposed, offers an opportunity for advocates of CME to argue that CME should be included in the measurement category. In §414.1355, CMS proposes that CPIA be defined on an annual basis and must meet certain criteria – much of which aligns closely with the goals of CME. While CME may not be directly relevant to an existing CPIA subcategory, it does improve beneficiary outcomes, leads to practice improvement, can be performed by providers of all types, is feasible to implement, can be validated by CMS, and is evidence-based.

Even if no changes were made to the proposed rule, a strong case can be made before CMS as to why CME should be included in the CPIA score. But it would still be wise of CMS to expand the subcategories outlined in §414.1365 to include medical education through comments in the final rule.

Alternative Payment Models

CMS set a high bar on requirements for APM track. Under the agency's criteria for payment models to be eligible for the APM track—which CMS calls "Advanced APMs"—the Bundled Payments for Care Improvement (BPCI) Initiative, the Comprehensive Care for Joint Replacement (CJR) Model, and Track 1 of the Medicare Shared Savings Program (MSSP) all will not qualify as APM's under the proposed rule. However, MSSP Tracks 2 and 3, Next Generation, and Pioneer—which all require downside risk—will qualify.

The proposed rule confirms that only Part B (traditional) Medicare payments will count toward the Advanced APM threshold. Payments from Medicare Advantage plans can count toward the "Other Payer" threshold beginning in 2021, but only if those payments are made through models that meet Advanced APM requirements. The rule does not address whether CMS will allow Track 1 ACOs to switch MSSP tracks mid-participation agreement to join an Advanced APM.

To be considered an "Advanced APM", the model must meet three criteria: The APM must require participants to use certified EHR technology; the APM must provide for payment for covered professional services based on quality measures comparable to those in the quality performance category under MIPS; and the APM must either require that participating APM entities bear risk for monetary losses of a more than nominal amount under the APM, or be a Medical Home Model expanded under section 115A(c) of the Act.

Another critical area of the APM section involves the definitions that will be associated with "financial risk criterion" and in excess of "nominal amount". CMS writes that financial risk for monetary losses under an APM must be tied to performance under the model and cannot be solely indirect losses related to financial investments made by the APM entity. Nominal is intended to be "minimal in magnitude" but not "a mere formality." The agency describes as an example that the law was not intended to consider one dollar of risk to be more than nominal.

To address risk of a nominal amount, CMS measures three specific dimensions: (a) marginal risk, which is a common component of risk arrangements—particularly those that involve shared savings—that refers to the percentage of the amount by which actual expenditures exceed expected expenditures for which an APM entity would be liable under the APM; (b) minimum loss rate (MLR), which is a percentage by which actual expenditures may exceed expected expenditures without triggering financial risk; and (c) total potential risk, which refers to the maximum potential payment for which an APM entity could be liable under the APM. CMS also proposes that for a APM to meet the nominal amount standard the specific level of marginal risk must be at least 30 percent of losses in excess of expected expenditures, and a minimum loss rate, to the extent applicable, must be no greater than 4 percent of expected expenditures, and total potential risk must be at least 4 percent of expected expenditures.

Discussion

Welcome news is the elimination of the all or nothing criteria of the meaningful use program. The exclusion of most ACO's under Medicare shared shavings is probably the most controversial part of the proposed rule as health systems have invested millions in the current Medicare shared savings program. That CMS is estimating that 87% of solo practitioners will be paying a penalty will also not be well received. Under MIPS CMS is estimating that non MD providers with the exception of nurse practitioners and physician assistants fare the worst including Chiropractors, Podiatrists and Dentists. Overall the proposed rule creates and opportunity for input from stakeholders on the final version of MACRA. We will include further analysis of this rule in the days ahead.

Comments are due on June 27, 2016 To Submit Comments

MACRA Proposed Rule April 28 2016

April 28, 2016

US Senate Committee on Homeland Security, Hearing: America’s Insatiable Demand for Drugs

Prescription drugs have been in the news for months: pricing issues, transparency problems, and the presidential campaign have all been keeping pharmaceutical companies in the limelight. Now, the United States Senate Committee on Homeland Security and Governmental Affairs has decided to get in on the action. The Committee recently held a hearing, America's Insatiable Demand for Drugs. This particular hearing focused on border security and the growing epidemic of opioid abuse and heroin addictions that drive demand for drugs from South and Central America.

The Committee heard testimony from five witnesses: General John F. Kelly, USMC (Ret.), Former Commander of the United States Southern Command; Jonathan P. Caulkins, Stever Professor of Operations Research & Public Policy of Heinz College at Carnegie Mellon University; Cheryl Healton, the Dean of the College of Global Public Health at New York University; Tony Sgro, the Chief Executive Officer at EdVenture Partners; and Robert Budsock, the President and Chief Executive Officer of Integrity House, Inc.

Opening Statements

In his opening statement, Chairman Ron Johnson opined that "among many causes, the root cause of our insecure border is America's insatiable demand for drugs." He mentions the fact that despite spending "approximately $25 billion per year on our 'war on drugs,'" we "interdict less than 10 percent of illegal drugs coming across our southwest border and somewhere between 11 and 18 percent coming in through our maritime borders."

In his opening statement, Senator Thomas Carper discussed how the "American demand for heroin and other drugs … fuels the violent tactics of the traffickers who move drugs, goods, and people across our borders." Senator Carper also acknowledged that these problems are complex, and that potential solutions are not quick or easy, but that this Committee values identifying and addressing the root causes of America's demand for illegal drugs.

Both Chairman Johnson and Senator Carper acknowledged the dramatic and deadly effect American drug demand is having on American public health institutions, as well as Central and South American citizens.

Panel Discussion

Advertising Campaigns

Chairman Johnson mentioned that the impetus behind this hearing was a conversation he had with General John F. Kelly. General Kelly, who was also a witness to this hearing, testified as to his experiences combating drug trafficking as the former Commander of the United States Southern Command. During that conversation, General Kelly asked Chairman Johnson why the successes of the anti-tobacco campaigns had not yet been applied to opioid abuse awareness. Chairman Kelly did not have a good answer, and responded by holding this hearing with two advertising experts: Dr. Cheryl Healton and Mr. Tony Sgro.

Prior to her current position, Dr. Healton spent fourteen years at the Legacy Foundation, where she worked on the truth® campaign about youth tobacco usage. She spoke of the successes and the challenges behind that campaign, and warned that, while a similar campaign may be beneficial to the current opioid crisis, it would also likely not have the same result. This is especially due to the fact that opioid addiction is known for altering the mental state of patients. However, she did feel that it may have a large impact on youth who have never tried opioids.

Mr. Sgro, suggested that peer to peer advertising of staying away from drugs like opioids is the best plan of action. He opined that messages against drugs would be best received by youth if they were being offered by youth, especially through social media platforms. He suggested the idea of a national competition to create such a campaign, founded by Congress.

Industry Responsibility

As with many of the hearings on this topic, the pharmaceutical industry is expected to shoulder some future responsibility. Dr. Healton suggested that Congress fund a study on "the 'unintended' consequences of pharmaceutical misadventure in pushing pain analgesics that in turn lead to heroin addiction." She believes that if a child is given an opioid for things like dental surgeries and sports injuries, they and their parents both should be educated on the potential harms.

Mr. Budsock mentioned that he believes that one of the major contributing factors to this epidemic is "the over-prescription of addictive pain killers in America, and that funding effective treatment and recovery programs can help to reduce the demand for drugs.

Conclusion

There are likely to continue to be more hearings on the topic, by a variety of committees in Congress. It is likely that some form of action will be taken, once a consensus is reached within at least one committee, and we will see this problem continue to play out and try to be resolved through legislative means.

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