Life Science Compliance Update

December 14, 2017

Medical Societies Ask Congress to Preserve Patient Access to Critical Part B Therapies



Eleven medical societies – including the American College of Rheumatology, American Academy of Ophthalmology, American Society of Clinical Oncology and American Urological Association – are urging congressional leaders to preserve patients’ access to critical Part B drug treatments by preventing the Centers for Medicare & Medicaid Services (CMS) from penalizing physicians for providing high-quality care.


The societies recently sent a joint letter to the chairs and ranking members of the Senate Finance Committee, the House Ways & Means Committee, and the House Energy & Commerce Committee. In the letters, the groups warn of serious impacts to patient access to care should Congress fail to prevent CMS from applying Merit-based Incentive Payment System (MIPS) adjustments to Part B drug payments. They argue that it could jeopardize patients in the communities most in need of access to these important treatments.


“This policy will negatively impact patients’ access to critical life- and sight-saving treatments,” the letter states, as it would put at risk the ability of specialists to provide the physician-administered drugs on which their patients depend. Drugs covered under Medicare Part B include therapies that are typically administered by a physician, either in an independent practice or hospital outpatient setting. They are not generally available at pharmacies and are not part of Medicare Part D prescription drug plans. 


The letter alleges that the policy is “not consistent with Congressional goals in the bipartisan passage of the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA). Under MACRA, Congress established a range of bonuses and penalties to which Medicare providers could be subjected through MIPS payment adjustments. In its 2018 Quality Payment Program final rule, CMS announced that it will begin to impose these payment adjustments to Part B drug payments in addition to physicians’ services under the Medicare fee schedule, a decision that represents a significant departure from current policy.


The current Part B drug payment structure already makes it difficult for certain providers (especially small and rural providers) to shoulder the financial burden of procuring and administering expensive Part B drugs. The new MIPS policy change would only worsen this problem by creating extreme volatility and financial uncertainty for physicians who administer these therapies.  


“While we had substantial and bipartisan Congressional support for a message to CMS to reevaluate their interpretation of the MACRA statute, CMS did not heed that request. We now need Congress to act immediately to curtail this policy and ensure patients have access to all the services and treatments they need,” the letter states.


The letter also urges Congressional leaders to address the weighing of the MIPS cost score category.


“CMS has not outlined sound methodologies for risk adjustment for physicians with patient populations at risk for high resource use, and cost measures necessary under MIPS are still under development. Work remains to ensure that the new measures are developed and integrated in a way that accurately reflects the complexities of cost measurement and does not inadvertently discourage clinicians from caring for high-risk and medically complex patients. We believe that these methodologies and measures must be developed and validated before CMS moves forward with implementing this category,” the letter states.


The letter concludes with the following statement, “[t]aken together, these two issues could create a perfect storm for specialties whose patients depend on physician-administered drugs. We stand ready to work with you on ensuring the implementation of MACRA is successful.”

November 16, 2017

CMS RFI Issued Regarding CMMI and Payment Models


In September, CMS issued a "request for information" (RFI) to solicit new ideas that will revamp CMS' Center for Medicare and Medicaid Innovation (CMMI) and the payment models the center creates. Specifically, CMS “is seeking your feedback on a new direction to promote patient-centered care and test market-driven reforms that empower beneficiaries as consumers, provide price transparency, increase choices and competition to drive quality, reduce costs, and improve outcomes.”

New Model Design

According to the RFI, CMMI will approach new model design with several guiding principles:

  1. Choice and competition in the market – Promote competition based on quality, outcomes, and costs.
  1. Provider Choice and Incentives – Focus on voluntary models, with defined and reasonable control groups or comparison populations, to the extent possible, and reduce burdensome requirements and unnecessary regulations to allow physicians and other providers to focus on providing high-quality healthcare to their patients. Give beneficiaries and healthcare providers the tools and information they need to make decisions that work best for them.
  1. Patient-centered care – Empower beneficiaries, their families, and caregivers to take ownership of their health and ensure that they have the flexibility and information to make choices as they seek care across the care continuum.
  1. Benefit design and price transparency – Use data-driven insights to ensure cost-effective care that also leads to improvements in beneficiary outcomes.
  1. Transparent model design and evaluation – Draw on partnerships and collaborations with public stakeholders and harness ideas from a broad range of organizations and individuals across the country.
  1. Small Scale Testing – Test smaller scale models that may be scaled if they meet the requirements for expansion under 1115 A(c) of the Affordable Care Act (the Act). Focus on key payment interventions rather than on specific devices or equipment.

CMMI states that it is looking to test models in eight focus areas: (1) Increased participation in Advanced Alternative Payment Models (APMs); (2) Consumer-Directed Care & Market-Based Innovation Models; (3) Physician Specialty Models; (4) Prescription Drug Models; (5) Medicare Advantage (MA) Innovation Models; (6) State-Based and Local Innovation, including Medicaid-focused Models; (7) Mental and Behavioral Health Models; and (8) Program Integrity. However, the Innovation Center may also test models in other areas.

New Direction

In August, after delaying several mandatory bundled payment models, CMS ultimately proposed to scale back the Comprehensive Care for Joint Replacement (“CJR”) Model, a bundled payment program for hip and knee replacement implemented by the Obama Administration, and eliminate the Episode Payment Models and Cardiac Rehabilitation Incentive Payment Model scheduled to begin on January 1, 2018.

In a Wall Street Journal op-ed announcing the RFI, Administrator Verma noted the following: “Clinicians, patients, entrepreneurs, state officials and others are busy designing new and better ways to provide health care. There are a lot of great ideas, and we want to hear from people on the front lines. No government agency has all of the answers, especially in an industry as large and multifaceted as health care.”

As has been previously noted, accountable care organizations, hospitals, and primary care providers were not mentioned at all in the RFI. This is a major shift in focus from an agency that once championed these care settings. This lack of inclusion gives one reason to believe that bundled payments will not only continue, but will be underscored as viable paths for physicians’ success under the MACRA alternative payment model track. In addition to a shift in focus of providers, discussion in the RFI of the Physician-Focused Payment Model Technical Advisory Committee (PTAC) initiative, centered on developing physician-driven APMs, indicate that CMMI will much more focused on specialty care and specialty physicians.

November 13, 2017

Accountable Care Organization Performance Results


2016 was the fifth performance year for the Medicare Shared Savings Program (MSSP). 2016 brought $652 million in savings to Medicare via Accountable Care Organizations, according to the Health Care Transformation Task Force.

The Shared Savings Program offers providers and suppliers (e.g., physicians, hospitals, and others involved in patient care) an opportunity to create a new type of health care entity, an Accountable Care Organization (ACO). An ACO agrees to be held accountable for the quality, cost, and experience of care of an assigned Medicare fee-for-service (FFS) beneficiary population. The Shared Savings Program has different tracks that allow ACOs to select an arrangement that makes the most sense for their organization.

Roughly one-third of MSSP ACOs generated savings in 2016, according to CMS data. In terms of quality, 330 of the 428 ACOs subject to pay-for-performance measures earned an average quality score of 94 percent. Ninety-eight of the ACOs garnered a 100 percent quality score. Overall, the average performance score improved by more than 10 percent across five measures: screening for fall risk, depression screening and follow-up, high blood pressure screening and follow-up, hemoglobin checks for diabetic patients, and diabetes eye exams.

ACOs that have been in MSSP since 2012 and 2013 accounted for $503 million in gross savings. The newer the participants, the less money they saved: ACOs that entered in 2014 saved $94 million, 2015 entrants saved $50 million and the 100 ACOs that entered MSSP in 2016 saved only $6 million.

The 2012 and 2013 ACOs received $351 million in shared savings payments, leaving the remaining $151 million as savings for CMS. That’s in contrast to 2015, when CMS spent $217 million more in awarding bonuses to ACOs in both the MSSP and Pioneer ACO programs than what participants were projected to have saved.

“These results demonstrate the promise of new models of care delivery and financing for improving patient outcomes and reducing spending,” stated David Lansky, Health Care Transformation Task Force Chair. “This provides further evidence that we need more, not less, public and private sector investigation of alternatives to traditional fee-for-service medicine.”

MSSP ACOs in the program for at least three years also decreased costs by an average of $10.1 million per organization in 2015. In comparison, MSSP ACOs just starting the program only cut costs by an average of $5.4 million per organization.

The top ten ACOs with the highest shared savings in 2016 were:

  1. Palm Beach ACO (Palm Springs, Fla.): $30,540,508
    2. Advocate Physician Partners Accountable Care (Rolling Meadows, Ill.): $28,924,272
    3. Hackensack (N.J.) Alliance ACO: $22,835,022
    4. USMM Accountable Care Partners (Troy, Mich.): $21,195,787
    5. AMITA Health ACO (Arlington Heights, Ill.): $20,489,157
    6. Cleveland Clinic Medicare ACO: $19,914,592
    7. Millennium ACO (Fort Myers, Fla.): $18,530,680
    8. UT Southwestern Accountable Care Network (Dallas): $17,464,034
    9. Memorial Hermann ACO (Houston): $14,025,212
    10. Orange Accountable Care of South Florida (Miami Lakes, Fla.): $13,033,788


Preview | Powered by FeedBlitz


March 2018
Sun Mon Tue Wed Thu Fri Sat
1 2 3
4 5 6 7 8 9 10
11 12 13 14 15 16 17
18 19 20 21 22 23 24
25 26 27 28 29 30 31