Life Science Compliance Update

February 24, 2017

Medical Device Parallel Review Program Made Permanent

My-review

A few months back, the U.S. Food and Drug Administration and the Centers for Medicare & Medicaid Services announced they are making permanent their “Program for Parallel Review of Medical Devices,” which is now operating as a pilot program.  The parallel review initiative allows concurrent FDA and CMS review of a medical device with the goal of reducing the time between FDA marketing approval or granting of a de novo request and Medicare coverage decisions, thereby “facilitating earlier access to innovative medical technologies for Medicare beneficiaries.”

Announcement of Extension

In the notice announcing the extension of the parallel review program, the agencies observe that the pilot program benefitted manufacturers by providing feedback to help design pivotal trials that can answer both agencies’ evidentiary questions. The notice also cites the program’s success in facilitating issuance of a Medicare national coverage determination less than two months after a medical technology received FDA premarket approval. The agencies are soliciting nominations from manufacturers of additional innovative medical devices to participate in the parallel review program. However, the agencies will only accept five candidates per year.  

Federal Register

In the official announcement, FDA and CMS describe the Parallel Review program is a collaborative effort that is intended to reduce the time between FDA marketing approval or FDA’s granting of a de novo request and Medicare coverage decisions through CMS’s National Coverage Determination (NCD) process. This program is intended to ensure prompt and efficient patient access to safe and effective and appropriate medical devices for the Medicare population

Parallel Review allows both FDA and CMS to review information about a medical device concurrently, rather than sequentially, while continuing to make their premarket review and coverage decisions consistent with their respective statutory authority. FDA works to ensure that only safe and effective medical devices are marketed in the United States. CMS makes coverage decisions for medical technologies, which are reasonable and necessary for the Medicare population. Neither FDA’s premarket review criteria nor CMS’s coverage processes criteria change when a medical device is accepted into the parallel review program.

Lessons Learned From the Parallel Review Pilot Program

The FDA and CMS write that they learned two primary lessons from the Parallel Review pilot program. First, they found that manufacturers benefit from engaging both Agencies at the pivotal clinical trial design phase. The feedback that manufacturers receive from both Agencies at the pivotal clinical trial design stage can assist manufacturers in designing pivotal trials that can answer both Agencies’ evidentiary questions. Thus, it is more likely that manufacturers will only need to conduct a single pivotal clinical study rather than several pivotal clinical studies to satisfy both Agencies. Second, concurrent review by the Agencies of clinical evidence can reduce the time from FDA premarket approval or the granting of a de novo request to an NCD. For example, on August 11, 2014, FDA approved a medical device that was part of the Parallel Review Pilot Program. On the same day, CMS initiated its national coverage analysis (NCA). CMS published a favorable final NCD on October 9, 2014, less than 2 months after the medical device received its premarket approval and 7 months before the NCD statutory due date.

Parallel Review Process

The program has two stages: (1) The pivotal clinical trial design development stage, and (2) the concurrent evidentiary review stage. The manufacturer should submit a request for parallel review prior to the start of the first stage by sending an email to Parallel-Review@ fda.hhs.gov, which indicates their interest in the program and includes the following information:

  1. Nomination of manufacturer:
  • Name of the manufacturer and relevant contact information;
  • name of the product;
  • succinct description of the technology and disease or condition the device is intended to diagnose or treat; and
  • state of development of the technology (that is, in pre-clinical testing, in clinical trials, currently undergoing premarket review by FDA)
  1. A statement that the manufacturer intends to meet jointly with FDA and CMS using FDA’s Pre-Submission program, or other mechanisms that allow for meetings of the three parties to gather and incorporate feedback from both Agencies about the design and analysis of their pivotal clinical trial, to support a marketing application and a National Coverage Determination.
  1. A statement that the medical device will require an original or supplemental application for premarket approval (PMA) or the granting of an FDA de novo request.
  1. The medical device is not excluded by statute from Part A and/or Part B Medicare coverage (and the request for parallel review includes a list of Part A and/or Part B Medicare benefit categories, as applicable, into which the manufacturer believes the medical device falls).
  1. A statement that the medical device addresses the public health needs of the Medicare population (and the request for parallel review includes an explanation of how).

Upon completion of the pivotal trial and submission of an original or supplemental PMA, or a de novo request, the Agencies intend to review the pivotal clinical trial evidence concurrently. Both Agencies will independently review the data to determine whether it meets their respective Agency’s standards and communicate with the manufacturer during their respective reviews.

February 23, 2017

Providers May Have More Time to Submit Electronic Clinical Quality Measures

Imgres

Eligible hospitals and critical access hospitals participating in the Hospital Inpatient Quality Reporting program and/or the Medicare EHR Incentive Program will have extra time for submission of electronic clinical quality measures. In a January 17, 2017 blog post, Kate Goodrich, MD, director of CMS' Center for Clinical Standards and Quality, said those hospitals submitting eCQM data for the 2016 reporting period (pertaining to the FY 2018 payment determination) will now have until Monday, March 13, at 11:59 p.m. PT, rather than the last day of February.

Inpatient Prospective Payment System

CMS also has plans to make some modifications to eCQM requirements as laid out in the FY 2017 Inpatient Prospective Payment System final rule. According to CMS, in order to help reduce reporting burdens while supporting the long-term goals of these programs, it intend to include proposals regarding the 2017 eCQM reporting requirements for the Hospital IQR and EHR Incentive Programs for eligible hospitals and critical access hospitals in the FY 2018 IPPS proposed rule that we anticipate to be published in the late spring of 2017.

Specifically, in the FY 2018 IPPS proposed rule, CMS plans to address stakeholder concerns regarding challenges associated with hospitals transitioning to new EHR systems or products, upgrading to EHR technology certified to the 2015 Edition, modifying workflows, and addressing data element mapping, as well as the time allotted for hospitals to incorporate updates to eCQM specifications in 2017. CMS is also considering to propose in future rulemaking to modify the number of eCQMs required to be reported for 2017 as well as to shorten the eCQM reporting period.

Goodrich said CMS is also mulling a modification of the number of eCQMs that have to reported for 2017, and a potential shortening of the reporting period.

"We believe that these efforts reflect the commitment of CMS to create a health information technology infrastructure that elevates patient-centered care, improves health outcomes, and supports the healthcare providers who care for patients," she wrote. "We continuously strive to work in partnership with hospitals and the provider community to improve quality of care and health outcomes of patients, reduce cost, and increase access to care."

Hospital Outpatient Prospective Payment System

This comes as the final Hospital Outpatient Prospective Payment System rule for 2017 unveiled eased several requirements for participants in the Meaningful Use program. For 2016 and 2017, all returning participants to the program will only have to attest to the meaningful use of electronic health records for 90 consecutive days, as opposed to an entire year. CMS, in its proposed rule, called for a shortened reporting period for eligible providers (EP), eligible hospitals (EH) and critical access hospitals (CAH).

The rule also eliminates clinical decision support and computerized order entry objectives for EHs and CAHs under the Medicare EHR Incentive Program beginning in 2017. What’s more, CMS is finalizing an application process for a one-time significant hardship exception for EPs from penalties in 2018. The hardship is available to EPs new to the EHR program and who are transitioning to the Merit-Based Incentive Payment System (MIPS) under the Medicare Access and CHIP Reauthorization Act (MACRA). Additionally, CMS notes that providers must demonstrate as part of Modified Stage 2 and Stage 3 of Meaningful Use that only a single patient viewed, downloaded and transmitted their records.

“These additions both increase flexibility, lower the reporting burden for providers and focus on the exchange of health information and using technology to support care,” CMS says in its announcement for the rule.

February 21, 2017

CMS Releases Report to Congress on CMMI

Patrick-Conway-MD

The Centers for Medicare and Medicaid Services (CMS) released a new report to Congress prepared by the CMS Innovation Center (CMMI) highlighting its achievements since its start in 2010 and laying out plans for implementation of future models. In conjunction with the report to Congress, Dr. Patrick Conway, Acting CMS Principal Deputy Administrator, published a blog post on the CMS website, highlighting the CMMI.

According to both the report and the blog post:

  • Over 30 new payment models have been launched over the past six years;
  • Investments in electronic medical records and a data and analytics infrastructure are sparking a new set of innovative companies;
  • The CMS Innovation Center’s portfolio of models has attracted participation from a broad array of health care providers, states, payers, and other partners. An estimated 18 million individuals, including CMS beneficiaries and individuals with private insurance included in multi-payer models, have been impacted by, have received care, or will soon be receiving care furnished by more than 207,000 health care providers participating in CMS Innovation Center payment and service delivery models and initiatives. These models are delivering care to people in every state across the nation;
  • Medicare exceeded – earlier than predicted – the goal to tie more than 30 percent of fee-for-service payments by the end of 2016 through alternative payment models to quality and cost metrics. Medicare is on pace to reach 50 percent by the end of 2018.

The future is also bright for CMMI, as there are several initiatives on the horizon, including:

  • The Medicare Diabetes Prevention Program expanded model, set to begin in 2018, will pay for services to prevent the onset of diabetes to all eligible Medicare beneficiaries, improving their health and that of the Medicare program both now and in the future. It is estimated that Medicare spent $42 billion in 2016 on fee-for-service, non-dual eligible, over age 65 beneficiaries with diabetes.
  • Three new payment models—the Acute Myocardial Infarction Model, the Coronary Artery Bypass Graft Model, and the Cardiac Rehabilitation Incentive Payment Model—will support clinicians in providing care to patients who receive treatment for heart attacks, heart surgery to bypass blocked coronary arteries, or cardiac rehabilitation.
  • Through the Comprehensive Primary Care Plus Model, primary care doctors can care for their patients the way they think will deliver the best outcomes, and they’ll get paid for achieving results and improving care.
  • One new payment model—the Surgical Hip and Femur Fracture Treatment Model—will support clinicians in providing care to patients who undergo surgery after a hip or femur fracture beyond hip replacement. In addition, updates have been finalized to the Comprehensive Care for Joint Replacement Model, which began in April 2016.
  • The Accountable Health Communities Model, beginning in 2017, will test whether increased awareness of and access to services addressing health-related social needs will impact total health care costs and improve health and quality of care for Medicare and Medicaid beneficiaries in selected communities.
  • Thirty-eight states and territories are engaged in the State Innovation Models initiative where they are testing their own best ideas to improve health, quality of care, and lower costs. Additionally, Vermont and Maryland have entered into global payment arrangements to improve care for the whole state’s population.

CMMI has recently announced more than five new or re-opened opportunities for clinicians to join Advanced Alternative Payment Models. CMS expects 125,000 to 250,000 clinicians to be participating in Advanced Alternative Payment Models by 2018. CMMI and CMS will continue to develop new payment models, guided by the following core principles: Supporting innovative payment and service delivery models with strong potential to improve health care quality and lower costs; engaging with and listening to consumers, providers, and other stakeholders allowing for open and transparent dialogue, including through the appropriate use of notice-and-comment rulemaking and ombudsmen; and evaluating results based on appropriately scoped and sized demonstrations and advancing best practices based on their impact on quality and cost.

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