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.

Are the Safe Harbors Still Safe? - OIG Issues Final Rule

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The Department of Health and Human Services Office of Inspector General published a final rule, after considering various comments from stakeholders, about safe harbor provisions of the Anti-Kickback statute. This article goes into detail of what the changes were, and how they affect various health care providers.

On December 7, 2016, the Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) published a final rule, revising safe harbors under the Anti-Kickback Statute (“AKS”). At the same time, the OIG revised the definition of “remuneration” under the Civil Monetary Penalty (“CMP”) rules regarding beneficiary inducements. As has always been the case, the safe harbor revisions will prevent certain initiatives of doctors, hospitals, and pharmacies from being treated as fraudulent kickbacks by Medicare and Medicaid. The final rule took effect January 6, 2017.

Read the full article in the February 2017 issue of Life Science Compliance Update

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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.

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