Shruti Barker

Shruti Barker

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Medicare Policies Modified to Support Smart Devices Use for Sharing Glucose Data

The Centers for Medicare & Medicaid Services (CMS) recently announced that Medicare coverage policies would be revised “to support the use of [continuous glucose monitors] in conjunction with a smartphone, including the important data sharing function they provide for patients and their families.” In turn, the agency’s contractors, known as Medicare Administrative Contractors (MACs), modified … Continue Reading

CMS Releases Instructions on PAMA Data Reporting

The Centers for Medicare & Medicaid Services (CMS) has now launched the new data reporting process for laboratories under the Protecting Access to Medicare Act (PAMA). Under CMS’s final PAMA rule, applicable laboratories must report private payor rates and other applicable information for certain clinical laboratory tests from a specified six-month data collection period. Additional … Continue Reading

CMS Publishes Final Rule to Implement PAMA’s Changes to Laboratory Test Reimbursement

Last week, the Centers for Medicare & Medicaid Services (“CMS”) published in the Federal Register its long-awaited final rule implementing the significant payment and related changes for clinical diagnostic laboratory tests under the Medicare Clinical Laboratory Fee Schedule.  The changes were directed by the Protecting Access to Medicare Act of 2014 (“PAMA”), which establishes a new … Continue Reading

FDA Releases Draft Guidance on IDE Device Categorization to Assist CMS Coverage Decisionmaking

Last week, the FDA issued draft guidance modifying its current policy on categorizing Investigational Device Exemption (“IDE”) devices, in support of the Centers for Medicare & Medicaid Services’ (“CMS’s”) Medicare coverage decisions.  The guidance is intended to implement a Memorandum of Understanding (“MOU”) between the agencies to streamline and facilitate efficient categorization.  FDA requested that … Continue Reading

Obama Administration Releases Final Data Security Policy Principles and Framework for Its Precision Medicine Initiative

As the White House continues to build out the details for the Precision Medicine Initiative (“PMI”), on May 25, 2016 it released a final set of principles on data security.  In a document that “provides a broad framework for protecting participants’ data and resources in an appropriate and ethical manner,” eight overarching data security policy … Continue Reading

The Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests Convenes its Inaugural Meeting

On August 26, 2015, the Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests (hereinafter the “Panel”) held its inaugural meeting.  The Panel was established by the Secretary of Health and Human Services under the authority of Section 216 of the Protecting Access to Medicare Act of 2014 (“PAMA”), which prescribes a new market-based payment system … Continue Reading
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