Pricing & Reimbursement

Industry: U.S. Implementation of ICD-10 Should Stay on Track

Devicemakers are urging the U.S. Congress not to delay ICD-10 implementation again, saying the new diagnostic codes are more precise and will allow healthcare providers to better track patient outcomes — resulting in savings for the Medicare payment program. Read More

Expert: Optimize Trials as CMS Coverage Narrows

The U.S. Centers for Medicare & Medicaid Services increasingly wants to see evidence of positive outcomes before it will cover a medical product, according to a new study that found recent coverage determinations 20 times less likely to be positive than in the past. Read More

Tests Could Double Diagnoses of Heart Attacks in Women: Study

New research suggests that high-sensitivity tests that measure the level of troponin protein in the blood may detect twice as many heart attacks in women as current standard tests, bringing rates in line with those of men. Read More

TGA Urged to Make LVT Turnover Scheme More Small Biz Friendly

Devicemakers are urging the Therapeutic Goods Administration to amend its low-value turnover exemption scheme for entries in the Australian Register of Therapeutic Goods to allow more small businesses to take advantage of it. Read More

FDA, CMS Approve First Product Under Pilot Joint Parallel Review Program

The FDA and Centers for Medicare & Medicaid Services have approved the first product ever under the two agencies’ joint pilot program for parallel review – Exact Sciences’ Cologuard, a noninvasive screening test for colorectal cancer. Read More

Draft Rule to Expand DME Competitive Bidding Could Cut Deep into Profits

Manufacturers of some types of durable medical equipment could see their Medicare and Medicaid reimbursement rates cut by more than a third if a proposed rule to expand the government’s DMEPOS competitive bidding program nationally takes effect. Read More

UK Watchdog Suggests Burden of Illness As Key HTA Factor

A new UK proposal would allow the country’s healthcare administration to consider “burden of illness” as a measurable component when assessing new medical products for government reimbursement. Read More

CMS Weighs Changes, Expansion of DMEPOS Competitive Bidding

The Centers for Medicare & Medicaid Services seeks industry input as it considers new payment rules and an expansion of the competitive bidding program for durable medical equipment and enteral nutrients, supplies and equipment. Read More

EU Pilot Aims to Curb Coverage Delays of Novel Technologies

Proving a novel medical device is safe and effective is only half the battle in bringing it to market. Read More