Technology

CMS Proposes Clarified Medicare Coverage “Reasonable and Necessary” Criteria for Breakthrough Devices

On Sept. 1, CMS proposed a new rule that would, among other things, shed some light on an issue that has been a perennial compliance and reimbursement stumbling block for developers of new lab tests: … [Read more...]

PANDEMIC

Hospitals, Labs, LTCs Face Big Fines for Failing to Meet New CMS COVID-19 Test Daily Reporting Rules

Nursing and other long-term care (LTC) facilities have been a hotspot for COVID-19 infection since the public health emergency began. On Aug. 27, CMS issued a new Interim rule requiring LTC facilities … [Read more...]

Stark Law

CMS Proposes to Peel Back Restrictions on Physician Owned Hospital Expansions

From the onset, the Administration has assigned a high priority to loosening Stark Law and Anti-Kickback Statute (AKS) restrictions. And now CMS has floated two new proposals allowing for greater … [Read more...]

Fee Schedules

2021 Medicare Physician Fee Schedule Slashes Lab Reimbursements 5% but Provides Some PAMA Relief

On Aug. 3, CMS released the proposed Medicare Physician Fee Schedule (PFS) rule for 2021. Bottom line on top: The agency is slashing lab reimbursement rates. Here are the four key takeaways for labs. … [Read more...]

Medicare Reimbursement

The 4 Things Labs Need to Know about CMS’ Newly Proposed 2021 OPPS Rule 

On Aug. 4, CMS posted the proposed Outpatient Prospective Payment System (OPPS) Rule for 2021.  In case you don’t feel like reading all 785 pages of the Rule, here’s a high level summary of the four … [Read more...]

New Laws

January 1, 2021 Is D-Day for Hospital Pricing Transparency 

It appears to be full speed ahead for hospital price transparency. The controversial effort to make hospitals divulge information about their healthcare pricing, including lab procedures, is very much … [Read more...]

In the News

Healthcare Organizations Call for Quick Action on Kickback Law Changes

Labs and the health industry have been waiting for years for some Stark Law and Anti-Kickback Statute (AKS) relief. Last October, HHS, CMS and the OIG finally unveiled the long-awaited plans to … [Read more...]

Reimbursement

OIG Medicare Lab Spending Report May Warn of Greater Scrutiny of Genetic and Automated Chemistry Tests

PAMA and market-based rate reductions for lab testing was supposed to save Medicare bundles of money. But according to a new OIG report, Medicare Part B spending on lab spending for 2018, the first … [Read more...]

Labs In Court

A roundup of recent cases and enforcement actions involving the diagnostics industry

Case: CMS revoked an Arizona lab’s CLIA certification in 2000. Three unsuccessful appeals and one failed petition to the U.S. Supreme Court later—eight years in total—the seven CLIA deficiencies, … [Read more...]

Labs In Court

Arizona Lab’s 20-Year Quest to Regain CLIA Certification Comes Up Empty

Case: CMS revoked an Arizona lab’s CLIA certification in 2000. Three unsuccessful appeals and one failed petition to the U.S. Supreme Court later—eight years in total—the seven CLIA deficiencies, … [Read more...]


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