Articles and Blogs

When you purchase an item, you assume that it can be used in any reasonable manner and the warranties will apply.  The same is true of buyers of medical products.  Take the humble tongue depressor.  Regulated by the Food and Drug Administration (“FDA”) pursuant to 21 C.F.R. § 800.6230, the tongue depressor is “…a device…Read More

Under the Americans with Disabilities Act (“ADA”)1,health care providers have an obligation to provide the deaf and hard of hearing with auxiliary aids needed to access and understand aural information and to engage in effective communication.2  Auxiliary aids include, among other things, qualified interpreters.  Under federal law, a “qualified interpreter” is defined as an interpreter…Read More

On April 9, 2013, the Centers for Medicare & Medicaid Services (“CMS”) announced the contract winners for Round 2 of the Durable Medical Equipment, Prosthetics, Orthotics and Supplies (“DMEPOS”) Competitive Bidding Program.  This article is intended to answer some frequently asked questions about the Round 2 Competitive Bidding Program and the effect on referral agents.

In a transmittal issued on April 5, 2013, CMS provided guidance on survey activities that will be affected by the sequestration cuts.  The transmittal provides guidance on several areas that will have an immediate and potentially negative effect on nursing homes and post-acute care providers.  These changes will affect the survey process as conducted by the state survey agencies.

The Centers for Medicare and Medicaid Services (“CMS”) announced today the contract suppliers for Round 2 and the national mail-order program of the Medicare Durable Medical Equipment, Prosthetics, Orthotics and Supplies (“DMEPOS”) Competitive Bidding Program. As of April 9, 2013, there are 799 suppliers that have been awarded contracts in this round, and these contracts will affect suppliers…Read More

The Centers for Medicare & Medicaid Services and Department of Health and Human Services Office of Inspector General have released a set of proposed regulations that extend the existing protection from the Anti-Kickback Statute and physician self-referral law (Stark Law) for donations of electronic health records.

On February 7, 2013, the United States Health Resources and Services Administration (“HRSA”) released guidance entitled “Statutory Prohibition on Group Purchasing Organization Participation” (“GPO Exclusion Guidance”).  This guidance addresses requirements related to drugs purchased at a discount under the 340B Program by hospitals subject to the 340B Program GPO exclusion restriction.  These include disproportionate share…Read More

The final rule for Stage 2 of Meaningful Use (“MU”) included an outline of the timeline for reviewing and publishing updates to the Clinical Quality Measure (“CQM”) specifications used in the EHR Incentive Program with the determination that the specifications should be updated more frequently than the rulemaking cycle for the Medicare and Medicaid EHR…Read More

ONC is seeking comments on how ONC and CMS policies could result in routine exchange of patient clinical data across care settings.  The deadline to submit comments is April 22, 2013. Click here for more information and procedures for comment submission. Should you have questions, please contact Alisa Kuehn at akuehn@hallrender.com or (317) 977-1475.

The ONC has made available on its website (healthit.gov) a variety of resources to assist those working toward Meaningful Use.  Below are links to a few of these resources: Click here for information on attestation, tipsheets, FAQs, tools and regulations related to Meaningful Use Stage 2. Click here to access the 2014 Edition Test Method…Read More