Showing 41 - 60 of 83 search resultsTo further refine your results, please use quotation marks to search for an exact phrase (e.g. “class action”).
Viewpoint
Health Care Congressional Outlook for the June Work Period
… bills, and work on that is expected to resume this week. 21st Century Cures The Senate’s version of the 21st Century Cures Act has …
Viewpoint
ML Strategies Health Care Congressional Outlook
… this summer. The Senate continues its work on the 21 st Century Cures Act , but funding issues continue to hamper progress. … preview, please click here . June 08, 2016 Blog Health Care 21st Century Cures Health Care Congressional Outlook mental …
Viewpoint
Information Blocking Rule: Key Considerations for 2022
… for Health Information Technology (ONC) issued the 21st Century Cures Act; Interoperability, Information Blocking, and the …
Viewpoint
Next Steps for 21st Century Cures 2.0
… Next Steps for 21st Century Cures 2.0 On Monday, April 27, Representatives Diana DeGette … that will build on the original 21st Century Cures Act enacted in December 2016 (Cures 1.0). While Cures 1.0 …
Viewpoint
CMS's Advance Notice and Call Letter: How Medicare Plans Can Report, Identify, and Address the Opioid Epidemic
… to substance use disorders, as required by the 21 st Century Cures Act. CMS proposed renaming HCC 55 to be “Drug/Alcohol …
Viewpoint
Bah, Humbug! HIPAA Compliance Isn’t Getting Any Easier
… of health information security and ratcheted up the fear factor associated with its HIPAA Breach Reporting Tool … the nation’s current opioid crisis and implement the 21 st Century Cures Act. These tools support critical federal policy …
Viewpoint
OIG Publishes Online Portfolio Highlighting its Body of Work on Drug Pricing and Reimbursement
… it also highlights OIG’s work that has yet to result in any action. The OIG portfolio contains five substantive … an ASP-based methodology, implemented through the 21 st Century Cures Act. The Recommendations section lists ten specific …
Viewpoint
CMS’s Draft 2018 Call Letter: Minor Updates, but Largely a Continuation of Current Policies
… Program.” Of note, CMS is also determining whether the 21st Century Cures Act may impact the pricing. 2018 Star Rating Updates …
Viewpoint
Flash: What the Election Means for Health Care
… in lame duck: There are two major outstanding issues, the 21st Century CURES Act and mental health legislation. Republicans will …
Viewpoint
Evolution & Revolution: Device Policy Priorities at FDA in 2019
… types of CDS were exempted from FDA oversight in the 2016 21st Century Cures Act (Cures Act). In the revised CDS draft guidance …
Viewpoint
FDA Convenes Two-Day Public Hearing on Human Cell and Tissue Product Regulatory Paradigm
… Act to the biomedical innovation package contained in the 21st Century Cures Act (H.R. 6), which was passed by the House in July of …
Viewpoint
Privacy and Security Round-up – Colorado Data Breach Law, Guidance from OCR
… or military identification number; or a financial transaction device. In addition, the law requires entities to … for future research. The guidance was mandated by the 21 st Century Cures Act, which required HHS to issue clarifications on how …
Viewpoint
ML Strategies Provides Outlooks for Fall & Lame Duck
… remains unchanged. The Senate version of the House-passed Cures package is still in limbo, and mental health reform is … mental health package, there is momentum behind the effort. 21st Century Cures : While securing passage this summer for the …
Viewpoint
Strategies to Unlock AI's Potential in Health Care, Part 2: FDA’s Approach to Protecting Patients & Promoting Innovation
… Congress liked what FDA was doing so much that in the 21st Century Cures Act certain software functionality was deleted from …
Viewpoint
HHS Proposes Sweeping Changes to AKS and Stark Law, Part 2: Cybersecurity Technology and Electronic Health Records
… blocking definition in the implementing regulations for the 21st Century Cures Act, which sets forth a knowledge standard such that a …
Viewpoint
ONC Publishes Report, Commentary on Information Blocking Rule Claims Trends
… in the Information Blocking Final Rule involved. While the 21st Century Cures Act (Cures Act) allows OIG to investigate any …
Viewpoint
What to Expect at FDA Following Commissioner Gottlieb's Departure
… the past few years to set the FDA’s agenda by passing the 21st Century Cures Act and other laws that include programmatic and …
Viewpoint
CMS Proposes Changes to Medicare Advantage Program for CY 2020
… misuse. Risk Adjustment Payments By way of background, the 21st Century Cures Act requires CMS to update the risk adjustment model …
Viewpoint
Drop in Warning Letters for Medical Devices Raises Interesting Questions About the Industry
… of the changes in 2017 were prompted by the passage of the 21st Century Cures Act, which exempted certain software products from the …
Viewpoint
CMS Proposes Changes to Medicare’s Coverage Determination Criteria and Expedites Approval of Breakthrough Devices
… FDA. FDA’s Breakthrough Devices Program is a product of the 21st Century Cures Act. The program is intended to expedite the …