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26 Oct 2011, 6:04 am
Topics will include Employer Preparedness to Include Veterans with Disabilities HHS Projects Medicare Advantage Enrollment Will Rise As Premiums Decline In 2012; Plans Face Increased Regulation & Enforcement HHS Credits Health Reform For Getting Health Coverage For Added 1 Million Young Adults 4th Circuit Rejects Two Challenges To Affordable Care Act Constitutionality Stamer Named Fellow In American College of Employee Benefits Counsel ABA TIPS Section… [read post]
4 Apr 2012, 6:37 pm
Industry is to blame, according to written comments from the Department of Health and Human Services (“HHS”) to the GAO report. [read post]
31 May 2017, 7:09 am
Changes to the rules governing calculation of the ceiling price and application of civil monetary penalties under the 340B drug pricing program will not be implemented until October 1, 2017 under a rule published by the Health Resources and Services Administration (HRSA) on May 19, 2017. [read post]
30 Nov 2015, 9:32 am
On November 18, 2015, the Obama Administration published final regulations to update requirements for group health plans and health insurance issuers under the ACA, particularly with regard to the changes they can make to the terms of their plan/coverage while retaining their “grandfathered” status. [read post]
9 Aug 2016, 2:48 pm
The Centers for Medicare & Medicaid Services (CMS) recently issued a proposed rule to address the significant backlog resulting from “an unprecedented and sustained increase” in its Medicare appeals. [read post]
3 Oct 2016, 7:50 am
On September 27, 2016, the Substance Abuse and Mental Health Services Administration (SAMHSA) published a final rule establishing annual reporting requirements for certain practitioners who prescribe buprenorphine-based medication-assisted treatment for opioid disorders under the Controlled Substances Act. [read post]
17 Apr 2019, 10:46 am
The Centers for Medicare & Medicaid Service (CMS) has issued regulations to address revised statutory requirements related to manufacturer calculation of Medicaid drug rebates. [read post]
16 Jul 2015, 1:48 am
Earlier this year, President Obama launched a high-profile “Precision Medicine Initiative” (PMI) to develop treatments, diagnostics, and prevention strategies tailored to the individual genetic characteristics of each patient. [read post]
3 Oct 2016, 5:40 am
The National Institutes of Health (NIH) has finalized the requirements for submitting clinical trial information for applicable clinical trials of drug products (including biological products) and device products on ClinicalTrials.gov. [read post]
29 Jun 2015, 4:32 pm
As previously reported, CMS announced a Medicare Shared Savings Program/Accountable Care Organization (ACO) “Investment Model” last fall to better coordinate care in rural and underserved areas where inadequate access to capital could hinder infrastructure development needed for successful population care management. [read post]
18 Apr 2016, 6:32 am
On April 19, 2016, the Health Resources and Services Administration (HRSA) is publishing a notice reopening for 30 days the comment period on its June 17, 2015 proposed rule entitled “340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation. [read post]
12 Jan 2016, 9:52 am
The Office of the National Coordinator for Health Information Technology (ONC) has released its final 2016 Interoperability Standards Advisory, which catalogs the “best available” interoperability standards and implementation specifications for industry use to fulfill specific clinical health information technology (IT) interoperability needs. [read post]
5 Aug 2015, 12:09 pm
The Obama Administration published final regulations on July 14, 2015 that implement Affordable Care Act requirements regarding coverage without cost sharing of certain preventive services, including contraceptive services. [read post]
23 May 2018, 3:19 pm
As previously reported, the Trump Administration has released its “Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. [read post]
18 Jan 2017, 10:10 am
The Centers for Disease Control and Prevention (CDC) has issued a final rule to strengthen the federal government’s ability to prevent the introduction, transmission, and spread of communicable diseases into the United States and interstate. [read post]
SAMHSA Releases Final and Supplemental Proposed Rules on Substance Abuse Records Privacy Protections
18 Jan 2017, 10:13 am
A new Substance Abuse and Mental Health Services Administration (SAMHSA) final rule is intended to modernize federal regulations governing the confidentiality of substance abuse records. [read post]
22 Feb 2016, 5:16 am
The Substance Abuse and Mental Health Services Administration (SAMHSA) published a proposed rule on February 9, 2016 that is intended to modernize regulations governing the confidentiality of substance abuse records to ensure that patients with substance use disorders have the ability to participate in new integrated health care models that emphasize coordinated care while addressing patients’ privacy concerns. [read post]
29 Jun 2015, 4:40 pm
CMS recently sent several major proposed Medicare CY 2016 payment rules to the White House Office of Management and Budget (OMB) for regulatory clearance – the last step before publication in the Federal Register. [read post]
29 Jun 2015, 4:39 pm
On June 26, 2015, the Centers for Medicare & Medicaid Services (CMS) released its proposed rule to update the Medicare end-stage renal disease (ESRD) prospective payment system (PPS) for calendar year (CY) 2016. [read post]
21 Nov 2016, 4:26 am
The Obama Administration has updated its regulatory agenda, listing the anticipated timing of pending and future regulatory actions, including a number of Department of Health and Human Services regulations. [read post]
