In this week’s episode, Gina Bertolini discusses two important aspects of the CMS Interoperability and Patient Access Final Rule that directly relate to health care providers, and how those aspects of the Final Rule will...more
12/17/2020
/ Centers for Medicare & Medicaid Services (CMS) ,
Conditions of Participation (CoP) ,
Coronavirus/COVID-19 ,
Electronic Medical Records ,
Health Care Providers ,
Health Clinics ,
Health Information Technologies ,
Hospitals ,
Information Blocking Rules ,
Interim Final Rules (IFR) ,
Medical Records ,
Medicare ,
ONC ,
Patient Access ,
Reporting Requirements
On Thursday, 29 October 2020, the HHS Office of the National Coordinator for Health IT (ONC) released an interim final rule (Interim Final Rule) that: (a) delays the compliance dates and timeframes for certain regulatory...more
In this week’s episode, Gina Bertolini, Lindsey Rogers-Seitz and Maggie Power discuss the Preventing Harm Exception to the Information Blocking Rule, which was recently finalized in the Office of the National Coordinator for...more
INTRODUCTION - The Department of Health and Human Services’ Office of the National Coordinator for Health Information Technology (ONC) is responsible for the implementation of key provisions of Title IV of the 21st Century...more
As we previously reported, the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) overhauled 42 U.S.C. §290dd–2, commonly referred to as “part 2.” Part 2 regulates the confidentiality of substance use disorder...more
In this week’s episode, Gina Bertolini, Lindsey Rogers-Seitz and Leah Richardson discuss a number of efforts undertaken by Congress and the U.S. Department of Health and Human Services (HHS) in recent weeks to expand the...more
5/21/2020
/ CARES Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Health Care Providers ,
Health Insurance ,
Interim Final Rules (IFR) ,
Medicare ,
Physicians ,
Popular ,
Public Health Emergency ,
Telehealth ,
Telemedicine
The Coronavirus Aid, Relief, and Economic Security Act (“CARES Act”), [1] signed into law March 27, 2020, significantly overhauls the federal law that governs the confidentiality of substance use disorder (“SUD”) records at...more
On Wednesday, President Trump issued an Executive Order (“E.O.”) granting broad control to U.S. Health and Human Services (“HHS”) Secretary Alex Azar over the production and distribution of health resources needed to prevent...more
On October 21, 2019, the Centers for Medicare & Medicaid Services (“CMS”) issued a Request for Information (“RFI”) on using advanced technology to further CMS’s program integrity efforts....more
This week’s episode is the second in an ongoing series focusing on recent efforts by the Substance Abuse and Mental Health Services Administration (SAMHSA) to update 42 C.F.R. Part 2 (Part 2) regulations related to the...more
10/17/2019
/ Confidential Information ,
Consent ,
Health Care Providers ,
Healthcare Facilities ,
Medical Records ,
Mental Health ,
Opioid ,
Patient Privacy Rights ,
Pharmaceutical Industry ,
Pharmacies ,
Podcasts ,
Prescription Drugs ,
Proposed Rules ,
SAMHSA ,
Substance Abuse
For the third time in as many years, the Substance Abuse and Mental Health Services Administration (“SAMHSA”) has proposed revisions to the Confidentiality of Substance Use Disorder Patient Records regulations at 42 C.F.R....more
This episode is the first in a series focusing on recent efforts by the Substance Abuse and Mental Health Services Administration (SAMHSA) to update 42 C.F.R. Part 2 (Part 2) regulations related to the confidentiality of...more
10/8/2019
/ Confidential Information ,
Data Privacy ,
Data Use Policies ,
Electronic Medical Records ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Manufacturer Liability ,
Medical Records ,
Mental Health ,
Multidistrict Litigation ,
Municipalities ,
Opioid ,
Patient Privacy Rights ,
Pharmaceutical Industry ,
Prescription Drugs ,
Proposed Legislation ,
Proposed Rules ,
Regulatory Agenda ,
SAMHSA ,
Substance Abuse
The Advanced Medical Technology Association (“AdvaMed”), a trade association of medical technology companies, has announced an update to its Code of Ethics on Interactions with U.S. Health Care Professionals, effective...more
On March 29, 2019, the Centers for Medicare & Medicaid Services (CMS), in partnership with the American Academy of Family Physicians (AAFP) and the Laura and John Arnold Foundation, announced its Artificial Intelligence (AI)...more
On January 17, 2019, North Carolina Attorney General Josh Stein (D) and Representative Jason Saine (R) held a press conference announcing plans to introduce legislation that would strengthen North Carolina’s Identity Theft...more
In the second episode of our series on the national opioid crisis, Gina Bertolini discusses the overlay of recent guidance concerning privacy laws such as the Health Insurance Portability and Accountability Act (HIPAA) and...more
3/1/2018
/ Confidential Information ,
Decision-Making Process ,
Department of Health and Human Services (HHS) ,
Diminished Capacity ,
Documentation ,
Drug & Alcohol Abuse ,
Final Rules ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
HIPAA Privacy Rule ,
Information Sharing ,
Medical Records ,
OCR ,
Opioid ,
PHI ,
Physician-Patient Confidentiality ,
Prior Authorization ,
SAMHSA ,
Substance Abuse ,
Trump Administration
Background - As many health care practitioners, health information management professionals, and health lawyers know, balancing patients’ privacy interests with the need to access accurate, up-to-date medical information can...more
On August 28, 2015, the Health Resources and Services Administration (“HRSA”) published proposed Omnibus Guidance (the “Proposed Guidance”) governing policies related to section 340B of the Public Health Service Act (“PHSA”),...more
9/8/2015
/ Affordable Care Act ,
AIDS ,
Compliance ,
Covered Entities ,
Drug Pricing ,
Fee-for-Service ,
Food and Drug Administration (FDA) ,
GPOs ,
Health Care Providers ,
Healthcare ,
HIV ,
Hospitals ,
HRSA ,
MCOs ,
Medicaid ,
Medicare ,
Omnibus Guidance ,
Pharmaceutical Industry ,
Pharmacies ,
PHSA ,
Prescription Drugs ,
Section 340B ,
Telemedicine
On July 8, 2015, the Centers for Medicare and Medicaid Services (“CMS”) released a Proposed Rule regarding the 2016 Hospital Outpatient Prospective Payment System (“OPPS”). The Proposed Rule, in addition to proposing updates...more
8/12/2015
/ Centers for Medicare & Medicaid Services (CMS) ,
EMTALA ,
Healthcare ,
Hospitals ,
Inpatient Prospective Payment System (IPPS) ,
MACs ,
Medicaid ,
Medicare ,
Medicare Administrative Contractors (MAC) ,
OPPS ,
Policy Violations ,
QIOs ,
Recovery Audit Contractors (RACs) ,
Two-Midnight Rule