Health Care Providers & Privacy

Adam Carter Rose

SEPTEMBER 2020 DEVELOPMENTS:

President Trump Signs Executive Order Aimed at Tying Domestic Drug Prices to Foreign Prices

CMS Releases Updated COVID-19 FAQs

OIG Announces Review of Hospital Payment Increase as Part of CARES Act Relief

CMS Issues Proposed Rule on “Reasonable and Necessary” Determinations and Immediate National Coverage of Breakthrough Devices

CMS Releases Fiscal Year 2021 Inpatient Prospective Payment System Final Rule

HIPAA Covered Entities and Business Associates Need an IT Asset Inventory List

CMS Releases Proposed Rule on Medicare Coverage of Innovative Technology, Definition of Medical Necessity

AUGUST 2020 DEVELOPMENTS:

CMS Extends Timeline for Finalizing Changes to Stark Law Regulations to August 2021

OCR Issues New HIPAA Guidance for Covered Entities Contacting Recovered COVID-19 Patients for Plasma Donations

CMS Establishes New COVID-19 Testing and Reporting Requirements

HHS Eases Federal Substance Use Disorder Confidentiality Rules

CMS Directs States to Resume Routine Surveys and Enforcement

CMS Final Rule Aims to Update Payment Policies Under the Medicare Physician Fee Schedule (PFS) for Calendar Year 2021

Proposed Legislation: TREATS Act Aims to Expand Use of Telehealth to Treat Substance Abuse Disorder

National Institutes of Health Delivers New COVID-19 Testing Technologies to Meet United States Demand

CMS Proposes Additional Cuts to Part B Reimbursement of 340B Drugs

Governor Lamont Signs Bill Extending Telehealth Flexibility

American Hospital Association Releases Data Showing Dramatic Impact of COVID-19 on Hospital & Health System’s Financial Health

FDA Issues New Template for Over-the-Counter at-Home Testing

OCR Issues Guidance on Federal Financial Assistance Recipients’ Compliance with Title VI of the Civil Rights Act of 1964

Connecticut Department of Public Health Commissioner Issues Order Temporarily Suspending the Requirements for Licensure, Certification, or Registration for the Duration of the COVID-19 public Health and Civil Preparedness Emergency

JULY 2020 DEVELOPMENTS:

OIG Updates Work Plan Related to COVID-19

Trump Administration Releases a Series of Executive Orders:

HHS OCR Warns Covered Entities Regarding HIPAA Violations

HHS Announces Additional $10B for Hospitals in High-Impact COVID-19 Areas

CMS to Restart FFS Audits on August 3, 2020

New COVID-19 Testing Requirements for Long Term Care Facilities

HHS Releases Final Rule to Allow for Greater Sharing of Patient Records Related to Substance Use Disorder Treatment

HHS Announces Over $4 Billion in Additional Relief Payments to Healthcare Providers Impacted by the Coronavirus Pandemic

CMS Directs Additional Resources to Nursing Homes in COVID-19 Hotspot Areas

CMS Issues Guidance on Providing Mental Health Resources During COVID-19

CMS Releases Guidance on the Allowance of Telehealth Encounters in eCQMs
- 2020 Quality Reporting
- 2021 Quality Reporting

CMS Proposes 2021 End Stage Renal Disease Prospective Payment System Rule

OIG Approves Discount Medical Plan Referral Arrangement

Massachusetts Adopts Permanent Telehealth Policy

Agency for Healthcare Research and Quality Identifies Next Steps in Expanding Telehealth

FDA Takes Action to Warn, Protect Consumers Against Dangerous Alcohol-Based Hand Sanitizers Containing Methanol

FDA Authorizes Additional COVID-19 Diagnostic Test Ahead of Flu Season

JUNE 2020 DEVELOPMENTS:

House Democrats Propose New Legislation to Bolster the Affordable Care Act

CMS Unveils Major Organizational Change to Reduce Provider and Clinician Burden and Improve Patient Outcomes

CMS Ends Emergency Blanket Waiver for the Nursing Home Staffing Data Submission Requirement

AARP and FBI Warn of COVID-19 Business Email Compromises, Cybercriminals Estimated to Have Stolen Billions during COVID-19

NIH Halts Clinical Trials of Hydroxychloroquine

HHS Announces MENTAL Health Innovation Challenge

DOL, HHS and Treasury Release Joint FAQs Regarding FFCRA and CARES Act Implementation

COVID-19 Executive Orders Affecting Health and Human Services

State Attorney Generals Signed Off on a Letter to Google and Apple Expressing Strong Concerns Regarding the Proliferation of Contact-Tracing Apps

Exposure Notification Privacy Act: A Bipartisan Bill Aimed at Regulating COVID-19 Contact Tracing Apps

U.S. House of Representatives Introduces the HEALTH Act

National Institute of Standards and Technology Releases Cybersecurity Guidance for Manufacturers of IoT Devices

HHS Awards $107.2 Million to Grow and Train Health Workforce

FDA Publishes New Web Page for COVID-19 Emergency Use Authorizations for Medical Devices

CMS Issues Guidance on Market Saturation and Utilization Data Tools

CMS Publishes News Alert for Medicare Coverage of COVID-19 Testing for Nursing Home Residents and Patients

CMS Announces Membership of Independent COVID-19 Commission on Safety and Quality in Nursing Homes

HHS Announces Operation Warp Speed Aims to Deliver 300 Million Doses of a Vaccine for COVID-19 by January 2021

FDA Posts Guidance on Adverse Event Reporting for Medical Devices Under Emergency Use Authorization (EUA) or Discussed in COVID-19-Related Guidance Documents

FDA Issues Warning Letters to Companies Inappropriately Marketing Antibody Tests

CMS Publishes Fact Sheet on Establishing Minimum Standards in Medicaid State Drug Utilization Review (DUR) and Supporting Value-Based Purchasing (VBP) for Drugs Covered in Medicaid, Revising Medicaid Drug Rebate and Third Party Liability (TPL) Requirements

CMS Issues Proposed Rule to Empower Commercial Plans and States to Negotiate Payment for Innovative New Therapies Based on Patient Outcomes

HHS Issues Guidance on HIPAA and Contacting Former COVID-19 Patients Regarding Blood and Plasma Donation

HHS Issues Notification of Enforcement Discretion for Telehealth Remote Communications During COVID-19 Pandemic

HHS Finalizes Rule on Section 1557 of the ACA Protecting Civil Rights in Healthcare

Top CMS Administrator Seema Verma Calls for Permanent Expansion of Telehealth Access Following COVID-19

Trump Administration Unveils Enhanced Enforcement Action Based on Nursing Home COVID-19 Data and Inspection Results

HHS Announces Additional Funding for Eligible Providers

NIH-Funded Study to Evaluate Drugs Prescribed to Children with COVID-19

Trump Administration Encourages Reopening of Healthcare Facilities

Senate Finance Committee Holds Hearing on FDA’s Foreign Drug Manufacturing Inspection Process

Chinese Patent Application for COVID-19 Vaccine Published
- Patent Application Research

HHS Announces New Laboratory Data Reporting Guidance for COVID-19 Testing

HHS Provides an Additional $250 Million to Help U.S. Health Care Systems Respond to COVID-19

CMS Issues FAQs for Nursing Home COVID-19 Data Release

CMS Issues COVID-19 Survey Activities, CARES Act Funding, Enhanced Enforcement for Infection Control Deficiencies, and Quality Improvement Activities in Nursing Homes

President Trump Announces Lower Out of Pocket Insulin Costs for Medicare’s Seniors

CMS Issues Proposed Rule to Amend HHS’ Risk Adjustment Data Validation Program

Trump Administration Unveils Enhanced Enforcement Actions Based on Nursing Home COVID-19 Data and Inspection Results

FDA Issues Guidance on the Effects of the COVID-19 Public Health Emergency on Formal Meetings and User Fee Applications

MAY 2020 DEVELOPMENTS:

HHS Announces 45-day Compliance Deadline Extension for Providers

HHS Announces Nearly $4.9 billion Distribution to Nursing Facilities Impacted by COVID-19

Trump Administration Announces Changes to Medicare Advantage and Part D to Provide Better Coverage and Increase Access for Medicare Benefici

September 16, 2020
COVID-19: State of Connecticut Governor's Executive Orders
March 21, 2020
COVID-19: Governor Lamont Issues Executive Order - "Stay Safe, Stay Home"
March 21, 2020
COVID-19 Guidance & Resources
March 20, 2020
COVID-19 Alert: State of Connecticut Initiatives
March 17, 2020
Reid & Riege COVID-19 Update: A Message to Our Clients and Friends

Adam Carter Rose

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