Health Care Providers & Privacy

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 Beneficiaries

• Contract Year 2021 Medicare Advantage and Part D Final Rule Fact Sheet

• CT DPH Requires COVID-19 Tests be Ordered by Physicians or Other Authorized Practitioners and That Results be Reported to the Ordering Practitioner

• Providers Must Act by June 3 to Receive Additional Relief Fund General Distribution Payment

• CMS Issues Nursing Home Reopening Recommendation FAQs

• CMS Updates Billing, Coding, and Coverage FAQ Guidance to Assist Medicare Providers

• CMS Gives States Additional Flexibility to Address COVID-19 Pandemic

• CMS Issues Interim Final Rule with Sweeping Changes in Responding to COVID-19 Public Health Crisis

• CMS Guidance Page on COVID-19 Waivers and Flexibilities

• HHS Extends Deadline for Attestation, Acceptance of Terms and Conditions for Provider Relief Fund Payments to 45 Days

• Group of Republican Senators Announce Plans to Introduce Data Privacy Bill

• CDC Issues Strategies to Mitigate Healthcare Staffing Shortages

• CMS Issues FAQs for Hospitals and Critical Access Hospitals Regarding EMTALA

• CMS Updates COVID-19 Guidance for MA Organizations and Part D Sponsors, Addresses the Status of Telehealth Visits for Risk Adjustment

• CMS Pre-Publishes an Interim Final Rule Regarding COVID-19 Reporting Requirements Applicable to Long Term Care Facilities

APRIL 2020 DEVELOPMENTS:

• Eligible Providers Can Submit Information to Receive Additional Provider Relief Fund Payments

• HHS FAQs Regarding Telehealth

• Understanding HHS’s Plan to Disperse Provider Relief Funds Authorized by the CARES Act

• CMS Reevaluates Accelerated Payment Program and Suspends Advance Payment Program

• HHS Launches COVID-19 Uninsured Program Portal

• CMS Clarifies Which Telehealth Services are Valid for Data Submissions for the HHS-Operated Risk Adjustment Program

• CMS Announces Merit-Based Incentive Payment for Clinicians Participating in COVID-19 Clinical Trial

• HHS Announces More Time for Hospitals to Apply for COVID-19 High-Impact Payments

• Trump Administration Releases COVID-19 Telehealth Toolkit to Accelerate State Use of Telehealth in Medicaid and CHIP

• HHS Announces CARES Act Funding Distribution to States and Localities in Support of COVID-19 Response

• CMS Issues FAQs Regarding Issuer Flexibility for Utilization Management and Prior Authorization

• Trump Administration Launces New Toolkit to Help States Navigate COVID-19 Health Workforce Challenges

• HHS Awards Nearly $165 million to Combat COVID-19 Pandemic in Rural Communities

• Connecticut Insurance Commissioner Approves Front-Line Health Care Worker “No-Cost” Life Insurance Coverage During COVID-19 Pandemic

• CMS Updates and Revises COVID-19 FAQs on Medicare Fee-for-Service Billing

• Secretary Azar Statement on New Partnership to Develop National Strategy for COVID-19 Therapies and Vaccines

• CMS Increases Medicare Payment for High-Production Coronavirus Lab Tests

• Connecticut Section 1135 Waiver Flexibilities

• Updated Medicaid and CHIP FAQs on Enhanced Federal Funding

• CMS Issues Guidance on Long-Term Care Facility Transfer Scenarios

• CMS, DOL, and Treasury Issue Guidance to Ensure Americans with Private Health Insurance Have Coverage of COVID-19 Diagnostic Testing and Certain Other Related Services, Including Antibody Testing, at No Cost

• CMS Issues Guidance Regarding Applicability of Diagnoses from Telehealth Services for Risk Adjustment in Medicare Advantage

• HHS Distributes $30 billion to Providers/Suppliers Based on Their Share of the 2019 Medicare Fee-for-Service Payments

• Trump Administration Announces Expanded Coverage for Essential Diagnostic Services Amid COVID-19 Public Health Emergency

• CMS Approves Approximately $34 billion for Providers with Accelerated/Advance Medicare Payment Programs

• CMS Issues New Infection Control Guidance to Protect Patients and Healthcare Workers from COVID-19

• CMS Approves Additional State Medicaid Waivers and Amendments to Give States Flexibility to Address COVID-19

• Emergency Medical Treatment and Labor Act (EMTALA) Requirements and Implications Related to COVID-19

• Guidance for Infection Control and Prevention of COVID-19 in Hospitals, Psychiatric Hospitals, and Critical Access Hospitals (CAHs): FAQs, Considerations for Patient Triage, Placement, Limits to Visitation and Availability of 1135 Waivers

• Guidance for Infection Control and Prevention of Coronavirus Disease (COVID-19) in Outpatient Settings: FAQs and Considerations

• FAQs on Telehealth and HIPAA

• Can COVID-19 Protections be Designed for Privacy?

• FCC Launches Program to Help Healthcare Providers Cover Telehealth Costs

• HHS Announces Upcoming Funding Action to Provide $186 million for COVID-19 Response

• HHS Supports State, Territorial and Tribal Public Health Labs with COVID-19 Rapid-Point-of-Care Test

• OCR Issues Guidance on HIPAA Compliance for Law Enforcement, Paramedics, Other First Responders and Public Health Authorities

• Microsoft Works With Healthcare Organizations to Protect From Popular Ransomware During COVID-19 Crisis:  Here’s What to Do

• CMS Issues Blanket Waivers of Stark Law Penalties to Support COVID-19 Response Efforts

• Connecticut Department of Consumer Protection Issues Guidance on Refilling and Reissuing Controlled Substance Prescriptions

• Connecticut Office of Health Strategy Waives Certificate of Need Approval Requirements for Temporary Bed Expansions and Temporary Service Suspensions

• U.S. Department of Health & Human Services (HHS), Office of Civil Rights (OCR) HIPAA Enforcement Discretion for Telehealth Remote Communications

• COVID-19 HHS Waivers<