Seventh Circuit Rules that Medical Necessity Trumps State-Imposed Cap on “Optional” Medicaid Coverage

October 24, 2012, 8:03 am

≫ Next: HIPAA Enforcement – The Gathering Storm Has Arrived

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In a class action lawsuit, the U.S. Court of Appeals for the 7th Circuit recently affirmed a lower court decision granting a preliminary injunction that prevented the state of Indiana from enforcing a $1,000 annual cap on Medicaid coverage for...
By: Gregory Fliszar

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HIPAA Enforcement – The Gathering Storm Has Arrived

November 16, 2012, 9:19 pm

≫ Next: The SMART Act: A Bipartisan Attempt to Make the MSP Act Workable

≪ Previous: Seventh Circuit Rules that Medical Necessity Trumps State-Imposed Cap on “Optional” Medicaid Coverage

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Since the Health Insurance Portability and Accountability Act (HIPAA) privacy rules became effective in April 2003, there has been minimal enforcement activity by the U.S. Department of Health and Human Services (HHS) Office of Civil Rights (OCR)....
By: Gregory Fliszar

The SMART Act: A Bipartisan Attempt to Make the MSP Act Workable

January 17, 2013, 8:41 pm

≫ Next: HHS Releases the Long-Awaited Final Omnibus HIPAA Rules

≪ Previous: HIPAA Enforcement – The Gathering Storm Has Arrived

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On January 10, 2013, President Obama signed into law H.R. 1845, which includes the Strengthening Medicare and Repaying Taxpayers Act of 2011 (SMART Act). The SMART Act amends several portions of the Medicare Secondary Payer (MSP) Act that apply to...
By: Gregory Fliszar

HHS Releases the Long-Awaited Final Omnibus HIPAA Rules

January 22, 2013, 8:18 pm

≫ Next: Highlights of the Omnibus HIPAA/HITECH Final Rule

≪ Previous: The SMART Act: A Bipartisan Attempt to Make the MSP Act Workable

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A pre-publication version of the much anticipated final Omnibus Health Insurance Portability and Accountability Act (HIPAA) rule (the Final Rule) was issued January 17, 2013 with publication in the Federal Register scheduled for January 25, 2013....
By: Gregory Fliszar

Highlights of the Omnibus HIPAA/HITECH Final Rule

March 7, 2013, 6:38 pm

≫ Next: Hospitals Prevail in Effort to Include Pennsylvania GA Days in the Medicare DSH Calculation

≪ Previous: HHS Releases the Long-Awaited Final Omnibus HIPAA Rules

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On January 25, 2013, the Office of Civil Rights (OCR) of the Department of Health & Human Services (HHS) published the long-awaited omnibus final regulation governing health data privacy, security and enforcement (Omnibus Rule). The Omnibus Rule is a...
By: Gregory Fliszar

Hospitals Prevail in Effort to Include Pennsylvania GA Days in the Medicare DSH Calculation

May 1, 2013, 9:12 am

≫ Next: HIPAA Audits Set to Begin in 2014: Another Enforcement Mechanism for HIPAA Compliance

≪ Previous: Highlights of the Omnibus HIPAA/HITECH Final Rule

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Two of Mercy Health System’s hospitals (Nazareth Hospital and the former St. Agnes Medical Center) successfully challenged, before Judge Ludwig of the U.S. District Court for the Eastern District of Pennsylvania, the Secretary of Health and Human...
By: Gregory Fliszar

HIPAA Audits Set to Begin in 2014: Another Enforcement Mechanism for HIPAA Compliance

March 7, 2014, 2:47 pm

≫ Next: HHS Releases a New Security Risk Assessment Tool

≪ Previous: Hospitals Prevail in Effort to Include Pennsylvania GA Days in the Medicare DSH Calculation

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The Department of Health and Human Services (HHS) is expected to launch its long-awaited HIPAA audit program sometime in 2014. The audit program will be run by HHS’ Office of Civil Rights (OCR), which is likely eager to get the program going after...
By: Gregory Fliszar

HHS Releases a New Security Risk Assessment Tool

April 30, 2014, 4:24 pm

≫ Next: CMS Withdraws Proposed Medicare Secondary Payer Rule

≪ Previous: HIPAA Audits Set to Begin in 2014: Another Enforcement Mechanism for HIPAA Compliance

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The Department of Health and Human Services (HHS) recently released a new security risk assessment (SRA) tool for small- to medium-sized health care providers. HIPAA requires covered entities to conduct periodic assessments of the administrative,...
By: Gregory Fliszar

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CMS Withdraws Proposed Medicare Secondary Payer Rule

October 20, 2014, 3:33 pm

≫ Next: OIG’s New Work Plan Focuses on the Security of Health Information

≪ Previous: HHS Releases a New Security Risk Assessment Tool

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On October 8, 2014, the Centers for Medicare & Medicaid Services (“CMS”) withdrew its Notice of Proposed Rule Making (“NPRM”) from the Office of Management and Budget that was to address how Medicare’s future interests should be protected pursuant to...
By: Gregory Fliszar

OIG’s New Work Plan Focuses on the Security of Health Information

December 5, 2014, 8:29 am

≫ Next: Cybersecurity Attack on Anthem, Inc. Highlights the Cybersecurity Risks for All Companies Handling Electronic Medical Records

≪ Previous: CMS Withdraws Proposed Medicare Secondary Payer Rule

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On October 31, 2014, The U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) released its Work Plan for fiscal year (FY) 2015. The Work Plan summarizes “new and ongoing reviews of activities that OIG plans to pursue...
By: Gregory Fliszar

Cybersecurity Attack on Anthem, Inc. Highlights the Cybersecurity Risks for All Companies Handling Electronic Medical Records

February 10, 2015, 10:30 am

≫ Next: Another Health Plan Hit By Massive CyberAttack and Class Actions Follow

≪ Previous: OIG’s New Work Plan Focuses on the Security of Health Information

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Health care providers, insurers and all who handle information on their behalf were put on notice last week that cybersecurity must be a high priority for their organizations....
By: Gregory Fliszar

Another Health Plan Hit By Massive CyberAttack and Class Actions Follow

March 31, 2015, 2:47 pm

≫ Next: Another Health Plan Hit By Massive CyberAttack and Class Actions Follow

≪ Previous: Cybersecurity Attack on Anthem, Inc. Highlights the Cybersecurity Risks for All Companies Handling Electronic Medical Records

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Coming fresh off the heels of the Anthem data breach Premera Blue Cross announced on March 17th that it was the victim of a “sophisticated” cyberattack that may have exposed the personal information of approximately 11 million of its members....
By: Gregory Fliszar

Another Health Plan Hit By Massive CyberAttack and Class Actions Follow

April 6, 2015, 1:17 pm

≫ Next: CMS Issues Proposed Rule That Would Extend Provisions of Mental Health Parity

≪ Previous: Another Health Plan Hit By Massive CyberAttack and Class Actions Follow

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Coming fresh off the heels of the Anthem data breach Premera Blue Cross announced on March 17th that it was the victim of a “sophisticated” cyberattack that may have exposed the personal information of approximately 11 million of its members....
By: Gregory Fliszar

CMS Issues Proposed Rule That Would Extend Provisions of Mental Health Parity

April 16, 2015, 4:34 pm

≫ Next: OCR Announces Another HIPAA Settlement and Warns Not to Forget About Paper Records

≪ Previous: Another Health Plan Hit By Massive CyberAttack and Class Actions Follow

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On April 6, 2015, the Centers for Medicare & Medicaid Services (“CMS”) released a proposed rule that would extend provisions of the Mental Health Parity and Addiction Equity Act of 2008 (the “Mental Health Parity Act”) to Medicaid managed care...
By: Gregory Fliszar

OCR Announces Another HIPAA Settlement and Warns Not to Forget About Paper Records

May 5, 2015, 6:48 pm

≫ Next: FTC Loses in LabMD Data Security Case: ALJ Sets High Bar for Consumer Harm

≪ Previous: CMS Issues Proposed Rule That Would Extend Provisions of Mental Health Parity

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On April 27, 2015, the U.S. Department of Health and Human Services (“HHS”) Office for Civil Rights (“OCR”) announced that Cornell Prescription Pharmacy (“Cornell Pharmacy”) had entered into a resolution agreement to settle, without an admission of...
By: Gregory Fliszar

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FTC Loses in LabMD Data Security Case: ALJ Sets High Bar for Consumer Harm

November 25, 2015, 1:06 pm

≫ Next: Gun Control and HIPAA

≪ Previous: OCR Announces Another HIPAA Settlement and Warns Not to Forget About Paper Records

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On November 13, 2015, an administrative law judge (“ALJ”) ruled against the Federal Trade Commission (“FTC”) in its high-profile data security case against LabMD. The ALJ ruled that the FTC had failed to show that LabMD’s conduct had caused harm to...
By: Gregory Fliszar

Gun Control and HIPAA

January 6, 2016, 3:30 pm

≫ Next: OCR Announces Two Significant HIPAA Breach Settlements

≪ Previous: FTC Loses in LabMD Data Security Case: ALJ Sets High Bar for Consumer Harm

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In the wake of recent gun violence and in a concerted effort to protect public safety, the Department of Health and Human Services (HHS) released a final rule published in the Federal Register January 6, 2016, that modifies the HIPAA Privacy Rule to...
By: Gregory Fliszar

OCR Announces Two Significant HIPAA Breach Settlements

March 22, 2016, 2:15 pm

≫ Next: Heads-Up! HIPAA Phase Two Audits Begin – Business Associates Included!

≪ Previous: Gun Control and HIPAA

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On consecutive days, the Office of Civil Rights (“OCR”) of the Department of Health and Human Services (“HHS”) recently announced two large HIPAA breach settlements. On March 16, 2016, OCR announced that it entered into a Resolution Agreement with...
By: Gregory Fliszar

Heads-Up! HIPAA Phase Two Audits Begin – Business Associates Included!

March 24, 2016, 10:46 am

≫ Next: OCR Announces New HIPAA Guidance on Ransomware

≪ Previous: OCR Announces Two Significant HIPAA Breach Settlements

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The Department of Health and Human Services (HHS) Office of Civil Rights (OCR) finally announced on March 21 that it is ready to begin Phase Two of its HIPAA audit program, which will include business associates. These audits, mandated by HITECH,...
By: Gregory Fliszar

OCR Announces New HIPAA Guidance on Ransomware

July 14, 2016, 6:51 am

≫ Next: FTC Overturns ALJ’s LabMD Decision and Reasserts its Role as a Data Security Enforcer

≪ Previous: Heads-Up! HIPAA Phase Two Audits Begin – Business Associates Included!

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In response to the increasing prevalence of ransomware cyber-attacks by hackers on electronic health information systems in hospitals and medical practices, the Department of Health and Human Services (HHS) Office for Civil Rights (OCR) announced on...
By: Gregory Fliszar

FTC Overturns ALJ’s LabMD Decision and Reasserts its Role as a Data Security Enforcer

August 26, 2016, 9:08 am

≫ Next: Hospitals Will Need Psychiatrists And Mental Health Professionals To Satisfy EMTALA

≪ Previous: OCR Announces New HIPAA Guidance on Ransomware

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On July 29, 2016, the Federal Trade Commission (“FTC” or “Commission”) reversed an FTC administrative law judge’s (“ALJ”) opinion which had ruled against the FTC, finding that the Commission had failed to show that LabMD’s conduct caused harm to...
By: Gregory Fliszar

Hospitals Will Need Psychiatrists And Mental Health Professionals To Satisfy EMTALA

November 8, 2017, 5:20 am

≫ Next: Google Partners With Ascension To Store And Analyze Millions Of Patient Health Records

≪ Previous: FTC Overturns ALJ’s LabMD Decision and Reasserts its Role as a Data Security Enforcer

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Hospitals that have emergency departments should call upon their “available resources” to screen and stabilize patients with mental health emergencies as required by the Emergency Medical Treatment and Labor Act (“EMTALA”) according to recent...
By: Gregory Fliszar

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Google Partners With Ascension To Store And Analyze Millions Of Patient Health Records

November 20, 2019, 8:54 am

≫ Next: HIPAA and COVID-19: Balancing Public Health Concerns and Patient Privacy in the Midst of a Pandemic

≪ Previous: Hospitals Will Need Psychiatrists And Mental Health Professionals To Satisfy EMTALA

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Google has confirmed that it is working with Ascension, one of the nation’s largest health systems in a project that will involve the health data of millions of Americans. Google and Ascension have partnered in a project to store and analyze patient data with the intended goal of using Google’s artificial intelligence tools to enhance patient care and medical decision making....
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HIPAA and COVID-19: Balancing Public Health Concerns and Patient Privacy in the Midst of a Pandemic

March 13, 2020, 2:32 pm

≫ Next: HHS Issues EMTALA Waivers As a Result of the COVID-19 Pandemic

≪ Previous: Google Partners With Ascension To Store And Analyze Millions Of Patient Health Records

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Although COVID-19 is not the first pandemic to hit the United States, the virus has thrown the country into uncharted territory as federal and state governments and agencies struggle to contain the virus’s quick-moving spread. As in past outbreaks, on February 3, 2020, the Office for Civil Rights of the U.S. Department of Health and…...
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HHS Issues EMTALA Waivers As a Result of the COVID-19 Pandemic

March 19, 2020, 3:43 pm

≫ Next: OCR Loosens Restrictions on Business Associates in Response to the COVID-19 Pandemic

≪ Previous: HIPAA and COVID-19: Balancing Public Health Concerns and Patient Privacy in the Midst of a Pandemic

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On March 13, 2020, the Secretary of the U.S. Department of Health And Human Services (HHS) issued a series of waivers pursuant to Section 1135 of the Social Security Act, following President Trump’s declaration that the COVID-19 pandemic constitutes a national emergency....
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OCR Loosens Restrictions on Business Associates in Response to the COVID-19 Pandemic

April 3, 2020, 10:17 am

≫ Next: First $30 Billion to be Immediately Distributed to Hospitals, Other Health Care Providers

≪ Previous: HHS Issues EMTALA Waivers As a Result of the COVID-19 Pandemic

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On April 2, 2020, the Office for Civil Rights (OCR) at the U.S Department of Health and Human Services (HHS) announced, effective immediately, that it will exercise its enforcement discretion and will not impose penalties for violations of certain provisions of the HIPAA Privacy Rule against health care providers or their business associates for the good faith uses and disclosures of protected health information (PHI) by business associates for public health and health oversight activities...
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First $30 Billion to be Immediately Distributed to Hospitals, Other Health Care Providers

April 13, 2020, 2:52 pm

≫ Next: OCR Releases Notification of Enforcement Discretion at COVID-19 Community-Based Testing Sites

≪ Previous: OCR Loosens Restrictions on Business Associates in Response to the COVID-19 Pandemic

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Although no details of this process have been officially released, Seema Verma, administrator for the Centers for Medicare & Medicaid Services (CMS) announced at Monday’s White House COVID-19 Task Force briefing that CMS will release an initial $30 billion distribution......
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OCR Releases Notification of Enforcement Discretion at COVID-19 Community-Based Testing Sites

April 15, 2020, 8:52 pm

≫ Next: CMS Releases Details on $30 Billion Payment to Hospitals and other Health Care Providers

≪ Previous: First $30 Billion to be Immediately Distributed to Hospitals, Other Health Care Providers

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On April 9, the Office for Civil Rights of the Department of Health and Human Services (OCR) released a notice of enforcement discretion to covered health care providers and their business associates that, during the COVID-19 public health emergency, OCR will not impose penalties for noncompliance with the regulatory requirements under the HIPAA rules in connection with the good faith participation in the operation of a COVID-19 Community-Based Testing Site(s) (CBTS)....
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CMS Releases Details on $30 Billion Payment to Hospitals and other Health Care Providers

April 15, 2020, 10:50 pm

≫ Next: CMS Announces Enhanced Nursing Home Reporting Requirements

≪ Previous: OCR Releases Notification of Enforcement Discretion at COVID-19 Community-Based Testing Sites

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On Friday, April 10 the Centers for Medicare & Medicaid Services released details on the disbursement of $30 billion from the $100 billion health care provider relief fund in the CARES Act (the Public Health and Social Services Emergency Fund) slated for hospitals and other health care providers....
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CMS Announces Enhanced Nursing Home Reporting Requirements

April 21, 2020, 4:44 pm

≫ Next: CMS Issues Recommendations to Reopen Health Care Systems in Areas with Low Incidence of COVID-19

≪ Previous: CMS Releases Details on $30 Billion Payment to Hospitals and other Health Care Providers

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On April 19, CMS announced two new reporting requirements for nursing homes: first, nursing homes will now be required to inform, on an ongoing basis, residents, their families, and representatives of confirmed or suspected COVID-19 cases in their facilities....
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CMS Issues Recommendations to Reopen Health Care Systems in Areas with Low Incidence of COVID-19

April 22, 2020, 2:49 pm

≫ Next: CMS Issues Blanket Waivers for Long-Term Care Facilities, SNFs and NFs

≪ Previous: CMS Announces Enhanced Nursing Home Reporting Requirements

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Following federal guidelines announced last Thursday by President Donald Trump, states are moving to reopen in phases amid the coronavirus pandemic (federal guidelines). On Sunday, April 19, 2020, CMS also released updated recommendations for how hospital systems can begin to reopen as well (CMS guidance)....
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CMS Issues Blanket Waivers for Long-Term Care Facilities, SNFs and NFs

May 3, 2020, 7:05 pm

≫ Next: Pennsylvania Hospitals Can Now Resume Elective Surgeries and Procedures

≪ Previous: CMS Issues Recommendations to Reopen Health Care Systems in Areas with Low Incidence of COVID-19

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Since the COVID-19 emergency declaration, CMS has issued a number of blanket waivers for health care providers, including nursing facilities (NFs) and skilled-nursing facilities (SNFs) retroactive to March 1, 2020, and effective through the end of the COVID-19-related emergency declaration. CMS has released a summary of these blanket waivers in a CMS guidance dated April 21, 2020 (the CMS guidance)....
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Pennsylvania Hospitals Can Now Resume Elective Surgeries and Procedures

May 3, 2020, 10:30 pm

≫ Next: HHS Proposes $9 Billion Lump Sum Payment for Hospitals to Remedy Unlawful 340B Payment Reductions

≪ Previous: CMS Issues Blanket Waivers for Long-Term Care Facilities, SNFs and NFs

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As announced by Secretary of Health Dr. Rachel Levine on Monday, April 27, Pennsylvania hospitals can now begin to perform elective surgeries and procedures as long as they are able to do so without jeopardizing the safety of patients and staff or the hospital’s ability to respond to the COVID-19 pandemic....
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HHS Proposes $9 Billion Lump Sum Payment for Hospitals to Remedy Unlawful 340B Payment Reductions

July 11, 2023, 9:15 am

≪ Previous: Pennsylvania Hospitals Can Now Resume Elective Surgeries and Procedures

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On Friday, July 7, 2023, the Centers for Medicare & Medicaid Services (CMS) published their long-awaited proposed remedy to the unlawful 340B drug payment reductions. Background: In 2018, CMS significantly reduced the Average Sales Price (ASP) plus six-percent (6%) formula for calculating 340B drug payments to ASP minus 22.5%. After conflicting decisions from the District of Columbia’s federal District and Appeals Courts, on June 15, 2022,......
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