RECENT HEALTH LAW NEWS


NJ Infertility Clinic Reaches $495,000 Data Breach Settlement
October 19, 2021 |Eric Fader | Cybersecurity | Electronic Health Records | HIPAA | Litigation
The New Jersey Attorney General’s Office announced on October 12 that Diamond Institute for Infertility and Menopause, LLC, based in Millburn, NJ, will pay a $495,000 penalty for allegedly violating HIPAA and state law by failing to implement appropriate cybersecurity measures. The New Jersey Department of Law & Public Safety’s…
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OCR Issues Guidance on COVID-19 Vaccination Disclosures and HIPAA
October 06, 2021 |Eric Fader | COVID-19 | Employer/Employee | HIPAA | Legislation and Public Policy
On September 30, the U.S. Department of Health and Human Services’ Office for Civil Rights (OCR) announced that it issued guidance to clarify that the HIPAA Privacy Rule does not prohibit businesses from asking customers, clients or employees to disclose their COVID-19 vaccination status. OCR felt compelled to weigh in…
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COVID-19 Designated as a Communicable Disease under New York HERO Act
October 04, 2021 |Brian Conneely and John Diviney | COVID-19 | Employer/Employee | Legislation and Public Policy
On September 6, 2021, New York Governor Hochul announced that the New York Commissioner of Health had designated COVID-19 as a highly contagious communicable disease that presents a serious risk of harm to public health under the New York HERO Act (the “HERO Act”). This new designation requires all New…
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HHS Awards $954 Million to Health Centers
September 30, 2021 |Eric Fader | COVID-19 | Legislation and Public Policy | Telehealth
The U.S. Department of Health and Human Services (HHS) has awarded $954 million to 1,292 community health centers across the U.S. for capital improvements. The funds, to be provided by HHS’s Health Resources and Services Administration (HRSA) under the American Rescue Plan Act, will advance health equity initiatives in medically…
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FTC Warns Health Apps on Data Breach Notification
September 29, 2021 |Eric Fader | Cybersecurity | Electronic Health Records | HIPAA | Legislation and Public Policy | Medical Devices and Wearables | Telehealth
The Federal Trade Commission (FTC) recently issued a policy statement confirming that vendors of apps and other connected devices that collect personal health information, such as glucose levels, heart rate, or fertility or sleep data, are subject to the FTC’s Health Breach Notification Rule. The rule, issued in 2009, requires…
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Welcome!
September 28, 2021 |Eric Fader | Uncategorized
Rivkin Rounds has been “YOUR PRESCRIBED DOSE OF HEALTH LAW NEWS” on Rivkin Radler’s website and in social media for almost three years, but today we graduate to LexBlog and our own URL! I’ve been condensing healthcare industry doings into bite-size pieces for 10+ years, including my pre-Rivkin existence, and…
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OIG Approves Hospital “Warranty” on Joint Replacement Procedures
September 24, 2021 |Ada Janocinska | Fraud and Abuse | Hospitals | Legislation and Public Policy | Medicare and Medicaid
The U.S. Department of Health and Human Services’ Office of Inspector General (OIG) recently issued a favorable Advisory Opinion on an arrangement that would allow a hospital to offer free items and services to patients who experienced certain complications after undergoing joint replacement procedures at the hospital. The arrangement only…
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DOJ Charges 138 with $1.4B in Telehealth Fraud, Other Schemes
September 21, 2021 |Eric Fader | COVID-19 | Fraud and Abuse | Home Health | Litigation | Medicare and Medicaid | Telehealth
On September 17, the U.S. Department of Justice (DOJ) announced criminal charges against 138 defendants for alleged healthcare fraud schemes that resulted in $1.4 billion in losses. Those charged included 23 doctors, 19 nurses and other licensed professionals, and 96 laypeople, in 31 federal districts across the U.S. Telehealth-related fraud…
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Federal Government Delays Enforcement of Price Transparency Rule
August 30, 2021 |Eric Fader | Affordable Care Act | Legislation and Public Policy | Pharmaceuticals | Private Insurers
The federal government will delay for six months its enforcement of key portions of the Transparency in Coverage (TiC) final rule that goes into effect on January 1, 2022. The change was announced in guidance issued jointly by the U.S. Departments of Labor, Health and Human Services, and the Treasury…
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OIG Issues Favorable Advisory Opinion on Arrangement between Medigap Plan and Hospital Network
August 23, 2021 |Ada Janocinska | Fraud and Abuse | Hospitals | Legislation and Public Policy | Medicare and Medicaid | Private Insurers
On August 16, the U.S. Department of Health and Human Services’ Office of Inspector General (OIG) issued a favorable Advisory Opinion regarding an arrangement between a Medicare Supplemental Health Insurance (“Medigap”) plan and a preferred hospital organization (PHO). The arrangement in question incentivized Medigap policyholders to seek inpatient care from…
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Delta Variant Prompts Mandatory Vaccinations and Mask Requirements
August 10, 2021 |Brian Conneely and John Diviney | COVID-19 | Employer/Employee | Legislation and Public Policy
The Delta variant, which increased COVID cases and hospitalizations, also prompted new federal and local COVID rules and mandates, and required employers to revisit their existing COVID policies. OSHA announced a new COVID Emergency Standard for health care employers to take effect in July 2021. This new Emergency Standard requires health care…
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New CT Cybersecurity Law Protects Against Liability for Data Breaches
August 05, 2021 |Benjamin Wisher | Cybersecurity | Electronic Health Records | HIPAA | Legislation and Public Policy
Connecticut Governor Ned Lamont recently signed into law “An Act Incentivizing the Adoption of Cybersecurity Standards for Businesses” (Public Act No. 21-119). Under the Act, “covered entities” that implement certain cybersecurity measures to protect against data breaches of “personal information” and “restricted information” will be insulated against the imposition of…
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Healthcare Employers Can Mandate Vaccines, but Some Caution Necessary
August 05, 2021 |Rivkin Rounds Staff | COVID-19 | Employer/Employee | Legislation and Public Policy
An article in the August issue of Healthcare Risk Management, “Healthcare Employers Can Mandate Vaccines, but Some Caution Necessary,” discussed recent federal guidance and court decisions that allow hospitals and other healthcare employers to require COVID-19 vaccines for their employees. Rivkin Radler’s Brian Conneely was quoted in the article. “Based…
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Hospitals Violate Price Transparency Rule; CMS Proposes Increased Penalties
July 30, 2021 |Eric Fader | Hospitals | Legislation and Public Policy | Medicare and Medicaid
A new federal hospital price transparency rule that took effect on January 1, 2021, requires hospitals to post all prices for services online in an easily accessible format. However, a report recently released by PatientRightsAdvocate.org found that 94.4% of hospitals were not in compliance with the rule, because one or more price…
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NY Department of Labor Issues Airborne Infectious Diseases Model and Standards for Worksites
July 29, 2021 |Rivkin Rounds Staff | COVID-19 | Employer/Employee | Legislation and Public Policy
The New York Department of Labor has issued Model Safety Plans and Standards for airborne infectious diseases. All employers, regardless of size and with a worksite in New York, must adopt a safety plan by August 5, 2021, and must post, distribute and include the plan in their handbooks to all employees…
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Proposed Physician Fee Schedule Adds Coverage for Remote Therapeutic Monitoring
July 21, 2021 |Eric Fader | Electronic Health Records | Home Health | Legislation and Public Policy | Medical Devices and Wearables | Medicare and Medicaid | Telehealth
The proposed 2022 Medicare Physician Fee Schedule released on July 13 by the Centers for Medicare & Medicaid Services (CMS) includes a new category of CPT codes for “remote therapeutic monitoring” (RTM). The new codes are in addition to the set of codes introduced in 2019 for remote physiological monitoring, usually called…
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Proposed Physician Fee Schedule Includes Expanded Telehealth Reimbursement
July 15, 2021 |Eric Fader | Behavioral Health | Legislation and Public Policy | Medicare and Medicaid | Telehealth | behavioral health
The proposed 2022 Medicare Physician Fee Schedule, released on July 13 by the Centers for Medicare & Medicaid Services (CMS), includes expanded reimbursement for behavioral health services delivered by telehealth, including reimbursing providers for audio-only telephone calls. The proposed expansion would allow Medicare beneficiaries with mental health or substance abuse disorders…
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NPDB Reporting Protected by Law in Some Cases, Gray Areas Problematic
July 08, 2021 |Rivkin Rounds Staff | Hospitals | Legislation and Public Policy | Litigation
An article in the July issue of Hospital Peer Review, “NPDB Reporting Protected by Law in Some Cases, Gray Areas Problematic,” discussed hospitals’ obligations to report doctors to the National Practitioner Data Bank (NPDB) and their protection against liability for doing so. Rivkin Radler’s Chris Kutner was quoted extensively in…
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Compounding the Fraud: Questionable Billing by Pharmacies
July 06, 2021 |Rivkin Rounds Staff | False Claims Act | FDA | Fraud and Abuse | Litigation | Medicare and Medicaid | Pharmaceuticals
Rivkin Radler partners Evan Krinick and Michael Sirignano authored an article, “Compounding the Fraud: Questionable Billing by Pharmacies,” in the July 6 issue of the New York Law Journal. The article discussed the U.S. Department of Justice’s continued concern over fraudulent claims for reimbursement to federal healthcare programs for compounded…
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OIG: Hospitals Need to Improve Oversight of Cybersecurity for Networked Medical Devices
June 29, 2021 |Eric Fader | Cybersecurity | Electronic Health Records | Hospitals | Legislation and Public Policy | Medical Devices and Wearables | Medicare and Medicaid
On June 23, the Department of Health and Human Services Office of Inspector General (OIG) posted on its website an Issue Brief entitled “Medicare Lacks Consistent Oversight of Cybersecurity for Networked Medical Devices in Hospitals.” According to the OIG, the Centers for Medicare & Medicaid Services should amend interpretative guidelines or other…
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NY Telehealth Waivers End
June 25, 2021 |Eric Fader | Legislation and Public Policy | Telehealth
New York’s State Disaster Emergency declaration, which had been extended through June 24 through a series of Executive Orders by Gov. Andrew Cuomo, has expired. Among many other things, the Executive Orders had removed certain restrictions on the provision of telehealth services. For example, since March 18, 2020, Gov. Cuomo’s…
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COVID-19 and Legal Chaos Dent CBD Market
June 17, 2021 |Rivkin Rounds Staff | Cannabis | FDA | Legislation and Public Policy
Rivkin Radler’s Marc Ullman was quoted in the NutraIngredients-USA article, “COVID-19 and legal chaos dent CBD market – but Congress and a stronger economy offer hope.” The article discusses the state of the CBD market amid the COVID-19 pandemic and legal battles. “The market is a mess and the FDA doesn’t want…
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Sham Speaker Fees Lead to Jail Term
June 17, 2021 |Eric Fader | False Claims Act | Fraud and Abuse | Litigation | Pharmaceuticals
On June 16, Jeffrey Goldstein, a former Manhattan physician, was sentenced to 57 months in prison for taking $196,000 in kickbacks from Insys Therapeutics, a defunct Arizona-based opioid manufacturer. Goldstein pled guilty to conspiracy in 2019 for accepting purported “speaker fees” from Insys in 2013-15 to prescribe the company’s fentanyl spray, Subsys. Goldstein was…
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OCR’s HIPAA Right of Access Initiative Continues
June 11, 2021 |Eric Fader | Electronic Health Records | HIPAA | Legislation and Public Policy | Litigation
The U.S. Department of Health and Human Services’ Office for Civil Rights (OCR) has pursued its HIPAA Right of Access Initiative since 2019. OCR’s 19th settlement under the initiative, with The Diabetes, Endocrinology & Lipidology Center, Inc. (DELC), curiously resulted in only a $5,000 fine. The West Virginia provider treats patients who…
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DOJ Announces COVID-19 Fraud Takedown
May 27, 2021 |Eric Fader | COVID-19 | Fraud and Abuse | Home Health | Litigation | Medicare and Medicaid | Telehealth
On May 26, the U.S. Department of Justice (DOJ) announced criminal charges against 14 defendants in six states for participation in healthcare fraud schemes related to the COVID-19 pandemic. The coordinated takedown involved fraudulent claims for laboratory testing, telemedicine fraud, pharmacy fraud, payment of kickbacks for referrals, and alleged misappropriation of COVID-19…
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FDA Issues Medical Device Safety Guidance for MRI Facilities
May 20, 2021 |Eric Fader | FDA | Hospitals | Legislation and Public Policy
On May 19, the U.S. Food and Drug Administration (FDA) issued final guidance for assessing the safety and compatibility of medical devices within magnetic resonance imaging facilities. The guidance applies to implanted devices, external devices like insulin pumps and pulse oximeters, and any other devices that may be brought into MRI rooms,…
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EHR Company in $3.8M Kickback Settlement
May 13, 2021 |Eric Fader | Electronic Health Records | False Claims Act | Fraud and Abuse | Litigation | Medicare and Medicaid
The U.S. Department of Justice recently announced that CareCloud Health, a Florida-based developer of electronic health records software, agreed to pay $3.8 million to resolve a whistleblower’s allegations that it paid illegal kickbacks to generate sales of its products. CareCloud’s marketing referral program called the “Champions Program” allegedly violated the federal Anti-Kickback Statute (AKS)…
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OIG Issues Favorable Advisory Opinion on Hospital/Physician Joint Venture ASC
May 05, 2021 |Ada Janocinska | Fraud and Abuse | Hospitals | Legislation and Public Policy
In a recent advisory opinion, the U.S. Department of Health and Human Services’ Office of Inspector General (OIG) concluded that certain investments by a health system, manager and physicians in an ambulatory surgery center (ASC) did not create a substantial risk of fraud and abuse under the federal Anti-Kickback Statute (AKS)…
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Recreational Cannabis Statutes’ Impact on NY and NJ Employers
April 26, 2021 |Rivkin Rounds Staff | Cannabis | Employer/Employee | Legislation and Public Policy
New York and New Jersey recently legalized recreational marijuana within less than 6 weeks of each other. While both acts prohibit employers from taking action against employees at least 21 years old who use marijuana recreationally and restrict employers from denying these employees’ employment rights and privileges based solely on…
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OIG Warns on COVID-19 Vaccine Billing
April 20, 2021 |Eric Fader | COVID-19 | Legislation and Public Policy | Private Insurers
In an April 15 notice on its COVID-19 portal, the U.S. Department of Health and Human Services’ Office of Inspector General (OIG) reminded healthcare providers that COVID-19 vaccines must be administered at no out-of-pocket cost to patients. OIG has received complaints from patients that their providers charged them for COVID-19 vaccines. Under…
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Insurance Fraud Scheme Lands Chiropractor in Prison
April 16, 2021 |Margarita Christoforou | Fraud and Abuse | Litigation | Medicare and Medicaid
The U.S. Department of Justice (DOJ) announced on April 13 that James Spina, a licensed chiropractor and the unlawful operator of Dolson Avenue Medical, P.C. (DAM), was sentenced to nine years in prison and three years of post-release supervision. DAM, a multi-disciplinary medical practice in Middletown, New York, purported to provide a…
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Bristol-Myers Squibb Settles MDRP Underpayment Claim for $75 Million
April 14, 2021 |Eric Fader | False Claims Act | Litigation | Medicare and Medicaid | Pharmaceuticals
The U.S. Department of Justice recently announced that Bristol-Myers Squibb (BMS) agreed to pay $75 million, plus interest, to resolve allegations that it knowingly underpaid rebates owed under the Medicaid Drug Rebate Program (MDRP). Of that total, $41 million plus interest will be paid to the federal government and the remainder to…
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HIPAA in an Evolving Health Care Environment
April 07, 2021 |Rivkin Rounds Staff | Behavioral Health | COVID-19 | Electronic Health Records | HIPAA | Legislation and Public Policy
On April 6, Rivkin Radler’s Ben Malerba gave a presentation to members of the Coalition for Behavioral Health. The presentation was entitled “HIPAA in an Evolving Health Care Environment: Proposed Changes for 2021 and Response to COVID-19.” The Coalition for Behavioral Health provides policy, advocacy, training and technical assistance to…
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NYS Legalizes Gestational Surrogacy: Changes for Health Care Providers
April 07, 2021 |Eric Fader | Legislation and Public Policy
On February 16, 2021, the Governor enacted the Child-Parent Security Act (“the Act”) through emergency regulations, legalizing compensated gestational surrogacy in New York State. With gestational surrogacy, a surrogate gestates an embryo for the intended parents. The embryo may contain the genetic material of the intended parents or donor gametes. Traditional surrogacy, where…
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Free Drug Program Avoids Sanctions Under AKS
April 06, 2021 |Ada Janocinska | FDA | Fraud and Abuse | Legislation and Public Policy | Medicare and Medicaid | Pharmaceuticals
In a recent advisory opinion, the U.S. Department of Health and Human Services’ Office of Inspector General (OIG) determined not to impose sanctions under the federal Anti-Kickback Statute (AKS) on a drug manufacturer program that offers a free drug to certain eligible patients. The manufacturer uses personalized medicine technology to make…
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Pandemic response, fraud and abuse top Biden’s enforcement priorities
March 31, 2021 |Rivkin Rounds Staff | COVID-19 | False Claims Act | Fraud and Abuse | HIPAA | Hospitals | Legislation and Public Policy | Litigation
A March 24 article in Wolters Kluwer’s Health Law Daily, “STRATEGIC PERSPECTIVES: Pandemic response, fraud and abuse top Biden’s enforcement priorities,” quoted healthcare industry experts who predict increased enforcement in the areas of fraud and abuse, False Claims Act (FCA) cases, and pandemic-related waivers. Rivkin Radler’s Robert Hussar was quoted…
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Shapiro Quoted on CBD Warning Letters in Vitamin Retailer
March 31, 2021 |Rivkin Rounds Staff | Cannabis | FDA | Legislation and Public Policy
A March 26 article in Vitamin Retailer, “FDA Warns Selling of Topical CBD Products Violates FD&C Act,” discussed the two warning letters recently issued by the U.S. Food and Drug Administration (FDA) to two companies for selling topical pain relief products containing CBD. The FDA claims that the sale of…
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FDA Warns that Topical Pain-Relief Products Containing CBD Violate FD&C Act
March 25, 2021 |Rivkin Rounds Staff | Cannabis | FDA | Legislation and Public Policy | Pharmaceuticals
This week, the U.S. Food and Drug Administration (FDA) issued Warning Letters that effectively declare that the presence of cannabidiol (CBD) as an inactive ingredient in topical over-the-counter (OTC) drug products is a  violation of the federal Food, Drug, and Cosmetic Act (FD&C Act). In a news release issued on March 22,…
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NYC Pharmacy Owner Charged with Healthcare Fraud
March 23, 2021 |Margarita Christoforou | Fraud and Abuse | Litigation | Medicare and Medicaid | Pharmaceuticals
The owner of Brooklyn Chemists in Gravesend, Brooklyn and Lucky Care Pharmacy in Flushing, Queens was recently indicted on charges of conspiracy to commit health care fraud, conspiracy to defraud the United States by paying kickbacks and bribes in connection with the provision of health care services, and unlawfully spending the proceeds…
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Time For CEs, BAs to Take Right of Access Seriously
March 18, 2021 |Rivkin Rounds Staff | Electronic Health Records | Employer/Employee | HIPAA | Hospitals | Legislation and Public Policy | Litigation
A March 11 article in the Health Care Compliance Association’s Report on Patient Privacy, “In Wake of 16th OCR Settlement, Time For CEs, BAs to Take Right of Access Seriously,” discussed the Right of Access Initiative that the U.S. Department of Health and Human Services’ Office for Civil Rights (OCR)…
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Smart Speakers Can Monitor Heartbeats
March 11, 2021 |Eric Fader | Home Health | Medical Devices and Wearables
Researchers from the University of Washington have developed a system that uses smart speakers and machine learning algorithms to monitor heartbeats without the need for physical contact. The system was described in a study published in Communications Biology. When a person sits within two feet of a smart speaker, the system sends out…
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False Claims Act Cases Poised to Jump Now and for Years to Come
March 04, 2021 |Rivkin Rounds Staff | Behavioral Health | False Claims Act | Fraud and Abuse | Hospitals | Litigation | Medical Devices and Wearables | Medicare and Medicaid | Pharmaceuticals
Rivkin Radler’s Evan H. Krinick wrote an article entitled “False Claims Act Cases Poised to Jump Now and for Years to Come” that was published in the March 5, 2021 issue of the New York Law Journal. The article discusses health insurance fraud cases in 2020 that involved kickbacks, provision…
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HIPAA Right of Access Initiative Marches On
February 26, 2021 |Eric Fader | Electronic Health Records | HIPAA | Hospitals | Legislation and Public Policy | Litigation
For those providers who somehow missed or ignored the first 15 settlements in the series, the U.S. Department of Health and Human Services’ Office for Civil Rights (OCR) recently announced that Sharp HealthCare, doing business as Sharp Rees-Stealy Medical Centers, agreed to pay a $70,000 fine for failing to provide a patient…
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Provider Relief Fund Audits Coming
February 23, 2021 |Rivkin Rounds Staff | COVID-19 | Legislation and Public Policy | Medicare and Medicaid
A February 15 article in Part B News, “Provider Relief Fund audits coming; pick your method and keep good records,” discussed the Provider Relief Fund (PRF) authorized under the Coronavirus Aid, Relief, and Economic Security Act (CARES Act). Rivkin Radler’s Bob Iseman was quoted in the article. Healthcare providers who…
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Flo Health Settles with FTC Over Privacy Violations
February 17, 2021 |Eric Fader | Cybersecurity | Electronic Health Records | Litigation | Medical Devices and Wearables | Telehealth
Flo Health, Inc., which markets a menstrual and ovulation tracking app, recently entered into a settlement with the Federal Trade Commission (FTC) to dispose of charges that Flo improperly shared consumer data with third parties, including Facebook and Google. The disclosure of the data, which included pregnancy status and sexual history of more than 100…
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