Many people experience hearing loss and related hearing issues. To date, to get a hearing aid, people needed a prescription and to see a licensed hearing aid specialist in order to be properly diagnosed and fitted for a...more
In an unprecedented move, the U.S. Food and Drug Administration (FDA or Agency) sent a warning letter to Amazon.com, Inc. (Amazon), a fulfillment house, with respect to distributing over-the-counter (OTC) drug products that...more
On July 6, the U.S. Food and Drug Administration (FDA) revised its emergency use authorization (EUA) for the COVID-19 antiviral treatment PaxlovidTM (nirmatrelvir and ritonavir) to allow prescribing by pharmacists for quicker...more
In this second installment of this blog series on the No Surprises Act interim regulations (NSA) we discuss: i) notice and consent requirements for out of network providers providing services at participating health care...more
In this two-part blog series, we dive into the key points for telemedicine providers in the several hundred pages of the No Surprises Act interim regulations (NSA). The good news for the telemedicine industry is that the...more
The U.S. Food & Drug Administration (FDA) recently issued draft guidance regarding the use of digital health technology (DHT) for the remote acquisition of clinical trial data.
DHT can take the form of hardware and...more
The U.S. Food & Drug Administration (FDA) previously issued emergency use authorizations (EUA) and adopted emergency policies in response to the COVID-19 public health emergency (PHE) to facilitate the availability of key...more
On December 8, 2021 and in response to the mandate under the 21st Century Cures Act to issue guidance on the use of real-world evidence (RWE) in regulatory decision-making, the U.S. Food and Drug Administration (FDA) released...more
The U.S. Food & Drug Administration (FDA) recently issued a discussion paper to gather feedback that will inform future policies and guidance regarding 3D printing medical devices at the point of care.
Amidst COVID-19...more
On November 12, 2021, the Centers for Medicare and Medicaid Services (CMS) announced that it is rescinding the Medicare Coverage of Innovative Technology and Definition of “Reasonable and Necessary” (MCIT/R&N) final rule,...more
On November 15, 2021, the U.S. Department of Health and Human Services (HHS) announced the withdrawal of the policy established during the previous administration that limited U.S. Food and Drug Administration’s (FDA) ability...more
Recently, the U.S. Food and Drug Administration (FDA) notified several pharmaceutical companies that they must repeat their clinical and bioanalytical studies conducted by Synchron Research Services (Synchron) or Panexcell...more
In response to President Biden’s Executive Order on Promoting Competition in the American Economy—which called for the Secretary of Health and Human Services to publish for notice and comment a proposed rule on...more
Undoubtedly in response to OIG’s November 2020 Special Fraud Alert: Speaker Programs issued, on August 6, 2021, PhRMA issued a statement addressing an update to the PhRMA Code on Interactions with Health Care Professionals,...more
The COVID-19 Public Health Emergency (PHE) is expected to prompt unprecedented levels of regulatory enforcement activity that is focused on the use of telemedicine. In fact, fraudulent and abusive telehealth practices was an...more
7/16/2021
/ Audits ,
CARES Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Data Privacy ,
Department of Justice (DOJ) ,
Enforcement Actions ,
FQHC ,
Fraud ,
Health Insurance Portability and Accountability Act (HIPAA) ,
OCR ,
OIG ,
Public Health Emergency ,
Relief Measures ,
Rural Health Care Providers ,
Telehealth
On June 30, 2021, the Centers for Medicare & Medicaid (CMS) released Open Payments data for the past year, 2020. This new data publication comes amid heightened government scrutiny of payments by drug and medical device...more
7/9/2021
/ Affordable Care Act ,
Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Enforcement Actions ,
Group Purchasing Organizations (GPO) ,
Manufacturers ,
Medical Devices ,
Medicare ,
OIG ,
Open Payments ,
Prescription Drugs ,
Sunshine Act
Florida’s telehealth emergency waivers ended on June 26, 2021, after Governor Ron DeSantis’ Office allowed the waivers to expire. The waivers were originally contained in Emergency Orders 20-002 and 20-003. On July 1, 2021,...more
On April 27, 2021, the U.S. Food and Drug Administration (FDA) sent a notice of noncompliance to Acceleron Pharma (Acceleron), accusing the company of failing to post clinical trial summary results on its cancer combination...more
The COVID-19 pandemic has created nothing short of a seismic shift in the delivery of health care services, especially where telehealth is concerned. Following the President issuing a proclamation that the COVID-19 outbreak...more
What You Need to Know: On December 18, 2020, the Food and Drug Administration issued the second emergency use authorization (“EUA”) for a vaccine for the prevention of COVID-19 in individuals 18 years of age and older. Under...more
The Centers for Medicare & Medicaid Services (CMS) issued updated guidance on the thresholds that Applicable Manufacturers and Group Purchasing Organizations are required to report annually under the Sunshine Act (42 U.S.C. §...more
11/18/2020
/ Centers for Medicare & Medicaid Services (CMS) ,
Civil Monetary Penalty ,
Consumer Price Index ,
Covered Recipients ,
Data Collection ,
Department of Justice (DOJ) ,
Group Purchasing Organizations (GPO) ,
Manufacturers ,
Nurse Practitioners ,
Open Payments ,
Physicians ,
Social Security Act ,
Sunshine Act
On August 20, 2020, the Department of Health & Human Services (HHS) released a statement, Rescission of Guidances and Other Informal Issuances Concerning Premarket Review of Laboratory Developed Tests, which announced that...more
As the U.S. continues to struggle to make COVID-19 tests available for symptomatic and asymptomatic individuals, FDA’s position regarding COVID-19 test standards is evolving. The FDA’s pivot is possibly a response to...more
The difficulties in accessing laboratory testing and securing prompt results present continuing challenges in the fight to control COVID-19. With scarce availability, there have been some attempts to limit tests to, or...more
On June 30, 2020, PhRMA released a Statement on Application of PhRMA Code Section 2 During Emergency Periods, which recognizes the difficulty in complying with the Code’s requirement that informative presentations given to...more