By Deniza Gertsberg, Esq., on October 2nd, 2024
Effective January 1, 2024, the Corporate Transparency Act (“CTA”) requires most businesses, including healthcare businesses, to report certain information regarding beneficial owners and company applicants. Willful failure to report or update beneficial ownership information may result in the imposition of penalties.
CTA in a Nutshell
The CTA and its implementing regulations seek to
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By Deniza Gertsberg, Esq., on August 8th, 2019 New Jersey pharmacy owners know that every New Jersey pharmacy must appoint a Pharmacist-in-charge (“PIC”) and a pharmacy cannot operate without a PIC for longer than 30 days. Below we review some of the many responsibilities that go with the title.
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By Deniza Gertsberg, Esq., on February 7th, 2019 In a newly proposed rule the Office of the Inspector General (“OIG”) is proposing to exclude from the discount safe harbor certain types of remuneration offered by drug manufacturers to Part D plan sponsors and Medicaid MCOs that may pose a risk to the Federal health care programs and beneficiaries. The OIG is also proposing to add two new safe harbors. The first would protect certain manufacturer point-of-sale reductions, and the second would protect certain fixed service fees that manufactures pay to pharmacy benefits managers for services rendered to the manufacturer that meet specific criteria.
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By Deniza Gertsberg, Esq., on September 11th, 2018 The New Jersey Board of Pharmacy and the New Jersey Board of Medical Examiners recently adopted new regulations and amended existing ones that effect the way providers practice. The changes concern pediatric immunizations performed by pharmacists and the administration of subcutaneous and intramuscular injections and venipunctures by certified medical assistants. We briefly summarize these recent changes below.
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By Deniza Gertsberg, Esq., on March 15th, 2018 New Jersey’s Division of Consumer Affairs is proposing to amend the Prescription Monitoring Program (PMP) to require pharmacies to electronically transmit information about prescriptions filled for gabapentin.
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By Deniza Gertsberg, Esq., on September 4th, 2017 Several of New Jersey’s professional licensing Boards recently adopted new controlled dangerous substance prescription requirements. Prescribers should be aware of the changes to avoid running afoul of the new regulations.
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By Deniza Gertsberg, Esq., on July 13th, 2017 In recognition of limitation of certain electronic prescribing software the NYS Health Commissioner approved a new blanket waiver for electronic prescribing requirements.
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By Deniza Gertsberg, Esq., on April 28th, 2016 Just days after the new e-prescribing rules went into effect, New York’s Commissioner of Health has issued ten blanket waivers that lift electronic prescribing requirements under exceptional circumstances. The waivers will be effective for a year, until March 26, 2017, when the Commissioner will re-evaluate provider and software feasibility and preparedness.
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By Deniza Gertsberg, Esq., on January 18th, 2016 When closing a New Jersey pharmacy, to protect patient access to medication and records and minimize the disruption to continuity of care, certain steps should be followed.
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By Deniza Gertsberg, Esq., on November 4th, 2015 Recent changes to the New York State Medicaid Program affect vaccine administration for pharmacies, claiming process for nurse practitioners, documentation requirements for transportation providers, and prior authorization for physical and occupational therapists. We summarize these changes.
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By Deniza Gertsberg, Esq., on October 6th, 2015 The New Jersey’s Prescription Monitoring Program (NJPMP), aimed at halting the abuse and diversion of prescription drugs, was substantially updated recently to impose new requirements on prescribers of Schedule II drugs and, separately, to stiffen penalties for pharmacists failing to timely report information about dispensing of the controlled dangerous substance (“CDS”).
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By Deniza Gertsberg, Esq., on September 8th, 2015 On March 13, 2015, Gov. Cuomo signed an amendment extending by one year, until March 27, 2016, the implementation date for the mandatory electronic prescribing.
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By Deniza Gertsberg, Esq., on May 26th, 2015 The Office of the Civil Rights (OCR) within the US Department of Health and Human Services recebtly settled a HIPAA violation case with a single location compounding pharmacy in Denver, Colorado. This is yet another HIPAA settlement underscoring the importance of properly implementing and maintaining a compliance plan.
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By Deniza Gertsberg, Esq., on April 23rd, 2015 In 2014, the Office of the Inspector General of the U.S. Department of Health and Human Services (OIG) reported “expected recoveries of over $4.9 billion.” The agency also excluded 4,017 individuals and entities and took 971 criminal actions. Similarly, the OIG pursued 533 civil actions against individuals and entities. According to the agency’s 2015 work
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By Deniza Gertsberg, Esq., on March 23rd, 2015 The mission of the Medicaid Fraud Division (MFD) within the Office of the State Comptroller is to prevent, detect, audit and investigate fraud, waste and abuse by New Jersey providers and recipients. As we look forward to the New Jersey Medicaid Fraud Division 2015 work plan, we look back at the agency’s activities in 2014.
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By Deniza Gertsberg, Esq., on November 23rd, 2014 The Office of Inspector General (OIG) within the U.S. Department of Health and Human Services recently issued two reports reminding providers and suppliers of the importance of carefully vetting their business arrangements before signing on the dotted lines.
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By Deniza Gertsberg, Esq., on October 13th, 2014 Earlier this year, the New Jersey Board of Medical Examiners (BME) issued a Certificate of Waiver to all New Jersey licensed physicians waiving enforcement of rules requiring a prescription to be written in the name of a person to whom a drug is administered (allowing prescription to be written to friends, family or first responders), examination before and follow-up after the issuance of a script. The Waiver is in effect for a year or until the BME adopts revised regulations.
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By Deniza Gertsberg, Esq., on August 11th, 2014 The U.S. Food and Drug Administration (FDA) has recently changed its guidelines for products containing acetaminophen to protect the public against the risk of acetaminophen-induced liver injury.
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By Deniza Gertsberg, Esq., on May 28th, 2014 In an effort to curb black market sale of prescription painkillers New Jersey is implementing changes to its paper prescription blanks. These changes represent the first change to the State’s prescription blanks since 2004.
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By Deniza Gertsberg, Esq., on April 21st, 2014 The New York State’s Office of the Medicaid Inspector General (OMIG) has released its program of activities for the current fiscal year. As in previous years, the agency’s audit and investigation function remain strong.
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