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.
|
||||
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. 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. 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. 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. 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. In recognition of limitation of certain electronic prescribing software the NYS Health Commissioner approved a new blanket waiver for electronic prescribing requirements. 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. 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. 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. 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”). 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. 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. 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 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. 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. 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. 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. 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. 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. Last year’s passing of the new HIPAA requirements signaled the government’s concern that individually identifiable health information needs stronger protection beyond the borders of the healthcare industry. HIPAA already recognized this need by imposing obligations on covered entities and their business associates in prior versions of the rule. In the latest rule update, however, the US Department of Health and Human Services, among other things, expanded the definition and responsibilities of business associates and now made them directly liable for HIPAA noncompliance. |
||||