INSIDE COMPLIANCE

Government Scrutiny of Patient Assistance Programs

September 26, 2017Emily BoydUncategorized

In the eyes of underinsured or uninsured patients, Patient Assistance Programs (PAPs) offer access to otherwise unaffordable medications. However, there are questions being raised whether PAPs are being abused by manufacturers as an inappropriate inducement. The government is increasing its inquiries into PAPs and is beginning to take more investigative action. PAPs are often funded by charitable donations from companies who benefit from the PAP paying for co-insurance for the very drugs the company manufactures. It is essential for companies seeking to develop or maintain charitable donations to remain compliant with existing regulations, but also be aware of forthcoming regulations as a result of present actions.

compliancefraud and abuseHHSkickbackOIGpatient assistancepharmaceuticalprescription drugsRegulation

Compliance Spotlight: Dominique Vittori, Abbott Laboratories

September 25, 2017Compliance Spotlight, Drugs & Devices

Dominique Vittori is a Regulatory Affairs Associate for Abbott Laboratories working within Abbott Diagnostics Division. Abbott Laboratories is a worldwide healthcare company that is most known for pharmaceutical development but eventually branched out to include medical devices, nutritional products and research-based drugs/pharmaceuticals. Ms. Vittori earned her Bachelor’s degree from the University of Illinois, where she majored Molecular and Cellular Biology. Ms. Vittori sought a career in compliance because of the opportunity to put her background and expertise in the sciences to use in a corporate setting, and has been most rewarded by the ability to see the tangible results of her work at Abbott Labs.

The following is an interview with Ms. Vittori where she gives an inside look into her daily life as a compliance professional.

Abbott LaboratoriesCompliance skillsFDAinterviewPharmaceuticalsRegulationRegulatory Affairs

History of Emergency Prescription Fulfillment Policies in the Wake of Hurricanes Harvey and Irma

September 22, 2017Sarah JohnsonDrugs & Devices

In the midst of a natural disaster people gather their children and pets, try to locate a temporary home, and worry what situation they may come home to. The first things people think to grab have nothing to do with their prescription drugs. However, according to a study performed by the U.S. Department of Health and Human Services, from 2011-2014, 46.9% of the population was prescribed a drug in the last 30 days; prescription drugs are an important factor in many peoples’ lives. When portions of the population are displaced from their homes during a natural disaster, they often forget their pill bottles and/or prescriptions. Thankfully, following Hurricane Katrina, regulations were put in place to help people in these situations.

disasterdrugfloridaharveyhurricaneirmaNABPpharmaceuticalpharmacypreparednesspuertoricotexasusviusvirginislands

Hurricanes Harvey and Irma Add Urgency to Congressional Flood Insurance Reform Effort

September 21, 2017Richard ShepherdFinance & Banking

In 2016, Congress introduced a bill to reform the National Flood Insurance Program. Proponents of the bill saw it as necessary reform to a debt-ridden and ineffective program, while opponents saw it as an attack against a necessary safeguard for coastal Americans. The National Flood Insurance Program was set to expire at the end of September 2016, until Congress extended the program through December 8, 2017. As Americans rebuild from Hurricanes Harvey and Irma, Congress contemplates reform and seeks to keep the program funded past December.

BankingcomplianceCongressFEMAfinanceFlood InsuranceInsuranceNFIPReform

Airways Circumvent Inefficient Regulation with Inefficient Workaround

September 20, 2017Uncategorized

A 2010 regulation heightened the in-flight hour requirements for ‘First Officers’ (i.e., copilots) from 250 hours to 1500 hours. Advocacy for this regulation came from the families of Colgan Air Flight 3407, a fatal jetliner crash which the National Transportation Safety Board (NTSB) determined was caused by pilots failing to respond to warnings that the airplane was about to stall. However, years into the implementation of the 1500 hours rule, the regulation has shown only questionable increases in flight safety. Critics argue that debatable increases in passenger safety do not offset the sharp increase in costs associated with pilot training. Instead, airlines have figured out a way to circumvent this questionably inefficient regulation by sacrificing commercial efficiency.

1500 hours ruleairlinesaviationFAAFirst OfficerflightinefficiencyNational Transportation Safety BoardpilotssafetyTransportation

Hurricane Harvey Aftermath Leaves Opportunity for Financial Fraud

September 19, 2017Tierney MasonFinance & Banking, Fraud & Abuse

On August 30, 2017, Trump signed Proclamation 9632 declaring September 2017 as National Preparedness Month, encouraging “all Americans… take action to be prepared for disaster or emergency by making and practicing their plans,” also citing that fewer than half of American families report having an emergency response plan. While it is important to have a disaster plan in place for your family to take care of their physical needs, it is also vital to be prepared for the possibility of scams and fraudulent activity in the wake of a natural disaster such as Hurricane Harvey.

FINRAfraudharveynatural disasterprice gougingSEC

Guest Post: A Post-Regulatory Recipe for Economic Leadership

September 19, 2017The Marketplace11 Comments

by William Devine, Guest Contributor

Apple has developed and distributed a curriculum that will teach students at 30 community colleges around the country to write code and create apps. What prompts this gift? A belief that we all bear responsibility for sustaining a functional economy. At a time when some corporate leaders and their legal teams focus on the perils of overregulation, the greatest regulatory risk an enterprise confronts may not be high compliance hurdles, but rather the possibility that regulators can’t keep the economy functioning well enough for the enterprise to do its most commercially inventive and societally valued work.

AppleGuest PostSWIFTtech educationtechnologytim cookwilliam devine

Putting the Brakes on New Jersey Transit

September 12, 2017Uncategorized1 Comment

New Jersey Transit, one of our nation’s busiest commuter railroads, is no stranger to service and safety issues. Once a model agency to others, it is now the U.S. leader for breakdowns, accidents, and fines. Last year the agency logged the most accidents of the nation’s 10 biggest commuter railways, including the deadly Hoboken train crash. This past March, Todd C. Barretta took the reins of New Jersey Transit’s Chief Compliance Officer—a position that had been vacant since the agency created a safety office in 2014. He lasted a mere six months before being demoted, suspended, and ultimately fired. The New Jersey Transit system is a dysfunctional runaway train that needs an overhaul of its operating system to ensure safety for passengers and employees.

compliance officerFederal Railroad AdministrationFRAHobokenNew Jerseypolitical appointmentssafety regulationTodd BarrettatransitTransportation

My Summer with the Office of Inspector General for the U.S. Department of Health and Human Services

September 11, 2017Fraud & Abuse1 Comment

This summer I had the opportunity to intern with the Office of Inspector General for the U.S. Department of Health and Human Services (OIG) in Washington, DC. I thoroughly enjoyed my time with OIG, and I learned a great deal about health care fraud, waste, and abuse. In spending my summer with OIG, I had a glimpse into the powerful regulatory bodies that protect the health care market from abuse. As I move forward with my career in regulatory work, I will take with me the invaluable experiences and skills from my internship.

21st Century Cures ActAnti-Kickback StatuteCenters for Medicare and Medicaid ServicesCivil Monetary Penalties LawCMPCMScorporate integrity agreementDepartment of JusticeDOJEmergency Medical Treatment and Active Labor ActEMTALAfalse claims actFederal health care program exclusionFederal health care programsfraud and abuseHealth and Human Serviceshealth care compliancehealth care fraud and abuseHHSintegrity agreementMACRAMedicaidmedicareMedicare Access and CHIP Reauthorization ActMedicare exclusionOffice of Inspector GeneralOffice of Inspector General for the U.S. Department of Health and Human ServicesOIGOIG HHSSocial Security ActU.S. Department of Health and Human Services

Privacy in Insecurity

September 8, 2017HIPAA & Health Information

Though the rain has stopped falling, Houston is still dealing with the aftermath of Hurricane Harvey, one of the largest and most destructive rainfall events on record. Healthcare providers in particular find themselves struggling to keep up with the various health problems caused by the flooding itself, on top of getting life-sustaining care to individuals with chronic or preexisting conditions. Crises like Harvey create serious problems for the delivery of care, but also for regulating it—circumstances are so uniquely devastating that standards can feel like barriers to necessary medical attention. And when family and friends are desperate to know if their loved one is out of danger, even the right of privacy seems negligible.

However, natural disasters and emergency events shouldn’t be used as an excuse to regulate away protections individuals depend on, such as the privacy and confidentiality of their personal information. Regulators must be careful when determining how to respond in a crisis—overreaching for the sake of bringing relief or under-regulating for flexibility can leave the public high and dry when the floodwaters recede.

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