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Delaware Health Law Blog

Written by Adam Balick on June 30, 2014

Delaware Office of Controlled Substances Issues Emergency Regulation Restricting Prescriptions of Extended Release Hydrocodone

On June 18, 2014, the Office of Controlled Substances issued an emergency regulation imposing a number of conditions on prescribing extended release hydrocodone that is manufactured without an abuse deterrent formulation (ADF).  The move is apparently Delaware’s reaction to the FDA’s approval last year of Zohydro ER, which approval has prompted concern among members of […]

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Written by Adam Balick on March 21, 2014

Medication Diversion as Abuse in Facilities

On February 14, Governor Markell signed into law House Bill No. 154, amending Titles 16 and 24 of the Delaware Code, as another action to help curb prescription drug abuse and diversion in Delaware. The law creates a new criminal offense and imposes penalties for diverting prescription drugs from a patient in a facility. More specifically, the law includes in the definition of “abuse” medication diversion “by knowingly, or intentionally, interrupting, obstructing, or altering the delivery or administration, of a prescription drug to a patient or resident” so long as the drug was prescribed or ordered by a healthcare provider for the patient or resident and where the diversion occurred without a prescription or order of a healthcare provider.

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Written by Adam Balick on March 7, 2014

The 2014 OIG Work Plan as a Guide to Fraud and Abuse Focus Areas

After a delay of several months, the Department of Health and Human Services, Office of Inspector General (“OIG”) released its Fiscal Year 2014 Work plan on January 31, 2014. After combing through Work Plan, we noticed new areas of OIG focus, which it believes may be ripe for fraud, waste, and abuse. The Delaware healthcare community—from physician practices to institutional providers—can stand to gain a great deal of insight by understanding the OIG’s focus and trends for the new year. Most importantly, the Work Plan can help providers identify potential areas of compliance risk before an issue arises. We have identified a few key OIG initiatives below.

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Written by Adam Balick on August 14, 2013

General Assembly Puts Limits on In-Office Dispensing of Controlled Substances

Practitioners who have established in-office dispensing as a convenience to patients, as well as the patients who look to their doctor to dispense medications, are going to see those systems impacted by a recent bill signed by the Governor. In yet another measure intended to address the prescription drug abuse epidemic in Delaware, Senate Bill 119 was signed into law on July 3, 2013 to limit the in-office dispensing of controlled substances.

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Written by Adam Balick on June 13, 2013

Shared Responsibility for Proper Prescribing and Dispensing of Controlled Substances

Delaware pharmacists have recently been reminded of their “corresponding responsibility” under Delaware and federal law. Regulations provide that while “the responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner… a corresponding responsibility rests with the pharmacist who fills the prescription.” 21 CFR § 1306.04; Delaware Controlled Substances Act Regulation 4.3.1

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Written by Adam Balick on April 18, 2013

Proposed Regulations to Require Accreditation of Medical, Dental and Podiatry Practices

On April 1st, the Department of Health and Social Services (“DHSS”), through the Office of Health Facilities Licensing and Certification, published proposed regulations governing accreditation standards and safety and sanitation standards that, if implemented, would apply to all medical offices, dentist offices and podiatry offices where certain invasive procedures are performed. Physicians, dentists, and podiatrists who perform even minor medical procedures in their offices while utilizing “any level of anesthesia” should carefully review the regulations, as the Delaware health care community will undoubtedly be surprised by the proposed new requirements that may soon apply to these practices.

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Written by Adam Balick on February 1, 2013

Delaware General Assembly Considers Expanding Immunity Connected to Mental Health Assessments

Pending in the Delaware Senate is a bill already passed unanimously in Delaware’s House of Representatives clarifying the law on immunity with regard to the process to detain or not detain a person for an involuntary mental health evaluation. House Bill #9 provides that immunity to civil damages and criminal penalties extends to peace officers, medical doctors, credentialed mental health screeners, and the facility in which the medical doctor or credentialed mental health screener practices, only for harm resulting from the mental health assessment, resulting clinical decision, and involuntary hold necessary until the person is presented to a designated psychiatric treatment facility, as required by the statute, and only if the peace officer, medical doctor, etc., did not intentionally inflict harm or engage in willful or wanton misconduct in connection with those activities.

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Written by Adam Balick on November 2, 2012

American Hospital Association Strikes Back at the RACs

Many health care providers are familiar with the costly exercise of fighting a Recovery Audit Contractor’s (“RAC”) determination of an overpayment through the administrative appeal process. But where providers take on the expense, the statistics on appeal are largely favorable. For fiscal year 2011, 43.4% of RAC determinations were reversed in the providers’ favor. The problem is that of the 903,372 claims identified as overpayments by RACs, only 56,620 claims were appealed at any level. Of those 56,620 claims, the 24,458 claims overturned during the appeal process translate to $37.9 million, or $1,550 per case.

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Written by Adam Balick on October 26, 2012

Delaware Bar Association Health Law Section Seminar

Please plan to attend a very special CLE/CME Seminar, “Health Law 101: What Every Lawyer and Healthcare Provider Should Know,” on Friday, November 30th, 2012, at the Medical Society of Delaware’s Conference Center in Newark. During this all-day seminar leading Delaware health law practitioners will cover a range of health law topics, from recent HIPAA-related developments and federal fraud and abuse laws to state law topics such as prescription drug monitoring and medical malpractice litigation.

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Written by Adam Balick on October 4, 2012

OIG RELEASES 2013 WORK PLAN

Yesterday the OIG issued its Work Plan describing the activities the OIG plans to initiate or continue with respect to HHS programs and operations in fiscal year 2013. The Plan identifies areas of government focus for each type of healthcare provider, as well as the OIG’s planned activities related to its oversight of Medicare Part A and B contractors, Medicare Part C and D programs, state Medicaid plans, and public health and human services agencies within the U.S. Department of Health and Human Services.

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