Category Archives: Pharmacy, Drugs, Medical Devices & Equipment

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Potential Implications to the ACA Under the Incoming Republican Administration – Part IV: Pharmacies

The Affordable Care Act (ACA), as a whole, did not have a significant impact on pharmacy services per se. However, a complete repeal would likely impact certain areas of pharmacy services including the drug benefit for the exchange plans, the donut hole for Medicare Part D, states’ necessary Medicaid rebates, and certain recipients of 340B drugs.… Continue Reading

DEA Tweaks, Walks Back Changes to Renewal Process

DEA recently revised an earlier announcement that would have eliminated the grace period for renewals of controlled substance registrations. After initially declaring that prescribers and other registrants would no longer be able to renew their expired registrations during a grace period, DEA announced it would instead continue allowing that practice – for now at least. As a result, registrants who … Continue Reading

Deciphering Florida’s New Laws on ARNP and PA Controlled Substance Prescribing

During the 2016 legislative session, Florida granted authority to both advanced registered nurse practitioners (ARNPs) and physician assistants (PAs) to prescribe controlled substances, subject to approval by their supervising practitioner. This change brings these professionals’ authority in line with what most other states allow. However, this was not a complete grant of prescribing authority and, as explained below, leaves these … Continue Reading

Recent CyberSecurity Incidents Emphasize Importance of Cyberinsurance

As the threat of cyberattacks continues to pose daily threats to businesses large and small, more companies have turned to cyber insurance products to shore up protection against these disruptive threats. A spate of recent incidents has highlighted the importance of taking steps to prepare for and mitigate possible damages. As such, healthcare entities have begun exploring Cyberinsurance as a … Continue Reading

Florida’s Adoption of Federal Exemptions for Wholesale Drug Distribution May Benefit Pharmacies, Practitioners and Hospitals

The 2016 Florida Legislature enacted substantial legislation (Ch. 2016-212, Laws of Florida) to bring Florida’s Drug and Cosmetic Act (Ch. 499, Florida Statutes) in line with the federal Drug Supply Chain and Security Act (“DSCSA”). Since the DSCSA preempts state law, the changes were necessary to avoid confusion between the state and federal exemptions to the term “wholesale … Continue Reading

Recent Legislative Developments Affecting Florida Pharmacies

Florida’s 2015 Legislative Session ushered in two new laws affecting pharmacies: One addressing pharmacist immunizations (HB 279) and the second clarifies that veterinarians are authorized to dispense compounded drugs and regulates “maximum allowable cost” pricing (HB 1049). In addition, the FDA has delayed enforcement of certain provisions of the federal Drug Quality and Security Act (DQSA) that went into effect … Continue Reading

OIG’s Rejection of Payments for Prescription Transfers Leaves Questions about Central Fill Pharmacy Arrangements.

The U.S. Department of Health & Human Services, Office of Inspector General (OIG) recently refused to bless a specialty pharmacy’s request to pay a per-prescription fee to retail pharmacies for “support services” to be provided in connection with prescriptions transferred to the specialty pharmacy (OIG Advisory Opinion 14-06). The OIG found that the per prescription fee could influence the retail … Continue Reading

Guidance Helps Medical Device Companies Determine Substantial Equivalence

When is a medical device substantially equivalent to another device? Like so much else, it depends. On July 15, 2014, the U.S. Food and Drug Administration (FDA) issued a draft guidance that aims to clarify that question. The document is officially directed at FDA staff, but it is equally instructive to companies seeking FDA approval for their devices.

The FDA … Continue Reading

FDA Offers Guidance for Choosing Prescription Drug Names

If you’ve seen your share of prescription drug commercials, you’ve likely marveled at the odd drug names: Moexipril. Oxcarbazepine. Zafirlukast. You might think pharmaceutical companies just prefer complex, new combinations of letters, but naming a drug requires more than a marketing brainstorm session. A recent draft guidance document from the U.S. Food and Drug Administration (“FDA”) shows many considerations go … Continue Reading

FDA Issues Draft Guidance for Drug and Device Information on Social Media

The Food and Drug Administration (“FDA”) recently issued two draft guidance documents relating to the use of Twitter and other social media by drug and medical device companies. Emphasizing that companies must give a balanced presentation of their products, the Agency stated that companies must provide risk information along with any benefit information within a tweet or similar promotional message.… Continue Reading

Florida Board of Pharmacy Clarifies that Pharmacies Can’t Compound Sterile Human Drugs for “Office Use”

The Florida Board of Pharmacy rules allow pharmacies to engage in office-use compounding. Rule 64B16-27.700, FAC. This allows pharmacies to compound drugs for physicians to use in treating their patients in the office without writing a patient-specific prescription. It does not allow the physician to dispense the office-use drugs to their patients (i.e. give the patient a supply to take … Continue Reading

Florida Says Can Do To Medical Cannabis

In the waning days of the 2014 legislative session, the Florida Legislature passed the Compassionate Medical Cannabis Act of 2014.  It is a very limited medical marijuana bill with very strict restrictions and conditions on use.  The bill allows access to only low-THC (tetrahydrocannabinol) cannabis (so-called “Charlotte’s Web”) for persons with cancer or another condition that produces seizures or … Continue Reading

Florida Acknowledges Exemption for Intracompany Sales of Pharmaceuticals

A new declaratory statement from Florida regulators clarifies the restrictions on intracompany sales of pharmaceuticals.  Previously, if one pharmacy in Florida wanted to send a bottle of prescription medicine to its sister pharmacy down the street, it had to obtain a type of wholesale drug distributor permit, as well as provide pedigree papers for the drug.  However, the new decision … Continue Reading

FDA Launches Medical Device ID Requirement

On September 24, 2013, the Food and Drug Administration (FDA) finalized a new rule requiring medical devices to bear special ID numbers. The numbers, called Unique Device Identifiers or UDIs, will identify the manufacturer, the specific model of a device, and other information such as batch or lot codes, serial numbers, and expiration dates. The UDIs are intended to improve … Continue Reading

HHS Makes Good on Its Promise: Releases HIPAA Guidance for Refill Reminder Programs

As previously reported, HHS announced earlier this month that it would be providing clarification on the HIPAA Privacy Rule as it relates to marketing and prescription refill reminder programs.  On September 19, 2013, HHS made good on that promise when the Office for Civil Rights announced guidance on when refill reminders and other communications about drugs currently being prescribed … Continue Reading

HHS to Revamp Limits on Payments to Pharmacies for Refill Reminder Programs

The HIPAA Privacy Regulations have long required covered entities to seek a patient authorization in order to use or disclose protected health information (“PHI”) for marketing purposes. However, the Office for Civil Rights made it clear in its Q and A on its website that pharmacies were allowed to provide refill reminders to patients without an authorization as this was … Continue Reading

Florida Board of Pharmacy Approves the Centralized Prescription Filling Rule (Central Fill Pharmacy) for Hospital Pharmacies

On August 14, 2013 the Florida Board of Pharmacy voted to approve central fill pharmacy in a hospital setting. Centralized prescription filling or “central fill” is where two pharmacies separate the duties and responsibilities of dispensing a prescription. Generally, one pharmacy will receive the prescription and send it to, or share it with, another pharmacy with which it has an

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Physician Face-to-Face Encounter Now Required by Medicare for Extensive List of DME Items

Physicians and Durable Medical Equipment (DME) suppliers need to be aware that, effective July 1, 2013, and to be enforced as of October 1, 2013, Medicare requires a physician/patient face-to-face encounter within 6 months prior to the physicians order for an item on an extensive DME list. This type of face-to-face encounter has been required since 2006 for power wheel … Continue Reading

Supreme Court Rules Pharmaceutical “Pay For Delay” Agreements Are Subject to Anti-Trust Review

The Supreme Court struck a blow for consumers when it ruled the Federal Trade Commission may file suit to prevent pharmaceutical companies from agreeing to pay generic drug manufacturers to keep generic drugs off the market for a specified period of time. Federal Trade Commission v. Actavis, Inc. (June 17, 2013).

The Court ruled that “pay for delay arrangements” … Continue Reading

New Challenge to Medicare Requirement that Ancillary Providers Obtain Physician Records to Justify Medical Necessity

For years now, ancillary providers ranging from durable medical equipment providers (DMEs), independent diagnostic testing facilities (IDTFs), and home health agencies have been required under Medicare regulations to obtain copies of referring physicians’ medical records to prove medical necessity for the items and services the physician ordered. Providers are to utilize a template “Dear Physician” letter created by CMS that … Continue Reading

Recent Judicial Activity on the Pharmacy Front

Reimbursement for the Difference Between the Brand and Generic Drug

Graphic Communications Local 1B Health & Welfare Fund “A”, et al., Appellants, vs. CVS Caremark Corporation, et al.,  State of Minnesota Court Of Appeals, Case No. A12-1555 (May 6, 2013).

A recent decision by the Minnesota Court of Appeals reversed the dismissal of a case against pharmacies for not … Continue Reading

Requested Chocolate Milk Change Highlights FDA Labeling Authority

Chocolate milk is serious business in school lunchrooms – and at the U.S. Food and Drug Administration (“FDA”). The FDA is calling for public comments about a requested change to milk labeling laws as a potential way to reduce childhood obesity. Currently, flavored milk, such as chocolate milk, that contains artificial sweeteners must be labeled as “no sugar added” chocolate … Continue Reading

Supreme Court to Decide Pharmaceutical “Pay for Delay” Case

The United States Supreme Court is set to decide whether a patent holder can pay to keep a challenger out of the market, or whether doing so violates antitrust laws.

Drug manufacturers are granted patents on their products for 20 years, giving them an exclusive right to manufacture and market the patented drug.  In order to bring a generic version … Continue Reading

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