Connecticut Enacts Law to Increase Access to Epinephrine Auto Injectors

On June 13, 2019, Connecticut Governor Ned Lamont signed into law Public Act No. 19-19 “An Act Concerning Epinephrine Auto Injectors” (PA 19-19). PA 19-19 went into effect on the same date.

This legislation expands access to epinephrine, which can be lifesaving when treating anaphylactic allergic reactions. PA 19-19 permits “authorized entities” to acquire and maintain a supply of epinephrine cartridge injectors, subject to certain conditions. With a few exceptions, authorized entities are for-profit or nonprofit entities or organizations that employ at least one “person with training.” The new legislation defines a person with training as a person who either:

  • Has completed and received a certification in a first aid course that has been approved by a “prescribing practitioner” pursuant to a medical protocol (as described below); or
  • Has received training in the recognition of the signs and symptoms of anaphylaxis, the use of an epinephrine cartridge injector and emergency protocol by a licensed physician, physician assistant, advanced practice registered nurse or emergency medical services personnel.

Prior to PA 19-19, drug wholesalers and manufacturers were permitted to sell epinephrine cartridge injectors to select categories of purchasers, including hospitals, physicians, nursing homes with a full-time pharmacist, pharmacies and certain other institutions with a full-time pharmacist.

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Supreme Court Rejects HHS Proposal that Could Have Significantly Lowered Certain Medicare DSH Payments to Hospitals

In a 7-1 decision released June 3, 2019, the U.S. Supreme Court vacated a proposal of the U.S. Department of Health and Human Services (HHS) that would have had the effect of significantly reducing Disproportionate Share Hospital (DSH) payments to thousands of hospitals for care furnished to low income patients in 2012.

In Azar v. Allina Health Services, Et Al., the Supreme Court held that HHS needed to comply with statutory notice and comment rulemaking procedures under the Social Security Act (Act) when making interpretive changes, because HHS sought to establish or change substantive legal standards.  As a result, HHS was required to publish its proposal to change the DSH payment calculations for 2012 for notice and comment, and its unilateral determination regarding the calculation of those payments was invalid. Continue Reading

OIG Issues Alert to Warn of ‘Free’ Genetic Testing Scams Seeking to Steal Information

On June 3, 2019, the U.S. Department of Health and Human Services Office of Inspector General (OIG) issued a fraud alert to notify consumers about genetic testing fraud schemes (the Alert). According to the OIG, fraudulent actors are using the provision of free genetic testing kits to obtain Medicare information from unwitting consumers, and then using the stolen information for purposes of fraudulent billing and/or identity theft. Continue Reading

OCR Issues Fact Sheet Listing Circumstances in which Business Associates May Face Direct Liability for HIPAA Violations

In a development that may – understandably – have been overlooked by many heading into Memorial Day weekend, on May 24, 2019, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) issued a Fact Sheet on Direct Liability of Business Associates under the Health Insurance Portability and Accountability Act (HIPAA).

The Fact Sheet provides an important reminder to covered entities, business associates, and their counselors regarding the circumstances in which OCR may – and may not – take enforcement actions directly against business associates for violations of HIPAA regulations. In the Fact Sheet, OCR explains that in 2009 the Health Information Technology for Economic and Clinical Health (HITECH) Act made business associates “directly liable for compliance with certain requirements” under HIPAA’s regulations, as addressed by OCR in its 2013 Omnibus Rule.

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U.S. Supreme Court Clarifies Scope of False Claims Act Statutes of Limitations

In a unanimous decision issued on May 13, 2019, the U.S. Supreme Court sought to resolve lingering confusion over the statute of limitations under the False Claims Act (FCA) for qui tam suits in which the federal government declines to intervene. In Cochise Consultancy, Inc. v. United States Ex Rel. Hunt, the Court held that a relator’s claim may be brought within 3 years after the government was made aware of underlying material claims, even where the government did not intervene in the case, because 10 years had not passed since the actions giving rise to such claims occurred, applying the periods in 31 U.S.C. § 3731(b)(2) to the case. Cochise addresses confusion over applicability of 31 U.S.C. § 3731(b), which contains two separate limitations periods (along with a repose period) that can apply to an FCA suit. Under that law, an FCA action may be brought (1) 6 years from the date of the violation, or (2) 3 years from the date the U.S. official responsible for acting knew or should have known of the violation, but no later than 10 years from the date the violation occurred.

The FCA makes it unlawful for individuals or entities to knowingly submit or cause to be submitted false claims for government payment. FCA suits may be brought by the government, or by private citizens in qui tam actions in the name of the United States. In qui tam actions the relator must serve the complaint on the government, and the government then has an opportunity to intervene in the suit.

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CMS Amends Regulations to Lower Drug Prices and Reduce Out-Of-Pocket Expenses in Medicare Advantage and Part D Prescription Drug Benefit Program

The Centers for Medicare and Medicaid Services (CMS) announced a final rule, to be published on May 23, 2019, amending the Medicare Advantage program (Part C) and Prescription Drug Benefit program (Part D) regulations. According to CMS, the purpose of the rule is to lower drug prices and reduce out-of-pocket expenses in the Medicare Advantage and Part D drug programs.

The major provisions are:

  1. Protected classes. The final rule contains an exception to the requirement that Part D sponsors include all Part D drugs in these protected classes on their formularies: (1) antidepressants; (2) antipsychotics; (3) anticonvulsants; (4) immunosuppressants for treatment of transplant rejection; (5) antiretrovirals; and (6) antineoplastics. The exception permits the use of prior authorization and step therapy for new starts (i.e., enrollees initiating therapy) — including confirming the use is for a protected-class indication.  This applies to all protected classes except antiretroviral medications. According to CMS, the exception permits indication-based formulary design and utilization management for new starts in the applicable classes, and Part D sponsors can exclude a protected-class drug that is being used for non-protected class indications.
  2. E-Prescribing and the Part D Prescription Drug Program. The final rule updates Part D E-Prescribing standards to require Part D sponsors to implement an electronic real-time benefit tool (RTBT) capable of integrating with at least one prescriber’s electronic prescribing (eRx) system or electronic health record (EHR), in order to provide prescribers complete, accurate, timely and clinically appropriate patient-specific real-time formulary and benefit (F&B) information (including cost, formulary alternatives and utilization management requirements). This must be in place by January 1, 2021, but CMS is encouraging plans to start implementation now.
  3. Medicare Advantage and Step Therapy for Part B Drugs. The final rule provides requirements under which Medicare Advantage plans may apply step therapy as a utilization management tool for Part B drugs.  CMS notes that utilization management tools such as step therapy enhances the ability of Medicare Advantage plans to negotiate drug costs and can also benefit taxpayers and Medicare Advantage enrollees through lower per unit costs or less overall cost for Part B drugs, while maintaining access to medically-necessary covered drugs. The rule adopts new adjudication timeframe requirements for organization determinations and plan reconsiderations related to requests for Part B drugs.

Seeking to Incentivize Self-Disclosures, DOJ Issues Guidance on Credit for Cooperation with FCA Investigations

On May 7, 2019, the U.S. Department of Justice (DOJ) provided important new guidance addressing cooperation credit that may be available to defendants in False Claims Act (FCA) investigations (Guidance).  The Guidance – issued in the form of an update to DOJ’s Justice Manual – explains how defendants in an FCA investigation may be awarded credit by DOJ for certain disclosures, cooperation, and remedial activities.

The Guidance is intended to incentivize companies and individuals to (i) be forthcoming with the government upon discovery of potential FCA violations, (ii) aid ongoing FCA investigations, and (iii) undertake appropriate remedial actions in response to misconduct. The Guidance provides examples of actions that FCA defendants may be able to take to reduce potential penalties under the FCA. As discussed below, DOJ’s examples appear to re-emphasize DOJ’s focus on individual accountability for corporate wrongdoing. Continue Reading

CMS Final Rule on Drug Pricing Transparency in Consumer Television Ads

On May 10, 2019, the Centers for Medicare and Medicaid Services published a Final Rule on drug pricing transparency in consumer advertisements. The new rule requires direct-to-consumer (DTC) television advertisements to include the list price of prescription drugs and biological products distributed in the US that are reimbursable by Medicare or Medicaid, whether directly or indirectly.

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Massachusetts Reaches $10 Million in Settlements Tied to Medicaid Billing for Home Health Services

On April 30, 2019, the Office of the Attorney General of Massachusetts (AG) announced that it had entered into two settlements totaling over $10 million with home health care companies to resolve allegations of submission of false claims to MassHealth – the Commonwealth’s Medicaid program. The AG entered into an $8.3 million settlement with Avenue Homecare Services of Dracut, and a $2.13 million settlement with Amigos Homecare of Lawrence, to resolve allegations that they billed MassHealth for unauthorized home health services. Continue Reading

HHS Exercises Discretion to Reduce Maximum Annual Civil Money Penalties for Certain HIPAA Violations

On April 26, 2019, the U.S. Department of Health and Human Services (HHS) issued a Notification of Enforcement Discretion (Notice) regarding imposition of Civil Money Penalties (CMPs) under HIPAA. In the Notice, HHS announces that it has revisited its prior interpretation of the standards for assessment of CMPs under the HITECH Act, and is exercising its discretion to reduce the maximum amount of CMPs that may be assessed annually for HIPAA violations based on culpability.

The official version of the Notice is dated April 30, 2019 and is available here. Continue Reading

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