Health Law & Policy Matters

Health Care Attorneys | Mintz Levin Law Firm

New Connecticut Pharmacy Rewards Disclosure Bill Took Effect July 1

Posted in Pharmacies, Privacy & Security/HIPAA/HITECH

Written by: Stephanie D. Willis

On June 12th, Connecticut governor Dannel P. Malloy signed into law ”An Act Concerning Pharmacy Rewards Programs And Protected Health Information“. The law went into effect July 1st, and applies to pharmacy retailers in the state of Connecticut. We profiled the version of the law passed by the Connecticut Senate in a previous blog post, but there are some key differences to note between the Senate version and the enacted version (and we provide a redline here).

1) Definitions:

The enacted version omits the “HIPAA authorization,” “Protected health information,” and “marketing” definitions included in the Senate bill. Instead, subsection (d) of the new law requires that these terms be defined in (i) the pharmacy rewards program’s promotional materials, (ii) in the plain language summary of the terms and conditions provided to the patient, and (iii) on the enrollment form “at the point of HIPAA authorization,” if these terms are actually used in these materials.

2) Rewards Program Terms and Conditions Summary Contents:

The enacted version uses different language than the Senate bill to describe the information required to be provided in the summary of the terms and conditions of pharmacy rewards programs. Although both versions of the legislative text require a plain language and written disclosure of the specific uses and disclosures that the HIPAA authorization allows in the terms and conditions, the enacted law requires that the disclosure statement be in bold font and that the disclosure statement explicitly warn that once the consumer signs the HIPAA authorization the consumer’s personal health information (PHI) may no longer be protected by federal and state privacy laws. In addition, the pharmacy retailer must provide the same warning to consumers if the PHI provided to the pharmacy rewards program will be disclosed to third parties.

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ML Strategies Posts Weekly Health Care Update on June 30, 2014

Posted in Health Care Reform, Payors & PBMs, Pharma & Medical Devices, Pharmacies

ML Strategies has posted its weekly Health Care Update.  This publication provides timely information on implementation of the Affordable Care Act, Congressional initiatives affecting the health care industry, and federal and state health regulatory developments.

This week policymakers are primarily focusing on the ramifications of the Supreme Court’s ruling in the much anticipated Burwell v. Hobby Lobby case, holding that closely-held companies cannot be required to cover contraceptives under employee health plans if the company’s owners have religious objections.

Click here to read this week’s Health Care Update.

Supreme Court: Closely-Held Corporations Are Protected by the Religious Freedom Restoration Act – Who Will Foot the Bill?

Posted in Health Care Reform, Payors & PBMs, Pharma & Medical Devices, Pharmacies

Written by:  Tara E. Swenson

Yesterday morning, the U.S. Supreme Court announced its decision in the much anticipated Burwell v. Hobby Lobby case, holding that closely-held corporations are protected by the Religious Freedom Restoration Act of 1993 (“RFRA”), and therefore cannot be required to pay for employee health plans that cover contraceptives if the corporation’s owners have religious objections.

The Affordable Care Act requires all health plans to cover preventive health services for women, which the Institute of Medicine has defined to include contraceptive products approved by the Food and Drug Administration.  The owners of three closely-held corporations, Hobby Lobby Stores Inc., Conestoga Wood Specialties Corp., and Mardel, opposed certain contraceptives that operate after an egg is fertilized and argued that being forced to facilitate access to such drugs or devices violates their religious beliefs.  The Supreme Court found that the requirement to provide contraceptive products substantially burdened the exercise of religious freedom and was not the least restrictive means to that ensure that women have access to these contraceptives.

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ML Strategies Posts Weekly Health Care Update on June 23, 2014

Posted in Health Care Reform, Payors & PBMs, Pharma & Medical Devices

ML Strategies has posted its weekly Health Care Update.  This publication provides timely information on implementation of the Affordable Care Act, Congressional initiatives affecting the health care industry, and federal and state health regulatory developments.  Major issues we are following this week include significant management changes at HHS, FDA regulation of medical devices, and the future of e-cigarette regulation.  Click here to read this week’s Health Care Update.

OCR Confirms that Medical Records Should Not be Left in the Driveway

Posted in Hospitals & Health Systems, Mergers, Acquisitions & Other Transactions, Physicians, Privacy & Security/HIPAA/HITECH, State & Federal Audits, Investigations & Litigation

Written by:  Dianne J. Bourque

The most recent Office for Civil Rights (“OCR”) HIPAA enforcement action serves as an important reminder to health care providers of the security risks associated with a mishandled medical records custody transfer and the risks of leaving paper records in the driveway.  The enforcement action and ensuing settlement – an $800,000 fine and corrective action plan – was levied against Parkview Health System, Inc., (“Parkview”) a provider of community-based health care services.  In 2008, Parkview took custody of the paper medical records of 5,000 – 8,000 patients in connection with a physician’s retirement and in anticipation of purchasing some of the physician’s practice.  In 2009, perhaps after the transaction fell through, although the Parkview Resolution Agreement does not specify, Parkview left 71 boxes of these medical records unattended in the driveway of the physician’s home, and, according to OCR, within 20 feet of a public road and a short distance from a heavily trafficked public shopping area.

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Can a Relator Be Held Liable for Using Confidential Company Documents to Support a Qui Tam Case?

Posted in Fraud & Abuse, State & Federal Audits, Investigations & Litigation

Last week, the U.S. District Court for the Eastern District of Pennsylvania issued a decision in Walsh et al. v. Amerisource Bergen Corp. et al denying the Relator’s motion to dismiss a counterclaim that alleged the Relator breached a confidentiality agreement by filing the underlying qui tam case.  Although courts have differed on whether enforcing confidentiality agreements runs counter to the purpose of the False Claims Act, the Walsh court ultimately rejected the Relator’s motion, finding that the Company pled sufficient facts to survive the motion to dismiss. Continue Reading

Five Lessons from OCR’s Reports to Congress on Breaches and HIPAA Rules Compliance

Posted in Privacy & Security/HIPAA/HITECH, State & Federal Audits, Investigations & Litigation, Uncategorized

Written by: Stephanie D. Willis and Dianne J. Bourque

Last week, the HHS Office of Civil Rights (OCR) released two reports required by the Health Information Technology for Economic and Clinical Health (HITECH) Act: (i) the Annual Report to Congress on Breaches of Unsecured Protected Information (Breach Report); and (ii) the Annual Report to Congress on HIPAA Privacy, Security, and Breach Notification Rule Compliance (Compliance Report). In reviewing the Breach and Compliance Reports, Chief Information Officers, compliance and privacy officers, and information security professionals in the health care field should note five key lessons: Continue Reading

ML Strategies Posts Weekly Health Care Update on June 16, 2014

Posted in Clinical Trials & Research/FDA, Health Care Reform, Hospitals & Health Systems, Payors & PBMs, Pharma & Medical Devices, Pharmacies, Physicians

ML Strategies has posted its weekly Health Care Update.  This publication provides timely information on implementation of the Affordable Care Act, Congressional initiatives affecting the health care industry, and federal and state health regulatory developments.

This week, stakeholders continue to focus on the 340B drug discount program as Obama Administration officials weigh their next course of action, following a major court ruling that potentially curtails HHS’ authority to regulate the program. Read our most recent post on the 340B program developments here.  Another development includes a major milestone for the Patient-Centered Outcomes Research Institute (PCORI), which will begin running clinical trials through their network in September 2015.   Additionally, in another delay for the Small Business Health Options Program (SHOP), CMS announced that the 18 states utilizing SHOP, could delay providing the “employee choice” option until 2016.

Click here to read this week’s Health Care Update.

 

 

HRSA “Interprets” Its Enjoined 340 Orphan Drug Rule into Effect

Posted in Hospitals & Health Systems, Pharma & Medical Devices

Written by Ellyn L. Sternfield

In January, I predicted that 2014 would be a game-changer for the 340B Drug Discount Program, in part because of HRSA’s announcement that, in June 2014, it would for the first time publish an omnibus rule governing 340B Program operations. 

But then, as I posted late last month, a federal district court invalidated HRSA’s earlier rulemaking involving the 340B orphan drug exception enacted by Congress, which exempted designated orphan drugs from qualifying for 340B discounts.  Through its orphan drug rule, HRSA had created an exception to the exception:  authorizing certain 340B covered entities to obtain designated orphan drugs at 340B discounted prices when the drugs were used for purposes outside the orphan designation.  Finding that HRSA lacked the statutory authority to promulgate its orphan drug rule, the district court enjoined HRSA from implementing the rule.  And industry commentators, including me, opined that the court’s ruling may well cause HRSA to reconsider its authority to issue a broad omnibus 340B rule in June.

The district court did offer the government the opportunity to submit further briefing as to whether the orphan drug rule could separately stand as interpretive.  On June 12th, the government filed a Notice with the district court and “respectfully declines the Court’s invitation to submit further briefing defining the challenged regulation as an interpretive rule.”  Instead, the government stated it would evaluate its options, including whether to appeal the court’s decision or propound an interpretative rule or guidance. 

Then on June 18th, HRSA published its own notice on its website: 

On May 23, 2014, the U.S. District Court for the District of Columbia issued a ruling in Pharmaceutical Research and Manufacturers of America v. US Department of Health and Human Services (HHS) (Civil Action No. 13-1501) that vacated the orphan drug regulation on the grounds that HHS lacks the statutory authority to engage in such rulemaking. However, the Court did not invalidate HRSA’s interpretation of the statute. HHS/HRSA continues to stand by the interpretation described in its published final rule, which allows the 340B covered entities affected by the orphan drug exclusion to purchase orphan drugs at 340B prices when orphan drugs are used for any indication other than treating the rare disease or condition for which the drug received an orphan designation

HRSA went on to state that 340B covered entities will be responsible for ensuring that any orphan drugs purchased through the 340B Program are not transferred, prescribed, sold, or  used for the designated orphan purpose, and that HRSA “encourages 340B stakeholders to work, in good faith, to resolve” any resulting disputes over the application of its orphan drug rule.

So HRSA was enjoined from implementing its orphan drug rule, ignored a court invitation to present an alternative justification for the rule as interpretive, but now considers the rule in effect because it has decreed the rule is interpretive.  I am sure the race to the courthouse has already begun.  And with less than two weeks left in its self-imposed June deadline, it remains to be seen if based on its interpretive authority, HRSA moves forward with publication of the promised 340B Program omnibus rule. 

The AMA Adopts New Telemedicine Guiding Principles

Posted in Hospitals & Health Systems, Payors & PBMs, Physicians, Telemedicine

Written by Carrie Roll

Last week, the American Medical Association (AMA) released new guiding principles on the provision of telemedicine services. The AMA’s guiding principles come on the heels of the Federation of State Medical Board’s (FSMB) adoption of its new model telemedicine guidelines and largely echoes the state boards’ views with a few notable exceptions. Unlike the FSMB guidelines, the AMA principles do not specifically address standards for prescribing, patient informed consent, or issues relating to physician financial disclosures or conflicts of interest. However, the AMA principles do touch on several issues not addressed by the FSMB guidelines, including medical liability insurance considerations, the encouragement of additional research, and participation in pilot programs to support the case for telemedicine. Continue Reading