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Health Law & Policy Matters

Health Care Attorneys | Mintz Levin Law Firm

Senators to Receive Update on Biosimilar Implementation from CDER’s Woodcock

Posted in Food and Drug Administration (FDA), Health Care Reform, Payors & PBMs, Pharma & Medical Devices, Pharmacies

Today, members of the Senate Health, Education, Labor & Pensions (HELP) Committee will have an opportunity to hear from and question Dr. Janet Woodock, the director of FDA’s Center for Drug Evaluation and Research (CDER), regarding the agency’s implementation of the new approval pathway for biosimilar products created under the BPCIA.  Dr. Woodcock is listed as the only person who will be presenting to the HELP Committee. Continue Reading

Medicare to Permit Value-Based Insurance Design in Medicare Advantage Plans

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

The Centers for Medicare & Medicaid Services (“CMS”) recently announced that, beginning January 1, 2017, Medicare Advantage plans in Arizona, Indiana, Iowa, Massachusetts, Oregon, Pennsylvania and Tennessee will be permitted to offer what are known as “value-based insurance design” (“VBID”) plans. Medicare Advantage plans have been unable to take advantage of VBID designs due to a federal prohibitions against varying benefit designs within a plan based on health status or other enrollee characteristics.  To overcome this obstacle, CMS is pointing to its authority under the Affordable Care Act to test innovative health care payment service delivery models.

Generally, VBID plans structure enrollee cost-sharing and other plan characteristics in a way that encourages the enrollees to utilize high-value health care services that are likely to improve their health status. Such plans are structured around certain clinical categories — typically chronic diseases — and have designs that are meant to reward the use of specific therapies or services by individuals falling in those clinical categories.

The VBID plans offered by Medicare Advantage carriers will be targeted at diabetes, congestive heart failure, chronic obstructive pulmonary disease (COPD), past stroke, hypertension, coronary artery disease, mood disorders, and combinations of these categories. CMS has indicated that certain other chronic conditions may be added in the future.

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Executives Should Take a Closer Look at Insurance Coverage after New DOJ Policies

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

Last week, we discussed the memorandum released by the Department of Justice emphasizing the Government’s commitment to holding individuals accountable when dealing with corporate wrongdoing. Our colleagues Heidi Lawson and Jacquelyn Burke also examined this memorandum’s impact on executives for the Mintz Levin Securities Matters blog. Executives should remember that their interests do not always match squarely with the company’s, and they should take a closer look at their insurance policies to make sure that defense costs for government investigations are covered. Click here to read the full post on Securities Matters.

Exellus BlueCross BlueShield – Latest Victim of a “Sophisticated” Health Plan Cyberattack

Posted in Payors & PBMs, Privacy & Security/HIPAA/HITECH

Exellus BlueCross BlueShield has announced that the personal information of at least 10 million members has been compromised in a “very sophisticated” cyberattack that occurred on December 23, 2013 and was discovered by the plan on August 5, 2015.  According to a notification posted on the company’s website, hackers may have accessed the name, date of birth, social security number, mailing address, telephone number, member identification number, financial account information and claims information of affected members.

Excellus is offering no specifics regarding the nature of the attack but states repeatedly, throughout its website notification and related FAQs, that it has found no evidence of sensitive information being removed from its systems or misused.  Excellus began the process of mailing notices to affected individuals on September 9, and is providing two years of credit monitoring.

The Excellus breach follows a string of significant health plan data breaches this year, including the Anthem breach affecting 80 million members, the Premara breach affecting 11 million members, and the comparatively small – although extremely significant CareFirst breach, affecting 1.1 million members.

Stay tuned for the inevitable class action lawsuit.  We will have more as this story develops.

DOJ Issues Memo Directing Prosecutors to Focus on Individual Accountability

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

The U.S. Department of Justice (DOJ) issued a memorandum on Wednesday from Deputy Attorney General Sally Quillian Yates that reaffirms the Government’s commitment to prosecuting individuals and formally instructs prosecutors to focus on individual accountability when dealing with corporate misconduct. Yates delivered additional remarks yesterday on the memorandum and its expected impact on criminal and civil investigations of corporations.  Having been publicly criticized for permitting corporations to take the fall and allowing individual wrongdoers off the hook, the DOJ has regularly tried to focus on individuals with only limited success. Some may view the memo as restating existing Government policy but it in fact represents a significant formal policy shift that almost requires prosecution of individuals in exchange for corporate cooperation credit.

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Drastic Changes Proposed for Clinical Research Rules

Posted in Clinical Laboratories, Clinical Trials & Research/FDA, Pharma & Medical Devices

The U.S. Department of Health and Human Services (“HHS”) and fifteen other Federal Departments and Agencies have announced a proposal to update the Federal Policy for the Protection of Human Subjects known as the “Common Rule,” originally promulgated in 1991.   A Notice of Proposed Rulemaking (“NPRM”), published on September 2, 2015, seeks comments on the proposal, which includes some dramatic changes for researchers. Continue Reading

Kissing Camels Antitrust Suit Clears the Hump of Summary Judgment

Posted in Antitrust, Hospitals & Health Systems, Physicians

In June, an antitrust suit brought by plaintiff ambulatory surgery centers (“ASCs”) against a health system, health insurers, and a trade association survived a motion to dismiss. Last week, the ASCs’ case cleared the hump of summary judgment and will now proceed to trial.  Kissing Camels Surgery Center LLC et al. v. Centura Health Corp. et al., 1:12-cv-03012 (D.Col. August 28, 2015).  The district court found sufficient evidence of a conspiracy to reduce competition for ambulatory surgery services, making summary judgment inappropriate.  The attached antitrust alert, Kissing Camels Antitrust Suit Against Health System Moves Past Another Hump in the Road, provides some background on the case and considers the District Court’s ruling against summary judgment, based on its finding that there was sufficient evidence of a conspiracy to reduce competition.

FDA’s New Four-Letter Guidance on Biosimilars

Posted in Food and Drug Administration (FDA), Health Care Reform, Payors & PBMs, Pharma & Medical Devices, Pharmacies, Physicians

After months of pressure from industry, health practitioners and even congressional stakeholders, FDA has finally proposed a convention for assigning nonproprietary names (also known as proper names) to biological products. The Agency published notice of its draft guidance on August 28th in the Federal Register, along with a proposed rule to assign new proper names to some already approved biologic products, including the only biosimilar product licensed so far under the abbreviated 351(k) pathway.

The industry has been waiting for some time for FDA’s policy position on nonproprietary naming of biological products, particularly for biosimilars and interchangeable biosimilars. With its position only partially decided in the draft policy, as described further below, the wait will go on while industry players continue advocating their positions to the Agency during the comment period.

So, what has FDA proposed?

In order to avoid inaccurate perceptions regarding the safety or effectiveness of biological products based on their licensure pathway – whether an original biologics application or an abbreviated biosimilar application – FDA has determined that the naming convention will apply to all biological products both prospectively and retrospectively. Per the draft guidance, all biological product nonproprietary names would consist of a core name and a designated four-letter suffix.  This convention will permit products with the same core name to be grouped together in electronic databases and systems, a benefit that would not be possible through use of a prefix. Continue Reading

Back to School – HIPAA 101

Posted in Accountable Care Organizations, Clinical Laboratories, Home Health & Hospice, Hospitals & Health Systems, Long-term Care/Skilled Nursing Facilities, Payors & PBMs, Pharma & Medical Devices, Pharmacies, Physicians, Privacy & Security/HIPAA/HITECH

After a summer that saw major data breaches at the Office of Personnel Management and UCLA Health System, this fall is a great time to take your organization back to school on HIPAA compliance and data security.  Here are four items to add to your fall to-do list, no #2 pencils required. Continue Reading

State Pharmaceutical Pricing Disclosure Laws: Old Story, New Refrain

Posted in Fraud & Abuse, Pharma & Medical Devices, Pharmacies, Reimbursement, State & Federal Audits, Investigations & Litigation

As a veteran of the AWP litigation era, I am struck by the recent state efforts to legislate transparency into pharmaceutical pricing.  Multiple states have introduced bills that would require pharmaceutical manufacturers to produce information to justify the sales price for their drugs.  But the idea that pharmaceutical manufacturers are unilaterally responsible for the costs borne by citizens of these states ignores the tangled web of policies and processes that makes up drug pricing and reimbursement in the United States. State legislators may want to examine the relatively recent history of state Average Wholesale Price (AWP) litigation, and each of their state’s response to the pricing transparency mandates incorporated into the early AWP case settlements, before moving forward to mandate transparency from just one player in the process. Continue Reading