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Health Care Attorneys | Mintz Levin Law Firm

Just in Time for the Phase II Audits: OIG Criticizes OCR’s Enforcement Efforts

Posted in Privacy & Security/HIPAA/HITECH

As HIPAA-regulated entities anxiously await the commencement of the Phase II HIPAA audit program, the Office of the Inspector General (OIG) for the Department of Health and Human Services (HHS) has issued a report critical of the Office for Civil Rights’ (OCR) HIPAA enforcement performance, effectively giving OCR “something to prove.”

The report, released on September 28, 2015, examines whether OCR — the office within HHS charged with enforcing HIPAA — is sufficiently exercising its oversight responsibilities. The OIG specifically focused on whether OCR is sufficiently overseeing covered entities’ compliance with HIPAA’s Privacy Rule.  The OIG found a number of areas where OCR’s oversight is lacking. Continue Reading

CMS Publishes Long-Awaited PAMA Proposed Rule

Posted in Clinical Laboratories, Hospitals & Health Systems, Physicians, Reimbursement

Late on Friday afternoon the Centers for Medicare & Medicaid Services (CMS) announced publication of the proposed rule (the “Proposed Rule”) implementing substantial changes to the Medicare Clinical Laboratory Fee Schedule (MCLFS) made by the Protecting Access to Medicare Act of 2014 (PAMA). PAMA significantly revised how CMS will pay for clinical laboratory testing by tying reimbursement amounts to private payor rates as of January 1, 2017. Continue Reading

“Two-Midnight” Rule Needs Tweaking, Says Federal Judge

Posted in Hospitals & Health Systems, Payors & PBMs, Reimbursement

A Federal Judge found that the Department of Health and Human Services (DHHS) failed to comply with the Administrative Procedure Act (APA) when it cut hospital inpatient payments by 0.2% as part of its “two-midnight” rule.  According to the DHHS Secretary, the pay cut was intended to offset the estimated $220 million it would cost to shift patients from outpatient to inpatient status under the rule, which allows Medicare to pay inpatient rates only if a patient stays in the hospital for two midnights.

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DOJ Clarifies Position on Individual Accountability in Corporate Investigations

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

Earlier this month, we discussedmemorandum issued by Deputy Attorney General Sally Quillian Yates of the U.S. Department of Justice (DOJ).  This memorandum, referred to as the “Yates Memo,” reaffirms the Government’s commitment to prosecuting individuals and formally instructs prosecutors to focus on individual accountability when dealing with corporate misconduct. As we discussed, the Yates Memo sets forth certain criteria that must be satisfied in order for a corporation to receive so-called “cooperation credit.” Notably, the Yates Memo requires a corporation to identify all individuals involved in the corporate wrongdoing and provide all relevant evidence implicating those individuals.

Last week, the U.S. Department of Justice’s  Assistant Attorney General in charge of the Criminal Division, Leslie R. Caldwell, spoke at the Global Investigations Review Conference in New York. Discussing the implication of the Yates Memo, AAG Caldwell stated, in part, that “…companies seeking cooperation credit must affirmatively work to identify and discover relevant information about culpable individuals through independent, thorough investigations.  Companies cannot just disclose facts relating to general corporate misconduct and withhold facts about the responsible individuals.  And internal investigations cannot end with a conclusion  of corporate liability, while stopping short of identifying those who committed the criminal conduct.”

On our Securities Matters blog, our colleague Bridget Rohde discusses these and other remarks made by AAG Caldwell regarding the Yates Memo.

Hot Topics in Laboratory Compliance at AHLA’s Fraud and Compliance Forum

Posted in Clinical Laboratories, Fraud & Abuse

Next week, my colleague Karen Lovitch will be co-presenting a discussion on Hot Topics in Laboratory Compliance at the American Health Lawyers Association’s Fraud and Compliance Forum in Baltimore, Maryland. The presentation will focus on:

  1. The health care fraud enforcement climate for laboratories;
  2. Relevant state and federal fraud and abuse laws;
  3. Legal risks presented by interactions with health care professionals and other sales and marketing activities; and
  4. Legal and business risks related to interactions with patients, including collection of outstanding invoices.

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Trouble Brewing for International Data Transfers Under U.S.-EU Safe Harbor

Posted in Clinical Trials & Research/FDA, Pharma & Medical Devices, Privacy & Security/HIPAA/HITECH

Today the EU threw a huge wrench into one of the ways that personal data goes back and forth between EU countries and the U.S., as reported in Mintz Levin’s Privacy and Security Matters Blog. Companies that currently rely on the U.S.-EU Safe Harbor Program – as  many in the health care industry do – need to think carefully and quickly about a back-up plan for these data transfers. Continue Reading

Upcoming AHLA Webinar – Behavioral Health and ACOs

Posted in Accountable Care Organizations, Health Care Reform, Hospitals & Health Systems, Physicians, Privacy & Security/HIPAA/HITECH

On Thursday Mintz Levin attorney Daria Niewenhous will be moderating an American Health Lawyers Association webinar entitled “Behavioral Health and ACOs—Challenges and Opportunities.”  The webinar will address the integration of behavioral health services and primary care to manage population health.  It will focus on the care improvements that can be realized by successfully integrating behavioral health into a patient-centered medical home and the legal and regulatory challenges associated with doing so.  Additionally, the presenters will provide real life examples of a large ACO’s experience with integrating behavioral health and the impact on health outcomes and expense. Continue Reading

September Health Care Qui Tam Update

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

Mintz Levin’s Health Care Enforcement Defense Group recently published another installment of its Health Care Qui Tam Update.  The September Update surveys 39 health-related False Claims Act (“FCA”) qui tam cases that were recently unsealed, discusses the trends in those cases, and spotlights three of them. Continue Reading

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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