Tag Archives: HHS

HHS OIG Inspector General Announces New Compliance Resource Portal

The Health Care Compliance Association (HCCA) kicked off its 22nd Annual Compliance Institute on Monday, April 16, 2018. During the opening remarks, Inspector General Daniel Levinson, of the Department of Health and Human Services (HHS) Office of Inspector General Office (OIG), announced the rollout of a new public resource to assist companies in ensuring compliance with Federal health care laws. The Compliance Resource Portal on the OIG’s website features:

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As More Health Care Employers Adopt Mandatory Vaccine Policies, DOJ and HHS Push Back on Behalf of Individual Workers

In the midst of one of the worst flu seasons to date, many hospitals and other health care organizations enforced mandatory flu vaccine policies for their employees to boost vaccination rates. However, recent litigation and governmental actions should serve as a reminder that health care entities should carefully consider safeguards whenever implementing mandatory vaccine policies and to not categorically deny all requests for religious exemptions based on anti-vaccination beliefs.

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HHS Moves to Strengthen Conscience Protections for Health Care Workers

Last week, the federal Department of Health and Human Services (HHS) made two announcements aimed at providing additional protections for health care workers who object to providing services on moral or religious grounds.

On January 18, 2018, HHS announced the formation of a new Conscience and Religious Freedom Division in the HHS Office for Civil Rights (OCR).  The stated goal of the new division is to “restore federal enforcement of our nation’s laws that protect the fundamental and unalienable rights of conscience and religious freedom.”

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Trump Administration Takes on VA Telehealth Opportunities

Throughout the campaign season and the first months of Donald Trump’s presidency, the current Administration has voiced a commitment to furthering telehealth advancement. For example, during the campaign, then-candidate Trump emphasized the importance of telehealth tools in reforming the U.S. Department of Veterans Affairs (“VA”). More recently, both U.S. Department of Health and Human Services Secretary Tom Price and Centers for Medicare and Medicaid Services Administrator Seema Verma stated in their confirmation hearings that they were interested in promoting the use of telehealth technology. On Thursday, August 3, 2017, VA Secretary Dr. David Shulkin, joined by President Trump, took steps towards fulfilling this commitment, announcing three telehealth initiatives aimed at improving access to and quality of care for veterans.

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FDA Announces November Public Hearing on Off-Label Communications: An Important Step Forward or a Signal that FDA is Headed Back to the Drawing Board?

On August 31, 2016, FDA issued a notification of public hearing and request for comments on manufacturer communications regarding unapproved uses of approved or cleared medical products. The hearing will be held on November 9-10, 2016, and individuals wishing to present information at the hearing must register by October 19, 2016. The deadline for written comments is January 9, 2017.

In the notice, FDA posed a series of questions on which it is seeking input from a broad group of stakeholders, including manufacturers, health care providers, patient advocates, payors, academics and public interest groups. The topics on which FDA is seeking feedback are broad, but generally include:

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HHS Telehealth Report To Congress: A Window Into Agency Thinking

Capitol%2034397155_jpgAs requested by Congress as part of an appropriations bill signed into law late last year, this month, the Department of Health and Human Services (HHS) released a report highlighting its e-health and telemedicine efforts.  The report makes for interesting reading, and while there are no significant surprises in the report, it offers a clear snapshot of some of the agency’s thinking regarding virtual care.

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The Scope of FDA’s Proposed Revisions to the IND Regulations May Not Be Sufficient to Achieve Its Stated Goals

Last week, the U.S. Department of Health and Human Services (“HHS”) announced that FDA intends to update its regulations governing clinical studies of new drugs.  More specifically, FDA intends to update Parts 312 and 16 of Title 21 of the Code of Federal Regulations (the “Code” or “CFR”).  In its announcement, HHS stated that the revisions will be focused on defining and clarifying “the roles and responsibilities of the various persons engaged in the initiation, conduct, and oversight of clinical investigations subject to [investigational new drug] requirements.”  The announcement also notes that the changes will “better protect the rights, safety and welfare of subjects and help ensure the integrity of clinical trial data.”

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“Your Patient’s Data, But Not Your Breach,” Rick Hindmand quoted by Diagnostic Imaging

Your responsibilities for reporting HIPAA violations are complex, but reasonably clear, if your practice is responsible for the breach. However, what if the protected health information of your patients is violated, not by you, but by one of your business partners? What are your responsibilities then? That depends on whether the partner is a business associate or another “covered entity.”

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Pursuing Medicare Appeals Is Not for the Impatient

Robert E. Wanerman

Even after the Secretary of HHS admitted that the current backlog of Medicare Part B appeals would take ten years to adjudicate at current staffing and funding levels, that was not enough for a hospital to obtain any relief from a court. Cumberland County Hospital System, Inc. v. Burwell, No. 15-1393 (4th Cir., Mar. 7, 2016).  In that case, a North Carolina hospital had initially been paid for over 900 claims, but those claims were subsequently determined to be ineligible after a post-payment review by a Recovery Audit Contractor (“RAC”), which sought to recover over $12 million from the hospital.  Although the hospital complied with the deadlines for filing administrative appeals, the Medicare Office of Hearings and Appeals had not held hearings or made determinations within the 90-day deadline in the Medicare statute. In order to expedite the process, the hospital sought a writ of mandamus from a federal court to order the Secretary to conduct the hearings.  The district court denied the motion, and the U.S. Court of Appeals for the Fourth Circuit agreed with the Secretary that no relief was warranted.

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HHS Publishes Roadmap for HIPAA Audits

One of the less well-known provisions of the Health Information Technology for Economic and Clinical Health (or “HITECH”) Act[1] is the requirement that the U.S. Department of Health and Human Services (“HHS”) periodically conduct audits to ensure that Covered Entities[2] and their Business Associates[3] are complying with the requirements of the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”).[4] In November 2011, the HHS Office for Civil Rights (“OCR”) launched the pilot phase of its HIPAA compliance audit program (“Audit Program”), selecting 115 entities nationwide to undergo privacy and security audits. While the pilot phase is not scheduled to wind up until December 2012, OCR recently made the protocol[5] guiding these compliance audits publicly available. By identifying individual areas of evaluation, defining the applicable performance criteria, and specifying how auditors will assess compliance with each, the protocol provides a comprehensive and extremely useful roadmap for entities anticipating an OCR audit and all other entities seeking to ensure HIPAA compliance. All Covered Entities and Business Associates should take note, as OCR recently announced that the Audit Program will likely continue through 2014.

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