Health Administrative Agency

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OIG Issues Revised Policy Statement Regarding Permissive Exclusion

On April 18, 2016, the Office of Inspector General of the United States Department of Health and Human Services (“OIG”) issued a revised policy statement containing the new criteria that OIG intends to use in implementing its...more

OIG Issues New Exclusion and CIA Guidance

On April 18, 2016, Inspector General Daniel R. Levinson announced the publication of updated guidance on how the Office of Inspector General (OIG) makes decisions about using its permissive exclusion authority and requiring...more

FDA Proposes Ban on Electrical Stimulation Devices for Aggressive or Self-Injurious Behavior

On April 25, the U.S. Food and Drug Administration published a proposed rule banning electrical stimulation devices (ESDs) used to treat aggressive or self-injurious behavior....more

CMS Proposes to Reverse 0.2 Percent IPPS Rate Reduction After Two-Midnight Rule Litigation Loss

In the FY 2017 IPPS Proposed Rule, CMS announced that it would reverse the 0.2 percent IPPS rate cut that was imposed in FY 2014 (and re-adopted in subsequent years) related to the Two Midnight Rule and increase the...more

Capturing Flagg: Fifth Circuit, En Banc, Holds that Failure to Complete Pre-suit Medical Board Review Renders Med Mal Defendants...

We previously wrote about the Fifth Circuit’s panel decision and the defendants’ petition for rehearing en banc in this case. As we reported earlier, the issue is whether a non-diverse defendant is improperly joined by...more

"New HHS OIG Criteria to Guide Resolution of Health Care Investigations"

The Office of Inspector General of the Department of Health and Human Services (OIG) has issued updated guidance on the use of its so-called permissive exclusion authority under Section 1128(b)(7) of the Social Security Act...more

FTC, ONC, OCR and FDA release online tool for mobile health app developers

While attending the International Association of Privacy Professionals annual global event, and listening to Chairwoman Edith Ramirez discuss the Federal Trade Commission’s (FTC) concerns about consumer privacy, the FTC, the...more

Employee Benefits & Executive Compensation Advisory: The ACA: New Concerns for Employer Plan Sponsors Under the Fair Labor...

The Affordable Care Act (ACA) anti-retaliation provisions have been in effect for several years, but have so far largely gone unnoticed. Now that employees can get financial assistance through the Health Insurance...more

Medicare Appeals 10-Year Backlog: D.C. Circuit Signals Enough is Enough

Issued within a month of one another, two cases regarding the Medicare appeals backlog reached opposite conclusions, providing a circuit-split. The first case from the D.C. Circuit, signaling a major shift toward judicial...more

Howard Young on Coming Changes To The Healthcare Space [Video]

Howard Young, co-head of the healthcare practice at Morgan Lewis, talks about some of the major forces driving change and consolidation within the healthcare industry. According to Young, innovations in technology and changes...more

Office of Medicare Hearings and Appeals Launches Settlement Conference Facilitation Pilot for Medicare Part A Claims

The HHS Office of Medicare Hearings and Appeals (“OMHA”) recently launched Phase III of the Settlement Conference Facilitation (“SCF”) Pilot to help resolve outstanding Medicare Part A appeals. The SCF program is one of...more

China FDA Announces Good Clinical Practices for Medical Devices

On March 23, 2016, the China Food and Drug Administration (“CFDA”) and the National Health and Family Planning Commission jointly promulgated the final revision to the 2004 Medical Device Clinical Studies Rules (“MDCSR”), the...more

Proposed Enrollment Rule Changes - de Facto Exclusion?

Proposed rules, touted as enhancing the provider enrollment process, would provide CMS with sanction authority that closely parallels the OIG’s exclusion authority. Under the proposed rules, CMS would have expanded bases to...more

OMHA Expands Settlement Conference Facilitation Program to Part A Appeals: 10 Things to Know

On Feb. 25, 2016, the Office of Medicare Hearings and Appeals (OMHA) conducted a teleconference to address Phase III of the Settlement Conference Facilitation (SCF) project, which also became effective on Feb. 25, 2016. SCF,...more

Court Allows 'Retroactive' Application of 2005 Wage Index Rule Limiting Reimbursement for Pension Plan Costs

On February 22, 2016, in Regents of the University of California v. Burwell, the U.S. District Court for the District of Columbia granted summary judgment in favor of the Secretary of Health and Human Services (the Secretary)...more

Fourth Circuit Affirms Hospital Did Not Have A Right to an ALJ Hearing Within 90 Days

On March 7, 2016, the United States Court of Appeals for the Fourth Circuit affirmed the district court’s dismissal of hospital system’s request for a mandamus order directing HHS to provide a hearing before an...more

Also In The News - Health Headlines - March 2016

OMB to Review Medicare Appeals Procedures – The Office of Information and Regulatory Affairs (“OIRA”) within the Office of Management and Budget (“OMB”) is set to review new Medicare appeals process proposed rulemaking. ...more

More Than a Family Affair: Six-Figure HIPAA Penalty Upheld for Unrepentant Home Care Agency due to PHI Access by Spurned Spouse of...

The Health Insurance Portability and Accountability Act of 1996, Public Law 104-191 and the regulations promulgated thereunder (“HIPAA”) should be now well-known to health care providers and health plans. Under HIPAA’s...more

FDA Issues Guidance on Cybersecurity Issues for Postmarket Medical Devices

On January 22, 2016, the Food and Drug Administration (FDA) issued draft guidance on cybersecurity risks associated with medical devices, and addressed steps that device manufacturers should take to mitigate such risks. The...more

Until Death Do Us Part – Divorce and HIPAA Violations: A Lesson in Safeguarding Protected Health Information

The Office of Civil Rights (“OCR”), a division of the Department of Health and Human Services, recently took the rare step of imposing civil monetary penalties against a large home health provider for violating the Health...more

Wage Index Reclassification Rule Struck Down by Second Circuit

On February 4, 2016, the United States Court of Appeals for the Second Circuit decided Lawrence + Memorial Hospital v. Burwell. The case addressed a regulation, issued by the Secretary of Health and Human Services...more

FDA Regulatory and Compliance Monthly Recap — February 2016

FDA publishes guidance on human factors review for devices, combination products - The FDA published two draft guidance documents and one final guidance document to address the incorporation of human factors studies in...more

Federal Court finds “Systemic Failure” in Processing of Administrative Appeals for Medicare Reimbursement Claims

A win for efficiency: The AHA suit may force shorter adjudication times for Medicare administrative appeals. In 2014, the American Hospital Association (AHA), along with three hospital systems, filed suit against the U.S....more

OCR for the Win: Lincare, Inc. HIPAA Enforcement Action

For the second time in history, on January 13, 2016, an Administrative Law Judge (ALJ) upheld the imposition of civil money penalties charged against a covered entity by the Office of Civil Rights in the Department of Health...more

Congressional Budget Office Issues Cost Estimate Report on Medicare Appeals Reform Act

On February 16, 2016, the Congressional Budget Office (CBO) issued a cost estimate report on the Audit & Appeals Fairness, Integrity, and Reforms in Medicare Act of 2015 (S. 2368). The purpose of the Act is to address the...more

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