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Health Updates

Read need-to-know updates, commentary, and analysis on Health issues written by leading professionals.

ONC’s Draft Trusted Exchange Framework: Seeking Nationwide Interoperability for Health Information Networks

by Ropes & Gray LLP on

On January 5, 2018, the Office of the National Coordinator for Health Information Technology (“ONC”), an office within the U.S. Department of Health and Human Services, released its Draft Trusted Exchange Framework (the...more

Pennsylvania Risperdal Decision Doesn’t Go As Far As Plaintiffs Suggest

by Reed Smith on

While the recent Pennsylvania Superior Court Risperdal decision is not a defense victory, it is certainly not as favorable for plaintiffs as they are making it out to be. While several issues were presented for appeal in...more

Partner Colin Zick Speaks to Bloomberg BNA about Cyberthreats and Healthcare Data

The federal government has identified two new cyberthreats that put patients’ personal data at risk for exposure. The threats, known as Spectre and Meltdown, exploit a vulnerability in many commercial computer chips...more

HELP ACT Would Do Little to Help Ease Concerns of 340B-Participating Hospitals

by McDermott Will & Emery on

The Helping Ensure Low-income Patients have Access to Care and Treatment (HELP ACT) is the third 340B-related legislation to be introduced this month. The HELP ACT goes well beyond the 340B PAUSE Act in the scope of its...more

Reminder: Hospitals must use QualityNet for attestation in 2018

by Bricker & Eckler LLP on

Eligible hospitals and critical access hospitals (CAHs) must now use the QualityNet Secure Portal (QNet) to submit meaningful use attestations for the Medicare Electronic Health Record (EHR) Incentive Program. ...more

Gainsharing Guidance: Clarification on Cost-Savings Arrangements Between Hospitals and Physicians

by Polsinelli on

The Office of Inspector General of the U.S. Department of Health and Human Services (OIG) recently posted its first advisory opinion interpreting a gainsharing arrangement – that is, a financial relationship under which...more

Federal v. State Trademark Registration for Marijuana-Related Goods and Services

by Farrell Fritz, P.C. on

Despite numerous states having legalized medical marijuana, and a handful of others having legalized marijuana for recreational use, it still remains impossible to obtain a U.S. federal trademark registration for marijuana...more

OIG Issues Favorable Advisory Opinion Addressing Gainsharing CMP Arrangement

by Dorsey & Whitney LLP on

On January 5, 2018, the Office of the Inspector General of the United States Department of Health and Human Services (“OIG”) released a favorable Advisory Opinion 17-09 that addresses Section 1128A(b)(1) of the Social...more

First-Ever De Novo Clearance by FDA’s Orthopedic Branch

by Knobbe Martens on

According to IlluminOss Medical, Inc.’s recent press release, the company has successfully obtained the first-ever de novo clearance from the FDA’s Orthopedic Branch for its minimally invasive bone stabilizaion system (the...more

REMINDER: February Deadline for HIPAA Breach Reporting

by Husch Blackwell LLP on

With the New Year underway, the deadline is quickly approaching for HIPAA covered entities to file their annual breach reports with the U.S. Department of Health & Human Services Office for Civil Rights (“OCR”)....more

CMS Announces Bundled Payments Care Improvement Model

by Tucker Arensberg, P.C. on

On January 11, 2018, CMS announced a new voluntary episode payment model (bundled payments for care improvement advanced–BPCI Advanced) that will test a new iteration of bundled payment for the following thirty-two (32)...more

Maryland Telehealth Update: RPM, Store and Forward and Looking Ahead

by Baker Ober Health Law on

The Maryland Medicaid telehealth landscape saw some expansion in late 2017. The growth may not go as far as stakeholders desire, but it is movement nonetheless....more

Six Things to Know on CMS's Guidance Addressing the Low Volume Medicare Appeal Settlement

by Polsinelli on

The Centers for Medicare and Medicaid Services (“CMS”) recently issued guidance that starting Feb. 5, 2018, CMS will begin the process for the Low Volume Appeal (“LVA”) settlement option that CMS had announced on Nov. 3....more

Court Overturns $350 Million Judgment in FCA Case: Materiality, Scienter, and Causation Standards Preclude Liability by “Zaps,...

by Reed Smith on

A Florida federal court issued a blistering opinion vacating a $350 million judgment in a False Claims Act (FCA) case, and granting the defendants’ motion for judgment as a matter of law. In doing so, the court joined a...more

Alston & Bird Healthcare Week In Review

by Alston & Bird on

On January 16, 2018, the Food and Drug Administration (FDA) issued a proposed rule entitled, Internal Agency Review of Decisions; Requests for Supervisory Review of Certain Decisions Made by the Center for Devices and...more

Middle District of Florida Vacates Massive Verdict Due to Plaintiff’s Failure to Prove Materiality and Scienter

In United States ex rel. Angela Ruckh v. Salus Rehabilitation, LLC, et. al., No. 8:11-CV-1303-T-23TBM (M.D. Fla. Jan. 11, 2018), the Middle District of Florida vacated a jury award totaling nearly $350 million because the...more

House Panel Approves Off-Label Communication, OTC Monograph User Fee, Good Samaritan Health Professionals Bills

by Reed Smith on

The House Energy and Commerce Health Subcommittee voted to approve the following health policy bills on January 18, 2017: H.R. 2026, the Pharmaceutical Information Exchange (PIE) Act. This bill would create a safe harbor...more

SAMHSA Finalizes Changes to Rules for Disclosure of Substance Abuse Records to Support Health Care Operations

by Reed Smith on

The Substance Abuse and Mental Health Services Administration (SAMHSA) has issued a final rule addressing the disclosure of substance use disorder patient records that is intended to facilitate health care activities while...more

ONC Proposes Trusted Exchange Framework for Health Information Networks

by Reed Smith on

The Office of the National Coordinator (ONC) for Health Information Technology has released a draft trusted exchange framework that proposes policies, procedures, and technical standards to further Congressionally-mandated...more

Window on Washington - Vol. 2, Issue 3

by Clark Hill PLC on

Shutdown. The government officially shutdown at 12:01am on Saturday but the effects have not yet been fully felt given it was the weekend. Yesterday, Senate Majority Leader Mitch McConnell announced that the Senate would vote...more

Federal Agencies Delay Implementation of Common Rule Revisions

by K&L Gates LLP on

On January 17, 2018, sixteen federal departments and agencies (the “Agencies”) delayed implementation of sweeping changes to the Federal Policy for the Protection of Human Subjects (the “Common Rule”) adopted a year ago that...more

HHS Delays Common Rule Again

by Bergeson & Campbell, P.C. on

On January 22, 2018, the White House again delayed the effective date of revisions to the Federal Policy for the Protection of Human Subjects, referred to as the Common Rule. Final revisions were published on January 19,...more

Capitol Hill Healthcare Update

by BakerHostetler on

With the government shutdown entering its third day, the Senate scheduled a procedural vote at noon today that could pave the way to end the stalemate – but it’s not clear there’s enough support to break the logjam and reopen...more

HIPAA As a Basis for FCA Liability? One Court Says Yes

by Dorsey & Whitney LLP on

Until very recently, no case existed in which FCA liability arose from a violation of the Health Insurance Portability and Accountability Act (“HIPAA”). But in United States v. America at Home Healthcare and Nursing Services,...more

Continuing Resolution Proposal to Extend Funding for the Federal Government

by Holland & Knight LLP on

Overview - On Jan. 16, Chairman of the House Appropriations Committee Chairman Rodney Frelinghuysen (R-N.J.) introduced a continuing resolution (CR), which would fund the federal government until Feb. 16. Congress has...more

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