Healthcare Dept. of Health and Human Services

News & Analysis as of

Are Attorneys Entitled to “HIPAA Rate”?

Over the past year, numerous lawsuits and complaints to the HHS Office for Civil Rights (“OCR”) have been filed by plaintiffs’ attorneys over a seemingly obscure HIPAA issue – the rate that health care providers and their...more

Manatt on Health Reform: Weekly Highlights - November 2015

Montana receives approval to expand Medicaid beginning 2016; California’s $6.2 billion Medicaid waiver receives pre-approval; and HHS proposes broadening circumstances under which states receive enhanced federal matching...more

Advisory Opinion: Free van shuttle services to medical facilities

On October 21, 2015 the Department of Health and Human Services Office of Inspector General posted Advisory Opinion No. 15-13. This Opinion relates to a request for Advisory Opinion about a plan to offer free van shuttle...more

Blog: OIG Releases FY2016 Work Plan: Areas to be Reviewed Include SNFs, Drug Pricing, HIPAA

The Department of Health and Human Services (HHS) Office of Inspector General (OIG) released this week its FY2016 Work Plan (Work Plan). The OIG Work Plan summarizes new and ongoing OIG reviews of various HHS programs and...more

OIG Guidance Addresses Compliance Risks of Emerging Trends in the Healthcare Industry

The Office of Inspector General of the U.S. Department of Health and Human Services (OIG) recently released new compliance guidance to help healthcare governing boards, attorneys, compliance officers and internal auditors...more

CMS finalizes significant Stark Law rulemaking

In July of this year, the US Department of Health & Human Services (HHS), Centers for Medicare & Medicaid Services (CMS) proposed significant changes to the regulations implementing the federal physician self referral law...more

OIG Posts Advisory Opinion on Free Transportation Program

On October 21, 2015 the Department of Health and Human Services Office of Inspector General posted Advisory Opinion No. 15-13. This Opinion relates to a request for Advisory Opinion about a plan to offer free van shuttle...more

Developments in Long-Term Care Q2 2015

The following summary highlights key federal court developments and administrative decisions involving skilled nursing facility survey and related issues during the second quarter of 2015....more

Millennium Health to Pay $256 million in False Claims Act Settlement

Millennium Health, one of the nation’s largest urine drug testing laboratories, has agreed to pay the government $256 million to resolve claims that it violated the Federal False Claims Act (“FCA”). The Settlement...more

EEOC Issues Proposed Rule on Wellness Programs and GINA

The Equal Employment Opportunity Commission (EEOC) has issued a proposed rule amending prior regulations under the Genetic Information Nondiscrimination Act of 2008 (GINA) to address incentives in workplace wellness programs....more

HIPAA and Text Messaging

Text messaging is pervasive. Doctors and other health care providers, covered entities, and business associates currently use (and embrace) the technology. Texting is easy, fast and efficient. It doesn’t require a laptop...more

Blog: Implications of the Cybersecurity Bill for the Health Care Industry

On Tuesday the Senate passed the Cybersecurity Information Sharing Act (CISA). The House had passed a similar bill, the Protecting Cyber Networks Act, in April of this year. The Act comes in the wake of many large scale data...more

Employee Benefits Developments - October 2015

The Internal Revenue Service (IRS), consistent with prior regulations from the Department of Health and Human Resources (HHS), issued supplemental proposed regulations requiring employer sponsored health plans to provide...more

Health Care Update - October 2015

Senate Working Group Pressing Forward on Telehealth - As Congress focuses on bigger picture policy decisions, including broad budget negotiations and raising the debt ceiling, there are some exciting developments on the...more

CMS Adopts Changes to Medicare & Medicaid EHR Policies

The Centers for Medicare & Medicaid Services (CMS) has published a sweeping final rule with comment period that specifies the requirements that eligible professionals (EPs), eligible hospitals, and critical access hospitals...more

Manatt on Health Reform: Weekly Highlights - October 2015 #4

HHS announces average premium price increases of 7.5% across; Michigan and Illinois launch the country’s first joint cloud-based, real-time Medicaid information management system; and the Marketplace carrier...more

New Affordable Care Act FAQs Issued

On October 23, the U.S. Department of Labor, the Department of Health and Human Services, and the Department of the Treasury (collectively, the “Departments”) jointly issued answers to frequently asked questions regarding the...more

The Deeper Dive: Medicare’s Fundamental Shift Toward P4P - What priorities should providers focus on in navigating the changing...

While Medicare’s path toward pay for performance (P4P) has evolved over time, 2015 is proving to be a landmark year. July marked the 50th anniversary of the Medicare program. And in self-described “historic announcements”...more

2016 Cost of Living Increases are Rare

On October 21, 2015, in Information Release 2015-118, the IRS announced cost-of-living adjustments to various dollar limitations under the Internal Revenue Code (the "Code") for pension plans and other related items for the...more

Washington Healthcare Update

Elections for Speaker of the House and Potential Changes at Ways and Means Committee - Rep. Paul Ryan (R-WI) announced Tuesday (Oct. 20) that he will run for the House Speaker position if the major House Republican...more

OIG Hospital Compliance Audits: Is Your Number Up? Are You Ready?

In its Work Plan for Fiscal Year 2012, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services (HHS) announced it would begin reviews of Medicare payments to hospitals to determine compliance...more

ONC Issues Final Health IT Interoperability Roadmap

The HHS Office of the National Coordinator for Health Information Technology (ONC) has released its final “Roadmap” to promote the secure exchange and use of electronic health information. The document, “Connecting Health and...more

340B Orphan Drug Interpretive Rule Struck Down by D.C. District Court: HHS and HRSA Lose In Second Round of Litigation Over 340B...

In an Opinion issued October 14, 2015, D.C. District Court Judge Rudolph Contreras granted Pharmaceutical Research and Manufacturers of America’s (“PhRMA”) motion for summary judgment against the U.S. Department of Health and...more

D.C. District Court Deals Blow to HHS 340B Program Interpretive Rule

Court says Congress has the power to make the change that HHS attempted with its Interpretive Rule, and thus it should be left to the legislative branch. A lawsuit challenging the Interpretive Rule, filed by the...more

District Court Rules Pharmaceutical Manufacturers Are Not Required to Discount Orphan Drugs - Regardless of the Condition Being...

HHS’ rule requiring pharmaceutical manufacturers to discount orphan drugs when they were used to treat non-rare diseases was inconsistent with Congress’ intent to exclude all orphan drugs from the 340B discount program for...more

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