News & Analysis as of

New OIG Special Fraud Alert Focuses on Suspect Practices of Labs and Referring Physicians - Certain Payment Arrangements May Be a...

The U.S. Department of Health and Human Services' Office of Inspector General (OIG) issued a new Special Fraud Alert on June 25, 2014, that focuses on certain compensation arrangements between laboratories and referring...more

CMS Proposes Elimination of CME Exception to Sunshine Act Reporting

The Centers for Medicare and Medicaid Services (“CMS”) issued a proposed rule that includes a plan to eliminate the continuing medical education (“CME”) exclusion to the reporting requirements under the federal Physician...more

CMS Proposes Changes to Sunshine Act Reporting

Drug and device manufacturers breathing a sigh of relief after completing their 2013 data submissions under the Physician Payment Sunshine Act (the “Sunshine Act’) must now contend with four proposed changes to the Sunshine...more

Healthcare Legal News - July 2014 • Volume 4, Number 2

In This Issue: - DO SUBSIDIZED HEALTH CARE PLANS PURCHASED UNDER THE AFFORDABLE CARE ACT TRIGGER THE ANTI-KICKBACK STATUTE? The advent of federally subsidized private pay health insurance under the Affordable...more

#HealthyPA Takes the Next Step

The governor’s recent announcement that 9 commercial insurers successfully applied to participate in Healthy PA is another positive development as negotiations between Department of Public Welfare and the Centers for Medicare...more

GAO Concludes States Should Strengthen Medicaid Managed Care Program Integrity Efforts

The Government Accountability Office (GAO) recently released a report examining why Medicaid managed care programs made an estimated $14.4 billion in improper payments for fiscal year 2013. GAO found that the improper...more

Health Care Update - June 2014 #3

In This Update: - CMS Getting New Leadership Roles - Implementation of the Affordable Care Act - Other Federal Regulatory Initiatives - Other Congressional and State Initiatives - Other...more

RAC Program Update: CMS Appoints Provider Relations Coordinator

On June 2, 2014, CMS posted a brief update on its Recovery Audit Contractor (RAC) program website announcing the creation of a “Provider Relations Coordinator” position within CMS. The announcement states that the role of...more

As Sunshine Act Reporting Deadline Looms, CMS Issues Additional Guidance

With the June 30 deadline for Phase 2 Sunshine Act reports by pharmaceutical and medical device manufacturers (“Applicable Manufacturers”) and group purchasing organizations (“GPOs’) quickly approaching, the Centers for...more

Medicare's LTCH Moratorium - CMS Issues Instructions and Proposed Regulation

From the early 1980s until the end of the first decade of the 21st century, the number of long-term acute care hospitals (LTCHs) expanded many fold. Addressing this growth, Congress, in enacting the Medicare, Medicaid and...more

CMS Proposal to Adopt New OMB Delineations May Affect Medicare Reimbursement, GME Payments, and Regulatory Compliance

On April 30, 2014, the Centers for Medicare and Medicaid Services (CMS) issued proposed rules for the Fiscal Year 2015 Medicare Hospital Inpatient Prospective Payment System, in which CMS announced several updates, including...more

Cloudy Skies Ahead for Providers? CMS’ Release of Medicare Billing Data Combined with Physician Payment Sunshine Act Data May...

In February 2013, we reported (on our Healthcare Law Blog) that the Centers for Medicare and Medicaid Services (CMS) announced the final rule for the Physician Payments Sunshine Act. In the interest of providing more...more

CMS Survey Guidance and Amendment to SOM Advance Copy of Revised F371; Interpretive Guidance and Procedures for Sanitary...

On May 20 the Centers for Medicare & Medicaid Services (CMS) issued S&C 14-34-NH devoted to the topic of egg preparation in skilled nursing facilities (SNFs). Lest one think that this is an odd or random topic, it is relevant...more

CMS Changes to Medicare Advantage and Prescription Drug Benefit Programs for Contract Year 2015

On May 19, 2014, the Centers for Medicare & Medicaid Services (“CMS”) issued a final rule, published in the Federal Register on May 23, 2014, that sets forth changes to requirements for Medicare Advantage (“MA”) and...more

OIG Proposes Updates to Exclusion and CMP Authority

The Department of Health and Human Services, Office of Inspector General (OIG) recently issued a pair of proposed regulations to update its exclusion and civil monetary penalty (CMP) authority. The proposed regulations...more

The Deadline for Submitting Comments Regarding the Self-Referral Disclosure Protocol Is Fast Approaching

On May 2, 2014, the Centers for Medicare and Medicaid Services (“CMS”) published a request for comments relating to the Self-Referral Disclosure Protocol (“SRDP”). The SRDP is a voluntary self-disclosure instrument that...more

CMS and ONC Propose Rule to Help Providers Make Use of EHR and to Extend Timeline for Meaningful Use

The Centers for Medicare and Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC) announced a proposed rule, on May 20, 2014, that would allow providers more flexibility...more

CMS, ONC Propose Flexibility for Certified EHR Technology and Extension of Stage 2 Meaningful Use Criteria

CMS and the Office of the National Coordinator for Health IT (ONC) jointly issued a Proposed Rule on May 21, 2014 that would grant eligible providers flexibility in what edition of certified electronic health record...more

HHS Proposes Extension of Deadline for EHR Compliance

According to the federal government, over 370,000 providers have participated in the Medicare and Medicaid Electronic Health Record ("EHR") incentive program since its inception in 2011. However, providers nationwide continue...more

Finally…CMMI announces first dozen HCIA Round 2 Awards

After much delay, the Center for Medicare & Medicaid Innovation (CMMI) today announced a dozen awards under its Health Care Innovation Award (HCIA) Round two competition. The $1 billion funding competition sought proposals...more

CMS Scaled Back Changes to the Medicare Part D Prescription Drug and Medicare Advantage Programs, but Some Important Revisions...

On May 19, 2014, the Centers for Medicare & Medicaid Services ("CMS") released a final rule ("Final Rule") completing changes to the Medicare Program's outpatient prescription drug benefit ("Part D") program and the Medicare...more

Manatt on Medicaid: Are Health Homes Here to Stay?

Launched amid a flurry of activity in late 2010, the Affordable Care Act’s (ACA’s) Medicaid health home program was quickly adopted by several states. To spur adoption of this coordinated care model, the ACA provided a 90%...more

Rule Overhaul to Save Health Industry Up To $640 Million, Medicare Says

On May 7, 2014, the U.S. Centers for Medicare & Medicaid Services (CMS) issued a long-awaited final rule in response to President Obama’s Executive Order (EO) 13563, “Improving Regulation and Regulatory Review,” which set as...more

So Much for Stop, Drop and Roll: CMS Proposes New Fire Safety Update

CMS has announced a proposed rule updating Medicare/Medicaid fire safety standards. In particular, CMS proposes to adopt the National Fire Protection Association’s (NFPA) 2012 edition of the Life Safety Code (LSC) and the...more

Fingerprinting Policy Implementation - Risk to Enrollment Status?

In March 2011, when CMS published regulations to implement the Medicare enrollment screening provisions of the Affordable Care Act, the requirement for background fingerprint screening was put on hold. In a recent Special...more

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