Hannah Whitman Clark

Hannah Whitman Clark


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Uncertainty Continues for Two-Midnight Rule's Payment Reduction

In Shands Jacksonville v. Burwell [PDF], No. CV 14-1477, 2015 WL 5579653, (D.D.C. Sept. 21, 2015), the United States District Court for the District of Columbia gave the Secretary of the Department of Health and Human...more

10/14/2015 - Administrative Procedure Act HHS Hospitals Inpatient Billing Medicare Notice and Comment Provider Payments Rulemaking Process Secretary of HHS Two-Midnight Rule

Open Payments Update: End of CME Exception for Sunshine Reporting

On July 17, 2015, CMS announced updates to the Law and Policy page on the Open Payments website to provide additional guidance regarding the termination of the continuing medical education (CME) exception for reporting under...more

8/17/2015 - CME CMS Medicare Open Payments Reporting Requirements Sunshine Act

Stark Regulations: Proposed Physician-owned Hospitals Provisions

In the proposed Physician Fee Schedule for 2016 [PDF], CMS recommends amending several requirements related to the physician-owned hospital and rural provider exceptions to the Stark law. As discussed more fully below, CMS...more

7/23/2015 - CMS Exceptions Hospitals Patient Referrals Physician Fee Schedule Physician-Owned Hospitals Rural Health Care Providers Stark Law

Again, the OIG Approves a Medigap Policy Contract with Preferred Hospital Networks

On June 12, 2015, the U.S. Department of Health & Human Services, Office of Inspector General (OIG) issued Advisory Opinion 15-08. This opinion continues the well-established pattern of favorable advisory opinions which...more

7/3/2015 - Anti-Kickback Statute Civil Monetary Penalty Fraud and Abuse Health Insurance HHS Hospitals Medigap OIG Preferred Hospital Networks Arrangement

CMS Pays $1.3 Billion to Hospitals for Settlements of Medicare Inpatient Appeals

On June 11, 2015, CMS announced that it had entered into settlements with over 1,900 hospitals for over 300,000 disputed inpatient billing claims. CMS updated its website dedicated to inpatient hospital reviews, noting that...more

6/27/2015 - CMS Healthcare Hospitals Inpatient Billing Medicare Settlement Agreements

Medicare Shared Savings Program - 2015: What's Changed, What's New, and What's to Come?

The most recent Shared Savings Program final rule, published in the Federal Register on June 9, 2015, finalizes a number of the revisions to the original November 2011 final rule that CMS proposed on December 8, 2014. In...more

6/17/2015 - ACO Participant Agreements ACOs Benchmarks CMS HHS Medicaid Medicare Medicare Shared Savings Program Physician Medicare Reimbursements SNF Waivers

Medicare Access and CHIP Reauthorization Act: Paving the Way for Broader Gainsharing Activities

On April 16, 2015, President Obama signed into law H.R.2, the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA), a critical piece of health care legislation which represents significant movement towards a health...more

4/28/2015 - CHIP Civil Monetary Penalty Gainsharing HHS Hospitals Medicare Medicare Access and CHIP Reauthorization (MACRA) OIG Physicians

Excluded Individual Not Precluded from Payment for Pre-exclusion Services

In Advisory Opinion 15-02 [PDF], issued February 9, 2015, the U.S. Department of Health & Human Services, Office of Inspector General (OIG) looked favorably on the Requestor’s inquiry as to whether receipt of Federal health...more

2/28/2015 - Advisory Opinions False Claims Act (FCA) HHS OIG

HHS Identifies Specific Goals to Move Toward Paying for Quality of Care

On January 26, 2015, the U.S. Department of Health and Human Services (HHS) announced a new initiative to shift Medicare reimbursements from volume to value using new payment methodologies for physicians and hospitals. Such a...more

2/9/2015 - Fee-for-Service Healthcare HHS Hospitals Medicare Physician Medicare Reimbursements Quality of Care Standards

Guidance, Not Regulations, Expected for 340B Drug Pricing Program

The long-awaited 340B “mega rule,” promised by the Health Resources and Services Administration (HRSA) to be published last summer, has now been officially nixed. HRSA recently announced that it will not release the...more

12/15/2014 - HRSA New Guidance Prescription Drugs Section 340B

OIG's 2015 Work Plan Highlights Departmental Priorities

Each year the Department of Health and Human Services, Office of the Inspector General (OIG) issues its Work Plan to identify for the provider community the key fraud and abuse issues on which it will focus on in the coming...more

11/24/2014 - Ambulance Providers Ambulatory Surgery Centers CMS Health Care Providers HHS Home Health Agencies Hospice Hospitals Medical Devices Nursing Homes OIG Prescription Drugs Work Plans

Highlights of the 2015 OPPS and ASC Final Rule

On October 31, 2014, CMS published its 2015 Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System Policy Changes and Payment Rates final rule. This annual rule affects the 4,000...more

11/18/2014 - CMS Final Rules Hospitals OPPS Patient Prospective Payment System

Highlights of OIG's Proposal to Amend Safe Harbors to the Antikickback Statute and CMP Rules, and to Add New Safe Harbors

On October 3, 2014, the Department of Health and Human Services Office of Inspector General (OIG) issued a proposed rule to establish new safe harbors under the antikickback statute and the civil monetary penalty (CMP) rules,...more

10/16/2014 - Affordable Care Act Ambulance Providers Anti-Kickback Statute CMP Law Cost-Sharing Medicare Modernization Act OIG Pharmacies Proposed Regulation Safe Harbors

OIG Approves Yet Another Medigap Policy Contract with Preferred Hospital Network

On September 17, 2014, the U.S. Department of Health & Human Services, Office of Inspector General (OIG) issued Advisory Opinion 14-08 [PDF]. This opinion is yet another favorable advisory opinion approving a Medicare...more

10/13/2014 - Anti-Kickback Statute Civil Monetary Penalty Health Insurance Hospitals Medigap OIG Safe Harbors

WEBINAR: Breach, Enforcement and Beyond: HIPAA Breach Notification Analysis and OCR Enforcement Activities

The Office for Civil Rights of the US Department of Health and Human Services revised the breach notification regulations last year in order to make the analysis of whether a breach occurred more objective. In addition, OCR...more

9/18/2014 - Breach Notification Rule Data Breach Data Protection Enforcement Enforcement Actions HHS HIPAA OCR

CMS Retracts Hospice Preauthorization Requirements for Part D Drugs

On July 18, CMS released new guidance retracting a major portion of its controversial preauthorization requirement for hospice beneficiaries. The new guidance supersedes portions of the March 10, 2014 guidance [PDF] that...more

8/8/2014 - CMS Healthcare Hospice Medicare Medicare Part D Prescription Drugs

CMS Publishes Proposed 2015 OPPS and ASC Payment Rule

On July 3, 2014, CMS posted the proposed CY 2015 outpatient perspective payment system (OPPS) and Ambulatory Surgical Center (ASC) payment rule, which was subsequently published in the Federal Register on July 14, 2014 [PDF]....more

7/25/2014 - CMS Healthcare Healthcare Facilities Hospitals OPPS Reimbursements Rulemaking Process

AMA Issues Telemedicine Guidelines

On June 11, 2014, the American Medical Association (AMA) released a new set of telemedicine principles, which emerged from its policy report addressing “Coverage and Payment for Telemedicine.” The AMA report details the...more

7/15/2014 - American Medical Association CMS Healthcare Reimbursements Telemedicine

CMS Issues Cost Savings Reforms to Medicare Regulatory Requirements

On May 12, 2014, CMS issued a final rule, reforming certain Medicare regulatory requirements and eliminating those identified as unnecessary, obsolete, or excessively burdensome. Many of the streamlined provisions relate to...more

6/12/2014 - CMS Healthcare Healthcare Reform Hospitals Medicare Terms and Conditions

Medicare Proposes Prior Authorization Process for Certain DMEPOS Items

On May 28, 2014, CMS issued a proposed rule to establish a permanent prior authorization process for certain durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) items that are “frequently subject to...more

6/9/2014 - CMS DMEPOS Enforcement Healthcare Medicare Prior Authorization Proposed Regulation

Maryland Waiver Hospitals Subject to New Reporting Requirements for Present on Admission Indicators

Maryland waiver hospitals (those operating under section 1814(b)(3) of the Social Security Act (SSA)) are no longer exempt from present on admission (POA) reporting. CMS Transmittal R1380OTN (Change Request 8709) notifies...more


Highlights of Proposed Rules for Skilled Nursing Facilities, Inpatient Rehabilitation Facilities, and Inpatient Psychiatric...

On May 1, 2014, CMS released proposed payment and policy changes for Medicare Skilled Nursing Facilities (SNFs), Inpatient Rehabilitation Facilities (IRFs), and Inpatient Psychiatric Facilities (IPFs). Some of the key changes...more

5/21/2014 - CMS Healthcare Inpatient Rehab Facilities IRF Claim Processing Payment Systems Proposed Regulation Public Comment SNF

Highlights of the Protecting Access to Medicare Act of 2014

On the first of this month, President Obama signed into law the Protecting Access to Medicare Act of 2014. The measure extends a multitude of provisions that were set to expire and also incorporates many provisions that may...more

4/28/2014 - Healthcare Healthcare Reform Medicare Protecting Access to Medicare Act

Maryland Health Care Commission Proposes to Extend and Revise EHR Incentive Regulations

On March 21, 2014, the Maryland Health Care Commission (MHCC) published proposed revisions to the existing Maryland Electronic Health Record Incentives regulations at COMAR 10.25.16. The proposed regulations [PDF] would...more

4/25/2014 - CMS EHR Healthcare Incentives Physician Payments

HIPAA Security Risk Analyses

As noted in Paul Kim and Hannah Whitman Clark's article regarding HIPAA Security Risk Analyses, CEs and BAs are required to review and update their risk assessments only under certain conditions after completing their initial...more

4/1/2014 - Data Protection HIPAA PHI Risk Assessment

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