Tag Archives: Department of Health and Human Services

New OIG Project Expands Telemedicine Audits to State Medicaid Programs

medicaid
Following on the heels of its plans to review Medicare payments for telehealth services, the federal Office of Inspector General (OIG) at the Department of Health & Human Services (HHS) just announced a new project to review state Medicaid payments for telemedicine and other remote services. Accordingly, providers who bill state Medicaid programs for telemedicine, … Continue reading this entry

Rand Corporation Issues Report on U.S. Blood System

blood system
“A robust, sustainable blood system is a crucial component of every health care system.”  That is how Rand Corporation’s recently issued comprehensive report entitled “Toward a Sustainable Blood Supply in the United States” (the “Report”) begins.  Issued as a result of research sponsored by the U.S. Department of Health and Human Services (“HHS”), the Report … Continue reading this entry

Hawai’i Receives Approval for the First State Innovation (Section 1332) Waiver

The federal Department of Health and Human Services and Department of Treasury (the Departments) agreed that certain small employer health insurance coverage provisions of the Affordable Care Act (ACA) would be waived for the state of Hawai’i, beginning with January 1, 2017. The waiver was authorized pursuant to Section 1332 of the ACA, which allows … Continue reading this entry

Hospital Short-Stay Review Ban Lifted by CMS

Effective September 12, 2016, the Centers for Medicare & Medicaid Services (CMS) lifted the temporary ban on patient status reviews of hospital short stays for Medicare beneficiaries. Those reviews are currently conducted by the Beneficiary and Family Centered Care (BFCC) Quality Improvement Organizations (QIOs).1 As of October 1, 2015, the responsibilities of the BFCC-QIOs include … Continue reading this entry

HRSA Proposes Administrative Process to Resolve Disputes Between 340B Program Covered Entities and Drug Manufacturers

Taking a step toward completing a requirement imposed by the Affordable Care Act, the federal government has proposed regulations that would create an administrative dispute resolution (“ADR”) process to resolve disputes between 340B Program covered entities and drug manufacturers. As proposed, the ADR process would be available for covered entities to submit claims that they have … Continue reading this entry

Injunction Enjoining Enforcement of HHS Attestation Rule Affirmed

The Court of Appeals for the District of Columbia affirmed the District Court’s decision in Central United Life v. Burwell on July 1, 2016. This decision is very significant for those assessing the future strength of, and compliance framework for, the fixed indemnity market. Central United Life v. Burwell enjoined the U.S. Department of Health … Continue reading this entry

Summary: Final Rule on Nondiscrimination in Health Programs and Activities

Section 1557 of the Affordable Care Act (“ACA”) establishes a broad prohibition on discrimination on the basis of race, color, national origin, sex, age or disability in health programs and activities. After almost 3 years of rulemaking activity, the Department of Health and Human Services(“HHS”) Office for Civil Rights (“OCR”) issued its final rule implementing … Continue reading this entry

Finance Committee Report Place Medical Device Arrangements under Increasing Scrutiny

Hospitals and providers participating in physician-owned distributorships, or “PODs” may be at increased risk for government investigation or enforcement. A Senate Finance Committee (SFC) Report issued this month highlights the SFC’s concerns that certain POD structures may violate fraud and abuse statutes, including the Anti-Kickback Statute, Stark Law, as well as the Sunshine Act. According … Continue reading this entry

Phase 2 of HIPAA Compliance Audits Now Underway

The Office of Civil Rights (OCR) within the U.S. Department of Health and Human Services (DHHS) recently announced that it has initiated Phase 2 of its audit program to assess Covered Entities’ and Business Associate’s compliance with the Health Insurance Portability and Accountability Act (HIPAA) privacy, security, and breach notification rules (the HIPAA Audit Program). … Continue reading this entry

FDA Unveils Action Plan to Combat Opioid Abuse

The U.S. Food and Drug Administration (“FDA”) recently announced a “far-reaching action plan” to evaluate and improve the agency’s prescription opioid policies. The announcement came amidst public criticism and mounting political pressure on the FDA to address the country’s “opioid abuse epidemic,” including a hold placed by Senate Democrat Edward J. Markey on President Obama’s … Continue reading this entry

Executive Gun Control Actions Result in HIPAA Modifications

In response to the Obama Administration’s executive actions to reduce gun violence, on January 4, 2016, the U.S. Department of Health and Human Services’ Office of Civil Rights (OCR) issued a final rule, which modifies the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule that previously prevented states from making information available to the … Continue reading this entry

New Guidance Outlines Requirements for State Innovation Waivers

New guidance from Centers for Medicare & Medicaid Services (CMS) places the spotlight on the ability of states to seek approval of “State Innovation Waivers” to test new approaches for delivering health insurance reform. Authorized under Section 1332 of the Affordable Care Act (ACA), State Innovation Waivers can grant statewide modifications to many of the … Continue reading this entry

2016 Expected to Be Monumental Year for 340B Drug Discount Program

The 340B Program continues to be an area of focus from federal policymakers, and recent activity and publications indicate that 2016 could be a monumental year for the program. Below is a breakdown of the recent and upcoming key initiatives related to the 340B Program.… Continue reading this entry

Court Strikes Down 340B Orphan Drug Rule Again: Will This Impact the “Mega Guidance”?

Regulatory-Developments
A federal court vacated the Department of Health and Human Services’ (HHS) Orphan Dug Rule that had allowed certain 340B Drug Pricing Program (340B Program) hospital covered entities to receive discounted prices when purchasing orphan drugs for a non-orphan use. In addition to its significant financial impact on hospital covered entities subject to the rule, … Continue reading this entry

Precision Medicine - Even Medicare Will Pay For It!

President Barack Obama announced in his 2015 State of the Union address that he was introducing a new Precision Medicine Initiative, supported with over $200 million in the proposed 2016 federal budget. “Precision Medicine” and “Personalized Medicine” are often used as interchangeable terms. Sylvia Burwell, Secretary of the Department of Health and Human Services (HHS), … Continue reading this entry

Omnibus 340B Guidance Raises New Issues for Covered Entities

The Department of Health and Human Services (HHS) released its proposed 340B Drug Pricing Program Omnibus Guidance (Omnibus Guidance) on August 28, 2015. The Omnibus Guidance offers comprehensive – and, in some cases, new – guidance for 340B Drug Pricing Program (340B Program) covered entities (including providers such as disproportionate share hospitals, critical access hospitals, … Continue reading this entry

What to Expect From HHS-OIG's New Litigation Team

CMS Releases Medicare Part B Supplier Billing and Payment Data
The Office of Inspector General at the U.S. Department of Health and Human Services (“HHS-OIG”) announced, on June 30, 2015 (during a health care conference), the creation of a new litigation team that will focus solely on levying fraud-based civil money penalties and excluding providers from Medicare and Medicaid for committing fraud. The point is to … Continue reading this entry

Recent OIG Audits of Home Health and Hospice Surveys May Signal Increased Scrutiny on Worker Qualifications

Recent audits by the Department of Health and Human Services Office of Inspector General (“OIG”) conclude that state survey agencies in a number of states and a leading national accrediting agency serving the home health and hospice industry failed to identify a significant number of deficiencies related to worker qualifications. Based on these findings, OIG … Continue reading this entry

HRSA Proposes Civil Monetary Penalties for Drug Manufacturers that Overcharge 340B Covered Entities

The Health Resources and Services Administration (HRSA) within the U.S. Department of Health and Human Services (HHS) published a notice of proposed rulemaking impacting the 340B Drug Pricing Program (340B Program) on June 17, 2015. The proposed rulemaking, required under the Affordable Care Act, address 340B drug ceiling price calculations and penalties that may be imposed … Continue reading this entry

The Medicaid Fraud Control Units: Fiscal Year 2014 Report

The Department of Health and Human Services (HHS) Office of Inspector General (HHS-OIG) has released its Fiscal Year (FY) 2014 Annual Report (Report) on the performance of the Medicaid Fraud Control Units (MFCUs) (OEI-06-15-00010, April 2015). Although the MFCUs reported another strong year in civil recoveries, criminal recoveries were significantly lower than last year, when … Continue reading this entry

ONC Releases Updated Guide to Privacy and Security of Electronic Health Information

The Office of the National Coordinator for Health Information Technology (“ONC”) of the U.S. Department of Health and Human Services (“HHS”) recently released Version 2.0 of the Guide to Privacy and Security of Electronic Health Information (“Guide”). The Guide is a tool intended to assist providers as they work to comply with federal programs’ requirements … Continue reading this entry

OIG Releases Compliance Guidance for Health Care Governing Boards

Compliance
The Office of Inspector General (“OIG”) of the U.S. Department of Health and Human Services (“DHHS”) released new compliance guidance for health care governing boards, attorneys, compliance officers and internal auditors on April 20, 2015. The guidance was developed in collaboration with the Association of Healthcare Internal Auditors, the American Health Lawyers Association, the Health Care … Continue reading this entry

Supreme Court Holds Providers Cannot Sue States to Challenge Low Medicaid Rates

The Supreme Court ruled, on March 31, in a 5-4 decision, that hospitals and all other providers cannot sue to force a state to pay higher Medicaid rates. The name of the case is Armstrong v. Exception Child Center. In Armstrong, the plaintiffs were a group of Idaho providers that furnish “habilitation services.” These are … Continue reading this entry

Roadmap to Prison: Lessons Learned from the Criminal Prosecution of Alpha Ambulance’s Leaders

CMS Releases Medicare Part B Supplier Billing and Payment Data
No one running an ambulance company ever planned to go to prison for doing his or her job. But that is a real possibility if the government knocks on the door, and the owner or manager is dishonest in his or her response to the inquiry. CMS contractors are increasing the number of audits they are performing … Continue reading this entry