On May 8, 2013, the Office of Inspector General for the U.S. Department of Health and Human Services (OIG) published an updated Special Advisory Bulletin (SAB) on the scope and effect of federal healthcare program exclusion. OIG is the agency with the authority to exclude from participation in Medicare, Medicaid, and other federal healthcare programs… Continue Reading
Category Archives: Health
Subscribe to Health RSS FeedMedicare Inpatient Hospital Proposed Rule for Fiscal Year 2014 Released
The Centers for Medicare & Medicaid Services (CMS) released the Hospital Inpatient Prospective Payment System (IPPS) proposed rule for fiscal year (FY) 2014 on April 26, 2013. The proposed rule addresses changes in payment rates for general acute care and long-term care hospitals effective October 1, 2013, as well as revisions to the Hospital Value-Based… Continue Reading
POD Promoter “Spin” Notwithstanding, OIG’s Special Fraud Alert on PODs Puts Current POD-Hospital/ASC/Manufacturer Relationships at Risk
As noted in our recent post, OIG’s recent Special Fraud Alert on Physician-Owned Entities is the strongest statement to date that investing in or doing business with a physician-owned distributor, or POD, is a significant Antikickback law risk, not only for the POD and its physician-investors but for the hospitals and ASCs that purchase from… Continue Reading
CMS Releases Preliminary Code Decisions for Drugs, Biologicals and Radiopharmaceuticals
Today, CMS released preliminary Healthcare Common Procedure Coding System (HCPCS) code decisions for drug, biological and radiopharmaceutical products that will be discussed at a May 8, 2013 public meeting. The release addresses 30 different agenda items and, for each application, CMS describes the request and offers its preliminary decision. Applicants may submit a response to the… Continue Reading
Obama Releases Budget Proposal
On April 10, 2013, President Obama released his Fiscal Year (FY) 2014 budget proposal. As reported widely in the days leading up to the budget’s release, it included numerous health proposals that would together generate approximately $400 billion in savings over the next 10 years. Many of these proposals also appeared in the President’s FY… Continue Reading
Protecting EHR Donations 2.0
In today’s Federal Register, OIG and CMS propose three discrete revisions to existing regulations protecting the donation of electronic health records and solicit comments for potentially more far-reaching changes. The current safe harbor to the federal Anti-Kickback Statute (AKS), 42 C.F.R. § 1001.952(y), and the exception to the Physician Self-Referral Law (Stark), 42 C.F.R. §… Continue Reading
More Guidance on Medicaid Expansion Released by CMS
Enhanced Federal Matching Funds for the “Newly Eligible”: On March 29, 2013, CMS released a final rule implementing the statutory increases in federal matching funds for the cost of providing care to individuals newly eligible for Medicaid via the expansion under PPACA. Specifically, beginning in 2014, states will receive 100% federal matching funds for the… Continue Reading
OIG: PODs “inherently suspect” under anti-kickback statute; Hospitals and ASCs warned of AKS risks to them if they purchase from PODs
In its strongest statement so far on the subject, the HHS Office of Inspector General (OIG) today released a Special Fraud Alert which concludes that physician-owned entities that distribute the implantable medical devices ordered by the physician-owners for their own patients (PODs) are “inherently suspect under the [Federal Health Care Programs] anti-kickback statute” (AKS). OIG… Continue Reading
Dutch Sunshine Act: Financial relations between pharmaceutical companies and healthcare professionals will be made public in the Netherlands in April
As of 10 April 2013, the transparency register regarding financial relations between pharmaceutical companies and healthcare professionals in the Netherlands will go live. Through the register, anybody from patients and journalists to competitors will be able to search per healthcare professional or per organization of healthcare professionals for financial relations with pharmaceutical industry. The self-regulatory… Continue Reading
Sunshine Regulations to Unmask PODs’ Financial Relationships
The final Sunshine regulations, published in the Federal Register on February 8, require applicable manufacturers (“AMs”) and applicable GPOs (“AGPOs”) to submit reports on physician ownership and investment interests. Notably, the regulations require physician-owned distributors of covered products (including implantable medical devices) (“PODs”) to collect and report information on their financial relationships with their physician… Continue Reading
A PCO SOS?
R. (on the application of Save our Surgery Ltd) v Joint Committee of Primary Care Trusts Following the public inquiry report into child deaths at the Bristol Royal Infirmary, the National Specialised Commissioning Group’s 2008 “Safe and Sustainable Review” (the “Review“) recommended that the number of specialist centres providing paediatric cardiac surgery be reduced from… Continue Reading
Attention Employers: HHS Issues Two Rules Regarding SHOP Exchanges
Section 1311(b)(1)(B) of the Affordable Care Act requires those States that opt to operate an Exchange to establish a Small Business Health Options Program (SHOP) Exchange through which small businesses can purchase insurance coverage for their employees. HHS established standards for the administration of the SHOP Exchanges in the Exchange Establishment Rule published on March… Continue Reading
HHS Finalizes Technical Parameters for Premium Tax Credits, Cost-Sharing Reductions and Other Benefits and Payments Related to Qualified Health Plans and the Exchanges
The final Notice of Benefit and Payment Parameters for 2014, issued on March 1, 2013, establishes the final standards for a number of policies and programs that implement the Affordable Care Act’s reforms to private individual and small group health insurance markets in 2014. These policies are designed to make health insurance more affordable for… Continue Reading
OPM Releases Final Rule on the Affordable Care Act’s Multi-State Plan Program
The U.S. Office of Personnel Management (OPM) released a final rule on March 1st establishing the Multi-State Plan Program (MSPP) pursuant to the Affordable Care Act. It is substantially the same as the proposed rule, with conforming changes to the non-discrimination provisions to conform to recent changes in the final Essential Health Benefits regulation. The… Continue Reading
CMS Releases Final Rule on the Affordable Care Act’s Health Insurance Reforms
The Centers for Medicare and Medicaid Services (CMS) released a final rule on February 22, 2013, implementing four key consumer protections enacted by the Affordable Care Act, including: Guaranteed Availability: Health insurance issuers must sell health insurance policies to all consumers who apply for coverage, regardless of health status. Guaranteed Renewability: Health insurance issuers will… Continue Reading
HHS Announces Medicaid Innovation Grants for 25 States
On February 21, 2013, HHS Secretary Sebelius announced that 25 states would receive State Innovation Model awards totaling nearly $300 million to help the states deliver high-quality care and lower costs for Medicaid recipients. The largest grants are in the form of “Model Testing” awards given to Arkansas, Maine, Massachusetts, Minnesota, Oregon, and Vermont. It… Continue Reading
Florida’s Governor Scott Announces Support for Medicaid Expansion
Just hours after receiving the official word from CMS that it has agreed in principle to approve Florida Medicaid’s statewide mandatory managed care waiver, Governor Rick Scott appeared at a press conference to announce that he will urge the Florida Legislature in the upcoming session to approve an initial three-year Medicaid expansion under the Affordable… Continue Reading
FTC issues advisory opinion approving physician hospital organization’s clinical integration model
On February 13, 2013, the FTC staff issued a favorable Advisory Opinion to the Norman Physician Hospital Organization (Norman PHO) allowing it to move forward with its clinical integration plan. The Norman PHO, an affiliation of the Norman Regional Health System and approximately 280 participating physicians, seeks to transition from a messenger model when dealing… Continue Reading
CMS Announces “Agreement in Principle” To Approve Florida Medicaid’s Statewide Managed Care Waiver
On February 20, 2013, Cindy Mann – the Director of CMS’s Center for Medicaid & CHIP Services – issued a letter to Florida’s Medicaid Director acknowledging the “significant progress” CMS and Florida Medicaid have made and the “agreement in principle” they have reached concerning Florida’s request to amend its section 1115 Medicaid demonstration project. That… Continue Reading
CMS Releases Final Rule on Essential Health Benefits
On February 20, 2013, the Centers for Medicare and Medicaid Services (CMS) released a final rule providing detailed standards for the essential health benefits (EHB) package as well as actuarial value requirements for plans that must offer EHB. The final rule also addresses the process for entities to become recognized accrediting entities for issuers of… Continue Reading
CMS Innovation Center Launches New Medicare ESRD Shared Savings Program
The Centers for Medicare and Medicaid Services (CMS) recently announced the launch of the Comprehensive ESRD Care (CEC) Initiative to test an innovative Medicare payment model to improve care for Medicare beneficiaries with End Stage Renal Disease (ESRD), while decreasing costs to Medicare. CMS hosted a call to discuss the new initiative on February 5,… Continue Reading
Final Rule to Implement Physician Payment Sunshine Act Released
Today, the Centers for Medicare and Medicaid Services (CMS) released the final rule to implement the federal Physician Payment Sunshine Act (commonly known as the Sunshine Act). The Sunshine Act requires applicable manufacturers of drugs, devices, biologicals, and medical supplies to track and publicly report payments and other transfers of value that they make to physicians… Continue Reading
Affordable Care Act – Exemptions to the Individual Mandate
The Centers for Medicare & Medicaid Services (CMS) and the Internal Revenue Service (IRS) took another step towards implementing the controversial “individual mandate” imposed by the Affordable Care Act (ACA)—which is set to take effect on January 1, 2014—by jointly issuing two proposed rules to implement the exemptions to that mandate on January 30, 2013…. Continue Reading
Review of issues for 2013
The following is a summary of some of the key issues Congress and the Administration will be debating in 2013. Please contact us with any questions. We are happy to provide further analysis as well as insight into other areas of interest. Agriculture: Tom Vilsack is expected to stay on as Secretary of Agriculture…. Continue Reading