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Telehealth and Health IT Policy: Considerations for Stakeholders

In recent months, as the conversation about reforming the health care system has shifted to achieving greater delivery system efficiencies, cost containment, and patient satisfaction, the role of health care...more

FDA to Strengthen Oversight of Certain In Vitro Diagnostic Devices

In the wake of a new Medicare reimbursement framework, FDA plans stricter regulation of some in vitro diagnostic devices. On July 31, 2014, the U.S. Food and Drug Administration (FDA; Agency) announced its intent to...more

Is Off-Label Drug Promotion Protected Free Speech?

It is a very common practice. Drug sales reps visit a client, usually a hospital, a clinic or a doctor, with the sole purpose of selling a drug or medical device. That is the primary way a doctor learns about a drug or...more

Teaching Hospitals and Physicians Must Take Action Now to Correct Erroneous Reports about them Submitted Under the Sunshine Act

On September 1, 2014, the Centers for Medicare and Medicaid Services (CMS) will make public the reports submitted by pharmaceutical and medical device manufacturers under the Sunshine Act. These reports will disclose...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

Commission-Based Sales Agreements for Medical Supplies and Equipment: More Whistleblower Activity on the Horizon? - A Wide Range...

The common industry practice of compensating independent contractor sales representatives on a "percentage of sales" commission basis may be creating an enhanced risk of False Claims Act liability for illegal kickbacks in...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

Health Care Reform Implementation Update - May 2014

Congress held several hearings last week ranging from Sylvia Burwell’s nomination for Secretary of the Department of Health and Human Services (HHS), to Medicare payment oversight, to post-acute care in Medicare. The Centers...more

CMS Releases Physician Medicare Billing Data

The U.S. Department of Health and Human Services (HHS) announced on April 9th a “historic” release of Medicare payment data to provide consumers with “unprecedented transparency on the medical services physicians provide and...more

Chance to Comment on Future of DMEPOS Payments

CMS recently took the unusual step of issuing an Advance Notice of Proposed Rulemaking (ANPR) regarding changes to Medicare payment methodologies for durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS)...more

Capital Thinking: Health Care

LEGISLATIVE ACTIVITY - This Week’s Hearings: - Wednesday, January 15: The House Committee on Veterans’ Affairs will hold a hearing titled “Vendors in the OR- VA’s Failed Oversight of Surgical Implants.” The House...more

OIG Report Concludes that Physician-owned Distributors Increase Utilization

In response to the U.S. Senate Committee on Finance’s continued questioning of physician-owned distributorships (PODs), the U.S. Department Health and Human Services Office of the Inspector General issued its long-awaited...more

10 Tips for Medical Technology Companies

The Centers for Medicare & Medicaid Services (CMS) has initiated a new review process of existing national coverage determinations (NCDs). This new process is designed to retire old policies and may present increased risks to...more

CMS Issues Proposed Rule That Will Update Payment Policies/Rates Under the Medicare Physician Fee Schedule

The Centers for Medicare & Medicaid Services (CMS) issued a proposed rule that will update payment policies and rates under the Medicare Physician Fee Schedule (MPFS) for calendar year (CY) 2014 on July 6, 2013....more

Bill Introduced to Curtail the Stark Law's In-Office Ancillary Services Exception

On August 1, Rep. Jackie Speier (D-CA) introduced H.R. 2914, the Promoting Integrity in Medicare Act. The legislation would provide that the Stark Law's in-office ancillary services (IOAS) exception is not available for...more

Client News Alert: Regarding Physician Payments Sunshine Act

On August 1, 2013 a new reporting obligation under the federal Physician Payments Sunshine Act (“Sunshine Act”) takes effect. The Sunshine Act was originally signed into law on March 23, 2010, as part of the Patient...more

CMS Proposes New Standards and Processes for Medicare Coverage of Investigational Devices and Related Clinical Studies and Trials

In its proposed update to the Physician Fee Schedule for calendar year 2014, the Centers for Medicare & Medicaid Services (CMS) suggested major revisions to its regulations governing Medicare coverage of investigational...more

Health Reform + Related Health Policy News - July 2013

In This Issue: - Top News ..Obama Administration Delays Employer Mandate One Year ..House Energy and Commerce Committee Releases Draft Legislation for SGR Fix ..CMS Proposes Payment Changes for Medicare...more

Getting the Best Medical Care: a Newsletter from Patrick Malone - July 2013

In This Issue: - Is There a Problem? Let Us Count the Ways - A Growing Awareness - Getting Objective Information - Recent Health Care News You Should Know About - Excerpt from Navigating Through Medical...more

Sunshine Act Requires Reporting All Payments to Physicians

Beginning August 1, 2013, manufacturers of Medicare or Medicaid covered drugs, medical devices, biologicals and medical supplies must collect and make publicly available data on physicians and teaching hospitals with whom the...more

Health Care Reform Update -- April 2, 2013

In This Issue: Implementation of the Affordable Care Act (ACA); Other HHS and Federal Regulatory Initiatives; Other Congressional and State Initiatives; Other Health Care News; and Hearings and Mark-Ups...more

CMS Issues Rules On Physician Payments Sunshine Act

People like to think they have it the hardest in life. I call it the competition among victims. If you are in the healthcare industry and fall under the Physician Payments regulations, then I think you are on your way to...more

Here Comes the Sun: Final Rules Implementing the Federal Sunshine Law

On February 1, 2013, the Centers for Medicare & Medicaid Services (CMS) released the long-awaited final rule implementing the Federal Sunshine Law (42 U.S.C. 1320a-7h). (The rule was subsequently published in the Federal...more

CMS Issues Final Rule for Implementing Sunshine Act

On February 8, 2013, 16 months after the statutory deadline, the Centers for Medicare & Medicaid Services (CMS) published in the Federal Register the final regulation implementing the physician payment transparency...more

CMS Issues Final Physician Payment Sunshine Act Regulations

On February 1, 2013, the Centers for Medicare and Medicaid Services (CMS) published the long-awaited final regulations implementing the Physician Payment Sunshine Act (Act or Sunshine Act). The Sunshine Act requires drug,...more

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