Selina Coleman (US)

Selina Coleman (US)

Selina practices healthcare law at the Washington, D.C. office of Norton Rose Fulbright.  Focusing on regulatory and litigation matters, Selina provides guidance on compliance questions related to the Physician Payments Sunshine Act, government investigations of Medicare or Medicaid billing, self-disclosures related to fraud-and-abuse laws, and appeals related to administrative reimbursement. Her clients include hospitals, pharmaceutical and medical-device manufacturers, and national retail pharmacy chains.  Selina also serves as the Steering Committee Co-Chair for the Health Law Section of the D.C. Bar.

Before joining Norton Rose Fulbright, Selina clerked for the Honorable Rebecca Beach Smith in the United States District Court for the Eastern District of Virginia.

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OIG launches new compliance resource portal

The OIG recently launched a new compliance resource portal, compiling some of its resources into one user-friendly webpage. The Compliance Resource Portal provides a list of links to categories of “handy resources for the public that can help ensure that you are in compliance with Federal health care laws,” and may serve as a valuable … Continue reading

Deregulatory wave prompts renewed examination of Stark Law application

In another sign that the Trump administration’s penchant for regulatory flexibility may apply to the federal fraud-and-abuse regulatory regimes, CMS administrator Seema Verma announced during an AHA Town Hall webcast on January 17 that CMS is convening an interagency group to examine possible ways to minimize the regulatory barriers of fraud-and-abuse laws, including the Stark … Continue reading

Relator’s pharmacy allegations dismissed; government’s U&C allegations survive

Although a Florida compounding pharmacy has scored a win against a whistleblower’s allegations, it continues to defend against the government’s allegations of improper inflation of its Usual & Customary charges submitted to TRICARE. The U.S. District Court for the Middle District of Florida granted motions to dismiss with prejudice in favor of the pharmacy RS … Continue reading

OIG rescinds advisory opinion to charity

For the first time, the OIG has rescinded an advisory opinion issued to a charity. According to the OIG, the advisory opinion – issued in 2006 and modified in 2015 –  was revoked because the charity “failed to comply with certain factual certifications” about independence from donors, potentially steering Medicare beneficiaries toward certain prescription drugs. … Continue reading

Judge doubles down on finding of materiality in FCA case

Federal courts continue to grapple with applying the “materiality” standard that is needed to cause a Stark Law violation or other underlying compliance matter to trigger False Claims Act liability. Although we have recently begun to gain a clearer view of what contractual requirements will not likely be viewed as material, at least one federal … Continue reading

Government audits shift to high error rates and significant variances

CMS has revamped its approach to pursuing alleged improper payments. Its new audit strategy with Medicare Administrative Contractors (MACs) will target providers and suppliers with the highest error rates or the most significant deviations. This is a significant shift in strategy to focus on outliers when seeking recoupment. Under the new audit process, through a process of … Continue reading

Six legal and regulatory risks facing specialty pharmacies

“Specialty drugs” are a fast growing sector of the pharmaceutical industry and are predicated to represent 50 percent of drug expenditures in the United States by 2020.[1] Specialty drugs are typically dispensed by specialty pharmacies. Although there is no agreed-upon industry definition of “specialty pharmacy,” generally, these pharmacies focus on dispensing and distributing high cost … Continue reading

Stay tuned – CMS plans to consider public comments received on the Sunshine Act

CMS announced that the agency “will consider the public  comments received [on the Open Payments / Sunshine Act program] in the future through possible rulemaking or publication of subregulatory guidance” in the recently released “Revisions to Payment Policies under the Physician Fee Schedule and Other Revisions to Part B for CY 2017.” But for now, CMS … Continue reading

CMS seeks feedback on standard form for SRDP submissions

CMS has asked for comments on a form for healthcare providers to disclose actual or potential violations of the federal self-referral (Stark) law.  The proposed format includes a disclosure form, a physician-information form, and a financial-analysis worksheet. As many providers know, CMS is significantly backlogged with self-disclosures, and so the standard form may help the agency more … Continue reading

Supreme Court hears arguments on “implied certification” FCA liability

On Tuesday, the U.S. Supreme Court appeared reluctant to embrace the government’s expansive view of liability under the False Claims Act (“FCA”), as it heard oral arguments in what may prove to be one of the most significant FCA cases in decades. While it is always hazardous to draw conclusions from questions at oral argument, … Continue reading

New OIG exclusion guidance places value on self-disclosure

The OIG has issued updated guidance on the agency’s exclusion authority, as announced by Inspector General Daniel Levinson at the HCCA’s 2016 Compliance Institute. According to the new guidance, good-faith self-disclosures will place providers at the lower-risk end of the spectrum for an exclusion release without integrity obligations.  As a result, providers have additional support … Continue reading

Government panelists speak on Medicare overpayments final rule

At the DC Bar program “The Medicare Overpayments Final Rule: Government Perspectives and Compliance Considerations” (Mar. 29, 2016), a panel of speakers from the OIG, CMS, and private practice discussed perspectives on the final rule’s guidance about the return of identified Medicare Part A and B overpayments within 60 days, implications of the final rule … Continue reading

CMS issues anticipated Medicare overpayments final rule; relaxes initial proposals

On February 11, 2016, CMS issued a final rule clarifying the requirement of § 1128J(d) of the Social Security Act (created by § 6402(d) of the Affordable Care Act) that health care providers must report and return overpayments within 60 days of the date when they have identified the overpayment or the date any applicable … Continue reading

Increased focus on data analysis by government agencies

At a recent DC Bar program called “The Use of Data by the OIG-DHHS and CMS/CPI in Medicare Program Integrity, Investigations and Compliance,” representatives from CMS and the OIG provided their perspectives on the evolving capabilities of government agencies to review and analyze large datasets related to the provision and reimbursement of healthcare services.… Continue reading

Healthcare leaders offer insights into US and Australia transparency

Pharma in Focus recently interviewed Rick Robinson, Norton Rose Fulbright’s global co-head of life science and healthcare, and his Australian colleague and Norton Rose Fulbright partner Bernard O’Shea. According to Robinson, greater transparency in reporting – just arrived in Australia – will likely have a “dampening” effect on payments and transfers of value to healthcare practitioners.  O’Shea … Continue reading

Tuomey settles for $72.4 million, will be sold and under CIA

Facing a $237 million verdict for alleged illegal compensation arrangements with doctors, Tuomey Healthcare System has agreed to settle with the government for $72.4 million.  According to the government’s press release, Tuomey will be sold to Palmetto Health, a multi-hospital healthcare system, as part of the settlement.  Tuomey must also retain an independent review organization … Continue reading

Not just physicians? Bill seeks to expand Sunshine Act to PAs and NPs

A bipartisan Senate bill (S. 2153) introduced this week would expand reporting obligations under the Sunshine Act / Open Payments program to cover payments or other transfers of value provided to physician assistants and nurse practitioners.   Right now, pharmaceutical and device manufacturers report on only their physician financial relationships, which could give rise to … Continue reading

New trends in statistical sampling

Although the trend of ever-larger FCA recoveries by the DOJ is not new, what is new is a recent trend by federal district courts to make it even easier for the government to prove cases against healthcare defendants by allowing relators to use statistical sampling to prove FCA liability.   Read about the impact that statistical … Continue reading

Challenge dropped to dismissal of allegations of pharmacy-reward fraud

A relator is dropping his appeal of a district court decision that granted a motion to dismiss FCA claims against CVS.  Procedural deficiencies were raised with relator’s appeal, including missing the filing deadline for his appeal in the U.S. Court of Appeals for the Seventh Circuit.  The underlying case, which will now stand, could encourage … Continue reading

Florida hospital pays $69.5 million to settle alleged Stark issues

The government has announced that a South Florida hospital district will pay $69.5 million to settle False Claims Act allegations related to financial arrangements with physicians. This case follows the trend of increased scrutiny of physician compensation, both by whistleblowers and by regulators: a trend that may escalate in light of the government’s fraud alert … Continue reading

OIG approves free 30-day supply of drugs for patients experiencing coverage delay

The OIG released an advisory opinion stating that it would not impose administrative sanctions against two drug manufacturers or their affiliated pharmacy for offering a free 30-day supply of an antineoplastic drug to patients who experience a delay in the insurance approval process. Although the advisory opinion addresses the provision of a limited free supply … Continue reading

Health Ethics Trust – call for submission for best compliance practices

Please consider submitting your organization’s compliance practices for recognition at this year’s Healthcare Best Compliance Practices Forum. The Health Ethics Trust’s Best Practices process assigns evaluation of submitted practices to independent panels of compliance professionals. The Health Ethics Trust has recognized 164 practices as Best Practices.  We invite our clients to submit their own practices … Continue reading