Ober|Kaler

Author

Latest Publications

Alan Arville

Final Rule on 340B Orphan Drug Exclusion Imposes New Compliance Requirements on Covered Entities and Contract Pharmacies

The 340B program permits eligible hospitals and other “safety-net” providers (Covered Entities) to purchase covered outpatient drugs from pharmaceutical manufacturers at significant discounts. The Affordable Care Act and the…more

340B, Compliance, Covered Entities, Exclusions, GPOs

See All Updates »

William Berlin

Top Ten Practical Antitrust Compliance Tips for Health Care Providers (and Other Entities)

To minimize the antitrust risk your hospital, physician group, health plan, or other health care organization faces in its day-to-day operations, such as contracting with providers and payors, or strategic activities, such as…more

Antitrust Provisions, Compliance, DOJ, FTC, Healthcare

See All Updates »

Jackson Boyd

Government Contracting: Beware Offerors - Past Performance By Your Proposed Subcontractors and Key Personnel May Not Count

A recent GAO decision, HK Consulting, Inc., B-408443 (Comp. Gen. Sept. 18, 2013), provides an important reminder that government agencies are not required to consider the past performance of an offeror’s proposed subcontractors…more

Contractors, FAR, Federal Contractors, GAO, Subcontractors

See All Updates »

Andrew Campbell

Social Media Compliance Issues for Community Banks

Andy Campbell presented “Social Media Compliance Issues for Community Banks,” a look at the benefits and risks for banks cultivating a social media presence. Andy’s presentation included discussion of: - regulatory…more

Banks, Community Banks, Compliance, FFIEC, Social Media

See All Updates »

Elizabeth Cappiello

Sequestration and its Impact on the Construction Industry

Pursuant to the Budget Control Act of 2011, sequestration is the process by which automatic across-the-board spending cuts are being imposed on government programs. Because Congress was unable to reach an agreement by its March…more

Construction Contracts, Contract Claims, Contractors, Federal Budget, Modification

See All Updates »

Kristen Cilento Carter

Part II: Exploration of Common Exceptions to the Stark Law

In this Presentation: Kristin Cilento Carter presented “Exploration of Common Exceptions to the Stark Law” as part of the program “Stark Physician Self-Referral Law,” an installment in the Fraud and Abuse Basics Bootcamp…more

Fraud, Fraud and Abuse, Healthcare, Healthcare Fraud, Stark Law

See All Updates »

Hannah Whitman Clark

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

Data Protection, HIPAA, PHI, Risk Assessment

See All Updates »

Marc Cohen

When It Comes to Medicare Payment, Physicians Have Choices

Health care providers can choose to enroll in, participate in, or opt out of Medicare, but… - Not everyone can choose equally and their choices will net direct outcomes in their practice income. Medicare jargon can be…more

CMS, Healthcare, Medicare, Physicians

See All Updates »

Thomas W. Coons

"Incident To" Personnel and Credentials: CMS's New Teeth to Address an Old Problem

Medicare’s “incident to” provision found at 42 U.S.C. § 1395x(s)(2)(A) addresses coverage of services and supplies furnished “incident to a physician’s professional service,” principally in a physician’s office or clinic…more

CMS, Compliance, Healthcare, Hospitals, IPPS

See All Updates »

Christopher P. Dean

CMS Proposes Enhanced Role for Non-Physician Practitioners in Rural Health Clinics

Recognizing the difficulty many rural health clinics (RHCs) face when recruiting health care practitioners, CMS recently proposed to change its interpretation of the Rural Health Clinic Services Act and allow RHCs to contract…more

CMS, Healthcare, Independent Contractors, Medicare, Rural Health Care Providers

See All Updates »

Samantha Flanzer

Program Integrity Priorities Revealed in FY 2015 HHS Budget

On March 14, 2014, President Obama unveiled his Administration’s proposed fiscal year 2015 budget for the Department of Health and Human Services (HHS). In total, the Administration is seeking $77.1 billion to fund HHS in FY…more

Affordable Care Act, CMS, Federal Budget, Healthcare Fraud, Healthcare Reform

See All Updates »

Joshua Freemire

HHS Office of Civil Rights Releases Several Model Notices of Privacy Practices

The HHS Office of Civil Rights (OCR) recently released several versions of a model Notice of Privacy Practices (NPP) for use by covered entity health plans and health care providers. The notices have been written specifically to…more

HHS, HIPAA, HIPAA Omnibus Rule, HITECH, Notice of Privacy Practices

See All Updates »

Amy E. Garber

ABA's Forum on Construction Industry 2013 Fall Meeting Focuses on P3s

This past September, the American Bar Association’s Forum on the Construction Industry held its annual Fall Meeting in Washington D.C. The program covered a wide range of issues concerning the present and future of…more

ABA, P3s, Public-Private Partnerships

See All Updates »

Leslie Demaree Goldsmith

Upcoming PQRS Deadlines

If you are submitting PQRS data, please make note of the following upcoming deadlines this month: March 21, 2014: - Last day for groups to submit 2013 data through the GPRO Web Interface webpage…more

Deadlines, PQRS

See All Updates »

Penny Somer Greif

Gimme an "A!" The SEC Proposes Regulation A Offerings for up to $50 Million

As we have noted in prior Bulletins, pursuant to Section 5 of the Securities Act of 1933 (Securities Act) and state securities laws, any offer and sale of a security must be registered with the Securities and Exchange Commission…more

Crowdfunding, JOBS Act, Regulation A, SEC, Securities Act of 1933

See All Updates »

Carel Hedlund

Medicare to Deny Certain Hospital Inpatient Claims for Hospice Patients

Under new CMS guidance, hospitals may have certain claims denied for inpatient services to a hospice patient. On November 7, 2013, CMS issued Change Request 8273 announcing changes in Medicare’s claims processing systems that…more

Healthcare, Hospice, Inpatient Billing, Medicare

See All Updates »

James Holloway

"Cursory Services" May Be "Worthless Services" Under False Claims Act

A recent federal court decision allowed the federal government to proceed with a False Claims Act (FCA) case involving an allegation that a health care provider’s “services were so cursory that they were worthless.” U.S. v…more

False Claims Act, Fraud, Medicare, Physician Medicare Reimbursements, Worthless Services Claims

See All Updates »

Stewart Kameen

Prime Contractors Beware: Small Business Means Small Business

As of August 15, 2013, prime contractors on federal projects must take on increased responsibility and accountability for hiring small business subcontractors. The U.S. Small Business Association (SBA) has implemented certain…more

Contractors, SBA, Small Business

See All Updates »

Julie Kass

Dodging the AKS: Marketplace Plans Are Not "Federal Health Care Programs"

In an October 30th letter addressed to Congressman Jim McDermott, the Department of Health and Human Services (HHS) Secretary, Kathleen Sebelius, left little to interpretation: Qualified health plans (QHPs) purchased through the…more

Affordable Care Act, Anti-Kickback Statute, CMS, False Claims Act, Health Insurance Exchanges

See All Updates »

Paul Kim

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

Data Protection, HIPAA, PHI, Risk Assessment

See All Updates »

Walter Kirkman

Maryland Changes Rules for Enforcement of Rights and Remedies Under Loan Documents Secured by Residential Property

The Maryland General Assembly has enacted legislation (House Bill 274/Senate Bill 708) that significantly impacts secured lenders’ rights to enforce financing documents secured by residential property. The legislation -- which…more

Lenders, Loan Documentation, Loans

See All Updates »

Joseph Kovars

Pending Legislation in Maryland Could Eliminate Bid Protest Appeals

On February 24, a bill was introduced in the Maryland House of Delegates which, if passed, will require a bid protester of a state contract to pay to the state up to 5% of the value of the contract on which it protested, if the…more

Appeals, Bid Protests, Bids

See All Updates »

Kevin LaTulip, Jr.

Maryland Court Affirms that Unpaid Recordation Tax on Indemnity Deed of Trust is not an Obligation of Beneficiary

In good news for foreclosing lenders in Maryland, the Circuit Court for Howard County has affirmed a Maryland Tax Court Memorandum and Order concluding that the recordation tax payable on an indemnity deed of trust ("IDOT")…more

Beneficiaries, Indemnity Deed of Trust, Property Tax, Recordation Taxes, Tax Exemptions

See All Updates »

John S. Linehan

Recent Settlements Underline the Antikickback Statute's Central Role in Health Care Enforcement

In recent years, the antikickback statute (AKS) has emerged as an essential legal weapon to combat alleged misconduct in the health care industry. The government’s enforcement patterns reflect how the AKS is increasingly used in…more

Affordable Care Act, Anti-Kickback Statute, Enforcement, False Claims Act, Healthcare

See All Updates »

Kristina Longo

FTC's Challenge to Phoebe Putney Merger Ends in Settlement Without Divestiture

On August 22, 2013, the FTC accepted, subject to final approval, a Consent Agreement Containing Order from Respondents Phoebe Putney Health System, Inc., Phoebe Putney Memorial Hospital, Inc., Phoebe North, Inc. (collectively…more

Certificate of Need, Competition, Divestiture, FTC, FTC v. Phoebe Putney Health System

See All Updates »

Catherine Martin

CMS Self-referral Disclosure Protocol: 2013 Update and Summary of Settlements

The CMS Self-referral Disclosure Protocol – Background - Under delegated authority, the Centers for Medicare and Medicaid Services (CMS) released its Self-Referral Disclosure Protocol (SRDP) on September 23, 2010, with…more

CMS, Healthcare, Medicaid, Medicare, Patient Self-Referral

See All Updates »

William Mathias

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

Affordable Care Act, CMS, Competitive Bidding, Durable Medical Equipment, Healthcare

See All Updates »

Robert Mazer

Medicare OPPS Lab "Packaging" Policy Raises Bundle of Issues

In previous Payment Matters articles, we described a policy included in the 2014 hospital outpatient prospective payment system (OPPS) final rule that would “package” certain clinical laboratory tests into OPPS, and CMS…more

Clinical Laboratories, CMS, Medicare, OPPS, Pharmaceutical

See All Updates »

Alan Mogol

California Heavy-Duty Vehicle Greenhouse Gas Emission Reduction Regulations

Lessors of tractors or trailers may be subject to California's regulations pertaining to the reduction of greenhouse gas emissions. California's regulations pertain to heavy-duty tractors and 53-foot or longer box-type…more

EPA, Greenhouse Gas Emissions, Pollution Control, Tractor-Trailers

See All Updates »

Christine Morse

Recent Court Decisions Affecting DSH Percentage Calculations May Impact Participation in the 340B Drug Discount Program

A number of recent developments affecting the Disproportionate Share Hospital (DSH) percentage calculation methodologies will likely have significant impact on 340B covered entities. DSH hospitals that participate in the 340B…more

CMS, Covered Entities, Disproportionate Share Adjustments, Healthcare, Hospitals

See All Updates »

Danielle Moskos

CMS to Test New Models of Care for Hospice: Summary of the Medicare Care Choices Model

On March 18, 2014, CMS launched an initiative to “develop innovate payment systems to improve care options for beneficiaries by allowing greater beneficiary access to comfort and rehabilitative care in Medicare and Medicaid.”…more

CMS, Healthcare, Hospice, Medicare

See All Updates »

Aaron Rabinowitz

Conflict of Interest in Research Regulations: Is Your Institution Compliant with the New Rules?

Although the Department of Health and Human Services (HHS) issued the final conflict of interest rule last year, many entities conducting research that is funded under Public Health Service (PHS) grants, cooperative agreements,…more

Compliance, Conflicts of Interest, HHS, Research Funding

See All Updates »

Eric Radz

Mechanic's Lien Waivers: Understand What You Are Waiving

In Maryland and elsewhere, a mechanic’s lien safeguards a contractor’s entitlement to payment on a private project. It is a statutory device that, if properly pursued, provides a contractor a security interest in the real…more

Contractors, General Contractors, Mechanics Lien, Subcontractors, Waivers

See All Updates »

Stuart M. Schabes

FATCA – 2013 and Beyond

Tax lawyer Stuart Schabes co-presented “FATCA – 2013 and Beyond” at The Perfect Storm: US Tax Legislation and IRS Compliance 2013, a program hosted by Philip Stein & Associates and ERM. The discussion included: - FATCA…more

Bilateral Agreements, Compliance, Enforcement, EU, FATCA

See All Updates »

Donna Senft

Ordering and Referring Initiative - Will Phase 2 Begin January 6th?

To complete a two-phase initiative that began in 2009, CMS again announced its intent to implement the Phase 2 claims edits, which would result in claim denials if the ordering or referring physician or nonphysician practitioner…more

See All Updates »

Gina L. Simms

PODCAST: How to Respond to a Search Warrant - Ten Practical Steps

Presented by Gina L. Simms and James P. Holloway of Ober|Kaler's Government Investigations and White Collar Defense Group, this podcast provides guidance to health care providers and other corporations on how to respond when the…more

Law Enforcement, Search & Seizure, Search Warrant

See All Updates »

Steven Smith

Good Governance for General Counsel: What Your Board Needs to Know Now

A host of regulatory and finance reforms have ushered in significant changes for health care entities, and likewise, for the boards that guide them. How can general counsel broach these changes with their boards and steer…more

Affordable Care Act, Board of Directors, Compliance, Conflicts of Interest, Corporate Counsel

See All Updates »

Howard Sollins

Adult Failure to Thrive and Debility Can No Longer Be Principal Diagnoses on Hospice Claim Forms

Hospices will have until October 1, 2014, to ensure they conform their coding practices to comply with a “clarification” issued by the Centers for Medicare and Medicaid Services (CMS) in its final FY2014 Hospice Wage Index and…more

CMS, Compliance, Elder Issues, Healthcare, Hospice

See All Updates »

Mark A. Stanley

CMS to Begin Implementing 25 Percent Threshold for LTCHs

CMS, in its federal fiscal year (FFY) 2014 final rule, has allowed its five-year moratorium on the 25 percent threshold payment adjustment policy to expire. Following the lifting of this moratorium, LTCHs that admit more than 25…more

CMS, Healthcare, Hospitals, Long-Term Care, Payment Plans

See All Updates »

E. John Steren

FTC Formalizes HSR Withdraw and Refile Procedures

The Hart Scott Rodino Act (“HSR”) requires parties to certain mergers and acquisitions meeting specified size thresholds to file pre-merger notification and report forms with the Federal Trade Commission (“FTC”) and the…more

Antitrust Litigation, DOJ, FTC, Hart-Scott-Rodino Act, Healthcare

See All Updates »

Lisa Stevenson

CMS Clarifies IRF Claim Processing

CMS published revisions to the inpatient rehabilitation facility (IRF) section of the Medicare Claims Processing Manual (Chapter 3, Section 140 of Pub. 100-04) in Transmittal 2638 on January 18, 2013. According to CMS, the…more

CMS, IRF Claim Processing, Medicare

See All Updates »

Paul Sugar

Pending Legislation in Maryland Could Eliminate Bid Protest Appeals

On February 24, a bill was introduced in the Maryland House of Delegates which, if passed, will require a bid protester of a state contract to pay to the state up to 5% of the value of the contract on which it protested, if the…more

Appeals, Bid Protests, Bids

See All Updates »

Sarah E. Swank

Foundations in HIPAA - Building Blocks of Health Law

Recent enforcement actions and the new Omnibus Rule implementing several HITECH obligations highlighted the need for a new look at HIPAA obligations for covered entities and now business associates. HITECH not only raised the…more

Enforcement, Healthcare, HIPAA, HIPAA Omnibus Rule, HITECH

See All Updates »

Sanford Teplitzky

OIG Calls PODs "Inherently Suspect"

Making its most strongly worded statement to date, the Department of Health and Human Services Office of Inspector General (OIG) issued a Special Fraud Alert on Physician-Owned Entities on March 26, 2013, calling physician-owned…more

Ambulatory Surgery Centers, Anti-Kickback Statute, Client Referrals, Fraud, Healthcare

See All Updates »

Anthony Vittoria

Certificate of Qualified Expert Not Always Required for Claim Against a Design Firm in Maryland

For over 15 years, Maryland law has required that a party asserting a claim against a design professional – such as an architect or an engineer – for negligence in the rendition of professional services must file a “certificate…more

Expert Testimony, Negligence, Subject Matter Experts

See All Updates »

Emily Wein

OCR Clarifies Permitted Disclosures, Including Mental Health Care

The disclosure of mental health records and other disclosure-related issues tends to be less than clear for providers in their efforts to comply with the federal privacy rules. Such issues relate to appropriate disclosures to…more

Healthcare, HIPAA, Mental Health, Mental Health Parity Rule, OCR

See All Updates »

Barbara Werther

How Sequestration May Impact Government Construction Contracts

Pursuant to the Budget Control Act of 2011, sequestration is the process by which automatic across-the-board spending cuts are being imposed on government programs. Because Congress was unable to reach an agreement by its March…more

Anti-Deficiency Act, Contractors, Federal Funding, Sequestration, Spending Cuts

See All Updates »

James Wieland

OCR Clarifies Permitted Disclosures, Including Mental Health Care

The disclosure of mental health records and other disclosure-related issues tends to be less than clear for providers in their efforts to comply with the federal privacy rules. Such issues relate to appropriate disclosures to…more

Healthcare, HIPAA, Mental Health, Mental Health Parity Rule, OCR

See All Updates »

This profile may constitute attorney advertising. Prior results do not guarantee a similar outcome. Any correspondence with this profile holder does not constitute a client/attorney relationship. Neither the content on this profile nor transmissions between you and the profile holder through this profile are intended to provide legal or other advice or to create an attorney-client relationship.