Ober|Kaler

100 Light Street
Baltimore, MD 21202, United States

  • 410.685.1120
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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

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Vicarious Liability of Motor Vehicle Lessors in Canada

The equipment finance industry breathed a sigh of relief when Federal legislation was enacted in 2005 preempting state laws imposing vicarious liability on lessors of motor vehicles. That relief may have been premature if the…more

Automotive Industry, Automotive Loans, Canada, Cars, Leases

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FTC's Success in St. Luke's Challenge Shows Litigation Risks to Merging Hospitals and Physicians

In the first fully litigated challenge by the Federal Trade Commission (FTC) to a hospital acquisition of physician practices, a federal district court judge ruled that St. Luke’s Health System’s (St. Luke’s) acquisition of a…more

Antitrust Litigation, FTC, Healthcare, Hospitals, Mergers

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2014 Maryland General Assembly Passes Bills Affecting Construction Industry

A number of bills were passed during the Maryland General Assembly’s 2014 legislative session that will impact certain sectors of the construction industry. Ober|Kaler has put together brief summaries of certain key…more

Construction Contracts, Construction Workers, Contractors, Prevailing Wages, Procurement Guidelines

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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

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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

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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

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AMA Issues Telemedicine Guidelines

On June 11, 2014, the American Medical Association (AMA) released a new set of telemedicine principles, which emerged from its policy report addressing “Coverage and Payment for Telemedicine.” The AMA report details the limited…more

American Medical Association, CMS, Healthcare, Reimbursements, Telemedicine

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Fee Policies for Missed Appointments

Providers may charge for missed appointments, but… Policies for missed-appointment fees must be clear and conspicuously posted, and are best acknowledged in writing by practice patients. However, when charging a Medicare…more

CMS, Disclosure Requirements, Fees, Healthcare, Medicare

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Medicare's LTCH Moratorium - CMS Issues Instructions and Proposed Regulation

From the early 1980s until the end of the first decade of the 21st century, the number of long-term acute care hospitals (LTCHs) expanded many fold. Addressing this growth, Congress, in enacting the Medicare, Medicaid and SCHIP…more

CHIP, CMS, Healthcare, Healthcare Reform, Hospitals

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Jury Verdict Against Millennium Provides Insight on Definition of Remuneration

Ameritox won the latest volley of an ongoing legal battle with Millennium when a federal jury in Florida awarded it $14.75 million on June 16, 2014. Ameritox persuaded the jury that Millennium’s free point of care test (POCT)…more

Anti-Kickback Statute, Kickbacks, Medicaid, Medicare, Remuneration

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Proposed Hospice Rule Focuses on Unbundling of Services

On May 8, CMS released a proposed rule in the Federal Register providing for a payment increase of 1.3 percent for fiscal year (FY) 2015. Among other provisions, CMS’s proposed rule offers hospice providers an update on hospice…more

Bundling Rules, CMS, Healthcare, Hospice, Medicare

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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

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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

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AMA Issues Telemedicine Guidelines

On June 11, 2014, the American Medical Association (AMA) released a new set of telemedicine principles, which emerged from its policy report addressing “Coverage and Payment for Telemedicine.” The AMA report details the limited…more

American Medical Association, CMS, Healthcare, Reimbursements, Telemedicine

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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

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CMS Proposes Relief for HH Face-to-Face and Therapy Reassessment Requirements

In the last issue, we reported on the difficulties faced by home health agencies (HHAs) in complying with the documentation requirements for the face-to-face (F2F) encounter between a patient and a physician before or shortly…more

CMS, Home Health Agencies, Home Health Care, Physician Payments, Physicians

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Pricing Issues Affecting Laboratories

Craig Holden co-presented "New Compliance Red Flags Workshop," a workshop hosted by G2 Intelligence. Over the past five years, the Departments of Justice and Health and Human Services have recovered $19.2 billion from…more

Affordable Care Act, Anti-Kickback Statute, Clinical Laboratories, Compliance, DOJ

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Privilege Upheld for Internal Investigation Preceding False Claims Act Litigation

The D.C. Circuit recently issued an important decision upholding the attorney-client privilege to protect corporate internal investigations. In re: Kellogg Brown & Root, No. 14-5055, 2014 BL 180217 (D.C. Cir. June 27, 2014)…more

Attorney-Client Privilege, False Claims Act, Internal Investigations, Investigations, Kellogg Brown & Root

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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

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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

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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

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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

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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

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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

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OIG Special Fraud Alert Questions Laboratory Payments to Physicians

On June 25, 2014, the Office of the Inspector General (OIG) issued a Special Fraud Alert addressing the issue of remuneration offered and paid by laboratories to referring physicians. The Special Fraud Alert expands upon…more

Clinical Laboratories, Fraud, OIG, Physician Payments, Risk Alert

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United States Supreme Court to Revisit State Action Doctrine

Which exercise of safeguarding the people will prevail: a State’s regulation of professionals providing services to its citizens, or the antitrust agencies’ protection of consumers against anticompetitive conduct? The United…more

Anticompetitive Agreements, Antitrust Litigation, FTC, SCOTUS, State Action Doctrine

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Maryland Waiver Hospitals Subject to New Reporting Requirements for Present on Admission Indicators

Maryland waiver hospitals (those operating under section 1814(b)(3) of the Social Security Act (SSA)) are no longer exempt from present on admission (POA) reporting. CMS Transmittal R1380OTN (Change Request 8709) notifies…more

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OIG Special Fraud Alert Questions Laboratory Payments to Physicians

On June 25, 2014, the Office of the Inspector General (OIG) issued a Special Fraud Alert addressing the issue of remuneration offered and paid by laboratories to referring physicians. The Special Fraud Alert expands upon…more

Clinical Laboratories, Fraud, OIG, Physician Payments, Risk Alert

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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

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Vicarious Liability of Motor Vehicle Lessors in Canada

The equipment finance industry breathed a sigh of relief when Federal legislation was enacted in 2005 preempting state laws imposing vicarious liability on lessors of motor vehicles. That relief may have been premature if the…more

Automotive Industry, Automotive Loans, Canada, Cars, Leases

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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

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Changes Proposed to PRRB Dissatisfaction Requirement

On May 15, 2014, CMS published in the Federal Register its FY 2015 IPPS Proposed Rule [PDF], which included changes and updates to its Medicare IPPS policies. 79 Fed. Reg. 27978-28384. One change that CMS proposes is to amend…more

Affordable Care Act, CMS, Hospitals, IPPS, Jurisdiction

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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

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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

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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: -…more

Bilateral Agreements, Compliance, Enforcement, EU, FATCA

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Fingerprinting Policy Implementation - Risk to Enrollment Status?

In March 2011, when CMS published regulations to implement the Medicare enrollment screening provisions of the Affordable Care Act, the requirement for background fingerprint screening was put on hold. In a recent Special…more

Affordable Care Act, Background Checks, CMS, Fingerprints, Healthcare

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Worthless Services/Substandard Quality of Care Criminal Prosecutions May Be on the Rise

If you are an operator of a skilled nursing facility (SNF), you might have faced the reality of insufficient medical staff and how it impacts your ability to deliver quality patient care to your residents. Or, you might have…more

Criminal Prosecution, Enforcement, Enforcement Actions, Healthcare, Indictments

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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

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CMS Survey Guidance and Amendment to SOM Advance Copy of Revised F371; Interpretive Guidance and Procedures for Sanitary Conditions, Preparation of Eggs in Nursing Homes

On May 20 the Centers for Medicare & Medicaid Services (CMS) issued S&C 14-34-NH devoted to the topic of egg preparation in skilled nursing facilities (SNFs). Lest one think that this is an odd or random topic, it is relevant to…more

CMS, Elder Issues, Healthcare, Medicaid, Medicare

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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

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FTC Defeats Another Hospital Merger

The Federal Trade Commission’s (FTC) recent streak of successfully challenging hospital mergers under section 7 of the Clayton Act (15 U.S.C. § 18) continues. On April 22, 2014, the United States Court of Appeals for the Sixth…more

FTC, Healthcare, Hospital Mergers, Hospitals, ProMedica

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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

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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

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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

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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

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A Primer on Technological Advances in E-Discovery

“E-discovery is pervasive. It’s like understanding civil procedure. You’re not going to be a civil litigator without understanding the rules of civil procedure. Similarly, you’re no longer going to be able to conduct litigation…more

Discovery, e-Discovery, Electronically Stored Information, Professional Development

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"Green" Light For Energy-Efficient Home Construction in Maryland

For those who believe that government programs may provide a stimulating effect on the private economy and promote positive changes in the ways in which we work and live, an enrolled bill, not yet signed into law, coming out of…more

Construction Loans, Energy Efficiency, Minority Business Enterprise Program

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The Self-Referral Disclosure Protocol: Settlement and Enforcement Trends (Presentation)

The Self-referral Disclosure Protocol (SRDP) permits health care providers to voluntarily disclose violations of the federal physician self-referral law, also called the Stark law. Emily Wein has presented a webinar discussing…more

Corporate Integrity Agreement, Healthcare, Healthcare Professionals, Hospitals, Medicaid

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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

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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

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Practice Groups
Areas of Practice
  • Agriculture
  • Alternative Dispute Resolution (ADR)
  • Antitrust & Trade Regulation
  • Appellate Practice
  • Art, Entertainment, & Sports Law
  • Bankruptcy
  • Business Organizations
  • Commercial Law & Contracts
  • Communications & Media Law
  • Construction Law
  • Debtor/Creditor
  • Finance & Banking
  • Government
  • Health
  • Immigration Law
  • Insurance
  • Intellectual Property
  • Labor & Employment Law
  • Litigation
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Locations
Other U.S. Locations
  • D.C.
  • Virginia
Number of Attorneys

100+ Attorneys

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