Ober|Kaler

100 Light Street
Baltimore, MD 21202, United States

  • 410.685.1120
  • 410.547.0699

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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Recent State Attorney General Merger Enforcement: Charting a Different Path from the Feds - or Not?

As hospital and physician consolidation continues, state Attorneys General (AG) have not abdicated the merger enforcement arena to the Federal Trade Commission (FTC) or the United States Department of Justice (DOJ) (collectively…more

Attorney Generals, Consent Order, DOJ, Enforcement, FTC

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Finally - A Different Result for a Government Contractor's Differing Site Condition Claim

For any government contractor that has had a differing site condition claim denied despite relying on a government geotechnical report about the subsurface conditions of the project site, the U.S. Court of Appeals for the…more

Breach of Contract, Construction Contracts, Construction Site, Covenant of Good Faith and Fair Dealing, Delays

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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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New DC Construction Codes Take Effect

Already on the forefront of green building innovation, the District of Columbia has adopted a new set of construction codes that, most notably, includes advanced energy and green construction regulations. On March 26, 2014,…more

Building Standards, Construction Contracts, Green Buildings

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Specialty Pharmacy Per-fill Fee Rejected by OIG

On August 15, 2014, the U.S. Department of Health & Human Services, Office of Inspector General (OIG) issued a “negative” opinion regarding a specialty pharmacy’s proposal to pay a per-fill fee to local pharmacies for support…more

Anti-Kickback Statute, Fraud and Abuse, HHS, OIG, Patient Referrals

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Highlights of OIG's Proposal to Amend Safe Harbors to the Antikickback Statute and CMP Rules, and to Add New Safe Harbors

On October 3, 2014, the Department of Health and Human Services Office of Inspector General (OIG) issued a proposed rule to establish new safe harbors under the antikickback statute and the civil monetary penalty (CMP) rules,…more

Affordable Care Act, Ambulance Providers, Anti-Kickback Statute, CMP Law, Cost-Sharing

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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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Providers Challenge CMS's Non-Hospital Rotation Rules for GME and IME

Prior to the enactment of the Affordable Care Act (ACA), CMS required hospitals to comply with a number of exacting payment and documentation rules in order to include as part of their graduate medical education (GME) and…more

Affordable Care Act, Healthcare, Healthcare Reform, Hospitals

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Maryland Court of Appeals Limits Right to Appeal Denial of Petition to Compel Arbitration

Private construction contracts routinely include arbitration clauses to ensure that disputes that arise from a project are resolved by a technically skilled arbitrator. Questions may arise, however, about whether an arbitration…more

Arbitration Agreements, Construction Contracts, Contractors, Final Judgment, Motion to Compel

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Veterans Access, Choice, and Accountability Act May Result in More Patients for Medicare Providers

The President signed the Veterans Access, Choice, and Accountability Act of 2014 [PDF] on August 7, 2014 (the “Act”). Ordinarily, the Department of Veterans Affairs (VA) provides medical care to veterans at Veterans Health…more

Department of Veterans Affairs, Healthcare, Medicare, Veterans, Veterans Administration

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What Employers Need to Know - Requests for Medical Information and the Genetic Information Nondiscrimination Act: Avoiding a Hidden Pitfall

The Genetic Information Non-discrimination Act took effect in November 2009. It should also be noted that many States, including Maryland, have separate statutes prohibiting the acquisition of genetic information and…more

Discrimination, EEOC, Employer Liability Issues, Genetic Materials, Genetic Testing

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CMS Releases New, Proposed Home Health Conditions of Participation

CMS published a proposed rule on Thursday, October 9th, 2014, updating the Home Health Agency (HHA) Conditions of Participation (CoPs). The proposed rule represents the first update to the HHA CoPs since 1989. Comments are due…more

CMS, Healthcare, Home Health Agencies, Medicare Participation Standards, Proposed Standards

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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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New DC Construction Codes Take Effect

Already on the forefront of green building innovation, the District of Columbia has adopted a new set of construction codes that, most notably, includes advanced energy and green construction regulations. On March 26, 2014,…more

Building Standards, Construction Contracts, Green Buildings

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CMS Releases New, Proposed Home Health Conditions of Participation

CMS published a proposed rule on Thursday, October 9th, 2014, updating the Home Health Agency (HHA) Conditions of Participation (CoPs). The proposed rule represents the first update to the HHA CoPs since 1989. Comments are due…more

CMS, Healthcare, Home Health Agencies, Medicare Participation Standards, Proposed Standards

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Small Business Securities Bulletin: Recent SEC Enforcement Actions Impact Compliance Landscape

There was not a lot of Securities and Exchange Commission (SEC) activity this past Spring and Summer that was directly relevant to most small and medium-sized SEC reporting companies, with the SEC focusing on credit ratings and…more

Compliance, Enforcement, Enforcement Actions, SEC, Small Business

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CMS Retracts Hospice Preauthorization Requirements for Part D Drugs

On July 18, CMS released new guidance retracting a major portion of its controversial preauthorization requirement for hospice beneficiaries. The new guidance supersedes portions of the March 10, 2014 guidance [PDF] that…more

CMS, Healthcare, Hospice, Medicare, Medicare Part D

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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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Provider Waives Attorney-Client Privilege in Qui Tam Case by Asserting Compliance with Law

A federal district court recently rejected a health care provider’s claim of attorney-client privilege and ordered the provider to produce written communications with its lawyers regarding the provider’s compliance with the…more

Anti-Kickback Statute, Attorney-Client Privilege, False Claims Act, Health Care Providers, Qui Tam

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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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Specialty Pharmacy Per-fill Fee Rejected by OIG

On August 15, 2014, the U.S. Department of Health & Human Services, Office of Inspector General (OIG) issued a “negative” opinion regarding a specialty pharmacy’s proposal to pay a per-fill fee to local pharmacies for support…more

Anti-Kickback Statute, Fraud and Abuse, HHS, OIG, Patient Referrals

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Audits and Appeals: A Routine Cost of Doing Business with Medicare

The Centers for Medicare and Medicaid Services has unleashed an alphabet of auditors to identify overpayments. These auditors are armed with the authority to conduct pre-payment reviews, and post-payment audits, as well as…more

Auditors, CMS, Medicare, Medicare Appeals Council, Webinar

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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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Highlights of OIG's Proposal to Amend Safe Harbors to the Antikickback Statute and CMP Rules, and to Add New Safe Harbors

On October 3, 2014, the Department of Health and Human Services Office of Inspector General (OIG) issued a proposed rule to establish new safe harbors under the antikickback statute and the civil monetary penalty (CMP) rules,…more

Affordable Care Act, Ambulance Providers, Anti-Kickback Statute, CMP Law, Cost-Sharing

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OIG Warns About Risk of Drug Coupons, But Offers No Solution

On September 18, 2014, the OIG simultaneously issued a Report [PDF] and Special Advisory Bulletin [PDF] warning about the potential fraud and abuse risks posed by coupons offered by pharmaceutical manufacturers when those…more

Co-payments, Fraud and Abuse, Medicare Part D, OIG, Pharmaceutical Manufacturers

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Laboratory Discount Arrangements Survive Antikickback Statute Scrutiny

There has been question for some time whether in evaluating certain discount arrangements involving clinical laboratory tests under the federal antikickback statute (FAS), discount charges should be measured against the…more

Anti-Kickback Statute, Clinical Laboratories, Fair Market Value, Laboratories

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New Baltimore City Law Limits Employee Criminal Record Checks: How Health Care Employers Are Affected

Effective August 13, 2014, certain Baltimore City employers will be restricted from asking applicants and employees about their criminal history. However, many health care employers will be exempt from this new law either…more

Assisted Living Facility, Background Checks, Ban the Box, Criminal Background Checks, EEOC

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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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New Federal Health Care Facility Regulations Could Mean More Construction Work

On April 16, 2014, the Centers for Medicare & Medicaid Services (CMS), an agency of the U.S. Department of Health and Human Services, published proposed rules that would amend the fire safety standards for hospitals, long-term…more

CMS, Construction Contracts, Construction Workers, Contractors, Healthcare

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Highlights of OIG's Proposal to Amend Safe Harbors to the Antikickback Statute and CMP Rules, and to Add New Safe Harbors

On October 3, 2014, the Department of Health and Human Services Office of Inspector General (OIG) issued a proposed rule to establish new safe harbors under the antikickback statute and the civil monetary penalty (CMP) rules,…more

Affordable Care Act, Ambulance Providers, Anti-Kickback Statute, CMP Law, Cost-Sharing

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Medigap Policy Contract with Preferred Hospital Networks Approved by OIG

On August 18, 2014, the U.S. Department of Health & Human Services, Office of Inspector General (OIG) issued another advisory opinion approving a licensed insurance broker’s proposal to establish a preferred hospital network as…more

Healthcare, Hospitals, Medicare, Medigap, OIG

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New Baltimore City Law Limits Employee Criminal Record Checks: How Health Care Employers Are Affected

Effective August 13, 2014, certain Baltimore City employers will be restricted from asking applicants and employees about their criminal history. However, many health care employers will be exempt from this new law either…more

Assisted Living Facility, Background Checks, Ban the Box, Criminal Background Checks, EEOC

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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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Recently Signed Executive Order Imposes New Restrictions on Federal Contractors

On July 31, 2014, President Obama signed an executive order that requires federal contractors to disclose any labor violations committed by their companies during the previous three years. Per the executive order, a company…more

Contractors, Employee Rights, Executive Orders, Fair Pay and Safe Workplaces, Federal Contractors

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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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A Landlord's Guide to Sublease Consents: There's More to It Than "Yes" or "No"

When a tenant asks its landlord to consent to a sublease the Landlord will rightly focus first on business concerns. Who is the subtenant? What is its financial condition? What will it do in the leased premises? Will it fit in…more

Landlords, Leases, Subletting, Tenants

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"Negligent Lending" - Is the Pendulum Swinging Back?

Following on the heels of the financial crisis, those of us who regularly represent lenders in workouts and enforcement actions have seen an uptick in so-called “negligent lending” cases – lender liability lawsuits where…more

Lending, Loans, Negligence

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New Clarifications Affect Physician and Hospital Medicare Part B Billing for Services Provided by Nursing and Other Staff "Incident to" Physician's Services

CMS recently released rules changing the requirements for Medicare coverage of services furnished incident to a physician’s, NP’s, or PA’s services. Howard Sollins, Donna Senft and Susan Turner explain the effect of the changes…more

CMS, Healthcare, Medicare, Medicare Part B, New Regulations

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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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New Clarifications Affect Physician and Hospital Medicare Part B Billing for Services Provided by Nursing and Other Staff "Incident to" Physician's Services

CMS recently released rules changing the requirements for Medicare coverage of services furnished incident to a physician’s, NP’s, or PA’s services. Howard Sollins, Donna Senft and Susan Turner explain the effect of the changes…more

CMS, Healthcare, Medicare, Medicare Part B, New Regulations

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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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More Turns in the FTC's Antitrust Enforcement Action Against Phoebe Putney Hospital, Inc.

The FTC’s long-running campaign against Phoebe Putney Health System, Inc.’s acquisition of Palmyra Park Hospital, Inc., continues. In an unusual sequence of events, the Commission first conditionally accepted a Consent Agreement…more

Antitrust Litigation, Certificate of Need, Divestiture, Enforcement, FTC

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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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New Clarifications Affect Physician and Hospital Medicare Part B Billing for Services Provided by Nursing and Other Staff "Incident to" Physician's Services

CMS recently released rules changing the requirements for Medicare coverage of services furnished incident to a physician’s, NP’s, or PA’s services. Howard Sollins, Donna Senft and Susan Turner explain the effect of the changes…more

CMS, Healthcare, Medicare, Medicare Part B, New Regulations

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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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Think You Are Covered By An Additional Insured Endorsement? Recent Opinion Serves as a Reminder to Read the Coverage Language

The United States Court of Appeals for the Fifth Circuit issued an opinion this month that should serve as a reminder to prime contractors to review the coverage granted to them as additional insureds on their subcontractors’…more

Additional Insured Endorsements, Commercial General Liability Policies, Construction Defects, Contractors, Due Diligence

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Audits and Appeals: A Routine Cost of Doing Business with Medicare

The Centers for Medicare and Medicaid Services has unleashed an alphabet of auditors to identify overpayments. These auditors are armed with the authority to conduct pre-payment reviews, and post-payment audits, as well as…more

Auditors, CMS, Medicare, Medicare Appeals Council, Webinar

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Finally - A Different Result for a Government Contractor's Differing Site Condition Claim

For any government contractor that has had a differing site condition claim denied despite relying on a government geotechnical report about the subsurface conditions of the project site, the U.S. Court of Appeals for the…more

Breach of Contract, Construction Contracts, Construction Site, Covenant of Good Faith and Fair Dealing, Delays

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A New Sheriff in Town: Federal Trade Commission Enforcement of Medical Information Security

A recent court decision found that the Federal Trade Commission (FTC) has authority to enforce the requirements for security of Protected Health Information, or PHI, as defined under the Health Information Portability and…more

Data Protection, EHR, FTC, Healthcare, LabMD

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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
See more
Locations
Other U.S. Locations
  • D.C.
  • Virginia
Number of Attorneys

100+ Attorneys

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