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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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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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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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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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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CMS Waves Partial White Flag in Appeals of Payment Status Denials

For the last several years, hospitals, on the one hand, and the Centers for Medicare and Medicaid Services and its contractors (collectively, CMS), on the other, have been engaged in a spirited dispute over claims denials for…more

Administrative Appeals, Claims Procedures, CMS, Final Rules, 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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Overview of the FY 2015 IRF Final Rule

On August 6th, the Centers for Medicare and Medicaid (CMS) published an Inpatient Rehabilitation Facility (IRF) final rule [PDF] in the Federal Register outlining (1) new Medicare payment policies and rates; and (2) guidance…more

CMS, Healthcare, Inpatient Quality Reporting, IRF Claim Processing

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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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OMHA Announces Two New Programs to Process Administrative Law Judge (ALJ) Hearings More Efficiently

Earlier this year, the Office of Medicare Hearings and Appeals (OMHA) announced that for most hearing requests received after April 1, 2013, it will be deferring assignment of ALJs. OMHA’s announcement is available on its…more

Administrative Hearings, ALJ, Mediation, OMHA, Statistical Sampling

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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 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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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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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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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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Discount Drug Program Passes OIG Scrutiny

On July 28th, 2014, the Department of Health and Human Services, Office of Inspector General (OIG) released favorable advisory opinion 14-05, concluding that a pharmaceutical manufacturer’s direct-to-patient discounted, cash…more

Anti-Kickback Statute, Civil Monetary Penalty, Drug Manufacturers, HHS, OIG

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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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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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OMHA Announces Two New Programs to Process Administrative Law Judge (ALJ) Hearings More Efficiently

Earlier this year, the Office of Medicare Hearings and Appeals (OMHA) announced that for most hearing requests received after April 1, 2013, it will be deferring assignment of ALJs. OMHA’s announcement is available on its…more

Administrative Hearings, ALJ, Mediation, OMHA, Statistical Sampling

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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 Landlord's Waivers: Five Potential Pitfalls For Landlords to Consider

Tenants, in the course of obtaining financing, often ask their Landlords to sign a Landlord’s Waiver. Landlord’s Waivers are intercreditor agreements for the benefit of the tenant’s lender or equipment lessor, stipulating the…more

Commercial Leases, Landlords, Tenants, Waivers

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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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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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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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The Trend of Stricter State Data Breach Laws Continues with Florida

Florida’s new Florida Information Protection Act, Fl. Stat. § 501.171, became effective July 1, 2014. The new law repeals and replaces Florida’s existing data breach notification requirements (Fl. Stat. § 817.5681) with more…more

Breach Notification Rule, Cybersecurity, Data Breach, FIPA, HIPAA

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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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WEBINAR: Preparing for the HITECH September Deadline - Tips for Negotiating Effective Business Associate Agreements under HIPAA

Business Associate Agreements (BAAs), in the current regulatory and technological environment, require careful review and negotiation of the implementation of the regulatory requirements. In meeting the September 23, 2014 HITECH…more

Business Associates, Contract Negotiations, Healthcare, HIPAA, HITECH

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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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