Health Care Advocacy, Lobbying & Monitoring
Mental Health Parity Legislation Enacted
Health Care
October 23, 2008

Richard L. Arenburg
Armin G. Brecher
Paul F. Concannon
Edmund Emerson III
Jennifer Faucett
Sandra K. Herron
Castles R. Hollis
Bruce F. Howell
Christopher J. Rylands
Steven G. Schaffer
Leah Mendelsohn Stone
Qian "Bonita" Wang

After more than a decade of deliberation and repeated extensions, mental health parity requirements for group health plans became permanent on October 3 as part of the Emergency Economic Stabilization Act (H.R. 1424) (the “Act”). The Act also added additional parity requirements for mental health benefits and requires parity in the treatment of substance use disorder (i.e. substance abuse) benefits as well.



Comparison of Presidential Candidates’ Health Care Proposals
Health Care
September 22, 2008

Cynthia E. Berry
Leah Mendelsohn Stone

As part of their campaigns for the presidency, both Senator McCain and Senator Obama have outlined health care reform proposals that aim to provide access to affordable health care. The candidates’ plans differ on how they would achieve their stated objectives.



New Stark Rules Bring Major Changes - 08/08
Health Care
August 27, 2008

Sandra K. Herron

On August 19, 2008, the Centers for Medicare and Medicaid Services published the latest changes to the Stark Law. The Stark Law regulates the types of arrangements into which physicians may enter. Violations of the Stark Law bring hefty civil fines and penalties.



Expansion of Competitive Bidding Program for Durable Medical Equipment, Prosthetics, Orthotics, and Supplies
Health Care
January 15, 2008

Alan K. Parver
Leah Mendelsohn Stone

The Centers for Medicare & Medicaid Services announced on January 8 the seventy Metropolitan Statistical Areas and eight product categories that will be involved in the second phase of competitive bidding for durable medical equipment, prosthetics, orthotics, and supplies.



HHS Proposes New Authority for Secretary to Overturn or Remand Departmental Appeals Board Decisions
Health Care
January 14, 2008

On December 28, 2007, the U.S. Department of Health and Human Services ("HHS") issued a proposed rule that would grant the Secretary of HHS new authority to overturn or remand certain decisions of the Departmental Appeals Board.



President Signs End-of-Year Healthcare Legislation - 01/08/08
Health Care
January 8, 2008

Steven Stranne

On December 29, 2007, the President signed into law the Medicare, Medicaid and SCHIP Extension Act of 2007. This legislative package made few substantive changes to Medicare, Medicaid or the State Children's Health Insurance Program.



CMS Issues Interim Final Rule Clarifying Definition of Targeted Case Management - 12/12/07
Health Care
December 12, 2007

On December 4, CMS published an interim final rule clarifying the definition of case management and targeted case management (TCM) services for which states may receive Medicaid payment.



CMS Proposes Final Medicare E-Prescribing Standards - 11/27/07
Health Care
November 27, 2007

On November 16, the CMS published a proposed rule to implement final e-prescribing standards for the Medicare Part D program (72 Fed. Reg. 64900). Any prescriber or dispenser who electronically transmits prescription data and certain other information related to a Part D beneficiary will be required to comply with these standards.



House Small Business Committee Holds Hearing on Small Supplier Concerns Over Medicare Competitive Bidding - 11/07/07
Health Care
November 7, 2007

Alan K. Parver

The U.S. House of Representatives Committee on Small Business, Subcommittee on Investigations and Oversight, held a hearing October 31, 2007 about the potential impact of the Medicare competitive bidding program on small providers.



CMS Issues Medicare Hospital Outpatient Prospective Payment System 2008 Final Rule - 11/07/07
Health Care
November 7, 2007

Alan K. Parver

On November 1, 2007, the Centers for Medicare & Medicaid Services (CMS) issued a final rule with comment period updating the hospital Outpatient Prospective Payment System for calendar year 2008.



OIG Finds Some Medicare Drug Plan Web Sites Do Not Meet Federal Requirements - 10/31/07
Health Care
October 31, 2007

Leah Mendelsohn Stone
Steven Stranne

A recently released report by the Department of Health and Human Services Office of Inspector General (OIG) revealed that approximately one-third of the Medicare Part D prescription drug plan sponsors' Internet web sites did not contain all of the content required by the Medicare regulations and that eighty-five percent of the web sites did not comply with Federal requirements for accessibility.



OIG Advisory Opinion Approves Physician On-Call Coverage Payment Arrangement - 10/24/07
Health Care
October 24, 2007

The Office of Inspector General issued an Advisory Opinion on September 27, 2007 announcing its approval of an arrangement in which a nonprofit hospital compensated physicians for emergency department on-call coverage.



House Fails to Override Presidential Veto of SCHIP Legislation - 10/23/07
Health Care
October 23, 2007

Anne B. Camper

On October 18, 2007, the House failed to override a Presidential veto of legislation that would have reauthorized the State Children's Health Insurance (SCHIP) program.



FDA Announces Changes in Drug and Device User Fees; Public Workshop on Cell/Scaffold Product Evaluation
Health Care
October 17, 2007

Announcements from FDA on Device and Drug User Fees; Public Workshop on In-Vitro Analysis of Cell/Scaffold Medical Product



CMS Issues Proposed Rule Limiting Medicaid Payments for Outpatient Hospital Services
Health Care
October 9, 2007

On September 28, the CMS published a proposed rule entitled "Medicaid Program; Clarification of Outpatient Clinic and Hospital Facility Services Definition and Upper Payment Limit" that could have potentially significant effects on Medicaid reimbursement for outpatient hospital services.



CMS Posts Enforcement, Audit and Corrective Action Plan (CAP) Summaries - 10/08/07
Health Care
October 8, 2007

The CMS has posted information regarding agency audit and enforcement initiatives pertaining to Medicare Advantage and Prescription Drug Plan organizations conducted since January of 2006.



CMS Proposes Changes to Medicaid Funding for School-Based Administration and Transportation - 10/08/07
Health Care
October 8, 2007

On September 7, the CMS issued a proposed rule titled "Elimination of Reimbursement Under Medicaid for School Administration Expenditures and Costs Related to Transportation of School-Age Children Between Home and School."



Temporary SCHIP Extension and Health Extenders Package Signed into Law - 10/03/07
Health Care
October 3, 2007

Leah Mendelsohn Stone

On Saturday, September 29th, President Bush signed into law a temporary funding extension of the State Children's Health Insurance Program, as well as a separate bill that will continue several health care programs that were set to expire on September 30th.



CMS Issues Final Rule on Revisit User Fees - 09/26/07
Health Care
September 26, 2007

On September 19, 2007, the Centers for Medicare & Medicaid Services published a final rule establishing "revisit user fees." These fees will be assessed against health care facilities participating in the Medicare program.



Stark II, Phase III: And Still More to Come! - 09/14/07
Health Care
September 14, 2007

Sandra K. Herron

On August 27, 2007, The Centers for Medicare and Medicaid Services (CMS) released the third phase of rulemaking to amend the regulations implementing the Ethics in Patient Referrals Act, commonly known as "Stark." This Phase III Final Rule (Phase III) was published on September 5, 2007 and will become effective 90 days later, on December 5, 2007. In publishing Phase III, CMS both responds to public comments on Phase II and addresses the entire regulatory scheme.



CMS Disapproves New York SCHIP Plan Amendment, Enforcing New Crowd-Out Guidance - 09/11/07
Health Care
September 11, 2007

C. Scott Greene

On September 7, 2007, the Centers for Medicare and Medicaid Services (CMS) disapproved the State of New York's proposed amendment to the State's Children's Health Insurance Program (CHIP) plan, marking the agency's first enforcement action based on noncompliance with the controversial new crowd-out policy issued on August 17, 2007.



CMS Issues Multiple Proposed and Final Rules on Medicare, Medicaid, and SCHIP Compliance and Reimbursement - 09/07/07
Health Care
September 7, 2007

Anne B. Camper

Between August 24 and August 31, 2007, the Centers for Medicare and Medicaid Services (CMS) issued or announced a number of proposed or final rules.



CMS Unveils New SCHIP Enrollment Policy - 08/28/07
Healthcare
August 28, 2007

On August 17, 2007, the Center for Medicaid and State Operations of the CMS issued a letter to State health officials regarding State initiatives to expand enrollment in the State Children's Health Insurance Program.



Congress Passes New Ethics, Lobbying, and Earmark Requirements - 08/20/07
Health Care & Advocacy & Government Relations
August 20, 2007

Cynthia E. Berry

Before recessing for the month of August, the U.S. House of Representatives and the U.S. Senate passed the "Honest Leadership and Open Government Act" (S. 1), which would tighten ethics guidelines, restrict lawmakers' interactions with lobbyists, increase lobbying disclosure, and impose new requirements on earmarking of federal funds.



Eight Circuit Denies Minnesota Appeal of CMS Rejection of Medicaid State Plan Amendment - 08/15/07
Health Care
August 14, 2007

In an opinion filed July 31, 2007, the U.S. Court of Appeals for the Eight Circuit rejected Minnesota's appeal of a Centers for Medicare and Medicaid Services (CMS) decision to deny a state plan amendment as a result of inadequate responses to the agency's increased scrutiny of Medicaid reimbursement and state funding mechanisms.



Proposed Stark Amendment Targets Physician-Owned Hospitals - 08/08/07
Health Care
August 8, 2007

On July 23, 2007, Representative Pete Stark co-sponsored legislation that included a proposed amendment to the Ethics in Patient Self-Referral Statute (the "Stark law"). The proposed amendment is part of the Children's Health and Medicare Protection Act of 2007 and significantly limits an important existing exception to the Stark law prohibition on certain physician referrals to hospitals.



House and Senate Passed SCHIP Bills - 08/07/07
Health Care
August 7, 2007

Leah Mendelsohn Stone

Prior to adjourning for the August recess, the Senate and the House of Representatives passed different bills reauthorizing the State Children's Health Insurance Program (SCHIP). Reconciling these bills in September may be complicated due to the variation in the bills and the issues that they raise.



CMS Document Sheds Light on the New Medicaid World - 07/31/07
Health Care
July 31, 2007

Sandra K. Herron

On July 20, 2007, the Centers for Medicare and Medicaid Services (CMS) Office of Acquisition & Grants Management issued a document that provides vital information to health care providers about what to expect during the coming years of intensified Medicaid review and enforcement.



CMS Says Providers Can Charge for Missed Appointments - 07/18/07
Health Care
July 18, 2007

On June 29, 2007, the Center for Medicaid & Medicare Services ("CMS") implemented a new policy that will allow physicians, providers, and suppliers to charge Medicare beneficiaries for missed appointments.



CMS Issues Final Medicaid Citizenship Documentation Rule - 07/17/07
Health Care
July 17, 2007

On July 13, 2007, the Centers for Medicare and Medicaid Services (CMS) published a final rule on citizenship documentation requirements for Medicaid eligibility.



MedCAC to Review CPAP Diagnostic Criteria - 06/26/07
Health Care
June 26, 2007

MedCAC announces upcoming meeting to discuss testing methods that may be used to support Medicare coverage for CPAP devices.



OIG Withdraws Proposed Rule on Exclusion for Excessive Charges - 06/19/07
Health Care
June 19, 2007

On Monday, June 18, 2007, the OIG of the HHS withdrew a proposed rule that would have clarified its authority to exclude providers from the Medicare and Medicaid programs for submitting claims containing excessive charges, responding to significant concerns raised by the provider community.



Final Rule on Cost Limit for Public Providers and Defining "Public" Status - 05/31/07
Health Care
May 31, 2007

On Friday, May 25, the CMS issued a final version of the Medicaid cost limit regulations proposed in January.



Legislation Introduced to Extend the 340B Drug Discount Program to Inpatient Drugs - 05/24/07
Health Care
May 24, 2007

On May 14, 2007, Senators Jeff Bingaman (D-NM) and John Thune (R-SD) introduced the "340B Program Improvement and Integrity Act of 2007." This bill would extend mandatory drug pricing discounts under the federal 340B program.



CMS Proposes Rule to Eliminate Federal Reimbursement for Medicaid Direct GME Payments - 05/07
Health Care
May 23, 2007

The Centers for Medicaid and Medicare Services issued a proposed regulation to clarify that costs and payments associated with graduate medical education (GME) programs are not eligible for federal financial participation under state Medicaid programs.



IRS Releases Guidance to Assist Tax-Exempt Organization in Completing Form 990 - 05/09/07
Health Care
May 9, 2007

On April 26, 2007, the Tax Exempt and Government Entities Division of the Internal Revenue Service ("IRS") released informal guidance to supplement revised instructions for IRS Form 990 for 2006.



CMS Issues Final Rule for Medicare Competitive Acquisition Program - 04/24/07
Health Care
April 24, 2007

Alan K. Parver

On April 2, 2007, CMS released the final rule implementing the new competitive bidding program for medical equipment, prosthetics, orthotics, and supplies (DMEPOS) as mandated by Congress in the MMA.



OIG Advisory Opinion Concludes Credit Card Rewards Doesn't Violate Anti-Kickback Statute - 04/17/07
Health Care
April 17, 2007

On April 3, the Office of Inspector General ("OIG") posted Advisory Opinion 07-03 in which it determined that a nursing home's utilization of rewards from credit card purchases does not violate the federal Anti-Kickback Statute. 42 U.S.C. § 1320a-7b(b).



Third Circuit Ruling: When Does the Fiduciary Exception to the Attorney-Client Privilege Not Apply? 04/09/07
Health Care
April 10, 2007

Paige Arden Stanley

Under the common-law evidentiary rule known as the "fiduciary exception" to the attorney-client privilege, certain fiduciaries who obtain legal advice during the execution of their fiduciary obligations may not thereafter assert the attorney-client privilege against their beneficiaries.



Fiscal Year 2008 Senate Budget Resolution - 03/21/07
Health Care
March 21, 2007

Alan K. Parver
Leah Mendelsohn Stone

On March 15 the Senate Budget Committee reported its fiscal 2008 budget resolution. The budget resolution contains notable provisions relating to Medicare and the State Children's Health Insurance Program (SCHIP). It also includes funding for Federally Qualified Health Centers.



CMS Withdraws Heightened Restrictions for Independent Diagnostic Testing Facilities - 03/06/07
Health Care
March 6, 2007



NGA Urges Part D Implementation Changes - 02/28/07
Health Care
February 28, 2007

On January 18, 2007, the Centers for Medicare and Medicaid Services (CMS) published a proposed regulation that would dramatically affect payments to public providers and state-Medicaid financing arrangements. Since the regulation was released, opposition to the regulation has been mobilizing.



SCHIP Reauthorization Remains a Top Congressional Priority - 02/13/07
Health Care
February 13, 2007

As lawmakers establish priorities for the 110th Congress, reauthorization of the State Children's Health Insurance Program (SCHIP) is being given top billing.



CMS Manual IDTF Changes - 02/13/07
Health Care
February 13, 2007

On January 26, 2007, the Centers for Medicare and Medicaid Services ("CMS") released modifications to the CMS Medicare Program Integrity Manual, Pub. 100-08 (the "Manual"), which detail CMS' position on carrier and contractor enforcement of new requirements for independent diagnostic testing facilities ("IDTF"s).



President Releases FY 2008 Budget - 02/06/07
Health Care
February 6, 2007

On Monday, President Bush sent his $2.8 trillion fiscal year (FY) budget to Capitol Hill, which preliminary analyses show includes $66 billion in savings from Medicare and $6.8 billion from Medicaid and the State Children's Health Insurance Program (SCHIP).



MRI Lease Agreements: Problems at a State Level - 01/31/07
Health Care
January 31, 2007

Illinois Attorney General Joins Whistleblower Suit Challenging Sham Physician Lease Arrangement



Senate Passes New Ethics, Lobbying, and Earmark Regulations - 01/29/07
Health Care
January 29, 2007

Cynthia E. Berry

After considerable debate, Senate leaders from both parties forged an agreement to pass legislation on January 18 that would tighten ethics guidelines, change lawmakers' relationships with lobbyists, and require stronger regulations regarding earmarks.



CMS Proposes Restrictions on Medicaid Payments to Public Providers and on Financing Arrangements with State Medicaid Programs - 01/23/07
Health Care
January 23, 2007

Anne B. Camper

On January 18, the Centers for Medicare and Medicaid Services published a proposed regulation that would dramatically limit payments to public providers and State Medicaid financing arrangements.



HRSA Proposes Changes to Definition of Patient and Contract Pharmacy Arrangements in the 340B Drug Pricing Program - 01/23/07
Health Care
January 23, 2007

On January 12, 2007, the federal Health Resources and Services Administration (HRSA) published two notices in the Federal Register proposing amended guidelines for the 340B Drug Pricing Program, which allows certain qualified providers (known under the program as "covered entities") access to substantially discounted prices on outpatient drugs.



Legislation Proposed to Restrict DOJ Practices on Waiver of Attorney-Client Privilege - 11/28/06
Health Care
November 28, 2006

R. Joseph Burby, IV

On November 21, 2006, Senator Arlen Specter (R-Pa.) introduced a bill that would prohibit the U.S. Department of Justice ("DOJ") from compelling companies to waive their attorney-client and work product privileges to avoid indictment or otherwise receive credit for cooperating with a federal investigation. Because health care fraud enforcement remains a top priority for the DOJ, the issue of waiver of attorney-client privilege is critical for health care providers because it affects providers' expectations that they can retain the confidentiality of internal investigations conducted by counsel and legal advice on compliance matters.



OIG Finds Medicare Beneficiaries Not Receiving Drug Subsidies - 11/27/06
Health Care
November 27, 2006

Cynthia E. Berry

On Friday, November 17, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) released a report highlighting that low-income Medicare beneficiaries are not receiving the drug subsidies to which they are entitled under the new Medicare drug benefit.



Medicare Finalizes Changes to Outpatient Hospital Payments - 11/07/06
Health Care
November 7, 2006

Cynthia E. Berry

On November 1, CMS released the Medicare Outpatient Prospective Payment System final rule, which describes many of the most significant changes to Medicare hospital outpatient payments in the coming year and is effective for services delivered on or after Jan. 1, 2007. The rule includes a 3.4 percent market basket update for hospital outpatient services as well as a host of other significant updates



Virginia Mason Settles Provider-Based Facility Fee Class Action Suit - 11/07/06
Health Care
November 7, 2006

In January 2005, two patients of Virginia Mason Medical Center filed suit against the healthcare provider seeking recovery of "facility charges" for treatment received at the hospital's downtown outpatient clinic, which is connected to the main hospital.



Fall Elections May Bring Increased Oversight of the Medicare Program - 10/30/06
Health Care
October 30, 2006

Alan K. Parver

Representative Fortney "Pete" Stark, Ranking Minority Member for the House Ways and Means Health Subcommittee recently identified areas in health law and policy that could draw the attention of a Democratically-led Congress.



Recent AHA Report Shows Uncompensated Care Costs Climbing - 10/30/06
Health Care
October 30, 2006

Recent statistics released by the American Hospital Association show that uncompensated care costs for U.S. hospitals continued to rise in 2005.



Congress Fails to Reach Health IT Agreement - 10/10/06
Health Care
October 10, 2006

Lawmakers involved in negotiating the differences between two health information technology (Health IT) bills (H.R. 4157, S. 1418) failed to reach an agreement prior to Congress' recess. The bills may still go to a conference committee if lawmakers can reconcile the differences.



CMS Announces DSH Allotments - 10/10/06
Health Care
October 9, 2006

Last week, CMS announced Medicaid disproportionate share hospital (DSH) allotment levels for states for FY 2005, as well as preliminary allotment levels for FYs 2006 and 2007.



Senate Finance Committee Heightens Pressure on Non-Profit Hospitals Over Charity Care - 09/20/06
Health Care
September 19, 2006

Senate Finance Committee Chairman Charles Grassley (R-Iowa) urged non-profit hospitals to increase the level of charity care they provide to the poor and uninsured, noting in a statement released September 12, 2006, the day before a Senate Finance Committee hearing was to begin, that in exchange for tax breaks, "[t]he public has a right to expect significant, measurable benefits in return." Although Senator Grassley said he was not anticipating legislation relating to the level of charity care provided by non-profit hospitals, he did not rule out such legislation.



MedPAC Discusses the Future of Medicare DSH and IME - 09/18/06
Health Care
September 18, 2006

On September 7 and 8, the Medicare Payment Advisory Commission (MedPAC) met in Washington to discuss the future of Medicare Disproportionate Share Hospital (DSH), Indirect Medical Education payments, and improvements to Medicare physician payments



Medicaid Commission Hears Testimony on Medicaid Financing Issues - 09/08/06
Health Care
September 8, 2006

On September 6 and 7, the Medicaid Commission met in Arlington, Virginia. One of the presentations focused on Medicaid reimbursement, financing issues, and the Bush Administration's budget proposals. The 28-member body, appointed by Department of Health and Human Services ("HHS") Secretary Michael Leavitt, was tasked in 2005 with advising HHS and Congress on ways to reform and modernize the Medicaid program. The Commission is comprised of current and former governors, state Medicaid officials, health policy academics, business leaders, patient advocates, and representatives from the provider community.



Executive Order Requires Health Care Price and Quality Information for Consumers -08/29/06
Health Care
August 29, 2006

On August 22nd, President Bush signed an executive order that requires departments that administer federal health care programs to provide cost and quality information to beneficiaries so that they can compare providers and services.



E-Regulation At Last - 08/29/06
Health Care
August 29, 2006

Sandra K. Herron

On August 8, 2006, the Office of Inspector General of HHS and Centers for Medicare and Medicaid Services published final rules creating a safe harbor to the Anti-kickback Statute and an exception to the Stark law for health information technology. Under the new rules, a hospital, or certain other entity "donors," may donate technology to physicians, or certain other "recipients," that facilitates the implementation of electronic health records and electronic prescribing.



OIG Announces Guidelines for State Medicaid False Claims Laws - 08/29/06
Health Care
August 29, 2006

On August 21st, the OIG issued guidelines for States' Medicaid false claims laws. The Deficit Reduction Act created financial incentives for States to enact laws that establish liability for people or entities that submit false or fraudulent claims to Medicaid programs. In order to qualify for the incentive, the laws must meet specified criteria.



Final CMS Report on Specialty Hospitals Sent to Congress - 08/22/06
Health Care
August 22, 2006

The Centers for Medicare and Medicaid Services (CMS) recently issued a report to Congress on physician investment in specialty hospitals. The report, mandated under the Deficit Reduction Act of 2005, addresses a range of issues relating to specialty hospitals, including investment transparency, Medicare reimbursement, and fraud and abuse.



CMS' Proposed Changes To Medicare Physician Fee Schedule: Implications For Stark II, Reassignment Rules, & IDTFS - 08/22/06
Health Care
August 22, 2006

On June 29, 2006, the Centers for Medicare and Medicaid Services ("CMS") issued a notice in the Federal Register that included proposed revisions to the work relative value units (RVUs) and proposed changes in the methodology for calculating practice expense RVUs. Less than two months later, on August 8, 2006, CMS announced that its release of a proposed rule to "revise payment rates and policies under the Medicare Physician Fee Schedule" (the "Proposed Rule").



CMS Releases Quality Standards for DMEPOS Suppliers - 08/22/06
Health Care
August 22, 2006

Alan K. Parver

On August 14, 2006, the Centers for Medicare and Medicaid Services (CMS) issued quality standards for suppliers of durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS). Read details in our alert.



Congress Examines Emergency Department Use Across the U.S. - 08/16/06
Health Care
August 16, 2006

Leah Mendelsohn Stone

The House Ways and Means Health Subcommittee recently held a hearing on emergency care in response to a report issued by the Institute of Medicine, which found that emergency care faces a growing crisis.



CMS Issues Outpatient Prospective Payment Proposed Rule - 08/15/06
Health Care
August 15, 2006

Leah Mendelsohn Stone

On August 8, CMS issued the proposed rule for the outpatient prospective payment system for calendar year 2007. In the same rule, CMS proposed a revision of payments for ambulatory surgical centers.



OIG Calls For Better Oversight of 340B Program - 7/25/06
Health Care
July 25, 2006

Congress established the 340B Drug Discount Program in 1992 to allow certain providers to receive substantial discounts on outpatient drugs because they serve the nation's poor and uninsured.



Tenet Agrees To Pay $900 Million in Settlement - 07/24/06
Health Care
July 24, 2006

Nearly two months after Tenet Healthcare Corporation ("Tenet") agreed to pay $21 million for illegal kickbacks to physicians and sell Alvarado Medical Center in San Diego, Tenet, the nation's second largest hospital chain, has reached a $900 million dollar settlement with the federal government ending a four-year investigation by the U.S. Justice Department into allegations of unlawful billing practices. Tenet has not admitted any wrongdoing.



OIG Study Results in Decrease in Physician Reimbursement for Five Oncology Procedure Codes - 07/18/06
Health Care
July 18, 2006

The Office of the Inspector General of the Department of Health and Human Services ("OIG") has released its report, "A Comparison of Average Sales Prices to Widely Available Market Prices: Fourth Quarter 2005," detailing the OIG's findings on the prices paid by hematologists and medical oncologists for thirty-nine Medicare Part B prescription drugs.



CMS Issues Guidance On Citizenship Verification Requirements For Medicaid Applicants & Recipients - 06/28/06
Health Care
June 28, 2006

Section 6036 of the Deficit Reduction Act of 2005 ("DRA) requires State Medicaid agencies to verify through documentation the citizenship status of all U.S. citizens receiving Medicaid. The verification provisions take effect July 1, 2006 and states are expected to comply as of that date.



New IRS Independent Contractor Test - 06/08/06
Health Care
June 8, 2006

In January of this year the Internal Revenue Service modified and simplified its test to determine whether an individual is working as an employee or independent contractor for employment tax purposes. This test has also been adopted by the Office of Inspector General and the Centers for Medicare/Medicaid Services for purposes of their bona fide employment safe harbor and exception under the Anti-Kickback Statute and the Physician Self-Referral Law known as the Stark Law.



Problems with Physician Recruitment Agreements: Hospital Avoids Medicare Exclusion - 06/01/06
Health Care
June 1, 2006

On May 17, 2006, Tenet Healthcare Corporation has agreed to divest itself of Alvarado Medical Center ("Alvarado") in San Diego, protecting Alvarado from a possible exclusion from participation in Medicare, Medicaid and all other Federal health care programs.



House Advances Health IT Legislation - 05/30/06
Health Care
May 30, 2006

On May 24, 2006, health information technology (health IT) legislation advanced from the House Ways and Means Health Subcommittee to the full committee. The House Energy and Commerce Health Subcommittee will mark up its own health IT legislation shortly. The Senate already passed a comprehensive health IT bill last December.



Congress Responds to the Enrollment Deadline for Part D - 05/23/06
Health Care
May 23, 2006

Cynthia E. Berry
Alan K. Parver

On May 15th, the enrollment deadline for the Medicare Part D prescription drug benefit went into effect; as a result, individuals with Medicare will not be able to join a plan until the next enrollment period (beginning November 15th) and will be subject to a lifetime financial late-enrollment penalty. Members in both the House and Senate have already introduced bills aimed at mitigating the effect of the deadline on seniors and other vulnerable groups.



IRS Launches New Compliance Audit Initiative Targeting Hospital Bond Issues - 05/16/06
Public Law & Finance
May 16, 2006

Robert C. Lewinson

Do you have outstanding tax-exempt bonds? The IRS recently announced that it was launching a new audit initiative, targeting qualified 501(c)(3) bond issues in general, and hospital bond issues in particular. Audits will focus primarily on post-closing compliance by bond issuers and conduit borrowers - especially focusing on private use, federal research agreements, management contracts and lease arrangements.



PBMs Win Another Battle but the War is Not Over - 05/03/06
Health Care
May 3, 2006

In a positive decision for the pharmacy benefit management industry, the United States District Court for the District of New Jersey recently held that a pharmacy benefits manager ("PBM") is not a fiduciary under the Employee Retirement Income and Security Act of 1974. Recent litigation and legislative trends reveal an increasing tendency to seek to hold PBMs to higher fiduciary duty standards.



Inspector General Issues First Open Letter - 05/03/06
Health Care
May 3, 2006

On April 24, 2006, the Inspector General of the Department of Health and Human Services issued guidance encouraging providers to voluntarily disclose violations of the physician self-referral law and the Anti-Kickback Statute. This guidance is Daniel Levinson's, the Inspector General, first Open Letter to Health Care Providers. This guidance relates his perspectives on compliance, the resolution of health care fraud cases, corporate integrity agreements, and the OIG's Provider Self Disclosure Protocol. This letter also introduces a new voluntary disclosure initiative that supplements prior guidance issued in 1998.



Once Again, Hospital's Unilateral Amendment of Medical Staff Bylaws Prohibited - 05/02/06
Health Care
May 2, 2006

In the wake litigation filed by the Medical staff of the Community Memorial Hospital of San Buenaventura and its ensuing settlement, see http://www.ama-assn.org/ama/pub/category/8102.html, a Florida court has struck down Lawnwood Medical Center's ability to unilaterally amend its Medical Staff bylaws. The Lawnwood case differs from San Buenaventura in that involves a St. Lucie County, Florida hospital governance law.



CMS Releases Proposed DMEPOS Competitive Bidding Rule - 05/02/06
Health Care
May 2, 2006

Alan K. Parver
Steven Stranne

On May 1, the CMS published in the Federal Register a proposed regulation implementing the competitive acquisition program for durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS). The proposed rule already had been published on the CMS website. Comments on the regulation are due by June 30. This summary will focus primarily on the issues associated with the implementation of competitive bidding, although the proposed regulation addresses several other issues as well.



State Legislators & Physicians Scrutinize The Pharmaceutical Industry's Gift-Giving Marketing Tactics - 04/12/06
Healthcare
April 12, 2006

Legislators in several states contemplate stricter regulation of the prescription drug industry's $7.3 billion annual physician marketing campaign with some physician support.



Proposed Rules Expand National Practitioner Data Bank - 04/04/06
Health Care
April 4, 2006

On March 21, 2006 the Department of Health and Human Services ("HHS") released Proposed Rules for the National Physician Data Bank that would incorporate statutory requirements under Section 1921 of the Social Security Act ("Section 1921"). Section 1921 requires states to report to HHS certain adverse licensure actions taken against health care entities as well as health care practitioners.



OIG Issues New Advisory Opinion Addressing Contractual Joint Ventures and Medicare Carve-Outs - 4/04/06
Health Care Client Alert
April 4, 2006

Stacey Godfrey Evans
Shay Zeemer Hable
Robin Heimann
Sandra K. Herron
Stuart C. Johnson
Robert D. Klingler
Robert C. Lewinson
Robert J. Lystad
Robert M.D. Mercer
Ryan T. Pumpian
Steven G. Schaffer
Stephen B. Schrock
Steven Stranne
Robert M. Travis

On March 28, 2006, the Department of Health and Human Services Office of the Inspector General posted a new advisory opinion, No. 06-02, that addresses various areas of interest, including contractual joint ventures, percentage based compensation arrangements and arrangements that try to limit exposure by "carving out" Federal health care program business.



Finally, Nurse Practitioners Authorized to Write Prescriptions - 04/04/06
Health Care
April 4, 2006

On March 27, 2006, legislation that will allow nurse practitioners to write prescriptions for patients left the Georgia State legislature for the Governor's signature. The bill and others like it were stalled in various committees, but lobbyists were successful in tacking on the necessary language to another unrelated nursing measure, Senate Bill 480, as an amendment.



Finally: Proposed Rules For E-Prescribing and EHR - 11/15/05
Health Care
November 15, 2005

This second part of a three-part series on E-Prescribing and Electronic Health Records ("EHR") will address the potential issues that may arise for physicians and physician group practices due to the implementation of the e-prescribing and EHR proposed rules ("Proposed Rules") released by the Health and Human Services' Office of the Inspector General and the Centers for Medicare and Medicaid Services.



Third Circuit Affirms Constitutionality Of HIPAA's "Routine Use" Exception To Disclosure Of Medical Records - 11/14/05
Health Care
November 14, 2005

On October 31, 2005, the Third Circuit Court of Appeals affirmed the decision of the U.S. District Court for the Eastern District of Pennsylvania granting summary judgment to the Secretary of Health and Human Services and holding that the "routine use" exception to HIPAA's medical records privacy rules was not an unconstitutional infringement on patients' privacy rights.



Electronic Medical Records on the Fast Track - 10/10/05
October 10, 2005

This Health Care Update discusses a new series of Health and Human Services regulations that will accelerate the use and the implementation of electronic medical records ("EMR") and electronic prescribing.



Expansive Interpretation of Medicare DSH Formula Adopted by Appeals Board - 10/07/05
Health Care
October 7, 2005

A recent Provider Reimbursement Review Board ("PRRB") decision, Ashtabula County Medical Center v. BCBS (2005-D49), expands the category of patients that are counted for Medicare Disproportionate Share Hospital ("DSH") payment purposes. Contrary to established CMS policy, the PRRB ruled in favor of Ohio providers permitting Medicaid DSH patients to be counted for Medicare DSH purposes. Such a policy change could significantly expand Medicare DSH payments for hospitals that treat a large percentage of uninsured patients.



Federal Court of Appeals Upholds HCQIA Immunity For Suspension of Disruptive Physician - 10/03/05
Health Care
October 3, 2005

Following a growing body of federal court decisions granting immunity to hospitals under the Health Care Quality Improvement Act (HCQIA) for suspension or revocation of physician staff privileges on grounds unrelated to quality of care, on September 12, 2005, the U.S. Court of Appeals for the Third Circuit held that the suspension of a physician's privileges for "unprofessional conduct" falls squarely within the purview of "professional review actions" for which HCQIA provides immunity from damages.



OIG Audits Oncology Practices - 09/19/05
Health Care
September 19, 2005

Under the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, the Office of the Inspector General of the Department of Health and Human Service is required to conduct a study to determine whether physician practices, particularly large practices, in the specialties of hematology, hematology/oncology, and medical oncology are able to purchase drugs at the new reimbursement amounts, which have been set at 106% of the average sales price.



IRS Publishes Propose Rule Identifying Circumstances in Which Tax Exempt Status is at Risk - 09/19/05
Health Care
September 19, 2005

In a climate that is increasingly concerned with organizational accountability, the Internal Revenue Service issued proposed rules to clarify the relationship between the regulations governing tax exempt status and the regulations on sanctions for excess benefit transactions.



Hurricane Response: Government Suspends Certain Healthcare Laws - 9/12/05
Health Care Client Alert
September 12, 2005

Sandra K. Herron

In the wake of what many are calling the greatest disaster in United States history, both the Federal and the Louisiana State governments have suspended the application of certain healthcare laws to the extent necessary, in the words of the Secretary of Health and Human Services, "to ensure that sufficient health care items and services are available to meet the needs of individuals enrolled in Medicare, Medicaid and SCHIP programs, and to ensure that health care providers that furnish such items and services in good faith, but are unable to comply with one or more of these requirements as a result of the effects of Hurricane Katrina, may be reimbursed for such items and services and exempted from sanctions for such noncompliance, absent any determination."



Public Safety and the Clinical Trials Database - 9/12/05
Health Care Client Alert
September 12, 2005

Thanks to the first Vioxx jury verdict and recent controversy over possible links between antidepressants and teen suicide, increased attention is being focused on the accessibility and transparency of prescription drug clinical trial results. Both concerned citizens and legislators have criticized the lack of information and data, particularly with respect to safety and side effects, available on many prescription drugs. Many advocate publicly accessible clinical trials' databases to address this issue.



Action to Allow Importation of Canadian Prescription Drugs Dismissed - 9/12/05
Health Care Client Alert
September 12, 2005

Efforts to allow the importation of Canadian prescription drugs into the United States market were recently hampered by a ruling by a federal district court. On August 26, the United States District Court for the District of Minnesota dismissed an action brought by consumers against a number of American drug companies.



State Malpractice Cap on Noneconomic Damages Applies to EMTALA Claims, Says Sixth Circuit - 9/9/05
Health Care Law Client Alert
September 9, 2005

In an issue of first impression for the U.S. Court of Appeals for the Sixth Circuit, Judge Deborah L. Cook, in Smith v. Botsford General Hospital, 6th Cir., No. 04-1436 (August 18, 2005), held that Michigan's malpractice cap on noneconomic damages applies to Emergency Medical Treatment and Labor Act ("EMTALA") claims.



CMS Issues New Regulations On Power Mobility Devices: DME Suppliers And Physicians To Be Impacted - 09/01/05
Health Care
September 1, 2005

On August 24, CMS issued interim final regulations governing the claims for power mobility devices ("PMD"), including power wheelchairs and power operated vehicles. The regulation, which will go into effect on October 25, 2005, will dramatically change the documentation required to support a claim for a PMD.



CMS Issues First Stark Advisory Opinion Since 1998 - 08/29/05
Health Care
August 29, 2005

The Centers for Medicare and Medicaid Services has issued its first advisory opinion under the Stark law, 42 U.S.C. § 1395nn et seq., since November, 1998.



Recent Study Finds That State Certificate Of Need Laws Are The Optimal Way To Regulate Physician-Owned Specialty Hospitals And Guarantee Ongoing Financial Viability Of Community Hospitals - 08/22/05
Health Care
August 22, 2005

A recent study ("Specialty Versus Community Hospitals: What Role For The Law?") published online by the journal Health Affairs states that the country's market-driven health care system is endangering the financial viability of our general community hospitals.



CMS to Allow Providers to Request Exclusion Waiver Based on Hardship - 08/15/05
Health Care
August 15, 2005

Raquel M. Gayle

On August 4, 2005, the Centers for Medicare and Medicaid Services published a proposed a rule that would allow providers to request a waiver of exclusion from the federal healthcare program based on hardship. Read details on the proposed rule in this Health Care Client Alert. For addition information, please contact Raquel Gayle.



New Patient Safety Law Includes New Challenges for Providers - 08/15/05
Health Care
August 15, 2005

On July 27, after many years of negotiation between the House and Senate, Congress passed patient safety legislation, the Patient Safety and Quality Improvement Act of 2005 (S. 544). The President signed the legislation into law on July 29.



Wisconsin High Court Strikes Down Noneconomic Damage Cap - 08/08/05
Health Care
August 8, 2005

Raquel M. Gayle

In a decision that raises further questions and concerns about the long-term shape of Georgia tort reform, the Wisconsin Supreme Court last week struck down as unconstitutional that state's limit, or "cap," on noneconomic damage awards.



CMS Releases Medicare OPPS Proposed Rule for CY 2006 - 08/08/05
Health Care
August 8, 2005

On July 18, the Centers for Medicare and Medicaid Services ("CMS") released the annual Medicare Outpatient Prospective Payment System proposed rule for the calendar year ("CY") 2006. CMS is accepting comments on the CY 2006 proposed rule until September 16, 2005. Once finalized, the rule will be effective for services furnished on or after January 1, 2006.



Government Scrutiny of Arrangements Between Physicians - 08/08/05
Health Care
August 8, 2005

Turn-key arrangements, where the imaging center "leases" all equipment, personnel and supplies necessary to provide imaging services to a referring physician's patients at the center's facility, are of particular interest to the government.



When "Plain English" Is Not Enough - 8/01/05
Health Care and Labor & Employment Law
August 1, 2005

Marilyn M. Fish
Shay Zeemer Hable
Sandra K. Herron



Proposed Legislation May Provide Inpatient Rehabilitation Facilities Some Relief From The "75% Rule" - 08/01/05
Health Care
August 1, 2005

In response to the Centers for Medicare and Medicaid Services' announcement that it will proceed with the implementation of the "75% Rule," the House and the Senate propose to provide inpatient rehabilitation facilities some relief from the harsh rule by introducing the Preserving Patients Access to Inpatient Rehabilitation Hospitals Act of 2005.



Guidance on Reporting Incidents to OHRP - 07/25/05
Health Care
July 25, 2005

The Office for Human Research Protections ("OHRP"), the agency responsible for overseeing the protection of human subjects participating in research conducted or supported by the Department of Health and Human Services, has issued guidance on reporting incidents to OHRP.



New Bankruptcy Amendments Affect Medicare - 06/17/05
Health Care
June 17, 2005

Wendy L. Hagenau

For most healthcare businesses, Medicare reimbursement is a lifeline. Any termination or interruption in Medicare payments causes severe financial difficulty for the healthcare business.



Patient Care Ombudsman - 06/13/05
Health Care
June 13, 2005

Wendy L. Hagenau

Over the last five to ten years, the number of healthcare businesses filing bankruptcy petitions has greatly increased. The bankruptcy courts found themselves grappling not simply with business issues, but also with issues of patient care. Judges founds themselves sometimes ill-equipped to evaluate whether a business proposal or business strategy would in fact have adverse effects on patient care. As a result, the bankruptcy amendments have added a new section to address the needs of patients when the healthcare business is in bankruptcy.



CMS Issues Final MMA Section 1011 Guidance - 06/10/05
Health Care
June 10, 2005

On May 9, almost 10 months after publishing a proposed implementation notice, the Centers for Medicare and Medicaid Services (CMS) released the final implementation notice for Section 1011 of the Medicare Prescription Drug Improvement and Modernization Act of 2003, which authorizes $250 million each year in federal reimbursement from FYs 2005 through 2008 directly to hospitals, physicians, and ambulance services for the costs associated with providing emergency services to undocumented and other specified immigrants.



CMS Releases New National Coverage Criteria for Mobility Assistive Equipment - 05/16/05
Health Care
May 16, 2005

On May 5, 2005, the Centers for Medicare and Medicaid Services announced new national Medicare coverage criteria for mobility assistive equipment. The policy governs a range of assistive items, from canes, crutches and walkers to power operated wheelchairs.



OIG Demonstrates Increased Willingness to Allow Physician Malpractice Insurance Subsidies - 01/12/05
Health Care
January 12, 2005

The Office of Inspector General of the U.S. Department of Health and Human Services (OIG) is the Federal agency that is charged with enforcing the Federal Medicare/Medicaid Anti-Kickback Statute, which makes it a criminal offense to knowingly and willingly offer, pay, solicit or receive any remuneration for referrals of items or services paid by Federal health care programs. In the past, OIG has expressed a deep distrust of arrangements in which hospitals or other entities subsidize malpractice insurance premiums for physicians. In the agency's view, physicians are potential referral sources and subsidies could be considered payments to influence referrals to hospitals. The OIG's first departure from this position was the creation of a safe harbor for obstetrical malpractice insurance subsidies on November 19, 1999. The safe harbor provision permits hospitals and other entities in rural or urban underserved areas to pay for some or all of the obstetrical malpractice insurance premiums for obstetrical practitioners, including physicians and certified nurse midwives. However, at the time, it was not clear that the agency would allow such subsidies in other areas.



Department of Health and Human Services Task Force Releases Report on Prescription Drug Importation - 12/23/04
December 23, 2004

Cynthia E. Berry

In this edition of the Advocacy & Government Relations Client Alert we discuss the final report (released on December 21) of the Department of Health and Human Services Task Force on Drug Importation. Reiterating that access to safe and affordable prescription drugs is an important policy goal, the Task Force concluded that drug importation would be costly to implement, provide little overall savings and, if not restricted to commercial importation from Canada, could be dangerous to consumers. The Task Force advised that all aspects of achieving safety, quality and cost-effectiveness must be comprehensively examined before imported drugs can be considered safe.



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