Tag Archives: health reform

New Regulations Implement Health Reform’s Enforcement Tools: Providers and Suppliers in Focus

by George B. Breen, Carrie Valiant, Emily E. Bajcsi, Anjali N.C. Downs, and Amy F. Lerman

On February 2, 2011, the Centers for Medicare and Medicaid Services (“CMS”) published new rules (“Final Rule”) authorized by the Affordable Care Act (“ACA”) creating a vigorous screening process for new and existing Medicare, Medicaid and the Children’s Health Insurance Program (“CHIP”) providers and suppliers; giving CMS authority to temporarily stop enrollment of new providers and suppliers; expanding the ability of CMS and States to temporarily suspend payments to providers and suppliers; establishing requirements for States to terminate providers from the Medicaid and CHIP programs; and adding several other enrollment-related provisions. Generally, the new rules are effective March 25, 2011.

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HEALTH REFORM: New Regulations Implement Health Reform’s Enforcement Tools: Providers and Suppliers in Focus

On February 2, 2011, the Centers for Medicare and Medicaid Services (“CMS”) published new rules (“Final Rule”)[1] authorized by the Affordable Care Act (“ACA”)[2] creating a vigorous screening process for new and existing Medicare, Medicaid and the Children’s Health Insurance Program (“CHIP”) providers and suppliers; giving CMS authority to temporarily stop enrollment of new providers and suppliers; expanding the ability of CMS and States to temporarily suspend payments to providers and suppliers; establishing requirements for States to terminate providers from the Medicaid and CHIP programs; and adding several other enrollment-related provisions. Generally, the new rules are effective March 25, 2011.

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CMS Publishes Solicitation for Industry Comment on RAC Program Expansion to Medicare Part C and Part D: Plans and Their Contracted Providers Should Consider Submitting Comments by 2/25/11 Deadline

On Monday, December 27, 2010, the Centers for Medicare & Medicaid Services (“CMS”) published a solicitation for public comments (“Solicitation for Comments”) regarding the expected implementation of the Recovery Audit Contractor (“RAC”) program to the Medicare Part C and Part D programs. 75 Fed. Reg. 81278 (Dec. 27, 2010). RAC auditing has been underway in the Medicare fee-for-service (“Medicare FFS”) program. CMS is now expanding RAC audits beyond Medicare Parts A and B to include Parts C and D as well, as authorized by the Affordable Care Act (“ACA” a/k/a “Health Reform”).[1] The Solicitation for Comments requests industry feedback on several key issues arising under the pending RAC program expansion. Comments are due by February 25, 2011. Managed care organizations (“MCOs”) that contract with CMS to operate Medicare Advantage (“MA”) and Medicare Part D Prescription Drug program lines of business – as well as their contracted providers and Part D pharmacies – are well-advised to submit comments to CMS to help inform the government as to the issues surrounding the expansion of the RAC audit program to the MA and Part D programs.

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CMS Proposes to Withdraw Regulations on Average Manufacturer Price Determination, Multiple Source Drug Definition, and Medicaid Federal Upper Limits

by Wendy C. Goldstein, Kathleen A. Peterson, Benjamin S. Martin, and Constance A. Wilkinson

On September 3, 2010, the Centers for Medicare & Medicaid Services (“CMS”) issued a proposed rule withdrawing regulations governing the determination of “Average Manufacturer Price” (“AMP”), the definition of “Multiple Source Drug,” and the application of federal upper reimbursement limits (“FULs”) for Multiple Source Drugs (the “Proposed Rule”). This withdrawal would impact the applicable regulations finalized by CMS in 2007 and 2008 but would leave intact other sections of the 2007 regulations, including, for example, the “Best Price” provisions and certain “definitions” (including the definition of “bona fide service fee”). Comments may be submitted to CMS until 5:00 p.m. EDT on October 4, 2010. We recommend that organizations consider commenting on the impact of the withdrawn regulations, as well as on the open items that have not been addressed under the recent “health reform” legislation. 

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HEALTH REFORM: CMS Proposes to Withdraw Regulations on Average Manufacturer Price Determination, Multiple Source Drug Definition, and Medicaid Federal Upper Limits

On September 3, 2010, the Centers for Medicare & Medicaid Services (“CMS”) issued a proposed rule withdrawing regulations governing the determination of “Average Manufacturer Price” (“AMP”), the definition of “Multiple Source Drug,” and the application of federal upper reimbursement limits (“FULs”) for Multiple Source Drugs (the “Proposed Rule”).[1] This withdrawal would impact the applicable regulations finalized by CMS in 2007 and 2008[2] but would leave intact other sections of the 2007 regulations, including, for example, the “Best Price” provisions and certain “definitions” (including the definition of “bona fide service fee”). Comments may be submitted to CMS until 5:00 p.m. EDT on October 4, 2010. We recommend that organizations consider commenting on the impact of the withdrawn regulations, as well as on the open items that have not been addressed under the recent “health reform” legislation.

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PPACA Amends Rehabilitation Act to Mandate Standards for Medical Diagnostic Equipment to Accommodate Individuals with Disabilities

by Shawn Gilman and Frank C. Morris, Jr.

A little-noticed provision of the Patient Protection and Affordable Care Act (PPACA) will significantly impact both health care manufacturers and providers.  The provision amends the Rehabilitation Act of 1973 to require regulations by March 23, 2012, mandating that all medical diagnostic equipment and health care provider locations be able to accommodate the needs of individuals with disabilities.  This requirement would mean a redesign of both diagnostic equipment and locations for patient interactions to assure that individuals with disabilities who could not utilize currently available diagnostic equipment or provider locations will, in the future, have access to the care and services available to individuals without disabilities.  They must be able to have access to—and independently be able to enter, use, and exit—the equipment to the maximum extent possible.  This is significant because of the often high cost of diagnostic equipment and space requirements at provider locations.

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HEALTH REFORM: PPACA Amends Rehabilitation Act to Mandate Standards for Medical Diagnostic Equipment to Accommodate Individuals with Disabilities

The Patient Protection and Affordable Care Act (“PPACA”) contains a provision that will significantly affect all types of health care manufacturers and providers.[1] Section 4203 of PPACA amends Title V of the Rehabilitation Act of 1973 (“Rehab Act”) by adding a new section that requires the Architectural and Transportation Barriers Compliance Board (“ATBCB”), in consultation with the Food and Drug Administration (“FDA”) Commissioner, to promulgate regulatory standards for medical diagnostic equipment used in physician offices, clinics, emergency rooms, hospitals, and other medical settings to accommodate the needs of individuals with disabilities. Particularly, the standards are intended to ensure that individuals with disabilities (a) have access to and use of the equipment, and (b) will independently be able to enter, use, and exit the equipment to the maximum extent possible. The medical diagnostic equipment explicitly mentioned in this provision includes examination tables and chairs, weight scales, and radiological equipment.

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HEALTH REFORM: New Regulations Implement Dependent Child Medical Coverage to Age 26

The Patient Protection and Affordable Care Act1 and Health Care and Education Reconciliation Act2 (together, the “Act”) added the requirement that group health plans that cover dependents now cover them through the age of 26. In the first joint guidance issued from all three of the responsible government agencies, Interim Final Rules (the “Regulations”)3 have clarified and applied the requirement. However, employers may be surprised by some of the details added by the Regulations.

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HEALTH REFORM: CMS Issues Draft Medicare Part D Coverage Gap Discount Program Guidance: Comments Due May 14, 2010

On April 30, 2010, the Centers for Medicare & Medicaid Services (“CMS”) issued a memorandum to all Medicare Part D Plan Sponsors outlining its draft guidance to implement the Medicare Coverage Gap Discount Program, beginning in 2011 (“Draft CGDP Guidance”). CMS will be accepting comments on the Draft CGDP Guidance via e-mail through May 14, 2010.

The Draft CGDP Guidance seeks to implement Section 3301 of the Patient Protection and Affordable Care Act (H.R. 3590) enacted on March 23, 2010, as amended by Section 1101 of the Health Care and Education Reconciliation Act of 2010 (H.R. 4872) enacted on March 30, 2010 (collectively, “PPACA”), otherwise known as the “Health Reform” law. The Part D Coverage Gap Discount Program and the Draft CGDP Guidance affect Part D Plans, drug manufacturers of Part D products, pharmacies, PBMs and all other companies and vendors involved in the chain of arrangements required to support the Part D program. We encourage all companies with Part D business and that contract to provide services to, or for the benefit of, Part D Plans to review the Draft CGDP Guidance and consider submitting comments to CMS by the May 14 deadline.

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HEALTH REFORM: Health Care Reform Increases Employer Exposure to Claims, Penalties and Litigations

The Patient Protection and Affordable Care Act as amended by the Health Care and Education Reconciliation Act of 2010 (the “Act”) implements significant changes to the provision of health care and health coverage applicable to all aspects of health care delivery, operation and administration. The Act imposes many different requirements on employers that become effective over time. These requirements are discussed in more detail in our Client Alert of April 8, 2010, entitled “Health Care Reform: What Employers Need to Know.” 

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