February 18, 2016
In February 2012, two years after the passage of the Affordable Care Act (“ACA”), the Centers for Medicare & Medicaid Services (“CMS”) issued a proposed rule, which was subject to significant public comment, concerning reporting and returning certain Medicare overpayments (“Proposed Rule”). On February 12, 2016, four years from the issuance of the Proposed Rule (and six years after passage of the ACA), CMS issued the final rule, which becomes effective on March 14, 2016 (“A and B Final Rule”).
The A and B Final Rule applies only to providers and suppliers under Medicare Parts A and B. The return of overpayments under Medicare Parts C and D are addressed in a final rule that was published by CMS in May 2014 (“C and D Final Rule”). To date, no final regulations have been adopted that address Medicaid requirements.
December 15, 2011
On December 14, 2011, the Centers for Medicare & Medicaid Services (“CMS”) issued long-awaited proposed rules with a lengthy preamble (collectively referred to herein as “Proposed Rules”) relevant to Section 6002 of the Patient Protection and Affordable Care Act, also known as the Physician Payment Sunshine Act. The Proposed Rules, along with sample reporting templates, are available athttps://s3.amazonaws.com/public-inspection.federalregister.gov/2011-32244.pdf.
Generally, the Physician Payment Sunshine Act requires applicable pharmaceutical, medical device, biological and medical supply manufacturers to report annually certain information to CMS regarding “payments and transfers of value” provided to “covered recipients.” The Physician Payment Sunshine Act also requires manufacturers and group purchasing organizations (“GPOs”) to report annually certain information to CMS regarding “ownership or investment interests” held by physicians and their immediate family members. The first report is due March 31, 2013. For an overview of the Physician Payment Sunshine Act, see the Epstein Becker Green health reform alert entitled “Federal Transparency Is Now a Reality: Challenges and Opportunities for Pharma, Devices, and PBMs.”
October 26, 2011
On October 20, 2011, the Centers for Medicare & Medicaid Services (“CMS”) released its final rule (“Final Rule”) implementing the voluntary Medicare Shared Savings Program (“Program”) for accountable care organizations (“ACOs”). The Program was established by Section 3022 of the Patient Protection and Affordable Care Act. The Final Rule was released in conjunction with revised antitrust guidance from the Federal Trade Commission (“FTC”) and the Department of Justice (“DOJ”), as well as with the establishment by CMS and the Department of Health and Human Services’ Office of Inspector General (“OIG”) of several waivers from various fraud and abuse laws. As part of this interagency effort to facilitate participation in the Program, the Internal Revenue Service (“IRS”) also issued a fact sheet regarding nonprofit organizations’ participation in ACOs.
Click here to download the entire alert in PDF format.
July 18, 2011
CMS proposes retraction of physician signature requirement for lab requisitions
The Centers for Medicare & Medicaid Services (CMS) published a proposed rule in the Federal Register on June 30, 2011, that would retract the CMS policy requiring that requisitions for clinical diagnostic laboratory tests be signed by a physician or non-physician practitioner (NPP). This signature requirement had been scheduled to take effect on January 1, 2011, but enforcement had been postponed. This requirement and the proposed change are discussed below.
June 26, 2011
Medicare Reimbursement for Beneficiaries with Permanent Pacemakers
By: Elizabeth Sullivan
The Centers for Medicare & Medicaid Services (CMS) have proposed modifying the current National Coverage Determination Manual to cover reimbursement for MRIs performed on Medicare beneficiaries with permanent pacemakers.
In its Proposed Decision Memo for Magnetic Resonance Imaging (MRI) (CAG – 00399R3) (“Memorandum”), CMS issued the statement that “evidence is adequate to conclude that magnetic resonance imaging (MRI) improves health outcomes for Medicare beneficiaries with implanted permanent pacemakers when . . . used according to the FDA-approved labeling for use in an MRI environment.”
April 6, 2011
On March 31, 2011, the Centers for Medicare & Medicaid Services (“CMS”) released for public comment a much-anticipated Notice of Proposed Rulemaking implementing the voluntary Medicare Shared Savings Program (the “Program”) for accountable care organizations (ACOs). Also on March 31, the Office of Inspector General, along with CMS, released a Notice with Comment Period to solicit comments regarding proposed waivers from the federal health care program fraud and abuse laws for provider payments made in connection with the Program. On the same day, the Federal Trade Commission and the Department of Justice issued a Notice with Comment Period soliciting comments regarding a “Proposed Statement of Antitrust Enforcement Policy Regarding Accountable Care Organizations Participating in the Medicare Shared Savings Program,” and the Internal Revenue Service issued a notice outlining its analysis of tax-exempt organization participation in Medicare ACOs.
September 28, 2010
On September 17, 2010, the Centers for Medicare & Medicaid Services (“CMS”) and the U.S. Food and Drug Administration (“FDA”) issued a notice in the Federal Register requesting public comment on a proposed new program referred to as “parallel review” (“Comment Request”). This program would give drug and device sponsors the option of receiving an FDA premarket evaluation and a Medicare National Coverage Determination at the same time. By reducing the waiting times associated with CMS and FDA product evaluations and decreasing the likelihood that product sponsors will have to conduct separate clinical studies for each agency, CMS and FDA believe that parallel review will hasten consumer access to new innovative products and minimize the burden that FDA reviews and Medicare National Coverage Determinations impose on drug and device sponsors. These changes will not only affect parties who are interested in drug and device innovation, but providers, payers, and health care consumers as well.
September 13, 2010
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.