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Focus on Regulation

Tag Archives: CMS

Trump touts “historic” plan to overhaul Medicare payments, create International Pricing Index

President Trump today touted “bold” plans to lower drug prices in unspecific terms.  Simultaneously, CMS issued an Advance Notice of Proposed Rulemaking (ANRPM), describing options to test Medicare reimbursement based on an “International Pricing Index” (IPI), under which U.S. drug prices would be benchmarked against 16 other countries that reportedly have lower drug prices.  This

CMS proposes requiring drug prices in TV ads

On October 15, CMS released a proposed rule titled “Medicare and Medicaid Programs: Drug Pricing Transparency,” which would require direct-to-consumer (DTC) advertisements for prescription drugs covered by Medicare or Medicaid to include the Wholesale Acquisition Cost (WAC).  This proposed rule resembles a rejected Senate amendment to the FY-2019 Labor-HHS-Education appropriations bill (analyzed here) that would

U.S. Senate passes bill requiring prescription drug ads to include prices (updated)

Update (9/18/2018): Last week, as the U.S. House of Representatives was reconciling its spending bill for the Health and Human Services Department (HHS) with the amendment package passed by the U.S. Senate that is discussed below, House Republicans declined to adopt S.Amdt. 3964, which would have provided HHS with $1 million to issue rules requiring pharmaceutical companies to list prices

“Double Dip” Effectively Approved by Center for Medicare and Medicaid Services

Last week the Centers for Medicare and Medicaid Services (CMS) issued Release No. 104 to Manufacturers and Release No. 180, which invalidated earlier agency releases addressing the treatment under the Medicaid drug rebate program of Federal Supply Schedule (FSS) purchases by Indian Health Service (IHS) facilities.

FDA and CMS Make Case Before Congress for FDA Oversight of Laboratory Developed Tests

On November 17, 2015, leaders from both the Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS) testified before the U.S. House of Representatives Committee on Energy and Commerce, Subcommittee on Health regarding regulation of Laboratory Developed Tests, or LDTs. Read More: FDA and CMS Make Case Before Congress for

CMS Releases Consumer Assistance Programs Final Rule

The Centers for Medicare & Medicaid Services (CMS) released a final rule on Friday, July 12th imposing requirements on various consumer assistance programs available to enrollees in Federally-Facilitated Exchanges (FFEs), State Partnership Exchanges, and to a more limited extent, State-run Exchanges. The final rule adopted conflict-of-interest, training and certification, and meaningful access standards applicable to

CMS Posts New Open Payments FAQs

The Centers for Medicare and Medicaid Services (CMS) recently released nineteen new FAQs on the Open Payments Program, under the Federal Physician Payments Transparency Act.  Effective August 1, 2013, applicable manufacturers will need to begin tracking payments and transfers of value under the Open Payments Program (also known as the federal Sunshine requirements).  The new

Miscellaneous Minimum Essential Coverage Provisions Final Rule

  The Department of Health and Human Services (“HHS”) released a final rule on June 26, 2013 addressing various aspects of the minimum essential coverage requirements imposed by the Affordable Care Act (“ACA”). Under the ACA, individuals must obtain and maintain health insurance that meets the definition of “minimum essential coverage” or face a tax

HHS Issues Proposed Rule Regarding Program Integrity and the Exchanges

On June 14, 2013, HHS released a Notice of Proposed Rulemaking proposing several new policies with respect to the Exchanges, focusing in large part on program integrity, including with respect to qualified health plans (QHPs) offered through both state-run Exchanges and the Federally-facilitated Exchange (FFE).  The rule also addresses the resolution of certain QHP-related grievances

CMS Hears Opposition to Preliminary Decisions on HCPCS Codes at Second of Three Public Meetings

Yesterday, CMS held the second of three public meetings to discuss preliminary decisions regarding applications for Healthcare Common Procedure Coding System (HCPCS) Level II codes.  Applicants submitted requests for new codes by early January, and CMS released preliminary decisions in response to those requests in April.  Those commenting on a preliminary decision are invited to

Protecting EHR Donations 2.0

In today’s Federal Register, OIG and CMS propose three discrete revisions to existing regulations protecting the donation of electronic health records and solicit comments for potentially more far-reaching changes.  The current safe harbor to the federal Anti-Kickback Statute (AKS), 42 C.F.R. § 1001.952(y), and the exception to the Physician Self-Referral Law (Stark), 42 C.F.R. §

More Guidance on Medicaid Expansion Released by CMS

Enhanced Federal Matching Funds for the “Newly Eligible”:  On March 29, 2013, CMS released a final rule implementing the statutory increases in federal matching funds for the cost of providing care to individuals newly eligible for Medicaid via the expansion under PPACA.  Specifically, beginning in 2014, states will receive 100% federal matching funds for the

HHS Announces Medicaid Innovation Grants for 25 States

On February 21, 2013, HHS Secretary Sebelius announced that 25 states would receive State Innovation Model awards totaling nearly $300 million to help the states deliver high-quality care and lower costs for Medicaid recipients.  The largest grants are in the form of “Model Testing” awards given to Arkansas, Maine, Massachusetts, Minnesota, Oregon, and Vermont.  It

Florida’s Governor Scott Announces Support for Medicaid Expansion

Just hours after receiving the official word from CMS that it has agreed in principle to approve Florida Medicaid’s statewide mandatory managed care waiver, Governor Rick Scott appeared at a press conference to announce that he will urge the Florida Legislature in the upcoming session to approve an initial three-year Medicaid expansion under the Affordable

CMS Announces “Agreement in Principle” To Approve Florida Medicaid’s Statewide Managed Care Waiver

On February 20, 2013, Cindy Mann – the Director of CMS’s Center for Medicaid & CHIP Services – issued a letter to Florida’s Medicaid Director acknowledging the “significant progress” CMS and Florida Medicaid have made and the “agreement in principle” they have reached concerning Florida’s request to amend its section 1115 Medicaid demonstration project.  That

Final Rule to Implement Physician Payment Sunshine Act Released

Today, the Centers for Medicare and Medicaid Services (CMS) released the final rule to implement the federal Physician Payment Sunshine Act (commonly known as the Sunshine Act).  The Sunshine Act requires applicable manufacturers of drugs, devices, biologicals, and medical supplies to track and publicly report payments and other transfers of value that they make to physicians

Affordable Care Act – Exemptions to the Individual Mandate

The Centers for Medicare & Medicaid Services (CMS) and the Internal Revenue Service (IRS) took another step towards implementing the controversial “individual mandate” imposed by the Affordable Care Act (ACA)—which is set to take effect on January 1, 2014—by jointly issuing two proposed rules to implement the exemptions to that mandate on January 30, 2013.

Going Over the Overpayment Cliff

Buried in the American Taxpayer Relief Act of 2012 (“ATRA”), the fiscal cliff legislation President Obama signed into law on January 2, 2013, is a seven-line provision amending the Social Security Act by extending the so-called “statute of limitations” for recovering Medicare overpayments. ATRA Section 638 appears to implement HHS-OIG’s May 2012 recommendation to CMS

HHS Announces No Enhanced Federal Matching Funds for Partial Medicaid Expansion, But Still Finds Ways to Ease Administrative Burden and Costs for States

The Patient Protection and Affordable Care Act (ACA) made 100% federal matching funds available through Medicaid for states to provide health benefits to all non-pregnant, childless adults with incomes up to 133 % of the federal poverty level (FPL) starting in 2014 (“the ACA Medicaid expansion”).  Since the Supreme Court decision in National Federation of

CMS Releases New List of Potential NCD Topics

On November 27, 2012, the Centers for Medicare & Medicaid Services (CMS) released a new list of Potential National Coverage Determination (NCD) Topics.  This list was released more than a year after CMS had solicited public input on items and services that may be inappropriately used or provide minimal benefit or items and services that

CMS Announces First “Qualified Entities” To Receive Medicare Data under Affordable Care Act Program

As part of the Patient Protection and Affordable Care Act, Congress created a new program making certain Medicare data available to “qualified entities” for the “the evaluation of the performance of providers of services and suppliers.”  On December 7, 2011, CMS published a final rule implementing the data use program, which it refers to as