Tag Archives: Coverage

House Panels Advance Medicare Policy Bills, including Hike in Civil/Criminal Penalties

The House Energy and Commerce Subcommittee on Health has approved the following seven bipartisan bills addressing the Medicare Part B program: HR 3245, which would significantly increase various Medicare civil and criminal penalties under sections 1128A and 1128B of the Social Security Act, which sponsors note have not been updated in 20 years. Maximum penalties … Continue Reading

Medicare, Medicaid Payment Policies, Fraud Authorities Enacted as Part of 21st Century Cures Act

Included in the 21st Century Cures Act are numerous changes to Medicare and Medicaid policies, including provisions with significant reimbursement impacts for certain types of Medicare providers and suppliers, along with changes intended to reduce the regulatory and administrative burdens associated with the use of electronic health records.  Furthermore, the law once again expands the … Continue Reading

FDA & CMS Extend Medical Device Parallel Review Program

The Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS) have announced that they are making permanent their “Program for Parallel Review of Medical Devices,” which is now operating as a pilot program.  The parallel review initiative allows concurrent FDA and CMS review of a medical device with the goal … Continue Reading

OIG Highlights Varying Local Medicare Part B Drug Coverage Policies; Recommends Single Entity to Make Drug Coverage Determinations

The OIG has issued a report entitled “MACs Continue to Use Different Methods to Determine Drug Coverage,” which reviews how Medicare Administrative Contractors (MACs) make Medicare Part B drug coverage determinations and ensure that claims are paid according to these determinations. Based on the results of a survey of MACs regarding 2012 Part B drug … Continue Reading

Senate Finance Committee Approves Medicare Appeals Reform Proposal

On June 3, 2015, the Senate Finance Committee approved by voice vote a bipartisan proposal to reform the Medicare audit and appeals process in an attempt to help ease the backlog of Medicare appeals and promote efficiency and transparency. The draft proposal, the “Audit & Appeal Fairness, Integrity, and Reforms in Medicare Act of 2015,” would, … Continue Reading

CMS Proposes Removing Two NCDs under Expedited Process

In 2013, CMS adopted an expedited administrative process to remove certain national coverage determinations (NCDs) older than 10 years since their most recent review. In December 2014, CMS removed seven NCDs under this process. On March 18, 2015, CMS proposed removing two more NCDs under this process, addressing coverage of Apheresis (therapeutic pheresis) and Smoking and Tobacco-Use … Continue Reading

Congressional Panels Take Steps to Speed Patient Access to Medical Innovation

On January 27, 2015, the House Energy and Commerce Committee released its “21st Century Cures Act” discussion draft, the product of a year-long, bipartisan effort by the Committee to accelerate the pace of medical cures in the United States. The nearly 400-page bill addresses a wide range of topics, including, among many other things: the … Continue Reading

OIG Examines Appropriateness of Medicare Ophthalmology Claims

The OIG recently assessed the appropriateness of claims submitted by providers for screening for, diagnosing, evaluating, or treating cataracts, wet age related macular degeneration (wet AMD), and glaucoma in 2012. The OIG estimates that Medicare paid $22 million for ophthalmology claims in 2012 that were potentially inappropriate, according to national and local coverage requirements, although … Continue Reading

President Signs Tax Bill with Medicare Provisions, Ebola Treatment/Vaccine Bill

In December 2014, President Obama signed into a law H.R. 5771, a tax extender bill that includes the “Achieving a Better Life Experience (ABLE) Act of 2014.” As discussed in a previous post, the law, P.L. 113-295, includes three Medicare provisions to finance the ABLE Act: revisions to payment adjustments for Medicare physician fee schedule misvalued … Continue Reading

CMS Removes Seven Medicare National Coverage Determinations, Leaving Coverage to MACs

Yesterday CMS posted a Final Decision Memorandum for the Expedited Removal of National Coverage Determinations (NCDs).  By way of background, in an August 7, 2013 Federal Register notice (78 FR 48164), CMS established an expedited process for removing NCDs under certain circumstances, such as when they are no longer contain clinically pertinent or when the items … Continue Reading

Congress Approves “ABLE Act” with Medicare Offsets

On December 16, 2014, Congress gave final approval to H.R. 5771, a tax extender bill that includes the “Achieving a Better Life Experience (ABLE) Act of 2014.” The ABLE Act provisions allow individuals with disabilities to establish tax free savings accounts to pay for qualified expenses (e.g. medical, post-secondary education, housing, and transportation expenses). Prior … Continue Reading

CMS Issues Final Medicare Coverage with Evidence Development (CED) Guidance

On November 20, 2014, CMS released its final Medicare coverage document entitled “Guidance for the Public, Industry, and CMS Staff: Coverage with Evidence Development.”  CED policy provides the framework for Medicare coverage of items or services on the condition that they are furnished in the context of approved clinical studies or with the collection of … Continue Reading

OIG Highlights Pitfalls of Inconsistent Local Medicare Coverage Policies

Inconsistent Medicare Part B local coverage determinations (LCDs) create disparities in Medicare beneficiary access to items and services, a recent OIG report concludes. The OIG focused on LCDs issued by MACs for Part B items and services performed by noninstitutional providers (e.g., medical procedures, evaluation and management services, imaging services, drugs, and tests), but excluded … Continue Reading

CMS Proposes Removing 10 Medicare National Coverage Policies

CMS has proposed removing 10 longstanding Medicare national coverage determinations (NCDs) under an expedited process outlined in an August 7, 2013 Federal Register notice. The NCDs under review address: Noninvasive Tests of Carotid Function, Tinnitus masking, Laser Procedures, L-DOPA,Stereotactic Cingulotomy as a Means of Psychosurgery, Carotid Sinus Nerve Stimulator, Electroencephalographic (EEG) Monitoring During Open-Heart Surgery, … Continue Reading

CMS Revises Medicare National Coverage Determination Process, Eases Path to Discontinue Outdated Coverage Policies

CMS has announced updates to the process for making Medicare national coverage determinations (NCDs) to provide clarity and transparency with regard to modifications made to the coverage process since the Medicare Modernization Act. Among other things, the notice addresses: the procedures for requesting an NCD or reconsideration of an existing NCD; public participation in the … Continue Reading

CMS Seeking Comments on Revisions to Coverage with Evidence Development (CED) Policy

CMS is inviting comments on a coverage document entitled “Draft Guidance for the Public, Industry, and CMS Staff Coverage with Evidence Development in the context of coverage decisions."  CMS’s CED policy provides the framework for conditional Medicare coverage of an item or service while additional clinical data is developed to support a “reasonable and necessary” … Continue Reading

CMS Highlights Potential National Coverage Determination (NCD) Topics

On November 27, 2012, CMS posted a list of medical items and services that it might consider for future Medicare coverage review, including potential NCD topics. The list is based on public response to CMS’s previous request for feedback on items and services that may be inappropriately used (i.e., underused, overused, or misused), may provide … Continue Reading

CMS Call: Preparing Physicians for ICD-10 Implementation (Oct. 25)

On October 25, 2012, CMS is hosting a national provider call on Preparing Physicians for ICD-10 Implementation. The call will cover, among other topics: practical pointers for providers on transitioning to ICD-10 (currently set for October 1, 2014); an overview of ICD-10 implementation requirements; plans for local coverage determination (LCD) and national coverage determination (NCD) … Continue Reading

CMS Solicits Comments on Coverage with Evidence Development Framework

CMS is seeking comments on its Medicare coverage with evidence development (CED) policy, under which CMS provides conditional Medicare coverage for an item while collecting clinical data. CMS is looking for feedback on the use of CED in national coverage determinations and its impact on Medicare and its beneficiaries. The input will be used to "to develop … Continue Reading

CMS Seeks Comments on Potential Medicare Coverage Determination Topics

CMS is inviting public comments on potential topics for Medicare national coverage determinations (NCDs) “to use Medicare coverage to help align program incentives with the best available clinical evidence.” While CMS issued a list of potential NCDs in 2008, the agency notes that there have been “significant developments in new technologies and changes to CMS authorities … Continue Reading

CMS ICD-10 Conversion Activities National Provider Teleconference (May 18)

CMS is hosting a national provider teleconference on “CMS ICD-10 Conversion Activities” on May 18, 2011. In addition to providing a general overview, the call will review the CMS Coverage and Analysis Group’s transition to ICD-10 for lab national coverage determinations, home health conversion, OASIS and procedure code reporting, and an update on claims spanning … Continue Reading

Parallel CMS/FDA Review of Medical Products

On September 17, 2010, CMS and FDA published a notice announcing that they are considering establishing a process for overlapping evaluations of premarket, FDA-regulated medical products when the product sponsor and both agencies agree to such parallel review. The process is intended to reduce the time between FDA marketing approval or clearance decisions and CMS … Continue Reading

Memorandum of Understanding Between FDA and CMS

This post was written by Paul Sheives and Areta Kupchyk. The FDA and CMS have entered into a Memorandum of Understanding (MOU), effective June 25, 2010, to promote collaboration and enhance knowledge and efficiency by sharing information and expertise. In particular, the MOU highlights the agencies’ “common needs for evaluating the safety, efficacy, utilization, coverage, payment, … Continue Reading
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