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The Centers for Medicare and Medicaid Services (CMS) is proposing significant and important modifications to its National Coverage Determination (NCD): Screening for Lung Cancer with Low Dose Computed Tomography (LDCT). Medicare pays for lung cancer screening, counseling, and shared decision-making visits, and for an annual screening for lung cancer with low dose computed tomography as a preventive service benefit under the Medicare program. CMS issued its NCD in 2015 initiating this screening benefit, but stakeholders have observed that many of the features of the initial NCD served as a barrier to the effectiveness of this screening program. The proposed NCD makes numerous improvements to this program and eliminates many of the barriers to qualified patients’ ability to gain access to important LDCT lung cancer screenings.

Last year, a formal joint request to reconsider the NCD was submitted to CMS by the GO2 Foundation for Lung Cancer, The Society of Thoracic Surgeons, and American College of Radiology (ACR), and CMS received numerous comments from various stakeholders, including from the Association for Quality Imaging. This new proposed NCD is in response to that request and the comments from stakeholders.Continue Reading New and improved proposed national coverage determination on screening for lung cancer with low dose CT

It is no secret that the coronavirus pandemic has driven our daily lives digital—work, education, social gatherings, and, of course, health care. Congress and CMS responded to the public health emergency by waiving limitations on reimbursement for telehealth services rendered to Medicare patients. These waivers introduced new flexibility and vastly expanded Medicare patients’ access to…

President Donald Trump has signed an executive order that commits the Department of Health and Human Services (HHS) to taking a series of regulatory and subregulatory actions intended to enhance the fiscal sustainability of the Medicare program, reduce regulatory burdens on providers, and increase beneficiary choice.  The planned initiatives, which would require further policy development…

In an effort to “modernize the Medicare program and bring the latest technologies and innovations to Medicare beneficiaries,” CMS has announced revisions to the local coverage determination (LCD) process.  Specifically, under authority provided in the 21st Century Cures Act and taking into account stakeholder feedback, CMS has issued Program Integrity Manual (PIM) changes intended…

The Medicare Payment Advisory Commission (MedPAC) has released its annual report to Congress on “Medicare and the Health Care Delivery System.” This year’s report includes recommendations for changes to emergency department services policies, along with analyses of potential changes that would impact physicians, medical equipment suppliers, post-acute care providers, and others.  Highlights include the following:…

James Bailey is the new CMS Medicare Pharmaceutical and Technology Ombudsman, a role Congress established in the 21st Century Cures Act to help expedite resolution of industry Medicare reimbursement concerns. The Ombudsman’s office is charged with fielding questions from pharmaceutical, biotechnology, medical device, diagnostic product manufacturers, and other stakeholders regarding Medicare coverage, coding, and …

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 would at least double under the bill. For instance, CMPs that are now $10,000 would be increased to $20,000, while criminal fines that are now a maximum of $25,000 would increase to $100,000. Maximum sentences also would be doubled, from five years to 10 years.
  • HR 1148, the Furthering Access to Stroke Telemedicine Act, to provide for Medicare reimbursement of neurological consults via telemedicine for beneficiaries presenting at hospitals or mobile stroke units.
  • HR 2465, the Steve Gleason Enduring Voices Act, to make permanent the current Medicare coverage of speech generating devices under the “routinely purchased” durable medical equipment payment category.
  • HR 2557, the Prostate Cancer Misdiagnosis Elimination Act, to provide coverage of DNA Specimen Provenance Assay (DPSA) testing for prostate cancer.
  • HR 3120, to amend the Health Information Technology for Economic and Clinical Health (HITECH) Act to remove the mandate that meaningful use standards become more stringent over time.
  • HR 3263, to extend the Medicare Independence at Home Medical Practice Demonstration Program.
  • HR 3271, to revise Medicare competitive bidding rules pertaining to diabetes test strips (DTS), including stronger enforcement of requirement that bidders cover at least 50 percent of the types of diabetes test strips on the market.

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

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…

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…

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…

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, among other things:Continue Reading Senate Finance Committee Approves Medicare Appeals Reform Proposal

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…

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…

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…

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 or services are used infrequently by beneficiaries. Removal of an NCD does not necessarily result in noncoverage; instead, it allows the local Medicare Administrative Contractors (MACs) to determine coverage.

CMS reviewed NCDs that have not been reviewed in 10 years in order to evaluate the continued need for those policies to remain active on a national scale, and on November 27, 2013 CMS published for public comment the first list of NCDs proposed for removal. After review of public comments, CMS is now removing the following NCDs from the NCD Manual, effective December 18, 2014:Continue Reading CMS Removes Seven Medicare National Coverage Determinations, Leaving Coverage to MACs

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).

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…

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…