This Week – December 1, 2018

This Week in Washington, D.C.

  • ACG Governors’ Advocacy Paying off: CMS Guidance on MIPS and Areas Impacted by Natural Disasters
  • CMS Releases Website Pricing Tool: Data Demonstrates the Value of GI Procedures
  • CMS Releases Proposed Rules on Medicare Drug Pricing
  • FDA Proposing to Modernize Device Approval Process

ACG Governors’ Advocacy Paying off:
CMS Guidance on MIPS and Areas Impacted by Natural Disasters

This week, the Centers for Medicare and Medicaid Services (CMS) released guidance for ACG members who live in areas of the country recently impacted by a natural disaster, and are subject to Medicare fee-for-service’s Merit-based Incentive Payment Systems (MIPS).

In October, ACG urged CMS to announce waivers for MIPS-eligible clinicians for the CY 2018 reporting year, to facilitate their complete recovery from the devastation of Hurricane Michael.  In September, ACG Governors from North Carolina, South Carolina, and Virginia sent a similar letter to CMS Administrator Verma in response to Hurricane Florence.

In early November, right before the wildfires began to damage California, CMS affirmed the MIPS “Extreme and Uncontrollable Circumstances Policy” in the 2019 Medicare physician fee schedule changes final rule.

Thank you ACG Governors! The ACG Board of Governors will continue to advocate on behalf of clinical GI and your patients, including efforts to reduce the regulatory burdens of GI practices.

The MIPS Extreme and Uncontrollable Circumstances Policy:
Here’s What You Need to Know

ACG members affected by Hurricane Florence, Hurricane Michael, and California Wildfires will not be required to submit an application to reweight the performance categories under MIPS due to these unforeseen circumstances.  Instead, ACG members will automatically receive a score equal to the performance threshold (set at 15 points for 2018).  This will result in a 0% payment adjustment (no bonus or cut) for the 2020 MIPS payment year.

Please Note: CMS will not grant this exemption if:

  • An ACG member submits data for two or more MIPS performance categories (Quality, Improvement Activities, and/or Promoting Interoperability) as an individual; or
  • An ACG member is part of a group or virtual group that submits data on behalf of its clinicians.

Impact on those participating in MACRA alternative payment models (APMs):

ACG members participating in a CMS-approved APM, who are subject to the APM scoring standard, are not covered by the automatic extreme and uncontrollable circumstances policy.  However, an ACG member who is subject to the APM scoring standard and identified as affected by an extreme and uncontrollable circumstance can apply for an exception to the MIPS’ Promoting Interoperability performance category.

Updated fact sheet: click here for more information on the MIPS Automatic Extreme and Uncontrollable Circumstances Policy. 


CMS Releases Website Pricing Tool:
Data Demonstrates the Value of GI Procedures

From Whitfield Knapple, MD, FACG, Chair of the Legislative and Public Policy Council

This week, CMS released an online tool that displays cost differences for certain procedures, including GI procedures.  This online tool was mandated when Congress passed the “21st Century Cures Act” in December 2016.

CMS’ “Procedure Price Lookup” is designed to help patients with Medicare to consider the cost differences among clinically appropriate settings.  This online tool allows consumers to compare copayments for certain procedures that are performed in both hospital outpatient departments and ambulatory surgical centers (ASCs).

ACG has long-advocated for such a tool that helps demonstrate the value of life-saving procedures such as colonoscopy, as well as to demonstrate the cost-effectiveness of performing these procedures in the ASC setting.  Thank you ACG members for your advocacy efforts.  ACG will continue to advocate on your behalf, using this data to fight for greater access to GI services for your patients and more equitable reimbursement for ACG members.

Some examples of the online tool:

As noted in the examples above, the tool displays national averages for the amount Medicare pays the hospital or ASC, and the national average copayment amount for the Medicare beneficiary.


CMS Releases Proposed Rules on Medicare Drug Pricing

On Monday, CMS issued a proposed rule on potential policy changes for the Medicare Advantage and the Medicare Part D prescription drug programs, which would begin in 2020.  According to CMS, these policy changes are designed to negotiate lower drug prices for Medicare beneficiaries.

While ACG supports the goal of negotiating lower drug prices for Medicare beneficiaries, ACG is very concerned about some of the proposals to achieve this goal.  Notably, an increase in the use of prior authorizations and  “step therapy” requirements.  As ACG members with IBD patients know, while step therapy and prior authorizations may achieve some savings from payors, these requirements significantly increase practice management burdens, and more importantly, can harm patient care.  Step Therapy entails the “fail first” drug therapy requirements, in which patients are forced by insurers to try and fail with one or more medications before the cost of the medication originally prescribed will be covered.  Ironically, step therapy often leads to unnecessary increases in health care and drug costs.  That is why ACG continues to fight to protect the sanctity of the patient-provider relationship, as the prescribing clinician and patient are best suited to determine the correct course of treatment.

Currently, Medicare Part D plans must include on their formularies all drugs in the following 6 classes: 1) antidepressants; 2) antipsychotics; 3) anticonvulsants; 4) immunosuppressants for treatment of transplant rejection; 5) antiretrovirals; and 6) antineoplastics.  The proposed rule would provide Part D plans with greater flexibility to negotiate discounts for drugs in these therapeutic classes.

Under the proposed rule, plans would be able to: 1) implement broader use of prior authorization and step therapy for protected class drugs, including to determine use for protected class indications; 2) exclude a protected class drug from a formulary if the drug represents only a new formulation of an existing single-source drug or biological product, regardless of whether the older formulation remains on the market; and 3) exclude a protected class drug from a formulary if the price of the drug increased beyond a certain threshold over a specified look-back period.

Step Therapy Coming to Medicare Part B?

CMS is also proposing a policy similar to the one implemented for Medicare Advantage in 2019, where plans would be able to use step therapy as a recognized utilization management tool in Medicare Part B.

Proposed Safeguards for Patients

Under the proposal, step therapy requirements may only apply to new starts of medication, must be reviewed and approved by the plan’s pharmacy and therapeutics committee, and coverage requests related to Medicare Part B drugs will be subject to rules that mirror the current rules in Medicare Part D.  Here are the nuts and bolts of what is currently required in Medicare Part D:

  • When a party makes a request for a drug benefit, the Part D plan sponsor must notify the patient and prescriber of its determination no later than 72 hours after receipt of the request (or for an exceptions request, the physician’s or other prescriber’s supporting statement).
  • When a party makes a request for a payment, the Part D plan sponsor must notify the provider of its determination and make payment (when applicable) no later than 14 calendar days after the receipt of the request.
  • When a Part D plan sponsor makes its decision (either favorable or unfavorable), it must give the patient written notice of this determination. Initial notice may be provided orally, but the written follow-up must be sent within 3 calendar days of the oral notice.
  • There is also an expedited determination process under Medicare Part D, where a plan sponsor must provide notice of its decision within 24 hours after receiving an expedited request.  Some examples that merit an expedited determination include: a delay that would adversely affect patient’s health, may seriously jeopardize life or health of a patient, or the patient’s ability to regain maximum function.

ACG is currently reviewing the proposed rule to determine the potential impact that these new changes may have on patient care and GI practices.


FDA Proposing to Modernize Device Approval Process

From Stephen Hanauer, MD, FACG, Chair of the FDA Related Matters Committee

On Monday, the U.S. Food and Drug Administration (FDA) announced plans to change the FDA’s 510(k) approval process, noting that they are “pursuing these changes to help keep pace with the increasing complexity of rapidly evolving technology.”

The FDA is considering making public on their website approved devices that have demonstrated “substantial equivalence to older predicate devices.”  The FDA wants to initially focus on predicates that are more than 10 years old.  By doing this “market-based approach,” the FDA believes that encouraging product developers to use more modern predicates would give patients and ACG members a choice among older and newer versions of a type of device, promote greater competition to adopt modern features that improve safety and performance, and help make sure that newer devices reflect more modern technology and standards that can improve patient care and outcomes.

In early 2019, FDA also intends to finalize guidance on establishing an alternative 510(k) pathway that allows manufacturers of certain well-understood devices to rely on objective safety and performance criteria to demonstrate substantial equivalence as the basis for the predicates used to support new products.  The FDA plans to rename this new approach the “Safety and Performance Based Pathway.” Through this new path, a company would demonstrate that a novel device meets modern performance-based criteria that have been established or recognized by the FDA and reflect current technological principles. These criteria would reflect the safety and performance of modern predicate devices.

Other notable information from the FDA’s statement:

  • Congress established the current 510(k) pathway in 1976.  FDA also noted that it will likely need assistance from Congress in order to modernize the 510(k) review process
  • The FDA’s 510(k) program is the most commonly used device premarket review pathway. In 2017, the agency cleared 3,173 devices through the 510(k) pathway, representing 82 percent of the total devices cleared or approved.
  • According the FDA: “manufacturers generally rely on comparative testing against predicate devices to show that a new device is as safe and effective as the predicate device. Older predicates might not closely reflect the modern technology embedded in new devices, or our more current understanding of device benefits and risks. In some cases, the predicate could be decades old. Data show that nearly 20 percent of current 510(k)s are cleared based on a predicate that’s more than 10 years old. That doesn’t mean the products are unsafe. But it does mean that some devices may not be continually improving, which is the hallmark of health technologies.”