CMS releases final Medicare audit protocol updates

The Centers for Medicare and Medicaid Services (CMS) has released the final protocols for 2017 audits of Medicare Parts C and D plans. This is the latest step in a process RegPulse has reported on during the initial release and as draft protocols underwent updates during the last year.

The audit protocol revisions affect the ways in which plan sponsors—such as Medicare Advantage Organizations (MAOs), Prescription Drug Plans (PDPs), and Medicare-Medicaid Plans (MMPs)—prepare and present information about their data universes to CMS. Sponsors that take part in these programs should review the changes and continue or update their programs assessments to identify the changes that affect them and plan appropriate responses.

Here is a summary of the relevant changes to the audit protocols in the final release, listed by program type:

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House approves bill to replace key provisions of the Affordable Care Act; All eyes turn to the Senate

The House of Representatives on May 4, 2017, narrowly voted 217-213 to pass the American Health Care Act (AHCA, H.R. 1628). No Democrat voted in favor of the bill and 20 Republicans voted against the bill. As many recall, the House on March 24, 2017, cancelled a planned vote on the AHCA due to a lack of support in the Republican conference.

In the ensuing weeks, three amendments to the AHCA were drafted by House members in an effort to win additional votes for the underlying bill. This ultimately paved the way toward passage in the House today on a slim majority vote. Following the vote, the House went into recess until May 16, 2017.

The AHCA now goes to the Senate for its consideration and likely modification in the coming weeks. Based on the next steps in the process, it may take well into the summer months before a final piece of legislation could be signed into law by President Trump.

The House bill seeks to repeal key provisions of the Affordable Care Act (ACA) and enact alternative health care policies that in general would:

  • Redesign advanceable, refundable tax credits for individuals who do not have access to employer-sponsored coverage
  • Restructure and cap federal Medicaid financing to the states
  • Repeal most taxes and fees enacted under the ACA; and
  • Provide $138 billion over 10 years in federal funding for state programs intended to help stabilize and reduce health insurance premiums in the non-group market.

Next week, Deloitte will produce a detailed summary of the AHCA as amended and passed by the House.

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Amidst ongoing debate over future of ACA Exchanges, CMS finalizes rule for 2018 and a timeline for submission of plans

The Centers for Medicare and Medicaid Services (CMS) last week released a final rule on the 2018 benefit year for Exchanges established under the Affordable Care Act (ACA), as well as a final timeline for health insurers to submit products for federally-facilitated Exchanges and other tools plans will need to submit products for ACA Exchanges for 2018. Notably, the final rule was published in the Federal Register on the same day that health insurers met with CMS Administrator Seema Verma and other Administration officials about the ACA Exchanges.

The final rule is intended to reduce volatility in the non-group and small group health insurance markets, and it finalizes with few changes policies included in a proposed rule published in the Federal Register on February 17, 2017. The final rule was published in the Federal Register on Tuesday, April 18, 2017, and its provisions take effect June 19, 2017. The policies in the final rule include changes requested by health insurers in previous years.

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CY 2018 changes and policy updates for Medicare health and drug plans

Summary of provisions and impacts

The Centers for Medicare and Medicaid Services (CMS) released its Advance Notice of Methodological Changes for Calendar Year (CY) 2018 for Medicare Advantage (MA) Capitation Rates, Part C and Part D Payment Policies and 2018 Draft Call Letter on February 1, 2017.

The purpose of the Advance Notice and draft Call Letter was to notify Medicare Advantage Organizations (MAO) and Part D sponsors of proposed changes to the Part C and Part D programs for the following plan year, including but not limited to:

  • Planned changes in the MA capitation rate methodology and risk adjustment methodology applied under Part C for CY 2018
  • Proposed changes in the Part D payment methodology for CY 2018
  • Proposed changes to the quality rating system and information the MAOs and Part D sponsors should consider while preparing their 2018 bids

CMS received many submissions in response to the request for comments on the Advance Notice and released final updates to MA and Part D Prescription Drug Programs for 2018 on April 3, 2017.
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How can medical device makers assess the FDA implications of 3D printing?

Adhering to FDA regulations on the manufacture of medical devices might be simpler when it’s more complicated.

That is to say: When manufacturers work in the traditional mode of large-scale, industrial production, they know the rules and are prepared to work under them. But what about when the manufacturing process becomes simpler – as in the case of 3D printing? How do the rules apply to that new frontier?

3D printing, or additive manufacturing (AM), offers device makers a range of potential advantages. They can be more innovative in design, address needs in a more customized way, and deliver products directly at the point of use. AM opens the door to offerings that would previously have been cost-inefficient because of scale.

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Republican health care bill would increase number of uninsured, maintain stability in individual market, Congressional Budget Office projects

The nonpartisan Congressional Budget Office (CBO) late Monday, March 13, 2017, released its analysis projecting that enactment of the American Health Care Act (AHCA) would increase the number of uninsured Americans by 4 million in 2017, rising to an increase of 14 million by 2018 and to 24 million by 2026.1 Under the AHCA, the total number of uninsured would stand at 52 million in 2026, approximately 19% of the US population under age 65. By comparison, approximately 10% of nonelderly Americans currently are uninsured, and the CBO projects that the uninsured population in the US would remain about that level each year through 2026 under the Affordable Care Act (ACA).

According to the CBO, the nongroup health insurance market “would probably be stable in most areas” under either the ACA or the AHCA.
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House begins consideration of legislation to repeal and replace key provisions of the Affordable Care Act

The House Ways and Means Committee and the House Energy and Commerce Committee today (Wednesday, March 8, 2017) are scheduled to begin marking up the American Health Care Act (AHCA), which would repeal and replace certain provisions of the Affordable Care Act (ACA). House Ways and Means Committee Chairman Kevin Brady (R-TX) and House Energy and Commerce Committee Chairman Greg Walden (R-OR) released the draft legislation late Monday, March 6, 2017.

The House Ways and Means Committee has jurisdiction over tax provisions in the legislation, while the House Energy and Commerce Committee has jurisdiction over provisions related to Medicaid.

In general, the draft legislation would maintain the ACA’s tax credits and states’ option to expand Medicaid in their current forms through December 31, 2019. Under the AHCA, new tax credits and Medicaid funding formulas would take effect beginning January 1, 2020.

The draft legislation in its current form would not make changes to the individual tax exclusion for employer-sponsored coverage, or certain ACA health insurance market reforms, including allowing adult children up to age 26 to stay on a parent’s health coverage and a prohibition on denying coverage or rate setting based on an individual’s pre-existing health conditions.

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CMS releases proposed rule intended to provide more certainty on health insurance markets, extends deadlines for plans to file products with Exchanges

The Centers for Medicare and Medicaid Services (CMS) on Wednesday, February 15, 2017, released a proposed rule intended to provide health insurers greater certainty about the individual and small group markets in the 2018 benefit year under the Affordable Care Act (ACA). Days later, a CMS division proposed providing plans with more time to file products for the federally-facilitated Exchanges in order to allow time to modify products in response to the proposed changes.

The policies proposed in the regulation generally have been requested by health insurers in previous years.

America’s Health Insurance Plans, a trade group representing insurers, issued a statement, saying, “We appreciate the Administration’s efforts in proposing policies intended to address stability, affordability, and choice, helping consumers get the coverage they need.”

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Regulatory, legislative efforts focused on ACA repeal move forward as Congressional Budget Office releases new health coverage projections

Hours after taking the oath of office on Friday, January 20, 2017, President Trump signed an executive order that opens the door for the secretaries of the departments of Health and Human Services (HHS), the Treasury, and Labor, as well as the leaders of other federal agencies, to take regulatory action to ease requirements under the Affordable Care Act (ACA) or waive or delay enactment of certain provisions.

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CMS provides updates on Quality Payment Program and new episode payment models as MACRA pushes forward

In late December 2016, the Centers for Medicare and Medicaid Services (CMS) released additional guidance for implementing the significant law the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) as a follow-up to the Final Rule released in October 2016.

While the fate of other legislation such as the Affordable Care Act is in question, the implementation of MACRA continues to move forward as planned with bipartisan support.  The released guidance includes a number of updates to support providers transitioning to the Quality Payment Program (QPP) established by MACRA, including the 2017 quality measure performance benchmarks to be used in the Merit-based Incentive Payment System (MIPS) and the patient relationship categories and codes used to measure cost under MIPS.

Additionally, CMS finalized three new episode payment models with tracks which may be considered advanced Alternative Payment Models (APMs) for purposes of the QPP, as well as released additional information on the ACO Track 1+ model, which will qualify as an advanced APM in 2018.

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