CMS proposes policy changes to Medicare Advantage, Medicare prescription drug benefit

The Centers for Medicare and Medicaid Services (CMS) on Thursday, November 17, 2017, released a proposed rule outlining policy changes to Medicare Advantage (MA) and the Medicare Part D prescription drug benefit (Part D). The proposed rule is intended to provide an opportunity for stakeholders to provide feedback to CMS ahead of the annual call letter process, with the draft call letter historically released in February.

The proposed rule includes policies intended to further CMS’ recently announced Patients Over Paperwork initiative, which aims to reduce regulatory and administrative requirements for health care stakeholders. In addition, the proposed rule continues the Administration’s efforts to exercise regulatory authority to help reduce out-of-pocket spending on prescription drugs.

The policies outlined in the proposed rule would apply to contract year 2019.

The proposed rule is scheduled for publication in the Federal Register on November 28, 2017, and CMS will accept comments through January 16, 2018.

Key provisions of the proposed rule are highlighted below.

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CMS moves forward with implementation of MACRA, other policy changes in Physician Fee Schedule Update

The Centers for Medicare and Medicaid Services (CMS) on Thursday, November 2, 2017, released final rules on Medicare reimbursement for 2018 that will have significant implications for providers’ margins and drive many provider and payer organizations to revisit their strategic objectives. The final rules for the 2018 performance period under the Quality Payment Program (QPP) of the Medicare Access and CHIP Reauthorization Act (MACRA) and the 2018 Part B Physician Fee Schedule Update include critical details that will have implications for providers related to value-based care, coding compliance, health information technology investments and telehealth services, among other issues.

The final rule for the MACRA QPP 2018 performance period is scheduled for publication in the Federal Register on November 16, 2017, and the final rule on the Part B PFS update is scheduled for publication in the Federal Register on November 15, 2017. Provisions of both rules will take effect January 1, 2018.

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CMS finalizes changes to payment policy under the 340B drug discount program

The Centers for Medicare and Medicaid Services (CMS) on November 1, 2017, released the 2018 Hospital Outpatient Prospective Payment System (OPPS) final rule, moving forward with a significant change in payment policy under the 340B drug discount program that was included in the proposed rule earlier released in July.

Beginning January 1, 2018, CMS will no longer reimburse most 340B-purchased drugs at the standard Part B rate of Average Sales Price (ASP) plus 6 percent, and instead will pay a rate of ASP minus 22.5 percent. The change in payment policy has drawn sharp criticism from hospital organizations, including litigation by the American Hospital Association, the Association of American Medical Colleges, America’s Essential Hospitals and member hospitals to block the change in payment policy.

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Open enrollment period for ACA Exchanges begins under President Trump for first time amid ongoing debate over cost-sharing reduction subsidies, ACA waivers

The open enrollment period for coverage for 2018 through the health insurance Exchanges created under the Affordable Care Act (ACA) begins today, Wednesday, November 1, 2017. This is the fifth open enrollment period since the Exchanges opened in 2014 and the first open enrollment period of President Trump’s Administration. The open enrollment period for the 39 states using the HealthCare.gov platform for plan year 2018 will close December 15, 2017; the open enrollment period in previous years ran through January 31 of the plan year. A number of states running their own Exchanges for plan year 2018 will have longer open enrollment periods than states using the HealthCare.gov platform.

This year’s open enrollment period begins after nine months of debate in Congress over various proposals to repeal and replace select provisions of the ACA, President Trump’s October 12, 2017, decision to stop reimbursing health plans for cost-sharing reduction (CSR) subsidies without congressional authorization, and a number of other regulatory decisions reflecting the Trump Administration’s position on the ACA.

Highlights of the current status of select issues related to the ACA Exchanges are provided below.

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Health care looms over final months of 2017 legislative, regulatory agenda; Latest executive order could kick off period of heavy regulatory activity

Repeal and replace of the Affordable Care Act (ACA) has dominated the headlines for much of 2017, but the expiration of the fiscal year 2017 budget resolution on September 30, 2017, has functionally moved that effort off the top-tier of near-term legislative priorities. That said, health care legislation remains on the congressional agenda this year, and a host of regulations are due to be released before December 31, 2017.

These legislative and regulatory developments will have a significant impact on the health care industry and should be taken into account by health care providers, health plans, health information technology firms, investors and other industry stakeholders as they evaluate their strategies and plan for 2018 and the years ahead.

Below are select highlights of the health care legislative and regulatory agenda for the remainder of 2017.

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CMS proposes to scale back scope of bundled payment model for joint replacement, cancel other mandatory bundled payment models

The Centers for Medicare and Medicaid Services (CMS) on Thursday, August 17, 2017, published a proposed rule that would reduce the number of geographic areas where hospitals and clinicians would be required to participate in the Comprehensive Care for Joint Replacement (CJR) bundled payment model focused on knee and hip replacements, and cancel cardiac and other orthopedic bundled payment models that are scheduled to begin on January 1, 2018.

As a member of Congress and in his confirmation hearings as Secretary of the Department of Health and Human Services (HHS), Secretary Tom Price raised concerns about regulations issued by the Obama Administration to test the orthopedic and cardiac bundles payment models in so many geographic areas on a mandatory basis.

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What’s next after Senate defeat of latest ACA repeal effort?

The Senate early in the morning of Friday, July 28, 2017, voted 49-51 to defeat the Health Care Freedom Act, which would have repealed targeted provisions of the Affordable Care Act (ACA). Three Republican Senators joined all Democrats in voting against the legislation, prompting Senate Majority Leader Mitch McConnell (R-KY) to pull the bill from the Senate schedule. Leader McConnell and Speaker of the House Paul Ryan (R-WI) have not indicated how they will proceed on legislation related to the ACA.

The House adjourned for its August recess from Friday, July 28, 2017, through Tuesday, September 5, 2017. Leader McConnell has said the Senate will adjourn Friday, August 8, 2017, through Tuesday, September 5, 2017.

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A renewed focus on the future of the 340B program

On Thursday, July 13, 2017, the Centers for Medicare and Medicaid Services (CMS) issued a proposed rule that updates the payment rates and policy changes in the Hospital Outpatient Prospective Payment System (OPPS). In the provisions, CMS proposes to change the payment rate for certain Medicare Part B drugs purchased by hospitals through the 340B program.

The proposed changes include adjusting the applicable payment rate for drugs acquired under the 340B program from average sales prices (ASP) plus 6 percent to ASP minus 22.5 percent. This potentially represents a significant reduction to how much Medicare pays 340B hospitals for Part B drugs under OPPS.

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CMS proposes changes to MACRA Quality Payment Program for 2018

The Center for Medicare and Medicaid Services (CMS) on June 30, 2017, published a proposed rule outlining changes for the 2018 performance year of the Quality Payment Program (QPP) under the Medicare Access and CHIP Reauthorization Act (MACRA). MACRA’s QPP includes the incentive payments for advanced alternative payment models (A-APMs) and the Merit-based Incentive Payment System (MIPS). Performance in 2018 will determine payment adjustments to clinicians that will be applied to their Medicare Part B payments in 2020.

The first performance year began January 1, 2017, for Part B payment adjustments in 2019.

MACRA repealed the sustainable growth rate (SGR) formula for updates to the Medicare Part B Physician Fee Schedule and sets payment updates for all years in the future. Through the QPP, the law is intended to link Medicare payment updates to quality and performance and drive the health care payment system across all payers away from fee-for-service reimbursement models.

Select key provisions of the proposed rule are highlighted below.

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Congressional legislative agenda dominated by the intermix of health care and tax issues

Health care and tax issues are at the top of the US legislative and regulatory agendas in 2017, as Republican majorities in the House of Representatives and the Senate work on legislation to repeal and replace key provisions of the Affordable Care Act (ACA) and to reform the tax code for both businesses and individuals. Republicans are using the budget reconciliation process to advance health care to make it easier to bring the legislation up for a vote in the Senate so long as certain conditions are met. They are expected to use a similar process for tax reform. Specifically, all provisions of legislation considered under budget reconciliation must be related to the federal budget deficit, taxes, mandatory spending programs (like Medicare or Medicaid but not Social Security, which is exempt from reforms under budget reconciliation) or the federal debt limit. Provided these and a few other conditions are met and the Congressional Budget Office (CBO) does not project that the bill will increase the federal budget deficit outside the operable budget window, the Senate can bring up legislation for a vote and pass it with a simple majority of 51 votes.

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