HHS Office of Inspector General flags MACRA vulnerabilities related to clinician awareness, program integrity

The Health & Human Services (HHS) Office of the Inspector General (OIG) in December 2017 released a report indicating that with regard to the implementation of the Medicare Access and CHIP Reauthorization Act (MACRA), the Centers for Medicare and Medicaid Services (CMS) continues to face vulnerabilities related to clinician awareness of MACRA’s Quality Payment Program (QPP) and program integrity to avoid fraud and improper Medicare Part B payment adjustments.

In a similar report from 2016, HHS OIG highlighted vulnerabilities related to providing guidance and technical assistance to clinicians and to developing information technology (IT) systems to support data reporting, scoring and Part B payment adjustments. HHS OIG found that CMS has made “significant efforts” to address these vulnerabilities.

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Proposed rule sets stage to expand availability of association health plans; HHS seeks comment on choice, competition in health care markets

On January 4, 2018, the Department of Labor issued a proposed rule outlining changes to the definition of “employer” under the Employee Retirement Income Security Act (ERISA) in an effort to make association health plans (AHPs) more broadly available to small employers and their employees. In doing so, the proposed rule would lay the groundwork for more small employers and their employees to join AHPs, which generally are considered large group health plans and are not subject to insurance market requirements for small group and non-group health insurance products that were enacted as part of the Affordable Care Act (ACA). Examples of such insurance market reforms include the essential health benefits (EHB) package.

ERISA is the 1974 federal law that generally regulates health coverage offered by large employers and pre-empts state insurance requirements for self-funded coverage.

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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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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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Final open enrollment for ACA health insurance exchanges under President Obama begins: What do the numbers tell us?

The open enrollment period for coverage for 2017 through the health insurance Exchanges created under the Affordable Care Act (ACA) begins today, Tuesday, November 1, 2016. This is the fourth open enrollment period since the Exchanges opened in 2014 and the final open enrollment period of President Obama’s Administration. The open enrollment period will close on January 31, 2017.

Sylvia Mathews Burrell, Secretary of the Department of Health and Human Services (HHS), on October 19, 2016, announced that the Administration expects 13.8 million people to enroll in coverage for 2017 during the open enrollment period. Following the 2012 Supreme Court decision that upheld the ACA’s individual mandate and made it easier for states to opt out of the ACA’s Medicaid expansion, the non-partisan Congressional Budget Office (CBO) projected that 25 million people would be enrolled in coverage through the Exchanges in 2017.1 Notably, enrollment in employer-sponsored coverage has not decreased as CBO projected in 2012, and Medicaid enrollment has exceeded the 2012 CBO projections.

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Major health care regulatory activity still to come under the Obama Administration

As many in the US prepare to shift their attention to the upcoming presidential debates and the final weeks of the campaign, the Obama Administration is poised to release some far-reaching regulations, which will have a significant effect on the health care marketplace, including a final rule on the new Medicare payment law and some changes intended to help shore up the health insurance Exchanges established under President Obama’s signature health care law.

Highlights of some of the most significant regulatory actions still to come in the final months of the Obama Administration are provided below.

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CMS issues proposed notice of benefit and payment parameters for 2018

The Centers for Medicare and Medicaid Services (CMS) released a proposed rule that would make a number of changes to the public health insurance Exchanges created under the Affordable Care Act (ACA). Many of the proposals are intended to take effect in 2018, but some would begin in benefit year 2017.

The proposed rule follows announcements from several national health insurers that they would reduce their participation in Exchanges in 2017, following continued financial losses.  Policy proposals, such as changes to the risk adjustment program, are intended to help boost the stability of the Exchanges and were addressed in a June 2016 white paper following the Department of Health and Human Services (HHS)-Operated Risk Adjustment Methodology Public Meeting, which was held on March 31, 2016.

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Long-awaited release of drug discount rule mega-guidance means hospitals need to act quickly—but think long-term

Long-awaited release of drug discount rule mega-guidance means hospitals need to act quickly—but think long-term

On August 27, the Health Resources and Services Administration (HRSA), one of the federal public health agencies within the Department of Health and Human Services, released a long-awaited draft guidance intended to clarify eligibility requirements for the 340B Drug Pricing Program. The publication of this guidance marks the beginning of a 60-day public comment period before the agency releases a final rule.

The “340B Drug Discount Program”, named for the authorizing section of the Public Health Service Act, is a US federal government program created in 1992 that requires drug manufacturers to provide outpatient drugs to eligible health care organizations/covered entities at significantly reduced prices. Pharmaceutical companies must adhere to the program’s price discount rules as a condition of their participation in Medicaid. Over the past several years, Congress, the Administration, and health care stakeholders have been attempting to balance the program’s goals of providing drug discounts to entities that serve lower income populations, while maintaining some parameters about the definitions of qualified drugs, patients, and eligible entities to limit the expansion of the program.

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HIX Compliance for Health Plans

HIX Compliance for Health Plans

New structures come with new rules and health insurance exchanges (HIX) are no exception. That said, health insurers need to know more than the new rules — they need to understand the protocols and priorities regulators intend to use in building out this new regulatory regime.

This is a significant compliance challenge, but it does not begin with a blank page. Other government programs’ (Medicare and Medicaid) compliance capabilities that may already be in place serve as useful models for the analogous requirements of HIX participation. In fact, many of the exchange compliance priorities the Centers for Medicare and Medicaid Services (CMS) shared in March 2014 are similar to those used to regulate Medicare Advantage and Part D plans. Following that logic, it is likely that enforcement measures on HIX plans may mimic these other existing federally-funded programs.

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