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2016 will bring flurry of new rules and regulations affecting healthcare


Last year ushered in a bevy of new rules and regulations that are already affecting the healthcare industry: a fix to the sustainable growth-rate pay formula for physicians; a mandatory bundled-payment program that would affect 67 markets across the country; tweaks to the CMS' value-based payment program; clarifications of waivers that aim to give states more flexibility in molding their Medicaid programs; and a down-to-the-wire budget deal that delayed taxes on Cadillac plans, medical devices and health insurance. But 2016 is expected to be just as eventful, with more rules and regulations expected.


Health plans will face penalties for publishing inaccurate provider directories: Medicare Advantage plans will have to pay $25,000 per day per member, while federal exchange plans must pay $100 per day per member.

All employers with at least 50 full-time-equivalent employees must offer affordable health insurance or face penalties under the Affordable Care Act, which would be a minimum of $2,000 per full-time employee. Previously, the rule applied only to companies with 100 or more FTE employees.

The CMS will implement Medicare's mandatory value-based purchasing program for home health agencies in nine states.


The CMS is expected to finalize the “60-day rule,” requiring providers and suppliers to return overpayments to Medicare no later than 60 days after they are identified.


HHS' Office for Human Research Protections and 15 other federal agencies will issue a final rule updating the “Common Rule” governing research on human subjects.

The CMS will propose rules on the methodology for the Merit-Based Incentive Payment system for Medicare's payments to physicians.


The CMS is expected to issue its final rule for Medicaid managed-care plans, including minimum medical-loss ratios.

Nearly 800 hospitals in 67 markets will begin participating in the CMS' mandatory Comprehensive Care for Joint Replacement bundled-payment model for hip and knee replacement operations.


The U.S. Food and Drug Administration will decide whether generic-drug makers can unilaterally update labels to reflect new safety-related information without waiting for brand-name manufacturers to update their labels.

Mid to Late 2016

The Federal Trade Commission and the U.S. Justice Department are expected to announce results of their antitrust review of the proposed Anthem-Cigna, Aetna-Humana, Walgreens-Rite Aid and Pfizer-Allergan mergers.

The Health Resources and Services Administration is expected to issue guidance on the 340B Drug Pricing Program, which requires drugmakers to offer discounts to providers serving low-income and uninsured patients.

The FDA is expected to issue rules for electronic cigarettes that could require the agency to regulate e-cigarettes as drugs or devices.


The CMS will issue a rule requiring healthcare providers to develop discharge plans for all Medicare inpatients and certain outpatients.

The CMS will issue a final rule on 2017 cost and quality benchmarking for accountable care organizations in the Medicare Shared Savings Program.

The U.S. Equal Employment Opportunity Commission will issue a rule clarifying that employers offering wellness programs as part of their health plans may provide limited financial and other incentives in exchange for an employee's spouse providing information about his or her current or past health status.

The Centers for Disease Control and Prevention will finalize guidelines for physicians who prescribe opioid pain medications.

The FDA will release final guidelines on the naming of biosimilar products, including requiring unique nonproprietary names to ensure consumers can differentiate between products.

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