The Affordable Care Act has entered its most pivotal year since being signed into law in 2010. About 20 million Americans gained coverage during the ACA’s inaugural open enrollment period, and hospitals and physicians are beginning to reorient how they deliver care to align with new payment models. It’s now more important than ever to stay atop the regulatory environment, as federal agencies provide the guideposts to an emerging new health economy. But that’s just the starting point. As consumers shoulder more of the costs for care, prepare to see dynamic changes as the industry shifts to compete for the newly insured.

Learn more about the healthcare regulatory environment through the following resources:

HRI regulatory spotlight: Bar raised for handling health information under final HIPAA rule
The final version of the HIPAA rule, released by HHS in late January, reflects two growing realities among the US health system. First, the rule takes a decidedly consumer-centric approach, strengthening existing patient protections for personal information and limiting how providers, insurers and others may use it. And second, the rule reflects a changing health system that is becoming more and more digital.

HRI regulatory spotlight: Hospitals granted broader role in exchange enrollment
New regulations issued by CMS allow hospitals to play an extensive role in helping uninsured or under-insured individuals understand their new health plan options under the ACA. But some hospital staff who aid in the process will be required to disclose potential conflicts of interest, especially if they have financial ties to insurers.

HRI regulatory spotlight: IRS: More flexibility, forgiveness on community assessment
One of the ACA’s new requirements for charitable hospitals is the completion of a community health needs assessment every three years. At the risk of potentially losing their tax exemption, the provision requires charitable hospitals to study the health needs of the community make those findings public. On April 3, the IRS issued proposed guidance that eases some of industry's concerns by indicating a considerable degree of flexibility and clarifying what would trigger the loss of tax-exempt status.

HRI regulatory spotlight: Pharma, providers must disclose financial ties
A final rule implementing the Physician Payment Sunshine Act could redefine the relationship between providers and the makers of drugs and devices. That’s the hope of lawmakers who aim to reduce conflicts of interest they believe are created by the undisclosed financial ties between industry and physicians.

HRI regulatory spotlight: FDA eyes stricter post-market surveillance for medical devices
Manufacturers must confront new rules and procedures around Unique Device Identifiers (UDIs) and greater transparency that could result in increased product liability if safety signals are not properly defined. The collection of more robust product information could improve development and manufacturing capability, as well as speed up product reviews and approval.

Health reform re-elected: ACA implementation in tough fiscal times
President Barack Obama's re-election reaffirms the future of the Affordable Care Act, the 2010 law which expands coverage and nudges the nation's health system away from fee-for-service medicine. But harsh financial pressures -- a looming $600 billion "fiscal cliff" and a growing long-term debt -- will add to an already challenging implementation plan. What will the impact of the US presidential election be on the cost of providing healthcare for your business?

Medicaid expansion: New patients, new challenges
Medicaid is expected to absorb more than 11 million new enrollees over the next decade, yet little is known about their health needs. Providers, insurers and drug companies must first understand the demographics behind the expansion before they can tailor their medical and business practices to take advantage of the opportunities they will provide

Health Insurance Exchanges: Long on options, short on time
In 2013, state exchanges will open for enrollment. Some states are prepared to establish their own exchanges, but many others will look to the federal government to run most-if not all-of their exchange functions. Understanding the nuances of the public and private exchange models and the new members will be critical for businesses to succeed in this new marketplace.

Final rules on ACA's employer mandate include new transition relief

The IRS issued final regulations providing guidance on the Affordable Care Act's employer shared responsibility provisions, sometimes called the 'employer mandate' or the 'pay or play' rules. The regulations apply for periods after December 31, 2014 to applicable large employers who fail to offer coverage to their full-time employees. The regulations extend earlier transition rules and provide new ones to help employers comply with the requirements.

Highlights of the final regulations include:

an extended transition period for employers with between 50 and 99 full-time equivalent employees, so they won't be subject to penalties until 2016

a temporary rule for employers with 100 or more full-time employees, so the largest penalty will not apply for 2015 if the employer offers coverage to at least 70% of its full-time employees (rather than 95% as will be required after 2015)

final rules for determining full-time employee status reflect the proposed regulations, including the optional look-back measurement period and stability period, with numerous clarifications and new definitions

additional guidance for the monthly method of determining full-time status

rules for determining full-time status for special categories of employment, including a new definition of seasonal employees

an additional year for employers who do not now offer coverage to their employees' dependents to comply, as long as coverage is offered to the children of employees by the 2016 plan year

safe harbors for determining if employer-provided coverage is affordable for employees for purposes of the employer penalties

The Treasury Department and the IRS plan to issue final regulations soon intended to simplify and streamline the associated employer reporting requirements.