HRI regulatory center

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 - New reporting requirements take effect in August

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: 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: Final rules provide needed clarity on risk management

The Department of Health and Human Services (HHS) recently released a proposed rule on three new ACA programs – risk adjustment, reinsurance, and risk corridors. The programs are intended to stabilize the health insurance marketplace and encourage participation in the exchanges. The proposed rule offers clarity on these programs, but also raises questions on how effective they will be in minimizing insurer risk and ensuring compliance with other ACA regulations.

HRI regulatory spotlight: Insurance rule provides flexible framework for states

In February 2013, The Centers for Medicare and Medicaid Services (CMS) released a final rule that provides a framework for states on how to run their insurance oversight programs. The rule also addresses areas such as age, tobacco and geographic rating, risk pools, enrollment periods and index rating. Insurers will need to fundamentally rethink their business strategies to stay in the game.

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.

The Massachusetts Experience:Employer-sponsored health insurance post reform

As implementation of the Affordable Care Act (ACA) presses forward, questions remain about how employers and workers will react to the law once it is in full effect.

Warning signs for the health industry: HRI post-election consumer survey results

69% of post-election healthcare consumers polled by PwC's Health Research Institute (HRI) ranked the need to reign in healthcare costs as the number one health industry priority for the Obama administration.

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.

2012 Food and Drug Administration Safety and Innovation Act (FDASIA)

FDASIA adds new fee categories for generics and biosimilars and more than doubles fees for medical devices. The reauthorization also introduces provisions for medical devices, supply chain monitoring, drug shortages, antibiotic development incentives, and more.