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New HIPAA Regulations in 2019

New HIPAA Regulations in 2019 | Healthcare and Technology news |

While there were expected to be some 2018 HIPAA updates, the wheels of change move slowly. OCR has been considering HIPAA updates in 2018 although it is likely to take until the middle of 2019 before any proposed HIPAA updates in 2018 are signed into law. Further, the Trump Administration’s policy of two regulations out for every new one introduced means any new HIPAA regulations in 2019 are likely to be limited. First, there will need to be some easing of existing HIPAA requirements.


HIPAA updates in 2018 that were under consideration were changes to how substance abuse and mental health information records are protected. As part of efforts to tackle the opioid crisis, the HHS was considering changes to both HIPAA and 42 CFR Part 2 regulations that serve to protect the privacy of  substance abuse disorder patients who seek treatment at federally assisted programs to improve the level of care that can be provided. Other potential changes to HIPAA regulations in 2018 included the removal of aspects of HIPAA that impede the ability of doctors and hospitals to coordinate to deliver better care at a lower cost.


These are the most likely areas for HIPAA 2019 changes: Aspects of HIPAA Rules that are proving unnecessarily burdensome for HIPAA covered entities and provide little benefit to patients and health plan members, and those that can help with the transition to value-based healthcare.

How are New HIPAA Regulations Introduced?

The process of making HIPAA updates is slow, as the lack of HIPAA changes in 2018. It has now been 5 years since there was a major update to HIPAA Rules and many believe changes are now long overdue. Before any regulations are changed, the Department of Health and Human Services will usually seek feedback on aspects of HIPAA regulations which are proving problematic or, due to changes in technologies or practices, are no longer as important as when they were signed into law.


After considering the comments and feedback, the HHS then submits a notice of proposed rulemaking followed by a comment period. Comments received from healthcare industry stakeholders are considered before a final rule change occurs. HIPAA-covered entities are then given a grace period to make the necessary changes before compliance with the new HIPAA regulations becomes mandatory and enforceable.

New HIPAA Regulations in 2019

OCR issued a request for information in December 2018 asking HIPAA covered entities for feedback on aspects of HIPAA Rules that were overly burdensome or obstruct the provision of healthcare, and areas where HIPAA updates could be made to improve care coordination and data sharing.


The period for comments closed on February 11, 2019 and OCR is now considering the responses received. A notice of proposed rulemaking will follow after careful consideration of all comments and feedback, although no timescale has been provided on when the NPRM will be issued. It is reasonable to assume however, that there will be some at least some new HIPAA regulations in 2019.

OCR was specifically looking at making changes to aspects of the HIPAA Privacy Rule that impede the transformation to value-based healthcare and areas where current Privacy Rule requirements limit or discourage coordinated care.


Under consideration are changes to HIPAA restrictions on disclosures of PHI that require authorizations from patients. Those requirements may be loosened as they are considered by many to hamper the transformation to value-based healthcare.


OCR is considering whether the Privacy Rule should be changed to make the sharing of patient data with other providers mandatory rather than simply allowing data sharing. Both the American Hospital Association (AHA) and the American Medical Association (AMA) have voiced their concern about this aspect of the proposed new HIPAA regulations and are against the change. Both organizations are also against any shortening of the timescale for responding to patient requests for copies of their medical records.


OCR is also considering HIPAA changes in 2019 that will help with the fight against the current opioid crisis in the United States. HHS Deputy Secretary Eric Hargan has stated that there have been some complaints about aspects of the HIPAA Privacy Rule that are stopping patients and their families from getting the help they need. There is some debate about whether new HIPAA regulations or changes to the HIPAA Privacy Rule is the right way forward or whether further guidance from OCR would be a better solution.


One likely area where HIPAA will be updated is the requirement for healthcare providers to make a good faith effort to obtain individuals’ written acknowledgment of receipt of providers’ Notice of Privacy Practices. That requirement is expected to be dropped in the next round of HIPAA changes.


What is certain is new HIPAA regulations are around the corner, but whether there will be any 2019 HIPAA changes remains to be seen. It may take until 2020 for any changes to HIPAA regulations to be rolled out.

Changes to HIPAA Enforcement in 2019

Halfway through 2018, OCR had only agreed three settlements with HIPAA covered entities to resolve HIPAA violations and its enforcement actions were at a fraction of the level in the previous two years. It was starting to look like OCR was easing up on its enforcement of HIPAA Rules. However, OCR picked up pace in the second half of the year and closed 2018 on 10 settlements and one civil monetary penalty – One more penalty than in 2018.


2018 ended up being a record year for HIPAA enforcement. The final total for fines and settlements was $28,683,400, which beat the previous record set in 2016 by 22%.

At HIMSS 2019, Roger Severino gave no indications that HIPAA enforcement in 2019 would be eased. Fines and settlements are likely to continue at the same level or even increase.


Severino did provide an update on the specific areas of HIPAA compliance that the OCR would be focused on in 2019. OCR is planning to ramp up enforcement of patient access rights. The details have yet to be ironed out, but denying patients access to their medical records, failures to provide copies of medical records in a reasonable time frame, and overcharging are all likely to be scrutinized and could result in financial penalties.


OCR will also be continuing to focus on particularly egregious cases of noncompliance – HIPAA-covered entities that have disregarded the duty of care to patients with respect to safeguarding their protected health information. OCR will come down heavy on entities that have a culture of noncompliance and when little to no effort has been put into complying with the HIPAA Rules.


The failure to conduct comprehensive risk analyses, poor risk management practices, lack of HIPAA policies and procedures, no business associate agreements, impermissible PHI disclosures, and a lack of safeguards typically attract financial penalties. OCR is also concerned about the volume of email data breaches. Phishing is a major problem area in healthcare and failures to address email security risks are likely to attract OCR’s attention in 2019.

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Many States Will Be Unprepared if Court Weakens Health Law

Many States Will Be Unprepared if Court Weakens Health Law | Healthcare and Technology news |

A Supreme Court ruling this spring could upend health insurance markets in at least 34 states, eliminating the federal subsidies that make coverage affordable for millions of Americans.

State governments, theoretically, have ways to forestall this outcome. But few have taken action. If they wait until the court rules, it may already be too late for a state to get started on an exchange so that it is ready for 2016.

The case, called King v. Burwell, concerns whether subsidies can be given to consumers in every state in the country or only in those that have established their own state marketplaces as part of the Affordable Care Act. So far, more than a dozen states and the District of Columbia have such marketplaces. Should the high court rule that subsidies can be distributed only in states running their own exchanges, markets in the remaining states would be substantially disrupted. Prices for insurance plans would sharply rise. Millions of people would drop their coverage.

A decision in the court case is expected in June; a new marketplace would need to be ready for shoppers in October in order to sell health plans for 2016. If those states want to make sure that subsidies keep flowing to their residents, they can build their own marketplaces. But it won’t be easy.

“Anyone who thinks you can just snap your fingers and you’ve got a state exchange is just wrong,” said Timothy Jost, a law professor at Washington and Lee University, who supports the Affordable Care Act.

Congress could prevent or eliminate a disruptive outcome by changing some language in the Affordable Care Act. That change may be more politically fraught than state-level actions in some parts of the country.

The Obamacare law lays out a series of clear requirements for state exchanges — some political, some operational. None of them are trivial.

The political challenges, for one, are substantial. States would need to endorse an exchange through legislation or executive action, as they have declined to do previously. The Affordable Care Act is so unpopular in some of these states that they have passed legislation explicitly barring the governor from establishing an exchange. And only eight states’ legislatures will even be in session in June when the court is expected to rule, according to David K. Jones, an assistant professor at the Boston University School of Public Health, who has studied the state exchange decision-making process and is a co-author on a recent essay in the New England Journal of Medicine spelling out the difficulties states will face.

Then there are the operational challenges. Every state marketplace needs a staff and the ability carry out a series of core functions, including regulating insurance plans, running a call center and managing a website that can enroll people in insurance coverage. Some of the states relying on the federal government are doing one or two of these functions, in an arrangement known as a partnership exchange, but most are not.

Most states will rely on contractors for major tasks, and state laws tend to require a lengthy process for contract procurement that can run six months or longer. Once contracts are signed, the states still need to hire call center employees, devise policies and build the website and its infrastructure.

Many of the 15 state marketplaces that started up last fall struggled to accomplish all of those things. Several states experienced website crashes and failures. And those early states had had more than three years to approve and design their exchanges.

Daniel Schuyler, a director at Leavitt Partners, a consulting firm that helped several states establish exchanges, estimates that building an exchange today would cost a typical state $40 million to $60 million and take between a year (if a state expedited its contracting schedule) and 18 months.

That would be faster than most states with their own exchanges managed in recent years, as well as less expensive. Late adopters would have the advantage of accumulated wisdom that the early states didn’t. They also would benefit from software and computer network contractors with more experience building the necessary computer systems. This year, Massachusetts replaced its failed software with an off-the-shelf product from another contractor. But it still needed to be retrofitted to work with the state’s system.

“You can buy an engine off the shelf, and an engine is the most important thing to make a car run,” said Nicholas Bagley, an assistant professor at the University of Michigan Law School, the other author of the New England Journal article.. “But you can’t drive something off the lot with just an engine.”

States waiting until now to act won’t have access to a substantial pot of federal money to help them get off the ground. States that have established exchanges so far sought substantial establishment grants from the federal government. By law, that funding stream expires at the end of the year, and the deadline for the last round of grant applications has already passed. (A few states that have been considering creating an exchange put in for the money.)

By law, all state exchanges must be financially self-supporting next year, which means that any states that start a new one will have to make a substantial initial investment.

“States don’t have any appetite to dip into their own coffers,” said Mr. Schuyler, who said his firm has talked with a few states about the possibility of starting a state exchange.

All of which means that the effect of a court ruling dismantling federal subsidies could be both substantial and lasting in large parts of the country. States will have the power to get subsidies to their residents. But not easily, and not right away.

“This is really going to be much more difficult for states to do quickly than a lot of people think,” Mr. Jones said.

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