On December 10, 2020, the U.S. Department of Health and Human Services (“HHS”) Office for Civil Rights (“OCR”) issued a Notice of Proposed Rulemaking (“NPRM”) to modify the HIPAA Privacy Rule. HHS stated that the proposed modifications, which are being issued as part of HHS’s “Regulatory Sprint to Coordinated Care,” are aimed at removing barriers to coordinated care, strengthening individuals’ access to their own medical information, and reducing unnecessary administrative burdens. Proposed changes to the HIPAA Privacy Rule in the NPRM include: Continue reading “HHS Issues Proposed Changes to the HIPAA Privacy Rule”
CARES Act Provider Relief Fund $30 Billion Distribution Announced by HHS
Immediate funds are now available for providers to receive a cash influx at a critical time. The challenge will not be receiving the funds, but rather keeping the funds after a future audit of compliance with the terms and conditions.
On April 10, 2020, the United States Department of Health and Human Services (HHS) announced the immediate distribution of an initial $30 billion in relief funding to providers in support of the nationwide COVID-19 response. The distribution is part of the $100 billion provider relief fund included in the Coronavirus Aid, Relief and Economic Security (CARES) Act recently passed by Congress. Importantly, HHS has noted that these are payments, not loans, to healthcare providers, and will not need to be repaid unless the provider does not comply with the terms and conditions.
To read the full text of this Duane Morris Alert, please visit the firm website.
The CARES Act Amends Federal Law Governing the Confidentiality of Substance Use Disorder Patient Records
The CARES Act (the “Act”), enacted on March 27, 2020, makes notable changes to federal law governing the disclosure of substance use disorder (“SUD”) records. The Act amends 42 U.S.C. 290dd-2, the governing statute of the regulations at 42 C.F.R. Part 2 (“Part 2”) to better align certain of its confidentiality requirements with HIPAA. The amendments do not change the basic premise that prior written consent of the patient is required for disclosure of SUD treatment records. However, once prior written consent of the patient is obtained, the amendments allow a covered entity, business associate, or Part 2 program to use or disclose SUD records for purposes of treatment, payment, and health care operations as permitted by HIPAA. Any information so disclosed may then be redisclosed in accordance with the HIPAA regulations. The amendments also allow a patient’s prior written consent to be given once for all such future uses or disclosures for purposes of treatment, payment, and health care operations, until the patient revokes his or her consent in writing. Continue reading “The CARES Act Amends Federal Law Governing the Confidentiality of Substance Use Disorder Patient Records”
OCR Loosens HIPAA Enforcement Amidst Coronavirus Pandemic
There are several measures OCR/HHS has taken to lessen the regulatory burden of HIPAA for health care providers amidst COVID-19. Here is the latest breakdown of important pronouncements and guidance set forth by OCR/HHS to help providers deal with COVID-19 and HIPAA compliance:
Continue reading “OCR Loosens HIPAA Enforcement Amidst Coronavirus Pandemic”
Cybersecurity and Emergency Preparedness for Long-Term Care
On January 13, 2017, the Centers for Medicare and Medicaid Services (“CMS”) sent a Memorandum (“Memo”) to State survey agency directors encouraging long-term care providers to “consider cybersecurity when developing or reviewing their emergency preparedness plans.” The Memo was a follow-up to the CMS long-term care emergency preparedness rule published in the Federal Register on September 16, 2016: “Medicare and Medicaid Programs; Emergency Preparedness Requirements for Medicare and Medicaid Participating Providers and Suppliers.” Under that final rule, long-term care facilities were held to additional standards, including requirements to have emergency and standby power systems in place. Nursing homes were also required to create plans regarding missing residents that could be activated regardless of whether the facility has activated its full-scale emergency plan. The rule was spurred on by recent flooding in Baton Rouge, Louisiana, and other emergency disasters, such as Hurricane Sandy and the 2009 H1N1 pandemic, according to CMS.
Whether State surveyors will actually enforce lack of cybersecurity plans for emergency preparedness as violations remains to be seen from this Memo. But certainly, a State survey agency could impose deficiencies for failure to have a proper cybersecurity plan and/or a proper cybersecurity back‑up plan as part of a facility’s emergency preparedness going forward. It is not clear why CMS decided to send this encouragement Memo three months after the Final Rule on emergency preparedness, but it likely has something to do with the fact that 2016 was a banner year for HIPAA privacy infractions and HIPAA enforcement by the Office for Civil Rights (“OCR”), the entity responsible for HIPAA compliance. In 2016, payouts for HIPAA violations skyrocketed to record heights of $23.51 million from OCR enforcers against health care providers. That number was triple the previous record of almost $7.94 million in payouts in 2014, followed by $6.19 million in payouts in 2015.
Continue reading “Cybersecurity and Emergency Preparedness for Long-Term Care”
Government Cracks Down On Nursing Home Use of Social Media
On August 5, 2016, the Centers for Medicare and Medicaid Services (CMS) published a Survey and Certification Memorandum (Notice) urging State health departments to enforce violations by nursing homes in posting patient images on social media. This development was interesting given that the Office for Civil Rights (OCR), the enforcer of the Health Insurance Portability and Accountability Act (HIPAA) Privacy and Security Rules, presumably should already be cracking down on any such violations of resident rights as a violation of HIPAA. According to Modern Healthcare, increased instances of nursing home staff inappropriately posting resident pictures on social media may have sparked this pronouncement by CMS.
Specifically, CMS will more strictly enforce, through State agencies, corrective actions to ensure that employee postings of residents in a degrading manner do not occur in the nursing home setting. Interestingly, the Notice does not discuss nursing homes reporting such employee conduct to OCR, but does indicate that employees should report such postings on social media of residents as abuse “to at least one law enforcement agency.” Continue reading “Government Cracks Down On Nursing Home Use of Social Media”
ACOs are More Important Than Ever for LTC Facilities
On January 26, 2015, the United States Department of Health & Human Services (HHS) announced its timeline for shifting Medicare reimbursements from volume-based criteria to value-based criteria. HHS has adopted a framework that categorizes health care payments according to how providers receive payment to provide care:
• Category 1—fee-for-service with no link of payment to quality
• Category 2—fee-for-service with a link of payment to quality
• Category 3—alternative payment models built on fee-for-service architecture
• Category 4—population-based payment
In Monday’s announcement, HHS disclosed its initiative to drive more of the Medicare payments to categories 3 and 4. This is the first time in history that HHS has set explicit goals for alternative payment models and value-based payments. HHS declared: “Improving the quality and affordability of care for all Americans has always been a pillar of the Affordable Care Act, alongside expanding access to such care. The law gives us the opportunity to shape the way health care is delivered to patients and to improve the quality of care system-wide while helping to reduce the growth of health care costs.”
By the end of 2016, HHS has set a goal of tying 30 percent of traditional, fee-for-service, Medicare payments to quality or value through alternative payment models, such as Accountable Care Organizations (ACOs) or bundled payment arrangements. By the end of 2018, the goal is 50 percent of these payments.
An ACO is an organization of health care providers that agree to be accountable for the quality, cost, and overall care of a group of Medicare beneficiaries. Reimbursement is tied to quality metrics to reduce the total cost of care for the assigned population of patients. Hospitals and physicians have been forming ACOs, and HHS’s most recent initiative should drive even more dollars in this direction.
However, in our experience, long-term care facilities (LTC Facilities) have been slow to adopt the ACO model. Refusal to join an ACO could result in fewer referrals from hospitals and other providers, since ACO members will refer to the facility (or facilities) within the ACO. LTC Facilities with high ratings for their Quality Measures (on Nursing Home Compare) and low re-hospitalization rates will be more attractive to ACOs. Now is the time to join an ACO, before it is too late.
WellPoint Pays HHS $1.7 Million to Settle HIPAA Security Violations
Covered Entities Cautioned Regarding Use of Business Associates
On July 8, 2013, health insurer WellPoint, Inc. entered into a Resolution Agreement with the U.S. Department of Health and Human Services, Office for Civil Rights (HHS), agreeing to pay HHS $1.7 million to resolve an HHS complaint regarding violations of the HIPAA Privacy and Security Rules during the period of October 23, 2009, through March 7, 2010. WellPoint reported a breach of electronic protected health information (ePHI) on June 18, 2010, leading to an HHS investigation that commenced on September 9, 2010.
The WellPoint matter serves as a reminder to HIPAA-covered entities and subcontractors that are business associates to comply with the HIPAA Security Rule and to prudently oversee the services provided by these business associates.
Click here to read the full Alert.
Increased Spotlight on Emergency Department Facility Coding by CMS, HHS and DOJ
Although the professional component of coding for evaluation and management services (“E&M Services”) has been scrutinized over the years, until recently, little attention has been given to coding practices for the facility component of these services—including emergency department facility services. In a September 24, 2012, letter written by Kathleen Sebelius, Secretary, U.S. Department of Health and Human Services (HHS); and Eric Holder, Jr., Attorney General, U.S. Department of Justice, to hospital leadership throughout the United States, HHS and the Justice Department expressed their concern that hospitals may be inappropriately coding E&M Services. Specifically, the letter notes that “CMS is initiating more extensive medical reviews to ensure that providers are coding evaluation and management services accurately.” In light of the recent attention on emergency department facility component coding practices, an area that so far has largely been overlooked by the regulators, any facility that has not reviewed its coding practices for the facility component of E&M Services may want to consider doing so at this time.
Click here to read the full Alert.
HHS OIG Notice Seeks Comments on Safe Harbors, Special Fraud Alerts
Once a year, as required by the Health Insurance Portability and Accountability Act of 1996, the Department of Health and Human Services Office of the Inspector General (“OIG”) solicits proposals to develop new or revised anti-kickback, fraud and abuse safe harbors. The OIG published its request for proposals for new or revised safe harbors in the December 29, 2011 Federal Register. The notice also seeks comments on developing special fraud alerts.
Continue reading “HHS OIG Notice Seeks Comments on Safe Harbors, Special Fraud Alerts”