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
The Centers for Medicare and Medicaid Services (CMS) and Office of Inspector General (OIG) issued the final rule regarding waivers of the application of the physician self-referral law, the Federal anti-kickback statute, and the civil monetary penalties (CMP) law provision relating to beneficiary inducements to specified arrangements involving accountable care organizations (ACOs) under section 1899 of the Social Security Act (the Act) (the “Shared Savings Program”). For purposes of the Shared Savings Program, providers must integrate in ways that potentially implicate fraud and abuse laws addressing financial arrangements between sources of Federal health care program referrals and those seeking such referrals. The Shared Savings Program focuses on coordinating care between and among providers, including those who are potential referral sources for one another—potentially in violation of the fraud and abuse laws.
In order to provide flexibility for ACOs and their constituent parts, the following five waivers have been created:
- ACO pre-participation waiver – waives the physician self-referral law and the Federal anti-kickback statute that applies to ACO-related start-up arrangements in anticipation of participating in the Shared Savings Program, subject to certain limitations, including limits on the duration of the waiver and the types of parties covered.
- ACO participation waiver – waives the physician self-referral law and the Federal anti-kickback statute that applies broadly to ACO-related arrangements during the term of the ACO’s participation agreement under the Shared Savings Program and for a specified time thereafter.
- Shared savings distributions waiver – waives the physician self-referral law and the Federal anti-kickback statute that applies to distributions and uses of shared savings payments earned under the Shared Savings Program.
- Compliance with the physician self-referral law waiver – waives the Federal anti-kickback statute for ACO arrangements that implicate the physician self-referral law and satisfy the requirements of an existing exception.
- Patient incentive waiver – waives the Beneficiary Inducements CMP and the Federal anti-kickback statute for medically related incentives offered by ACOs, ACO participants, or ACO providers/suppliers under the Shared Savings Program to beneficiaries to encourage preventive care and compliance with treatment regimes.
The waivers apply uniformly to each ACO, ACO participant, and ACO provider/supplier participating in the Shared Savings Program. The waivers are self-implementing; parties need not apply for a waiver. Rather, parties that meet the applicable waiver conditions are covered by the waiver.
On April 12, 2012, the Centers for Medicare & Medicaid Services (“CMS”) released a final rule with comment period (“Final Rules”) implementing changes to the Medicare Advantage program and Medicare’s prescription drug benefit program, referred to as Medicare Parts C and D, respectively. Part C and D plan sponsors and other participants should carefully review the changes, particularly those related to increased transparency and exclusion from Parts C and D. The Final Rules are the latest effort by CMS to improve accountability, transparency, and effectiveness of the Medicare program.
Continue reading CMS Releases New Medicare Advantage and Medicare Part D Rules, Implements Several Provisions of ACA
On February 9, 2012, the Department of Health and Human Services, the Department of Labor, and the Department of the Treasury jointly issued final regulations pursuant to the Affordable Care Act regarding plain-language health insurance plan descriptions. Health insurers will soon be required to present health plan benefits and coverage information in a clear, consistent and comparable manner.
Continue reading Making Insurance Plans Comparable: Regulations Released Requiring Plain-Language Insurance Information
On January 13, 2012 CMS issued Transmittal 153, implementing section 3108 of the Affordable Care Act which now allows physician assistants to perform level of care certifications and recertifications in skilled nursing facilities. The physician assistant may perform the certification or recertification if the physician assistant collaborates with the physician but does not have a direct or indirect employment relationship with the facility. The new transmittal will be implemented on February 13, 2012 and the changes will be effective with items and services furnished on or after January 1, 2011.
Read CMS’ full transmittal here.
On December 20, 2011 the Supreme Court of the United States set the date to hear challenges to the health care reform law. On March 26 – 28 the Court will hear five-and-a-half hours of oral argument on the several challenges to the Affordable Care Act that are currently pending before the Court. The first day is reserved for oral argument on the federal anti-injunction act’s effect on commerce clause challenges to the Affordable Care Act, and on the second day the Court will hear the long-anticipated argument on the constitutionality of the Affordable Care Act’s individual mandate. The final day is reserved for argument on the severability of the individual mandate and the constitutionality of the Medicaid expansion created through the Affordable Care Act.
On December 16, 2011, the Department of Health and Human Services (HHS) recently issued a guidance bulletin detailing its current thinking on the implementation of ‘essential health benefits’ (EHB) under the Affordable Care Act (ACA). Specifically, the bulletin addresses covered services under the ACA’s mandate that certain insurers provide EHB by 2014. The ACA defines EHB as:
Continue reading HHS Issues Guidance on ‘Essential Health Benefits’ under ACA
The Centers for Medicare & Medicaid Services (CMS) issued its final rule today establishing the Affordable Care Act’s (ACA’s) Consumer Operated and Oriented Plan (CO-OP) program. The CO-OP program was established to provide financial support, in the form of loans, for the creation of non-profit, private, consumer-governed health insurance companies that will be qualified to offer insurance plans through the ACA’s health insurance exchange markets. As CMS described in the final rule, the goal of the CO-OP plans is to increase the number of plans that are focused on integrated care and plan accountability, as well as to increase competition and promote efficiencies, premium reductions, and improve enrollee services and benefits. This final rule establishes a two-year time frame for CO-OP plans to transition to member-elected boards, clarifies that certain existing insurers are ineligible for funding, and sets forth the instances in which CO-OP plans may receive state or local government funding. The final rule likewise describes the CO-OP’s obligation to remain compliant with state and federal standards for insurers.
Read the full text of the rule here.
The Department of Health and Human Services (HHS) recently cited as “excessive” a 12% insurance rate increase proposed by Everest Insurance under a Pennsylvania insurance plan. HHS’ finding that the rate increase was excessive was the first such move under the Affordable Care Act, which gives HHS the authority to review insurance rate increases over 10% and cite them as excessive. Although the Affordable Care Act does not give HHS the authority to sanction insurers attempting to push through excessive rate increases, the hope is that publicizing the excessive rate increases will increase transparency and accountability.
Read HHS’ full news release here.
vIn a highly anticipated decision, on November 14, 2011 the United States Supreme Court granted certiorari in three cases on the constitutionality of the Affordable Care Act (“ACA”): National Federation of Independent Business v. Kathleen Sebelius, Secretary of HHS, et al.; Florida, et al. v. Department of Health and Human Services; and Department of Health & Human Services et al. v. Florida, et al. The Court’s review will address four fundamental questions: (1) whether the ACA’s individual mandate is constitutional, (2) whether the individual mandate may be severed from the ACA if it is unconstitutional, (3) whether the claim brought by the opponents to the mandate is barred by another federal statute, and (4) whether the ACA’s expansion to Medicaid coverage was valid. The Court has granted a total of four and a half hours of oral argument for the three issues, which is highly unusual. This decision will be monumental for the future of the ACA, and will be closely followed by Duane Morris attorneys.
View the United States Supreme Court’s order here.