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The National Guideline Clearinghouse (NGC) website, “guideline.gov,” compiles the latest information on medical treatment for use by healthcare organizations, physicians, bulk purchasers, educational institutions, and state and local governments, while also providing guidance on medications and procedures ranging from miniscule to critical. The NGC contains over 20 years of evidence-based clinical practices and medical guidelines, and was first created by the Agency for Healthcare Research and Quality (AHRQ) in partnership with the American Medical Association (AMA). AHRQ created the NGC to keep patients safe, develop and track changes to healthcare, and to help doctors and nurses improve the quality of patient care.

Although the database is accessed daily, the operating costs are about $1.2 million per year and with the Trump Administration looking to execute budget cuts, the Department of Health and Human Services (HHS) has decided to delete the database after July 16, 2018. AHRQ officially halted updates to the database and has stopped creating new guideline summaries as of July 2, 2018. AHRQ is receiving expressions of interest from stakeholders interested in carrying on NGC’s work. It is not clear, however, when or if NGC will be available again. AHRQ’s official announcement is available here: https://www.guideline.gov/home/announcements.

Not only is the future of the database uncertain, but so is the future of the AHRQ. The 2019 fiscal year budget proposed by President Donald Trump would transfer AHRQ’s duties to the National Institutes of Health (NIH), creating a new agency titled the National Institute for Research and Quality. It is unclear whether this new agency will relaunch the database, but at this point there appears to be no plans of another agency or organization taking over or continuing the operation of the NGC. The deletion of the NGC and the elimination of such a vast resource is a major loss to the medical community.

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July 2018- Section 1877 of the Social Security Act, widely known as the physician self-referral law, prohibits a physician from making service referrals payable by Medicare to entities that they may have a financial relationship with. Section 50404 of the Bipartisan Budget Act (“BBA”) of 2018 added provisions to section 1877(h)(1) of the Social Security Act. The added section does not limit an applicable signature requirement to specific exceptions and entities are not restricted to the rule of only once every 3 years with the same referring physician. Moreover, the addition “does not include a reference to the occurrence of referrals or the payment of compensation during the 90 day-period when the signature requirement is not met.”

To be in accordance with the added provision to the Social Security Act, CMS proposed to delete §411.353(g), which is the special rule for certain arrangements involving temporary noncompliance with signature requirements, and instead codify in proposed §411.353(e). Alternatively, CMS has proposed to amend existing §411.353(g) by: “(1) revising the reference at §411.353(g)(1) to specific exceptions and signature requirements; (2) deleting the reference at §411.353(g)(2) to the occurrence of referrals or the payment of compensation during 90-day period when the signature requirement is not met; and (3) deleting the limitation at §411.353(g)(2).”

Public comments on the proposed rules are due by September 10,2018.

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July 2018 – On July 12, 2018, the Centers for Medicare & Medicaid Services (“CMS”) proposed rules aimed at fundamentally improving the nation’s healthcare system and restoring the doctor-patient relationship. The proposal is “one of the most significant reductions in provider burden undertaken by any administration,” according to CMS director Seema Verma. The new proposed rules include the promotion of digital health technology, expanded telemedicine coverage, new documentation requirements, and a newly developed focus on interoperability.

The proposed rules are promoting digital health technology by expanding telemedicine coverage. According to the new rules, CMS will start to pay physicians for virtual check-ins over the phone with their patients to see if the need to come in for an office visit and will also pay them for remote evaluation of images and videos taken by their patients. The intended purpose of this proposed rule is to ameliorate patient concerns in a convenient manner by reducing unnecessary cost to the system with needless office visits.

Moreover, the enactment of the proposed rules would overhaul the current documentation requirements. Instead of having a system with four kinds of documentation requirements, the proposed rules would create a system with one set of documentation requirements that would have four distinct code levels. The overhaul is estimated to save clinicians an estimated 51 hours per year if 40% of their patients are in Medicare. The idea is to have the clinicians documenting material that will capture the patient’s health data rather than spending time typing information to bill a certain level of code.

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June 2018 – On June 19, 2018, the Centers for Medicare & Medicaid Services (“CMS”) issued a Request for Information (“RFI”) seeking public input on how to address any undue impact and burden of the physician self-referral law, 42 U.S.C. § 1395nn (the “Stark Law”).

By way of background, the Stark Law addresses the concern that health care decision making can be unduly influenced by a profit motive and when physicians have a financial incentive to refer patients for health care services, overutilization in medical services may result. To counter such concerns, the Stark Law, subject to certain exceptions: (1) prohibits physicians from making referrals for certain designated health services (“DHS”) payable by Medicare to an entity with which the physician (or an immediate family member) has a financial relationship; and (2) prohibits the entity from filing claims with Medicare (or billing another individual, entity, or third-party payer) for those referred services.

In response to a prior RFI published by CMS requesting comments on improvements that can be made to the health care delivery system that reduce unnecessary burdens, the commenters identified compliance with the Stark Law and its regulations as one of the top areas of burden. In response to these concerns, CMS is now requesting additional information. Specifically, CMS is interested in thoughts on issues that include the structure of arrangements between parties that participate in alternative payment models or other novel financial arrangements, the need for revisions or additions to exceptions to the Stark Law and terminology related to alternative payment models and the Stark Law.

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Please Join The HLP at the 2018 Physicians Legal Issues Conference in Chicago, Illinois

The Health Law Partners (HLP) is proud to be part of the upcoming Physician Legal Issues Conference co-sponsored by the American Bar Association Health Law Section and Chicago Medical Society.  The conference will take place at the Intercontinental Hotel in Chicago on June 7-9, 2018.  Adrienne Dresevic, Esq., a founding partner of the HLP, is Co-Chairing the conference this year.  Jessica Gustafson, Esq., a founding partner of the HLP, will be a featured speaker at the conference. Ms. Gustafson’s speech is titled, Will Medicare Revoke Your Billing Privileges? Don’t Answer “No” Too Quickly.  Her session addresses key issues for providers and suppliers facing revocation of billing privileges, including: an overview of CMS’s revocation authority, how CMS is using this authority against provider and suppliers, and strategies for appealing revocation.  Attend the conference to learn the latest on health reform, payor alignment, clinical integration, healthcare employment and other issues that impact the legal profession. Programming includes topics such as: Stark Law, Health Reform, Anti-Kickback, and more!

To the view the brochure with program details please click here.  To register for the conference please click here.

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March 2018 – Recent additions to the Medicare Shared Savings Program (“MSSP”), include several changes aimed to encourage Medicare beneficiaries to take a more proactive approach with their health care.

By way of background, on March 23, 2010, Section 3022 of the Affordable Care Act added section 1899 (42 U.S.C. § 1395jjj) to the Social Security Act, requiring that the U.S. Department of Health & Human Services (“DHHS”) establish the MSSP. The program provides for a new type of health care entity, an Accountable Care Organization (“ACO”), that is held accountable for the quality and experience of care for a population of assigned Medicare beneficiaries while reducing the rate of growth in health care spending for that population. Under the MSSP, an ACO’s quality and financial performance is assessed annually by the Center for Medicare and Medicaid Services (“CMS”) based on its assigned beneficiaries to determine whether the ACO has met the quality performance standards and reduced growth in expenditures compared to a historical financial benchmark. ACOs that meet or exceed a minimum savings rate and satisfy minimum quality performance standards are eligible to receive a portion of the shared savings generated which incentivizes ACOs to improve the coordination and quality of care. There are different tracks or programs, depending on the amount of risk an ACO wishes to assume.

On February 9, 2018, President Trump signed H.R. 1892, entitled the Bipartisan Budget Act of 2018, into law which, among other things, inserts 42 U.S.C. § 1395jjj(m) providing that certain ACOs (limited to ACOs in risk-bearing tracks) may apply to establish an ACO Beneficiary Incentive Program to provide incentive payments to beneficiaries who are furnished certain qualifying services by an ACO.

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In the world of litigation healthcare providers can potentially fall victim to the False Claims Act (“FCA”) when they file medical claims for reimbursement from either Medicaid or Medicare. FCA claims against hospitals and other healthcare related entities usually involve allegations that the healthcare provider knowingly or recklessly filed a false claim for payment from a federally funded government program. Under the FCA qui tam provisions, private citizens, known as “relators”, can file lawsuits where they have suffered no personal injury. Instead, these relators allege the federal government was defrauded and can obtain a substantial monetary reward if they are successful in recovering a judgement from the court.

A hotly contested issue in qui tam cases is whether the violation of the regulation alleged in the case is material to the government’s obligation to pay a healthcare claim. For instance, whenever a physician or supplier of medical services completes a form 1500, it certifies the claims were medically indicated and necessary and that any “false claims, statements, or documents, or concealment of a material fact, may be prosecuted under applicable Federal or State laws.” Historically, the issue in a lot of cases involving alleged false claims is whether the claim made by the healthcare provider is either a “condition of payment” or a “condition of participation” in the governmental program. If the alleged false claim only violated a condition of participation, as opposed to a condition of payment, then there could be no false claim in violation of the FCA. Courts reasoned that conditions of payment were central to the government’s decision to pay claims as opposed to a mere violation of a condition of participation that could be handled administratively by the enforcing governmental agency.

After the United States Supreme Court’s ruling in Universal Health Servs. v. United States ex rel. Escobar 136 S. Ct. 1989 (2016), the old condition of payment or condition of participation standards for materiality were largely abandoned. Instead, the Supreme Court, adopted a new “rigorous” materiality standard. Escobar, 136 S.Ct. at 2004 n.6. Although promulgated conditions of payment in statutes or regulations are relevant in attempting to establishing materiality, they are not “automatically dispositive.” Id. at 2003. Moreover, the Supreme Court held that “A misrepresentation cannot be deemed material merely because the Government designates compliance with a particular statutory, regulatory, or contractual requirement as a condition of payment. Nor is it sufficient for a finding of materiality that the Government would have the option to decline to pay if it knew of the defendant’s noncompliance.” Escobar, a relator is now faced with a steeper climb to show that the violation of a particular statute or regulation is material to the government’s decision to a pay the medical claim.

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In its recent Advisory Opinion No. 17-05, OIG stated that the Proposed Arrangement (“Arrangement”) would not violate the anti-kickback statute (“AKS”) nor would it prompt administrative sanctions under the Civil Monetary Penalties (“CMP”) provision of the Social Security Act, prohibiting inducements to beneficiaries.

The Proposed Arrangement discussed in the Opinion centers around a retail pharmacy chain offering a voluntary membership program to Federal healthcare program beneficiaries that includes discounts on certain prescriptions and clinic services.

OIG further noted that Program Members receiving discounts would also be eligible to earn rewards in the form of credits when certain merchandise in-store photo-finishing services were purchased. On its face, the Arrangement would appear to invoke prohibitions of the CMP and AKS, since the discounted items and services and earned credits could induce a beneficiary to select the retail pharmacy chain as his or her supplier for federally reimbursable items or services.

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Home Health Agencies will now have an additional 6 months to comply with a new CMS rule intended to advance the quality of patient care.

CMS published a final rule on July 10th delaying the effective date for its rule addressing conditions of participation for home health agencies. CMS has moved the effective date of the rule back 6 months from its original July 13, 2017 to January 13, 2018. This delay pushes back the implementation of regulations primarily focused on improving patient quality of care.

Under the new rule Home Health Agencies are directed to begin implementing data-driven performance improvement projects. These data-driven programs are concentrated on quality assessment programs targeting indicators related to improved outcomes for patients and other quality indicators across the home health spectrum of care. This quality program requirement is now set to phase-in on July 13, 2018 instead of January 13, 2018.

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The Health Law Partners (HLP) is proud to be part of the upcoming Physician Legal Issues Conference co-sponsored by the American Bar Association Health Law Section and Chicago Medical Society.  The conference will take place at the Intercontinental Hotel in Chicago on June 8-9, 2017.  Adrienne Dresevic, Esq., a founding partner of the HLP, is Co-Chairing the conference this year.  Abby Pendleton, Esq., a founding partner of the HLP, will be a featured speaker at the conference. Ms. Pendleton’s speech is titled, Your Practice is Being Audited: Complying, Fighting and Winning. Her session addresses key issues when facing an audit including: appeals processes and auditors’ concepts, considerations affecting the decision to appeal, successful strategies for appeals, and using the audit to enhance future compliance. Attend the conference to learn the latest on health reform, payor alignment, clinical integration, and other issues that impact the legal profession. Programming includes topics such as: Stark Law, Health Reform, Anti-Kickback, and more!

 

To the view the brochure with program details please click here.  To register for the conference please click here.

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