Issued in January 2018, the so-called Brand Memo reminded Department of Justice (DOJ) attorneys that “[g]uidance documents cannot create binding requirements that do not already exist by statute or regulation.” It also instructed DOJ attorneys that they “may not use noncompliance with guidance documents as a basis for proving violations of applicable law in affirmative … Continue Reading
As previously discussed here and over on Health Industry Washington Watch here, this past Thursday, CMS and OMB issued the final, 600+ page Medicaid Rebate Program Final Rule. The pre-Federal Register version of the final rule may be accessed here. While we are still processing what this will mean for drug manufacturers and other health … Continue Reading
As noted in our recent Health Industry Washington Watch blog post, outgoing House Speaker John Boehner and the Obama Administration have reached agreement on a two-year, $80 billion budget/debt-ceiling deal that includes Medicare and Medicaid “offsets” to finance other spending. For manufacturers of generic pharmaceuticals marketed under abbreviated new drug applications, Section 602 of the proposed … Continue Reading
Today the House Energy and Commerce Committee is marking up H.R. 6, the 21st Century Cures Act, a high-profile, bipartisan bill that seeks to accelerate the pace of medical cures in the United States through a variety of reforms addressing drug and device development and approval, clinical trial design, research funding, interoperability of health technology, … Continue Reading
Last week, President Obama signed into law a bill that will eradicate Social Security Numbers (SSNs) from all Medicare beneficiary cards over the next eight years. Medicare has four years to begin issuing cards with new identifiers, and four years after that to reissue cards to current beneficiaries. The removal of SSNs from the cards is not only expected to decrease the risks associated with identity theft for Medicare beneficiaries, but also Medicare's risk of exposure associated with breaches of protected health and personal information under HIPAA and state privacy laws.… Continue Reading
On April 16, 2015, President Barack Obama signed into law the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA). The bill permanently transforms the structure of Medicare physician reimbursement and enacts several changes to Medicare payment, program integrity and policy provisions that will affect both health care providers and pharmaceutical/medical device manufacturers. The most … Continue Reading
CMS has issued an educational article on the FDA's approval of the first biosimilar product, and what implications this approval will have for Medicare coverage. CMS plans to ensure that Medicare beneficiaries will have access to this new product, as it does for other drugs that receive FDA approval. The CMS article addresses several questions that have arisen regarding biosimilars.… Continue Reading
Earlier this week, the Court of Appeals for the Federal Circuit reversed and remanded the Court of Federal Claims’ August 2014 decision in CGI Federal Inc. v. The United States, in which the Court of Federal Claims ruled that the Centers for Medicare and Medicaid Services (CMS) could include contract clauses that deviated from federal … Continue Reading
As mentioned on our Health Industry Washington Watch blog, committees in both the House of Representatives and Senate last week addressed the speed at which medical innovations are approved and available for patient use. The House Energy and Commerce Committee’s “21st Century Cures Act” discussion draft, released on January 27, 2015, is a wide-reaching bill … Continue Reading
The Office of Inspector General (OIG) of the Department of Health and Human Services published a major proposed rule on October 3, 2014 amending the Anti-Kickback Statute (AKS) safe harbors and the Civil Monetary Penalty (CMP) rules to protect a number of payment practices not previously allowed under those regulations. The proposed rule and the … Continue Reading
In a much-anticipated decision, the U.S. Court of Appeals for the District of Columbia Circuit last month affirmed the lower court's ruling in favor of the hospital plaintiffs in Allina Health Services, et al. v. Sebelius (D.C. Cir., No. 13-5011, Apr. ___, 2014). The otherwise good news for providers, however, was called into question by the appellate court's instructions as to the proper remedy in the case.… Continue Reading
On December 11, 2013, CMS released an advance notice of proposed rulemaking soliciting comments on specific practices for which civil monetary penalties may or may not be imposed for failure to comply with Medicare Secondary Payer reporting requirements. Among other issues, CMS is seeking comments and proposals on mechanisms and criteria that it would use to evaluate whether and when it would impose penalties for noncompliance with Medicare Secondary Payer reporting requirements.… Continue Reading
In preparation for data collection to begin under the Physician Payment Sunshine Act Final Rule on August 1, 2013, the Centers for Medicare & Medicaid Services (CMS) released yesterday the list of teaching hospital covered recipients to which payments and other transfers of value must be reported by applicable drug and device manufacturers. The list, … Continue Reading
On March 13, 2013, the Centers for Medicare & Medicaid Services (CMS) concurrently issued CMS Ruling Number CMS-1455-R (the Administrator's Ruling) and a proposed rule, "Part B Inpatient Billing in Hospitals" (the Proposed Rule). The Administrator's Ruling and Proposed Rule address the submission of Medicare Part B inpatient claims where a Medicare Part A claim for a hospital inpatient admission is denied by a Medicare review contractor on the grounds that the inpatient admission was not "reasonable and necessary."… Continue Reading
On February 1, 2013, the Centers for Medicare & Medicaid Services released the long-awaited final rule implementing the physician payment transparency provisions, commonly referred to as the Physician Payment Sunshine Act, in the Obama administration’s 2010 health care reform legislation. The Sunshine Act joins the list of significant federal laws addressing potential conflicts of interest … Continue Reading
On February 1, 2013, the Centers for Medicare & Medicaid Services (CMS) of the Department of Health and Human Services (HHS) released the long-awaited Final Rule to implement the “Sunshine” provisions of the Affordable Care Act of 2010 (ACA). The Sunshine provisions – intended to provide increased transparency on the scope and nature of financial … Continue Reading
A recent case out of a district court in Michigan suggests medical providers may have a new method to obtain payment for bills that were denied by an insurance company - Medicare Secondary Payer Act's (MSP) private enforcement provision. Mich. Spine & Brain Surgeons, PLLC v. State Farm Mut. Auto. Ins. Co., No. 12cv11329, 2013 U.S. Dist. LEXIS 17721, *1 (E.D. Mich. Feb. 11, 2013).
In Michigan Spine, an insured covered by Medicare and State Farm automobile insurance was involved in a severe car accident. Id. at *2. Following the accident, the insured underwent extensive neurosurgery performed by Michigan Spine and Brain Surgeons, PLLC ("Michigan Spine"). Id. at *5. Michigan Spine submitted its charges to State Farm, but Sate Farm refused to cover the individual claiming that her injuries were from preexisting conditions and unrelated to the car accident. Id. at *5-*6. The insured then submitted her claim to Medicare which made a partial payment to Michigan Spine. Id. at *6.… Continue Reading
There seems to be growing awareness that engaging in a "business, trade, or profession," can easily subject any person or entity to what is known as the Medicare secondary payer ("MSP") law--a series of provisions in Title XVIII the Social Security Act, governing the hierarchy of who pays first among applicable insurers. Given its scope and complexity, understanding and complying with the MSP law can be overwhelming. Further, although failure to comply carries obvious risk, conforming to what the law requires may also trigger certain risks of its own.… Continue Reading
President Obama recently signed the Medicare IVIG Access and Strengthening Medicare and Repaying Taxpayers Act (commonly referred to as the SMART Act) to alleviate some of the confusion surrounding the Medicare Secondary Payer Act (MSP), which allows Medicare to seek reimbursement, and potential penalties, from "responsible" parties. These "responsible" parties include tort defendants, such as drug and medical device manufacturers, who become primary payers once they settle or have a judgment awarded against them in a case involving a Medicare beneficiary. The SMART Act will, among other things, introduce a three-year statute of limitations for which the government may bring an action for reimbursement and create a minimum settlement/judgment threshold below which the government will not seek reimbursement.… Continue Reading
This post was written by Matthew R. Sheldon and Alexander Y. Thomas. The Second Circuit Court of Appeals is reviewing a lower court decision disqualifying a former in-house attorney from acting as a False Claims Act qui tam relator against his former employer. The relator was formerly general counsel to Unilab, a subsidiary of Quest … Continue Reading
The Centers for Medicare & Medicaid Services (CMS) has recently updated the information on its website with respect to the Medicare, Medicaid, and SCHIP Extension Act of 2007 (MMSEA), Section 111 "Mandatory Insurer Reporting" requirements. The recent updates cover (1) a revised implementation timeline for certain liability insurance (including self-insurance) total payment obligation to claimant settlements, (2) revised guidance on claims involving exposure, ingestion, and implantation issues, (3) upcoming improvements to the Medicare Secondary Payer (MSP) program, (4) a new exception for certain settlements paid into a qualified settlement fund and (5) a new way for certain injured Medicare beneficiaries to satisfy their past and future MSP obligations.… Continue Reading
Notably absent from last month's Department of Health and Human Services Semiannual Regulatory Agenda was any indication of where the Centers for Medicare and Medicaid Services ("CMS") and the Food and Drug Administration ("FDA") stand with respect to their notice with request for comments, issued last fall, on the proposed parallel review process for medical products. While CMS and FDA officials confirmed that they are currently reviewing comments submitted during the review period, they declined to speculate on when they intend to act. The comments submitted, however, provide insight into industry views on this important issue, including widespread discontent with the approval mechanisms currently available. We have undertaken a review of all of the comments submitted and extracted the eight main concerns cited in the following analysis.… Continue Reading
On July 8, 2011, Centers for Medicare & Medicaid Services (CMS) announced that it had awarded Myers and Stauffer, LC a contract to prepare a monthly survey of retail community pharmacy (“RCP”) prescription drug prices. The contract is in furtherance of CMS’s commitment to develop and publish “Average Acquisition Cost” (“AAC”) data reflecting RCPs’ purchase … Continue Reading
On May 16, 2011, the Office of Inspector General ("OIG") published a report with the results from its nationwide review of the Centers for Medicare and Medicaid Services ("CMS'") oversight of the Health Insurance Portability and Accountability Act of 1996 ("HIPAA"). In its review, the OIG sought to determine the sufficiency of CMS' oversight and enforcement actions pertaining to hospitals' implementation of the HIPAA Security Rule. Pursuant to the Security Rule, covered entities, such as hospitals, must implement technical, physical, and administrative safeguards for the protection of electronic protected health information ("ePHI"). According to the OIG, CMS' oversight and enforcement actions were "not sufficient," leaving limited assurance of the security of hospitals' ePHI.
The report details the results from the OIG's audits of seven hospitals. The audits disclosed "numerous internal control weaknesses." Specifically, the OIG identified 151 vulnerabilities in the systems and controls intended to protect ePHI. Of these vulnerabilities, 124 were categorized as "high impact." These vulnerabilities placed the confidentiality, integrity, and availability of ePHI at risk. The consequences of the high impact vulnerabilities is that it (1) may result in the highly costly loss of major tangible assets or resources; (2) may significantly violate, harm, or impede an organization's mission, reputation, or interest; or (3) may result in human death or serious injury.… Continue Reading
