On April 30, 2019, the Criminal Division of the U.S. Department of Justice (“DOJ”) released a new corporate compliance guidance document for prosecutors titled “Evaluation of Corporate Compliance Programs” (“Guidance”). The Guidance sheds light on how the DOJ evaluates the effectiveness of a company’s compliance program – whether white collar- or antitrust-oriented – focusing on the program’s design, implementation and practical application. Notably, this Guidance applies to the entire Criminal Division as opposed to only the Fraud Section, to which the prior 2017 guidance applied. In fact, the head of the DOJ’s criminal division, Assistant Attorney General Brian Benczkowski, in a speech at the 2019 Ethics and Compliance Initiative Conference, explained that one of the purposes of the Guidance is to “better harmonize the prior Fraud Section publication with other Department guidance and legal standards.”
Below is this week’s “Capitol Hill Healthcare Update,” which is posted on Mondays when Congress is in session. Note that because Congress will be in recess for the Memorial Day holiday, the next “Capitol Hill Healthcare Update” will be posted on June 3.
LAWMAKERS QUESTION DEMOCRATS’ STRATEGY ON DRUG PRICING
House Democrats last week combined bipartisan bills designed to lower drug prices with controversial legislation related to the Affordable Care Act, prompting Democratic and Republican lawmakers to question whether party leaders are committed to bipartisan solutions to control drug costs.
By combining the two issues in one bill, the legislation won House approval but on a near-party line vote. Republicans accused Democrats of being more interested in politics than consensus on lowering drug prices.
Here is this week’s “Capitol Hill Healthcare Update,” which is posted on Mondays when Congress is in session
HOUSE TO VOTE ON BILL COMBINING ACA, DRUG PRICING PROVISIONS
The House is scheduled to vote on legislation Thursday that would package new funding for state-based marketplaces and enrollment outreach efforts under the Affordable Care Act (ACA), with provisions designed to lower prescription drug prices.
Some of the drug pricing provisions enjoyed bipartisan support when considered earlier this year in the Energy and Commerce Committee and the Judiciary Committee. But House Republicans aren’t expected to support the overall bill because of the ACA funding and provisions that would roll back the Trump administration’s plan to lower insurance premiums for healthier Americans, which Democrats have derided as “junk” insurance plans.
Here is this week’s “Capitol Hill Healthcare Update,” which is posted on Mondays when Congress is in session.
DRUG PRICES: CONGRESS RETURNS, PICKS UP WHERE LAWMAKERS LEFT OFF
Congress reconvenes today after a two-week spring recess, with lawmakers in both parties continuing their focus on prescription drug prices.
House and Senate committees are planning a series of hearings and votes on drug pricing legislation, beginning Tuesday and going through at least June. The issue is also on the agenda at a White House meeting Tuesday with House Speaker Nancy Pelosi, D-Calif., Senate Minority Leader Chuck Schumer, D-N.Y., and President Donald Trump.
Senate Finance Committee Chairman Chuck Grassley, R-Iowa, said he’s working with the panel’s top Democrat, Sen. Ron Wyden, D-Ore., on bipartisan drug pricing legislation that he hopes to introduce by mid-June.
Senate HELP Committee Chairman Lamar Alexander, R-Tenn., saidhis committee will take action this summer on a series of bills designed to reduce healthcare costs. Alexander said he favors extending the Trump administration’s proposed regulation requiring negotiated rebates in Medicare Part D plans to be extended to commercial plans. The senator said he hoped to approve several measures that are under his committee’s jurisdiction this summer, combine them with legislation approved by Grassley’s committee and have the package ready for consideration by the full Senate.
In the House, Majority Leader Steny Hoyer, D-Md., said votes on drug pricing bills could be scheduled for next month. Those bills – already approved by the Ways and Means Committee and the Energy and Commerce Committee – include requiring drug manufacturers to publicly justify price increases and launch prices, requiring HHS to disclose rebates negotiated by pharmacy benefits managers and ending “pay-for-delay” patent settlements that critics say block generic competition.
While those bills are mostly bipartisan and in some cases noncontroversial, House Democrats have introduced more sweeping proposals to lower drug prices, such as permitting HHS to negotiate with manufacturers over prices and using the threat of invalidating manufacturers’ patents to force price concessions.
On Feb. 11, 2019, two Department of Health and Human Services (HHS) agencies, the Office of the National Coordinator for Health Information Technology (ONC) and the Centers for Medicare and Medicaid Services (CMS), released their long-awaited proposed rules designed to further HHS’ goal of promoting electronic health information interoperability and implementing many of the provisions mandated under the 21st Century Cures Act (Cures Act). Notably, these proposed rules were released shortly before the HHS Office for Civil Rights deadline for comments about potential changes to improve coordinated care. Taken together, recent HHS rulemakings suggest that interoperability is coming, and significant requirements are in store for providers, payors, health information technology developers and players.
The Cures Act charged ONC with the responsibility of implementing many of the provisions designed to advance interoperability, including the provisions addressing information blocking and certification requirements for health information technology (health IT) developers. The ONC rule also contains widespread revisions to the agency’s Health IT Certification Program and the 2015 edition certification criteria to further support access to, exchange of and use of electronic health information. Continue Reading
On March 6, 2019, the U.S. Department of Justice (DOJ) announced that Linda Sue Kalina pled guilty to wrongfully disclosing the protected health information (PHI) of another individual in violation of the Health Insurance Portability and Accountability Act of 1996 (HIPAA). Kalina was a patient information coordinator with the University of Pittsburgh Medical Center (UPMC) and its affiliate, Tri Rivers Musculoskeletal Centers (TRMC). From March 7, 2016, through June 23, 2017, Kalina improperly accessed the health information of 111 UPMC patients who had never been provided services at TRMC. In her capacity as a patient information coordinator, Kalina was authorized to access patient information contained in UPMC’s electronic medical record system as necessary to provide services to patients. Among others, Kalina accessed and disclosed the health information involving two individuals who worked at Kalina’s former employer. Read more >>
Recently, in Dantry v. Unemployment Compensation Board of Review, No. 1665 C.D. 2017 (Pa. Cmwlth. 2019), the Commonwealth Court of Pennsylvania reversed the order of the Unemployment Compensation Board of Review (Board) which had affirmed the Unemployment Compensation Referee’s decision that Jami M. Dantry (Dantry) was ineligible for unemployment compensation benefits because Dantry’ s conduct rose to the level of willful misconduct based on a violation of the Health Insurance Portability and Accountability Act of 1996 (HIPAA), the Family Educational Rights and Privacy Act (FERPA), and for insubordination. The Commonwealth Court of Pennsylvania remanded the matter to the Board for the issuance of a decision determining whether Dantry’s alleged insubordination constituted willful misconduct.
Senate Democrats recently introduced the Stop Price Gouging Act (S. 378), which seeks to place an excise tax on pharmaceutical companies in proportion to price spikes on prescription drugs.
The bill generally requires a company to justify to the Department of Health and Human Services (DHHS) any spike in prescription drug prices, but it is short on details regarding the criteria the inspector general of DHHS would have to abide by when analyzing the spike.
Private equity (PE) investors entered the physician practice management (PPM) market in 2011, and eight years later the PPM sector continues to be a ripe middle market for PE investors looking to diversify their portfolios. However, as the healthcare market continues to change in light of increasing vertical integration between payors and providers and disruption caused by new players such as Amazon, changes may be on the horizon for PE investment in the PPM space. Read more >>
Smart speakers are voice-activated, internet-connected devices with an integrated virtual assistant that can answer questions, follow instructions and control other smart devices. Nearly one in five U.S. adults has access to a smart speaker, and it has been estimated that in 2018, the number of smart speakers installed reached 100 million worldwide. Using voice recognition, a smart speaker’s virtual assistant can understand what is being said and act upon it. Once the system is activated, it records what is being said and sends it over the internet to the main processing service, which deciphers the speech and sends a response back to the smart speaker. Smart speakers can control other smart devices upon verbal command and perform tasks such as controlling music, lights, television and home security systems, as well as playing audible books.