Category: Daily News

Gordon and Rees reported that effective April 1, the Medicare Secondary Payer Recovery Portal (MSPRP) is equipped to accept electronic payments for Medicare conditional payment reimbursements.

Answers to common inquiries were subsequently released by CMS on April 12, 2019 called “Electronic Payments on the Medicare Secondary Payer Recovery Portal (MSPRP) and Commercial Repayment Center Portal (CRCP) Frequently Asked Questions and Answers.” Such functionality was originally referenced in the Strengthening Medicare and Repaying Taxpayers (SMART) Act of 2012.

In the alert, CMS specifically indicated that to make an electronic payment through the MSPRP, one does not need a new or updated user access. The option is available to any user on any matter to which the user already has access.

Payments are not required to be made through the MSPRP. Payers may continue to remit a paper check to satisfy Medicare conditional payment demands. However, any refund issued by the Medicare recovery contractor will still be made via paper check and will not be made electronically, to date.

In order to make an electronic payment through the MSPRP, the matter to which you wish to apply payment must be in “demand” status. There is no option to remit payment electronically unless the amount has been demanded.

Therefore, if payment is desired to be made on a Conditional Payment Notice instead of a Demand for Reimbursement, a written check still must be mailed to the CRC/BCRC for application to the claim.

Furthermore, CMS clarifies that when paying online, this does not mean that the full demand amount must be paid. If a Redetermination Request has been submitted on a portion of the conditional payments being asserted, a user can still submit a partial electronic payment.

Finally, CMS reported that the electronic payments utilize Pay.gov to secure the transaction, where payments can be made utilizing a savings/check account, debit card, or PayPal linked to a bank account. Credit cards, however, are not being accepted for payment at present. Also, the limit for each payment method is posted, as well.

Once payment has been made. a confirmation of payment will be posted to the MSPRP on the Payment Status page. Additionally, an Electronic Payment History status will list the status of all electronic payments, as well as the amount and payment date.

In summary, the new electronic payment system appears to streamline the payment process significantly, with much quicker application times and updates to the portal.

The U.S. Justice Department has joined a pair of whistleblower lawsuits alleging a drugmaker now owned by Mallinckrodt Plc improperly promoted an expensive multiple sclerosis treatment and paid kickbacks to doctors who prescribed the drug.

Reuters reports that the lawsuits, filed in federal court in Philadelphia, claimed Questcor Pharmaceuticals, which Mallinckrodt acquired in 2014, defrauded government healthcare programs by illegally marketing H.P. Acthar Gel. Last year, Acthar represented 35 percent of Mallinckrodt’s $3.2 billion in net sales.

Mallinckrodt in a statement said it disagrees with the allegations and has been in “advanced settlement talks with the government over the past several months.”

The lawsuits were filed in 2012 and 2013 by former Questcor employees Charles Strunck and Scott Clark under the False Claims Act, which allows whistleblowers to sue companies on the government’s behalf to recover taxpayer money paid out based on fraudulent claims.

The lawsuits are filed under seal so the government can investigate their claims. The Justice Department following an investigation may intervene in the cases, which is typically a major boost for them.

In his complaint, Strunck alleged Questcor in an effort to boost sales paid doctors illegal kickbacks in the form of bribes, speaker fees and consulting deals in exchange for promoting and prescribing Acthar.

His lawsuit also alleged that Questcor’s sales staff used deceptive and misleading marketing tactics to promote Acthar for uses and treatment regimens not approved by the U.S. Food and Drug Administration.

The Justice Department in court filings in both lawsuits made public on March 11 said it was intervening in the cases and planned to file its own complaint within 90 days. The lawsuits were then unsealed.

Mallinckrodt in January 2017 agreed to pay $100 million to resolve claims that Questcor violated antitrust laws by sharply increasing the price of Acthar while ensuring that no rival medicine appeared on the market.

The California Chamber of Commerce has released its annual Job Killer list, which includes 28 bills that would harm California’s economic growth and job creation should they become law. “These bills represent some of the worst policy proposals affecting California employers and our economy currently being considered by Legislature,” said CalChamber President Allan Zaremberg. Of the 28 bills on this list, those of most concern to employers include:

— AB 51 (Gonzalez; D-San Diego) Ban on Arbitration Agreements – Significantly expands employment litigation and increases costs for employers and employees by banning arbitration agreements made as a condition of employment, which is likely preempted under the Federal Arbitration Act and will only delay the resolution of claims.
— AB 628 (Bonta; D-Oakland) Uncapped New Leave of Absence for Employees and Their Family Members – Significantly expands the definition of sexual harassment under the Labor Code, which is different than the definition in the Government Code, leading to inconsistent implementation of anti-harassment policies, confusion, and litigation. Also, provides an unprecedented, uncapped leave of absence for victims of sexual harassment and their “family members” which is broadly defined.
— AB 673 (Carrillo; D-Los Angeles) Unfair Expansion of Penalties Against an Employer for Alleged Wage Violation – Unfairly exposes an employer to being penalized twice for the same violation, by allowing both an employee and the Labor Commissioner to recover the same civil penalties through civil litigation.
— AB 882 (McCarty; D-Sacramento) Limitation on Ability to Maintain a Safe Workplace. Significantly undermines an employer’s ability to maintain a safe, drug-free workplace, by prohibiting an employer from discharging an employee who has tested positive for a drug that is being used for medical purposes.
— AB 1468 (McCarty; D-Sacramento/Gallagher; R-Yuba City) Targeted Tax on Opioids – Unfairly imposes an excise tax on opioid distributors in California, which will increase their costs and force them to adopt measures that include reducing workforce and increasing drug prices for ill patients who need these medications the most, in order to fund drug prevention and rehabilitation programs that will benefit all of California.
— SB 37 (Skinner; D-Berkeley) Staggering Corporate Tax Hike – For certain companies, SB 37 would raise California’s corporate tax rate – already one of the highest in the nation – up to a staggering 22.26%, which amounts to an increase of about 150% and which will undoubtedly discourage companies from locating or further investing in the state.
— SB 135 (Jackson; D-Santa Barbara) Substantial Expansion of California Family Rights Act – Significantly harms small employers in California with as few as 5 employees by requiring these employers to provide 12 weeks of a protected leave of absence each year, in addition to existing leaves of absences already required, as well as potentially requiring larger employers to provide 10 months of protected leave, with the exposure to costly litigation for any alleged violation.
— SB 567 (Caballero; D-Salinas) Expands Costly Presumption of Injury – Significantly increases workers’ compensation costs for public and private hospitals by presuming certain diseases and injuries are caused by the workplace and establishes an extremely concerning precedent for expanding presumptions into the private sector.

CalChamber will periodically release job killer watch updates as legislation changes. Reporters are encouraged to track the current status of the job killer bills

A small group of medical experts quietly advise U.S. health insurers on new drugs. These relatively unknown expert committees have been involved in drug coverage decisions for decades. Their members’ identities are kept secret due to federal regulations aimed at preventing pharmaceutical industry interference.

But, according to Reuters Health, their power has grown more recently with the consolidation of most of the U.S. pharmacy benefits business under OptumRx, CVS and Express Scripts. Taken together, their three advisory committees now guide drug coverage for more than 90 million Americans.

Pharmacy and therapeutics (P&T) committees also hold sway over record numbers of novel and expensive medicines introduced into the U.S. market each year, more often with less evidence of effectiveness or safety than in the past.

New drugs that may fall under their scrutiny in the next year include potentially life-saving therapies for spinal muscular atrophy and Duchenne muscular dystrophy as well as oral treatments for migraine, diabetes and multiple sclerosis.

Their decisions have new consequences as the pharmacy benefits companies they advise are more likely to exclude a new treatment from coverage if it is deemed on par with existing therapies. Or they can demand discounts – or rebates – from drugmakers in exchange for the coverage.

“If the committee says (a treatment) is no better than the existing drug, there is a very decent possibility that it might get a less preferred status or not be included” for reimbursement, said Jack Hoadley, a health policy expert at Georgetown University.

Market and regulatory changes in the last 10 years, as well as the Affordable Care Act, have resulted in significant modifications to health care delivery models. Traditionally, P&T committees limited the impact of their decisions to the populations associated with their hospital or health plan/

However, as hospitals have begun to transform into larger health systems and even integrated payer organizations, P&T committees must consider both inpatient and outpatient needs of patients in multiple hospitals and ambulatory care settings.

The function of the P&T committee has not necessarily changed, but its scope has expanded. Considerations of quality, cost (reimbursement), and access (accreditation) affecting P&T committees over the past decade will become even more important as new drugs and biotech therapies enter the market and the shortage of primary care physicians intensifies.

Pharmacists, physical therapists, nurses, and physicians are assuming new leadership responsibilities, making them partners with P&T committees in improving clinical care and cost performance for health systems.

The Federal Trade Commission sued the health information company Surescripts, alleging that the company employed illegal vertical and horizontal restraints in order to maintain its monopolies over two electronic prescribing, or “e-prescribing,” markets: routing and eligibility.

The FTC’s complaint against Surescripts, filed in federal court on April 17, 2019, is the latest example of the agency’s commitment to stopping anticompetitive tactics in the health care industry that raise the cost of care.

In February, the FTC reached a a global settlement with the pharmaceutical manufacturer Teva Pharmaceuticals Industries Ltd., barring the company from engaging in reverse-payment patent settlement agreements that block consumers’ access to lower-priced generic drugs.

Last month, the Commission barred another pharmaceutical company, Impax Laboratories LLC, from entering into reverse-payment patent settlements after concluding that Impax used this tactic to block consumers’ access to a generic version of the extended-release opioid pain reliever Opana ER.

And in a record court victory for the Commission last year, a federal court ordered another pharmaceutical company, AbbVie Inc., to pay $448 million to consumers who overpaid for testosterone replacement drug Androgel because of AbbVie’s illegal tactics to maintain its monopoly over the drug.

In the complaint filed on April 17, 2019 against Surescripts, the FTC is seeking to undo and prevent Surescripts’s unfair methods of competition, restore competition, and provide monetary redress to consumers.

“For the past decade, Surescripts has used a series of anticompetitive contracts throughout the e-prescribing industry to eliminate competition and keep out competitors,” said Bureau of Competition Director Bruce Hoffman. “Surescripts’s illegal contracts denied customers and, ultimately, patients, the benefits of competition – including lower prices, increased output, thriving innovation, higher quality, and more customer choice. Through this litigation, we hope to eliminate the anticompetitive conduct, open the relevant markets to competition, and redress the harm that Surescripts’s conduct has caused.”

E-prescribing provides a safer, more accurate, and lower-cost means to communicate and process patient prescriptions than traditional paper prescribing. According to the complaint, Surescripts monopolized two separate markets for e-prescription services:

— The market for routing e-prescriptions, which uses technology that enables health care providers to send electronic prescriptions directly to pharmacies;
— The market for determining eligibility, a separate service that enables health care providers to electronically determine patients’ eligibility for prescription coverage through access to insurance coverage and benefits information, usually through a pharmacy benefit manager.

The FTC alleges that Surescripts intentionally set out to keep e-prescription routing and eligibility customers on both sides of each market from using additional platforms (a practice known as multihoming) using anticompetitive exclusivity agreements, threats, and other exclusionary tactics. Among other things, the FTC alleges that Surescripts took steps to increase the costs of routing and eligibility multihoming through loyalty and exclusivity contracts.

According to the FTC’s complaint, Surescripts successfully used these tactics to stop multiple attempts by other companies to enhance competition in the routing and eligibility markets. According to the FTC’s complaint, Surescripts’s anticompetitive tactics thwarted competitors from gaining share in the routing and eligibility markets, enabling the company to maintain at least a 95 percent share in each market over many years. The complaint alleges that Surescripts succeeded in maintaining its monopolies in routing and eligibility, despite the explosive growth of routing and eligibility transactions – from nearly 70 million routing transactions in 2008 to more than 1.7 billion in 2017.