Proposed Stark Law Revisions Expected Soon
June 28, 2019 | Eric D. Fader | Fraud and Abuse | Legislation and Public Policy | Medicare and Medicaid
The Centers for Medicare & Medicaid Services (CMS) expects to release proposed revisions to the federal physician self-referral prohibition (Stark Law) before Labor Day, according to Kim Brandt, CMS’s principal deputy administrator for operations. Brandt was speaking at an industry conference. Potential Stark Law changes were recently discussed here. CMS had requested input from the …
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NY AG Enforces Pharmacy Drug Price Disclosure Law
June 26, 2019 | Eric D. Fader | Legislation and Public Policy | Pharmaceuticals
New York State Attorney General Letitia James announced on June 13 that her office had sent cease-and-desist letters to 44 pharmacies that violated the law requiring them to maintain drug retail price lists. State law requires each pharmacy to maintain a list of prices for the 150 most commonly prescribed drugs, update the list at …
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FDA in Fact-Finding Mode on CBD
June 20, 2019 | Eric D. Fader | Cannabis | FDA | Legislation and Public Policy | Pharmaceuticals
The U.S. Food and Drug Administration (FDA) released a Consumer Update regarding cannabidiol (CBD) on June 14. Observing that CBD “seems to be available almost everywhere,” the FDA noted that the science, safety, and quality of CBD-containing products are unproven and said that it is working to learn more about the safety of CBD. Unapproved …
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Physician Jailed for Prescribing Drugs to Non-Patients
June 18, 2019 | Margarita Christoforou | Fraud and Abuse | Litigation | Pharmaceuticals
A physician who operated weight-loss clinics in Georgia is facing 33 months in prison after pleading guilty to Conspiracy to Unlawfully Dispense Controlled Substances (Oxycodone), according to a June 13 press release issued by the U.S. Department of Justice. Dr. Johnny Di Blasi was arrested at Miami International Airport as he was attempting to flee …
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Pharma Companies Sue to Block Drug Price Disclosure Rule
June 17, 2019 | Eric D. Fader | Legislation and Public Policy | Medicare and Medicaid | Pharmaceuticals
Three of the largest pharmaceutical companies in the U.S. filed suit on June 14 against the U.S. Department of Health and Human Services (HHS), claiming that HHS doesn’t have the power to compel companies to include list prices of prescription drugs in television advertisements. HHS’s new rule is set to take effect on July 9. …
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Insys Settles Kickback Case, Files for Bankruptcy
June 12, 2019 | Eric D. Fader | False Claims Act | Fraud and Abuse | Litigation | Pharmaceuticals
The U.S. Department of Justice announced on June 5 that Arizona-based opioid manufacturer Insys Therapeutics agreed to pay $225 million to settle civil and criminal kickback charges. Last month, Insys’s founder and former CEO John Kapoor was found guilty on federal racketeering charges arising out of a bribery scheme that rewarded the company’s sales managers …
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CMS Issues RFI to Reduce Paperwork
June 11, 2019 | Cassandra Rivais DiNova | Electronic Health Records | Legislation and Public Policy | Medicare and Medicaid
On June 6, the Center for Medicare & Medicaid Services (CMS) issued a Request for Information (RFI) regarding its Patients over Paperwork Initiative. CMS is seeking public input on ways to reduce administrative and regulatory burdens on healthcare providers, with an overall goal of reducing healthcare costs and increasing the time providers spend with their …
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Medical Practitioners Call for Change to Massachusetts Marijuana Regulations
June 10, 2019 | Mark J. Wagner Jr. | Cannabis | Hospitals | Legislation and Public Policy
More than 40 physicians, clinicians and researchers from Harvard Medical School, Massachusetts General Hospital and other institutions issued a 16-page Statement of Concern to Massachusetts lawmakers requesting that the Commonwealth’s Cannabis Control Commission suspend processing new business licenses and conduct a public health assessment of its “Social Equity Program.” These practitioners are criticizing the inadequacy …
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Supreme Court Sides with Hospitals on Change in Medicare DSH Payments
June 6, 2019 | Margarita Christoforou | Hospitals | Legislation and Public Policy | Litigation | Medicare and Medicaid
In a 7-1 decision, the U.S. Supreme Court ruled on June 3 that the Department of Health and Human Services (HHS) may not adjust the rates it pays hospitals for serving low-income patients without first giving them an opportunity to comment on the changes. The Medicare Act requires public notice and a 60-day comment period …
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CMS Issues Final Rule to Improve PACE Program for Frail and Elderly
June 5, 2019 | Ada Kozicz | Employer/Employee | Home Health | Legislation and Public Policy | Medicare and Medicaid | Pharmaceuticals
On May 28, the Centers for Medicare and Medicaid Services (CMS) issued a final rule to improve and modernize the Programs of All-Inclusive Care for the Elderly (PACE). The rule is the first major change to the program since 2006. CMS expects that the changes will help incorporate current best practices in the care rendered …
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