Medicare Sets Pricing Plan For Biotech Copycat Drugs
In other regulatory news, Medicare continues its scrutiny of short hospital stays, new patient protections for transgender people are imminent, the FDA considers further regulation of HIV drugs and a battle continues over a federal drug discount program.
CQ Healthbeat:
Medicare Rebuffs Pricing Complaints For Copycat Biotech Drugs
Medicare officials last week finalized what they call a competitive pricing plan for a new wave of copycat versions of expensive biotech drugs, rebuffing arguments from pharmaceutical firms and lawmakers who sought unique payments for each individual treatment. The Centers for Medicare and Medicaid Services on Oct. 30 released the final version of its payment rule for treatments provided in doctors' offices, which includes a plan to lump all copycat versions of biotech drugs into a group for setting reimbursement rates, which are based on average sale prices. These medicines are often given by needle in doctors offices, and thus their reimbursement is covered through the physician fee rule. (Young, 11/2)
CQ Healthbeat:
Hospitals Win Relief From 'Bounty Hunters' In Medicare Rule
Contractors hired by the government to review Medicare claims have been largely sidelined in a battle over how the big health program pays for short hospital stays, an area in which Medicare may overspend as much as $3.3 billion a year. The Centers for Medicare and Medicaid Services revised its approach to monitoring short-stay reimbursement through the final version of its payment rule for hospital outpatient services. At issue are treatments for people who are not expected to spend more than a night, if that long, inside hospitals. Medicare pays a higher rate for so-called inpatient services, and has been trying to get hospitals to stop seeking this reimbursement for shorter stays. (Young, 11/2)
Marketplace:
New Protections For Transgender Patients Are Coming
The U.S. Department of Health and Human Services is finalizing specific provisions of a rule under the Affordable Care Act that broadens civil rights protection. This is the first federal law to prohibit discrimination on the basis of sex in healthcare, which means hospitals, nursing homes, health insurers and doctors are barred from discriminating against transgender Americans — as well as others based on sex. (Gorenstein, 11/2)
The Hill:
FDA Issues Guidelines For HIV Drugs
The Food and Drug Administration (FDA) is looking to assert more control over HIV drug manufacturers. Pharmaceutical companies are now facing new guidelines for developing drugs to treat Human Immunodeficiency Virus, which causes AIDS. (Devaney, 11/2)
CQ Healthbeat:
340B Fight Centers on Prescriptions Outside Hospitals
Heated battles about a federal discount drug program center on when the so-called 340B benefit can be applied to treatments for patients whose care is ordered or delivered by providers outside of hospitals. Hospitals are protesting draft federal restrictions that would end their savings for cancer treatments and other drugs administered in their facilities through the slow infusion process when these medicines are prescribed by doctors that aren't affiliated with the hospitals. Pending 340B guidelines also would halt a practice of providing discounted or free drugs through discharge prescriptions, which people fill at local pharmacies to use at home. (Young, 11/2)