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D.C. Week: Congress Passes Spending Bill

D.C. Week: Congress Passes Spending Bill

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WASHINGTON — Just before dawn on Friday, Congress passed another short-term spending bill that addresses several significant healthcare issues, such as the opioid crisis and keeping community health centers running, and it keeps the government open until late March.

Congress Passes Short-Term Spending Bill

Congress passed a stopgap spending bill early Friday that included 10 years of funding for the Children’s Health Insurance Program (CHIP) and $7.8 billion for community health centers (CHCs), and permanently removed a cap on Medicare outpatient therapy payments.

The measure passed by a vote of 71-28 in the Senate and 240-186 in the House; President Trump has signed it.

The bill, which will keep the government open through March 23, also includes funding for assisting victims of national disaster in Puerto Rico and the U.S. Virgin Islands, and it repeals the Independent Payment Advisory Board (IPAB), an unpopular feature of the Affordable Care Act. It also extends CHIP for 10 years, up from the 6-year extension the program received in the previous short-term spending bill.

The CHIP extension is “just remarkable providing unprecedented security and certainty for the families that depend on CHIP, and the state governments that need more predictability to map out their own expenditures,” said Sen. Orrin Hatch (R-Utah).

Top Democrat Blasts GOP on Healthcare

Saying congressional Republicans have made “concerted efforts” to be “deeply disruptive” towards American healthcare, House Minority Whip Steny Hoyer (D-Md.) ripped GOP leadership during a speech here Tuesday.

Lawmakers from both parties need to “reach across the aisle” to address healthcare, he declared.

Hoyer, the second-ranking Democrat in the House since 2011 and House Majority Leader from 2007-2011, spoke at the AcademyHealth National Health Policy Conference for 20 minutes in a hastily-scheduled session that organizers had squeezed into the program only the day before. He rarely looked down at his notes as he addressed a packed hotel ballroom, seeming less like a politician and more like a man who had something to get off his chest.

“What America’s healthcare system needs is stability,” Hoyer said, hammering on staple Democratic themes regarding Republican efforts to undermine the Affordable Care Act and the “dangerous instability” that has resulted.

More Help Needed With Opioid Crisis, Senators Told

Congress has made strides in helping battle the opioid abuse epidemic, but much more needs to be done, witnesses told a Senate committee on Thursday.

“The opioid epidemic is taking a terrible toll on pregnant women and infants,” Stephen Patrick MD, MPH, a neonatologist at Vanderbilt University, in Nashville, Tenn., said at a Senate Health, Education, Labor, & Pensions (HELP) Committee hearing on the effect of the opioid crisis on children and families. “Every day, people are dying. Pregnant women are not getting the treatment they need and infants are spending their first few weeks in withdrawal … These are our brothers and sisters and they need our help.”

Legislation passed by Congress, including the Comprehensive Addiction and Recovery Act, the 21st Century Cures Act, and the Protecting Our Infants Act “moved forward important public health priorities but would benefit from additional [reinforcement],” Patrick said. For example, “The Protecting our Infants Act resulted in a comprehensive strategy document from SAMHSA [the Substance Abuse and Mental Health Services Administration], but as [SAMHSA] notes, implementation is dependent on funding.”

Pressure Rises for Right-to-Try Bill

Earlier this week, two Republican congressmen sent a letter to House Speaker Paul Ryan (R-Wis.) and Majority Leader Kevin McCarthy (R-Calif.) urging them to bring a “right-to-try” bill to a vote in the House as soon as possible.

The bill, called the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act, passed in the Senate last August.

It would allow individuals with life-threatening illnesses to obtain experimental drugs prior to FDA approval. However, the law does not require drug companies to make their products available, and the FDA already has a pathway to allow such access. Industry in general has not sought changes to that pathway. Nevertheless, some in Congress are unsatisfied with the FDA’s policies and implementation and are seeking to loosen the reins.

“The fundamental purpose of the Right to Try Act is very simple: it merely allows terminally ill patients who have exhausted all other options to try medications that have passed basic Food and Drug Administration safety protocols but not completed the full, multi-year approval process. This bill safeguards any pharmaceutical company that may wish to participate in Right to Try, but it in no way requires participation to begin with,” wrote Reps. Andy Biggs (R-Ariz.) and Brian Fitzpatrick (R-Pa.) in a letter signed by 40 other members and sent to House leadership on Monday.

New 3-Drug Combo for HIV OK’d

A new three-drug combination pill for HIV-1 infection won FDA approval late Wednesday, said manufacturer Gilead Sciences.

To be sold as Biktarvy, the product includes the integrase inhibitor bictegravir and two reverse transcriptase inhibitors, emtricitabine and tenofovir alafenamide. It is approved for once-daily oral administration, with no food intake requirement, baseline viral load, or CD4+ cell count restrictions, Gilead said.

The drug combination was tested in numerous clinical trials. Last July, for example, investigators reported on two phase III studies in which the product was given as first-line therapy, achieving undetectable viral loads in 90% of patients. Those studies also suggested that resistance to the combination would be slow to develop.

Next Week

On Monday, President Trump is expected to release his FY 2019 budget proposal.

On Wednesday and Thursday, the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee will meet to discuss Exparel (bupivacaine liposomal injectable suspension) for “local analgesia and as a nerve block to produce regional analgesia.”

And on Wednesday only, the same committee and the FDA’s Drug Safety and Risk Management Advisory Committee will assess Hydexor, a fixed-dose combination oral tablet, “that contains hydrocodone, acetaminophen, and promethazine,” for treating severe, short-term acute pain.

Also on Wednesday, a subcommittee on Oversight and investigations for the House Committee on Energy and Commerce will evaluate the impact of healthcare consolidation

On Thursday, a health subcommittee for House Committee on Energy & Commerce will explore the oversight of the Department of Health and Human Services.


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